RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States), Priority Review (China)

Structure/Sequence

Sequence Code 156629

Source: *****

Clinical Trials associated with Sotatercept

NCT07600723

/ Not yet recruitingPhase 4

A Phase 4, Prospective, Open-label, Single-Arm Study to Evaluate the Safety of Sotatercept in Adults With Pulmonary Arterial Hypertension (PAH) in India

Researchers are looking for other ways to treat people in India with pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH). In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. This causes high blood pressure in the lungs and can overwork the heart. PAH can make it hard to breathe and be active.
Researchers want to learn if sotatercept, the study medicine, can be given with standard treatment to help treat PAH. The standard treatment (the usual treatment) for PAH includes one or multiple medicines. However, these may not fully work or treat the symptoms of PAH in some people.
The goal of this study is to learn about the safety and tolerability of sotatercept when it is given with standard treatment to people in India.

Start Date04 Nov 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT07498803

/ Not yet recruitingPhase 2IIT

Sota-ES - A Prospective, Non-randomized, Open-label, Multi-center Study of the Activin Signaling Inhibitor Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome

The present study seeks to provide pilot data on the safety and efficacy of medical therapy with sotatercept in patients with an established diagnosis of congenital heart disease and Eisenmenger syndrome.
CHASE is an interventional, single-arm, open-label study, that will enroll 40 patients with an established diagnosis of CHD and Eisenmenger syndrome. PAH background therapy may be present at the discretion of the investigators at the time of enrolment. CHASE will be performed only in countries where standard PAH therapies are available and reimbursed. At the end of the 24-week patient period, PAH treatment is left to the investigator's discretion.

Start Date01 Sep 2026

Sponsor / Collaborator

Philipps University of Marburg

NCT07646860

/ Not yet recruitingPhase 2

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.

The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.

Start Date31 Aug 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Sotatercept

100 Translational Medicine associated with Sotatercept

100 Patents (Medical) associated with Sotatercept

250

Literatures (Medical) associated with Sotatercept

01 Oct 2026·SEMINARS IN ONCOLOGY

A systematic scoping review of cancer-related anemia treatment: Comparative trial outcomes, current guidelines, and future perspectives

Review

Author: Elkhalifa, Dana H ; Lub-de Hooge, Marjolijn N ; Jansman, Frank G A

INTRODUCTION:

Cancer-related anemia (CRA) adversely affects quality of life and clinical outcomes. Despite extensive research, uncertainty remains regarding the optimal use of erythropoiesis-stimulating agents (ESAs), iron, and transfusions. This scoping review synthesizes efficacy and safety evidence and compares international management guidelines.

METHODS:

A systematic search of PubMed and Embase identified English-language studies on CRA published from 2000 up to November 30, 2024. Randomized controlled trials were reviewed to assess treatment efficacy and safety, and international guidelines were analyzed to compare management recommendations.

RESULTS:

Fifty-six randomized controlled trials and 10 international guidelines were included. ESAs and iron supplementation were effective in improving hemoglobin concentration and reducing transfusion requirements, particularly in context-dependent settings. Combination therapy with ESAs and iron consistently demonstrated superior hematologic responses compared with ESA monotherapy without additional safety concerns. Both conventional and newer intravenous (IV) and oral iron formulations showed benefit across different clinical contexts, with faster responses generally favoring IV iron in some settings, while emerging evidence supports oral iron as a viable alternative in absolute iron deficiency. Emerging therapies, including sotatercept and selected adjunctive approaches, showed preliminary signals of efficacy in limited studies, warranting further investigation. Guidelines generally restrict ESAs to chemotherapy-induced anemia or high-risk patients. For iron therapy, discrepancies exist regarding indications and administration route; most guidelines prioritize IV over oral iron for both functional iron deficiency and absolute iron deficiency. Significant regional gaps in guideline availability were identified, particularly in Africa, South America, Asia-Pacific, and the Middle East.

CONCLUSION:

CRA management relies on ESAs, iron supplementation, and transfusions, but guideline heterogeneity and regional discrepancies necessitate harmonization and individualized approaches. Updated, globally representative recommendations and further research in under-studied populations are essential.

01 Aug 2026·JHLT open

Sotatercept treatment in a patient with end-stage bronchiolitis obliterans syndrome after lung transplantation

Article

Author: Li, Chang ; Saini, Shyla ; Eisenberg, Elliot ; Hannah-Clark, Simone ; Powell, Charles ; Vallabhajosyula, Saarwaani ; Poor, Hooman D ; Wang, Jing ; Scheinin, Scott ; Seethamraju, Harish ; Zhang, Jimmy

Bronchiolitis obliterans syndrome (BOS), the most common form of chronic lung allograft dysfunction after lung transplantation, is characterized by progressive small airway disease (SAD) and is associated with poor outcomes and limited therapeutic options. Sotatercept, an activin-signaling inhibitor approved for pulmonary arterial hypertension, has been associated with improvements in physiologic markers of SAD in patients with pulmonary hypertension. In this report, we describe a 55-year-old woman with primary ciliary dyskinesia status post bilateral lung transplantation who developed stage 3 BOS complicated by hypercapnic respiratory failure requiring mechanical ventilation. Following initiation of off-label sotatercept, she experienced rapid clinical and radiologic improvement, permitting transient liberation from mechanical ventilation before succumbing to progressive respiratory failure. Further study is required to assess the potential role for activin pathway modulation in advanced BOS.

01 Jul 2026·European Journal of Internal Medicine

Sotatercept for pulmonary arterial hypertension

Letter

Author: Elgendy, Islam Y ; Abuzaid, Ahmed Sami ; Badran, Ahmed Samy ; Elbahloul, Mohammed A

247

News (Medical) associated with Sotatercept

04 Aug 2026

·www.businesswire.com

Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2026 Financial Results; Highlights Key Regulatory and Clinical Milestones Across Broad, Diverse Pipeline

Total Worldwide Sales Were $16.6 Billion (5% Growth; 4% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.4 Billion (5% Growth; 4% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $463 Million WINREVAIR Sales Were $588 Million (75% Growth; 75% Growth ex-FX) Animal Health Sales Were $1.8 Billion (8% Growth; 5% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.4 Billion (5% Growth; 4% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $463 Million WINREVAIR Sales Were $588 Million (75% Growth; 75% Growth ex-FX) Animal Health Sales Were $1.8 Billion (8% Growth; 5% Growth ex-FX) GAAP Loss per Share Was $0.54; Non-GAAP Loss per Share Was $0.13; GAAP and Non-GAAP Loss per Share Include a Charge of $2.31 per Share for the Acquisition of Terns Received U.S. FDA Approval for LIPFENDRA (enlicitide), the First and Only Once-Daily Oral PCSK9 Inhibitor To Reduce LDL-C in Adults With Hypercholesterolemia Announced Positive Data From TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (sac-TMT) in Certain Patients With Advanced or Recurrent Endometrial Cancer Announced Positive Phase 3 Results From Once-Weekly Investigational Oral HIV Treatment Regimen of Islatravir and Lenacapavir, in Collaboration With Gilead Narrows and Raises Expected Worldwide Sales Range To Be Between $66.3 Billion and $67.3 Billion Now Expects Non-GAAP EPS To Be Between $2.66 and $2.76; Outlook Includes Charges of $2.43 per Share for the Acquisition of Terns, Comprised of a One-Time Charge of $2.31 per Share as Well as Costs of Approximately $0.12 per Share To Finance the Acquisition and Advance MK-4208 (Formerly TERN-701) RAHWAY, N.J.--(BUSINESS WIRE)--Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2026. “We continued to make substantial progress across our business this quarter, driven by strong execution and growing contributions from new product launches,” said Robert M. Davis, chairman and chief executive officer. “The FDA approval of LIPFENDRA is an exciting moment for our company and for patients, marking the latest milestone in our nearly 70-year legacy in cardiovascular disease. Together with key regulatory and clinical advances across oncology, HIV and immunology, this achievement reflects the strength of our pipeline and portfolio transformation as we bring forward the next wave of innovation. I am confident in the ongoing execution of our strategy as we deliver for patients and further enhance our long-term growth trajectory.” Financial Summary $ in millions, except EPS amounts Second Quarter 2026 2025 Change Change Ex- Exchange Sales $16,607 $15,806 5% 4% GAAP net (loss) income2 (1,335) 4,427 N/M N/M Non-GAAP net (loss) income that excludes certain items2,3* (330) 5,366 N/M N/M GAAP EPS (0.54) 1.76 N/M N/M Non-GAAP EPS that excludes certain items3* (0.13) 2.13 N/M N/M *Refer to table on page 7. N/M - Not meaningful For the second quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $0.54 and non-GAAP loss per share was $0.13. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Terns Pharmaceuticals, Inc. (Terns) of $2.31 per share. Both GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment related to a license agreement with Jiangsu Hengrui Pharmaceutical Co., Ltd. (Hengrui Pharma). Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as income and losses from investments in equity securities. Non-GAAP EPS in the second quarter of 2025 also excludes tax benefits primarily resulting from favorable audit reserve adjustments. Year-to-date results can be found in the attached tables. Second-Quarter Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers. Second Quarter $ in millions 2026 2025 Change Change Ex-Exchange Commentary Total Sales $16,607 $15,806 5% 4% Pharmaceutical 14,760 14,050 5% 4% Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in diabetes. KEYTRUDA/ KEYTRUDA QLEX 8,366 7,956 5% 4% Growth primarily driven by strong global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), cervical cancer, head and neck cancer and bladder cancer, as well as higher global demand in metastatic indications, including urothelial cancer. Sales of KEYTRUDA QLEX were $463 million. GARDASIL/ GARDASIL 9 1,169 1,126 4% 3% Increase primarily due to higher demand in Asia Pacific and Europe, as well as favorable timing of tenders in Europe, partially offset by lower demand in certain other international markets. PROQUAD, M-M-R II and VARIVAX 592 609 -3% -3% Decrease primarily reflects lower demand in the U.S., partially offset by higher net pricing in the U.S., higher demand in Europe and favorable private-sector purchasing patterns for M-M-R II in the U.S. WINREVAIR 588 336 75% 75% Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe. BRIDION 497 461 8% 8% Growth primarily due to higher demand and net pricing in the U.S. JANUVIA/JANUMET 429 623 -31% -31% Decline primarily due to lower demand and net pricing in the U.S. due to competition, as well as lower demand in China and most other international markets due to ongoing generic competition. Lynparza* 365 370 -1% -2% Relatively flat compared with prior year. PREVYMIS 295 228 29% 28% Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications. Lenvima* 283 265 7% 6% Growth primarily due to higher demand in the U.S., partially offset by lower net pricing. WELIREG 271 162 67% 67% Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan, as well as favorable wholesaler purchasing patterns in the U.S. OHTUVAYRE 204 - - - Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc. Includes a benefit from the timing of specialty pharmacy purchases in the U.S. CAPVAXIVE 184 129 42% 40% Increase primarily driven by launch uptake in several international markets, particularly in Asia Pacific and Europe, as well as in the U.S. VAXNEUVANCE 148 229 -35% -36% Decline primarily due to favorable prior period public-sector activity in the U.S., which increased sales in that period, as well as lower demand in the U.S. and in most international markets in the current period due to competitive pressure. LAGEVRIO 5 83 -95% -95% Decline largely due to lower demand in Japan and the U.S. Animal Health 1,775 1,646 8% 5% Growth attributable to both Livestock and Companion Animal product portfolios. Livestock 1,041 961 8% 6% Growth primarily driven by higher demand for ruminant and poultry products. Companion Animal 734 685 7% 5% Growth primarily due to new product launches. Sales of BRAVECTO line of products were $359 million and $335 million in the current and prior-year quarters, respectively, which represents an increase of 7%, or 4% excluding impact of foreign exchange. Other Revenues** 72 110 -35% -34% Decline primarily due to lower revenue from third-party manufacturing arrangements. *Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Second-Quarter Expense and Related Information The table below presents selected expense information. $ in millions GAAP Acquisition- and Divestiture- Related Costs4 Restructuring Costs (Income) Loss From Investments in Equity Securities Non- GAAP3 Second Quarter 2026 Cost of sales $4,395 $1,067 $184 $- $3,144 Selling, general and administrative 2,904 17 - - 2,887 Research and development 9,741 6 (1) - 9,736 Restructuring costs 151 - 151 - - Other (income) expense, net 99 - - (191) 290 Second Quarter 2025 Cost of sales $3,557 $576 $165 $- $2,816 Selling, general and administrative 2,649 15 1 - 2,633 Research and development 4,048 3 53 - 3,992 Restructuring costs 560 - 560 - - Other (income) expense, net (7) - - (61) 54 GAAP Expense, EPS and Related Information Gross margin was 73.5% for the second quarter of 2026 compared with 77.5% for the second quarter of 2025. The decrease was primarily due to higher amortization of intangible assets and inventory write-downs. Selling, general and administrative (SG&A) expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches. Research and development (R&D) expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone Life Sciences (Blackstone). R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma. Other (income) expense, net, was $99 million of expense in the second quarter of 2026 compared with $7 million of income in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities. The income tax provision for the second quarter of 2026 was $654 million on a pretax loss of $683 million, resulting in an effective income tax rate of (95.9)%. This effective income tax rate includes a 108.9 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded. GAAP loss per share was $0.54 for the second quarter of 2026 compared with earnings per share of $1.76 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 81.1% for the second quarter of 2026 compared with 82.2% for the second quarter of 2025. The decrease was primarily due to higher inventory write-downs. Non-GAAP SG&A expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches. Non-GAAP R&D expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone. R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma. Non-GAAP other (income) expense, net, was $290 million of expense in the second quarter of 2026 compared with $54 million of expense in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense. The non-GAAP income tax provision for the second quarter of 2026 was $882 million on pretax income of $550 million, resulting in a non-GAAP effective income tax rate of 160.3%. This effective income tax rate includes a 146.2 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded. Non-GAAP loss per share was $0.13 for the second quarter of 2026 compared with earnings per share of $2.13 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma. A reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows. Second Quarter $ in millions, except EPS amounts 2026 2025 EPS GAAP EPS $(0.54) $1.76 Difference 0.41 0.37 Non-GAAP EPS that excludes items listed below3 $(0.13) $2.13 Net (Loss) Income GAAP net (loss) income2 $(1,335) $4,427 Difference 1,005 939 Non-GAAP net (loss) income that excludes items listed below2,3 $(330) $5,366 Excluded Items: Acquisition- and divestiture-related costs4 $1,090 $594 Restructuring costs 334 779 Income from investments in equity securities (191) (61) Increase to net loss / decrease to net income before taxes 1,233 1,312 Estimated income tax benefit5 (228) (373) Increase to net loss / decrease to net income $1,005 $939 Pipeline and Portfolio Highlights In the second quarter, the Company achieved key regulatory milestones across the portfolio while continuing to advance its broad and diverse pipeline. Oncology: U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each with WELIREG, for the adjuvant treatment of certain patients with clear cell renal cell carcinoma (ccRCC), based on Phase 3 LITESPARK-022 trial. Approvals represent first approved combination of a PD-1 and hypoxia-inducible factor-2 alpha inhibitor for these patients. In July, FDA approved expanded use of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, as treatment before and after surgery for adult patients with muscle-invasive bladder cancer (MIBC), including cisplatin eligible patients based on Phase 3 KEYNOTE-B15 trial; the expansion builds upon prior approval of this regimen for cisplatin ineligible patients based on Phase 3 KEYNOTE-905 trial. FDA approved KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of PD-L1 positive (Combined Positive Score [CPS] ≥10) advanced TNBC, based on Phase 3 KEYNOTE-D19/ASCENT-04 trial. FDA granted Breakthrough Therapy designation (BTD) for calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA, for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%). Announced that Phase 3 TroFuse-005 trial evaluating sac-TMT, an investigational anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. First Phase 3 results from the Company’s broad sac-TMT clinical development program, which includes 17 ongoing global Phase 3 trials across multiple tumor types. At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, new research was presented across over 25 types of cancer, reinforcing long-term impact of KEYTRUDA and momentum in the Company’s rapidly advancing oncology pipeline, including: Five-year follow-up data from Phase 2b KEYNOTE-942 trial, in collaboration with Moderna, underscoring continued potential of intismeran autogene (mRNA-4157/V940) in combination with KEYTRUDA for patients with stage III/IV melanoma following complete resection. Data from Phase 3 OptiTROP-Lung05 trial, led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA in China, adding to ongoing research of novel treatment approaches for patients with NSCLC. Results from final analysis of KEYNOTE-522 evaluating KEYTRUDA in combination with chemotherapy, reporting a continued survival benefit for patients with high-risk early-stage TNBC. U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each with WELIREG, for the adjuvant treatment of certain patients with clear cell renal cell carcinoma (ccRCC), based on Phase 3 LITESPARK-022 trial. Approvals represent first approved combination of a PD-1 and hypoxia-inducible factor-2 alpha inhibitor for these patients. In July, FDA approved expanded use of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, as treatment before and after surgery for adult patients with muscle-invasive bladder cancer (MIBC), including cisplatin eligible patients based on Phase 3 KEYNOTE-B15 trial; the expansion builds upon prior approval of this regimen for cisplatin ineligible patients based on Phase 3 KEYNOTE-905 trial. FDA approved KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of PD-L1 positive (Combined Positive Score [CPS] ≥10) advanced TNBC, based on Phase 3 KEYNOTE-D19/ASCENT-04 trial. FDA granted Breakthrough Therapy designation (BTD) for calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA, for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%). Announced that Phase 3 TroFuse-005 trial evaluating sac-TMT, an investigational anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. First Phase 3 results from the Company’s broad sac-TMT clinical development program, which includes 17 ongoing global Phase 3 trials across multiple tumor types. At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, new research was presented across over 25 types of cancer, reinforcing long-term impact of KEYTRUDA and momentum in the Company’s rapidly advancing oncology pipeline, including: Five-year follow-up data from Phase 2b KEYNOTE-942 trial, in collaboration with Moderna, underscoring continued potential of intismeran autogene (mRNA-4157/V940) in combination with KEYTRUDA for patients with stage III/IV melanoma following complete resection. Data from Phase 3 OptiTROP-Lung05 trial, led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA in China, adding to ongoing research of novel treatment approaches for patients with NSCLC. Results from final analysis of KEYNOTE-522 evaluating KEYTRUDA in combination with chemotherapy, reporting a continued survival benefit for patients with high-risk early-stage TNBC. Vaccines and Infectious Diseases: In July, presented new data for daily and weekly options across HIV treatment and prevention pipeline at 26 th International AIDS Conference (AIDS 2026). Hosted HIV investor event to highlight these data. In collaboration with Gilead, presented first Phase 3 results for islatravir/lenacapavir (ISL/LEN), an investigational oral once-weekly single-tablet HIV treatment regimen, which maintained virological suppression in adults with HIV who switched antiretroviral therapy. ISL/LEN has the potential to be the first approved oral, once-weekly HIV treatment. Presented first results from a Phase 2b study evaluating switch to investigational once-weekly oral islatravir and ulonivirine (ISL/ULO) in adults with virologically suppressed HIV-1. Received regulatory approvals in Japan and China for ENFLONSIA for the prevention of RSV lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. In July, presented new data for daily and weekly options across HIV treatment and prevention pipeline at 26 th International AIDS Conference (AIDS 2026). Hosted HIV investor event to highlight these data. In collaboration with Gilead, presented first Phase 3 results for islatravir/lenacapavir (ISL/LEN), an investigational oral once-weekly single-tablet HIV treatment regimen, which maintained virological suppression in adults with HIV who switched antiretroviral therapy. ISL/LEN has the potential to be the first approved oral, once-weekly HIV treatment. Presented first results from a Phase 2b study evaluating switch to investigational once-weekly oral islatravir and ulonivirine (ISL/ULO) in adults with virologically suppressed HIV-1. Received regulatory approvals in Japan and China for ENFLONSIA for the prevention of RSV lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. Cardiometabolic and Respiratory: In July, FDA approved LIPFENDRA (enlicitide), the first and only once-daily oral PCSK9 inhibitor, as an adjunct to diet and exercise, to reduce LDL-C in adults with hypercholesterolemia, based on two Phase 3 trials from the CORALreef clinical program: CORALreef Lipids and CORALreef HeFH. At week 24, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively. In July, FDA approved LIPFENDRA (enlicitide), the first and only once-daily oral PCSK9 inhibitor, as an adjunct to diet and exercise, to reduce LDL-C in adults with hypercholesterolemia, based on two Phase 3 trials from the CORALreef clinical program: CORALreef Lipids and CORALreef HeFH. At week 24, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively. Immunology: Announced positive topline results from Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active ulcerative colitis (UC). Initial topline results from primary analyses of two Phase 2 studies evaluating tulisokibart: In hidradenitis suppurativa (HS), the study met its primary and key secondary endpoints. Full results will be shared at an upcoming medical meeting. In systemic sclerosis-associated interstitial lung disease (SSc-ILD), the study did not meet its primary endpoint and will be discontinued. No new safety concerns were identified. Announced positive topline results from Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active ulcerative colitis (UC). Initial topline results from primary analyses of two Phase 2 studies evaluating tulisokibart: In hidradenitis suppurativa (HS), the study met its primary and key secondary endpoints. Full results will be shared at an upcoming medical meeting. In systemic sclerosis-associated interstitial lung disease (SSc-ILD), the study did not meet its primary endpoint and will be discontinued. No new safety concerns were identified. Business Development: Completed acquisition of Terns for $6.8 billion. Added MK-4208, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor recently granted BTD by the FDA for the treatment of certain adults with Philadelphia chromosome-positive chronic myeloid leukemia. Completed acquisition of Terns for $6.8 billion. Added MK-4208, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor recently granted BTD by the FDA for the treatment of certain adults with Philadelphia chromosome-positive chronic myeloid leukemia. Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.* Oncology FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With ccRCC; Based on Results From Phase 3 LITESPARK-022 Trial FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Treatment Before and After Surgery for Adults With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial, Combined With Previous Approvals Based on Phase 3 KEYNOTE-905 Trial FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Trodelvy, as First-Line Treatment of PD-L1+ Advanced TNBC; Based on Results From Phase 3 KEYNOTE-D19/ASCENT-04 Trial European Commission Approved KEYTRUDA Plus Padcev as First PD-1 Inhibitor Plus ADC Regimen for Adults With Cisplatin-Ineligible Resectable MIBC; Based on Results From Phase 3 KEYNOTE-905 Trial FDA Granted BTD for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients With Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC The Company Announced TroFuse-005 Trial Evaluating Sac-TMT Met Primary Endpoints of OS and PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer The Company and Moderna Presented 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at ASCO 2026 KEYTRUDA as Monotherapy Significantly Improved PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient Tumors Compared to Chemotherapy; Results From Phase 3 KEYNOTE-C93 Trial The Company Highlighted New Long-Term Data and Advancements Across Broad Oncology Portfolio and Pipeline Research at ASCO 2026 The Company Completed Acquisition of Terns Vaccines and Infectious Diseases The Company, in Collaboration With Gilead, Announced That the Once-Weekly Investigational Oral HIV Treatment Regimen of Islatravir and Lenacapavir (ISL/LEN) Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy The Company Presented New Data on Daily, Weekly and Monthly Options Across its HIV Treatment and Prevention Pipeline at AIDS 2026 The Company Announced Initial Access Plans for Alimatravir (MK-8527), Its Investigational Once-Monthly Oral Pre-Exposure Prophylaxis in Phase 3 Development; Multi-Faceted Strategy Aims To Enable Rapid, Broad and Sustainable Access to Alimatravir, if Approved, in Low- And Middle-Income Countries The Company Announced New Agreement With AIDS Drug Assistance Program Crisis Task Force To Improve Access and Care for People Living With HIV FDA Approved an Additional Indication for CAPVAXIVE in Children and Adolescents Aged 2 Through 17 at Increased Risk for Pneumococcal Disease; Based on Results From Phase 3 STRIDE-13 Trial Cardiometabolic and Respiratory FDA Approved LIPFENDRA, the First and Only Once-Daily Oral PCSK9 Inhibitor To Reduce LDL-C in Adults With Hypercholesterolemia; Based on Results From CORALreef Lipids and CORALreef HeFH Trials Immunology Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active UC Animal Health The Company’s Animal Health Business Completed Acquisition of TARGAN, Broadening Its Commercial Poultry Portfolio Through TARGAN’s Innovative High-Speed Biodevice Technology *References in the above news release titles have been modified for the purpose of this announcement. Upcoming Investor Event The Company will hold an Oncology Investor Event to coincide with the European Society for Medical Oncology Congress 2026 on Monday, Oct. 26, 2026, at 6 p.m. CET / 1 p.m. EDT, during which senior management will provide an update on the Company’s oncology strategy and program. The event will take place in Madrid, Spain, and will be accessible via live audio webcast at this weblink. Full-Year 2026 Financial Outlook The following table summarizes the Company’s full-year financial outlook. Full Year 2026 Updated Prior Sales* $66.3 billion to $67.3 billion $65.8 billion to $67.0 billion Non-GAAP Gross margin3 Approximately 81% Approximately 82% Non-GAAP Operating expenses3** $42.0 billion to $42.7 billion $36.0 billion to $36.8 billion Non-GAAP Other (income) expense, net3 Approximately $1.4 billion expense Approximately $1.3 billion expense Non-GAAP Effective income tax rate3 35.0% to 36.0% 23.5% to 24.5% Non-GAAP EPS3*** $2.66 to $2.76 $5.04 to $5.16 Share count (assuming dilution) Approximately 2.48 billion Approximately 2.48 billion *The Company does not have any non-GAAP adjustments to sales. **Includes one-time R&D charges of $9.0 billion for the acquisition of Cidara Therapeutics, Inc. (Cidara) and $5.7 billion for the acquisition of Terns. Outlook does not assume any additional significant potential business development transactions. ***Includes one-time charges of $3.62 per share for the acquisition of Cidara and $2.31 per share for the acquisition of Terns. The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective income tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results. The Company is raising and narrowing the range for its full-year sales outlook and now anticipates full-year 2026 sales to be between $66.3 billion and $67.3 billion, including a positive impact from foreign exchange of approximately 1% at mid-July 2026 exchange rates. The Company now expects the full-year non-GAAP effective income tax rate to be between 35.0% and 36.0%, including the impact of the non-tax deductible one-time charges for the acquisitions of Cidara and Terns. The Company now expects full-year 2026 non-GAAP EPS to be between $2.66 and $2.76, including a positive impact from foreign exchange of approximately $0.15 per share at mid-July 2026 exchange rates. This range includes one-time charges of $9.0 billion, or $3.62 per share, related to the acquisition of Cidara and $5.7 billion, or $2.31 per share, related to the acquisition of Terns. This range also includes costs of approximately $0.12 per share to finance the Terns acquisition and advance MK-4208. The charges related to Terns were not previously included in the outlook. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share in the aggregate related to certain business development transactions. Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions. Earnings Conference Call Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, Aug. 4, at 9 a.m. EDT via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website. All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590. About Our Company At Merck & Co., Inc., Rahway, N.J., USA, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “Company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Appendix Generic product names are provided below. Pharmaceutical BRIDION (sugammadex) CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) ENFLONSIA (clesrovimab-cfor) GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) JANUMET (sitagliptin and metformin HCl) JANUVIA (sitagliptin) KEYTRUDA (pembrolizumab) KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) LAGEVRIO (molnupiravir) Lenvima (lenvatinib) LIPFENDRA (enlicitide) Lynparza (olaparib) M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live) OHTUVAYRE (ensifentrine) PREVYMIS (letermovir) PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) VARIVAX (Varicella Virus Vaccine Live) VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) WELIREG (belzutifan) WINREVAIR (sotatercept-csrk) Animal Health BRAVECTO (fluralaner) 1 Available in some markets as KEYTRUDA SC. 2 Net (loss) income attributable to the Company. 3 The Company is providing certain 2026 and 2025 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the Company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. 4 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations, licensing arrangements and asset acquisitions, and recognition of fair value step-up to inventories for asset acquisitions. 5 Includes the estimated income tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments for all periods presented. Amount in the second quarter of 2025 also includes a $146 million benefit primarily resulting from favorable audit reserve adjustments. GAAP 2Q26 2Q25 $ 16,607 $ 15,806 5% $ 32,893 $ 31,335 5% 4,395 3,557 24% 8,590 6,976 23% 2,904 2,649 10% 5,604 5,202 8% 9,741 4,048 * 22,333 7,669 * 151 560 -73% 346 629 -45% 99 (7 ) * 237 (43 ) * (683 ) 4,999 * (4,217 ) 10,902 * 654 571 1,363 1,388 (1,337 ) 4,428 * (5,580 ) 9,514 * (2 ) 1 (5 ) 8 $ (1,335 ) $ 4,427 * $ (5,575 ) $ 9,506 * $ (0.54 ) $ 1.76 * $ (2.26 ) $ 3.77 * 2,470 2,513 2,471 2,522 -95.9 % 11.4 % -32.3 % 12.7 % $ 4,395 1,067 184 1,251 $ 3,144 2,904 17 17 2,887 9,741 6 (1 ) 5 9,736 151 151 151 – 99 (191 ) (191 ) 290 (683 ) (1,090 ) (334 ) 191 (1,233 ) 550 654 (219 ) (3) (50 ) (3) 41 (3) (228 ) 882 (1,337 ) (871 ) (284 ) 150 (1,005 ) (332 ) (1,335 ) (871 ) (284 ) 150 (1,005 ) (330 ) $ (0.54 ) (0.35 ) (0.12 ) 0.06 (0.41 ) $ (0.13 ) -95.9 % 160.3 % $ 8,590 2,081 421 2,502 $ 6,088 5,604 49 49 5,555 22,333 6 33 39 22,294 346 346 346 – 237 (371 ) (371 ) 608 (4,217 ) (2,136 ) (800 ) 371 (2,565 ) (1,652 ) 1,363 (421 ) (3) (135 ) (3) 80 (3) (476 ) 1,839 (5,580 ) (1,715 ) (665 ) 291 (2,089 ) (3,491 ) (5,575 ) (1,715 ) (665 ) 291 (2,089 ) (3,486 ) $ (2.26 ) (0.70 ) (0.27 ) 0.12 (0.85 ) $ (1.41 ) -32.3 % -111.3 % 2026 2025 2Q June YTD 1Q 2Q June YTD 1Q 2Q June YTD 3Q 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch % $16,286 $16,607 $32,893 $15,529 $15,806 $31,335 $17,276 $16,400 $65,011 5 4 5 3 14,349 14,760 29,109 13,638 14,050 27,688 15,611 14,843 58,142 5 4 5 3 7,906 7,904 15,810 7,205 7,956 15,161 8,142 8,337 31,641 -1 -2 4 2 128 463 590 5 35 40 - - - - 341 365 706 312 370 682 379 389 1,450 -1 -2 4 2 256 283 539 258 265 523 258 272 1,053 7 6 3 2 199 271 470 137 162 300 196 220 716 67 67 57 56 148 122 270 119 107 226 136 164 525 15 15 20 20 1,069 1,169 2,238 1,327 1,126 2,453 1,749 1,031 5,233 4 3 -9 -10 538 592 1,130 539 609 1,148 684 619 2,451 -3 -3 -2 -3 202 148 350 230 229 459 226 140 825 -35 -36 -24 -26 206 134 340 228 121 349 204 119 673 10 9 -3 -4 142 184 325 107 129 236 244 279 759 42 40 38 36 1 2 3 79 21 100 - - - - 525 588 1,114 280 336 615 360 467 1,443 75 75 81 81 131 204 335 178 178 - - - - 109 126 235 106 123 229 112 129 470 3 3 3 3 78 78 156 68 80 147 82 83 312 -2 -4 6 1 472 497 969 441 461 902 439 499 1,841 8 8 7 7 272 295 568 208 228 436 266 275 978 29 28 30 27 75 101 176 67 83 150 77 79 306 21 17 17 10 82 77 159 70 74 145 81 87 312 4 2 10 8 59 60 119 90 86 176 82 67 325 -30 -31 -32 -33 34 22 56 83 96 179 43 25 247 -77 -77 -69 -69 28 5 32 102 83 185 138 57 380 -95 -95 -82 -83 367 258 625 549 372 921 382 302 1,604 -31 -30 -32 -32 207 171 378 247 251 498 243 199 940 -32 -33 -24 -25 774 641 1,416 865 703 1,568 1,004 770 3,340 -9 -9 -10 -11 1,791 1,775 3,566 1,588 1,646 3,234 1,615 1,505 6,354 8 5 10 6 1,064 1,041 2,105 924 961 1,885 1,023 987 3,896 8 6 12 7 727 734 1,461 664 685 1,349 592 518 2,458 7 5 8 4 146 72 218 303 110 413 50 52 515 -35 -34 -47 -6

Clinical ResultPhase 3Breakthrough TherapyDrug ApprovalAcquisition

30 Jun 2026

·www.biospace.com

Quince Therapeutics Appoints Recognized Leaders in Pulmonary Medicine to Scientific Advisory Board

SOUTH SAN FRANCISCO, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Quince Therapeutics, Inc. (Nasdaq: QNCX), a clinical stage biopharmaceutical company focused on the development of novel, disease modifying therapies for serious underserved diseases, today announced the formation of a Scientific Advisory Board (SAB) of leading clinicians to support the advancement of LAM-001, an inhaled formulation of rapamycin (mTOR inhibitor) designed to enhance pulmonary delivery and reduce systemic exposure. Comprised of internationally recognized experts in pulmonary medicine, the SAB will be instrumental in progressing the development of LAM-001 across multiple pulmonary indications including pulmonary hypertension associated with interstitial lung disease (PH-ILD), bronchiolitis obliterans syndrome post lung transplant (BOS), and sarcoidosis associated pulmonary hypertension (SAPH). “I am honored to serve as the Chairman of Quince’s Scientific Advisory Board to help guide the development of LAM-001 across a range of pulmonary conditions where evidence strongly suggests it has a direct effect on the underlying disease pathophysiology,” commented Paul Yu, M.D., Ph.D., Director, Cardiovascular Research Center, Massachusetts General Hospital. “On behalf of the SAB, we are encouraged by the clinically relevant improvement seen in measures of lung function in patients with functional class III pulmonary hypertension treated with LAM-001. With continued development, we believe LAM-001 has the potential to provide patients with a much needed treatment option that, importantly, may be utilized in conjunction with currently available therapies to achieve better health outcomes.” Scientific Advisory Board members: Paul Yu, M.D., Ph.D. (Chairman of SAB) Dr. Paul Yu is Director of the Cardiovascular Research Center at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School, where he holds the Charles and Elizabeth Sanders Endowed Chair. A physician-scientist trained in immunology and cardiovascular medicine, Dr. Yu’s research focuses on BMP and TGF-β signaling in cardiovascular homeostasis, repair, and disease. His work spans pulmonary vascular disease, cardiovascular rheumatology, and rare disorders such as fibrodysplasia ossificans progressiva. Dr. Yu has translated several scientific discoveries into therapeutics, including contributions to sotatercept for pulmonary arterial hypertension and the clinical repositioning of saracatinib for fibrodysplasia ossificans progressiva (FOP). He has published over 120 peer-reviewed studies and has been elected to the American Society for Clinical Investigation. Aaron Waxman, M.D., Ph.D. Dr. Aaron Waxman is Director of the Pulmonary Vascular Disease Program at Brigham and Women's Hospital and Associate Professor of Medicine at Harvard Medical School. Dr. Waxman’s clinical practice and research programs center on pulmonary arterial hypertension (PAH), right heart failure, thromboembolic disease, and the broader spectrum of pulmonary vascular disease. Across local and national efforts, Dr. Waxman has served as Principal Investigator on more than 15 clinical trials in pulmonary hypertension. These include the Phase 2 SPECTRA trial of sotatercept, which helped establish activin signaling inhibition as a novel therapeutic pathway in PAH, and the INCREASE trial of inhaled treprostinil in pulmonary hypertension associated with interstitial lung disease—a study that defined a new treatment standard for a previously underserved patient population. He has authored more than 180 peer-reviewed publications, and his research has been supported by the National Institutes of Health, including the National Heart, Lung, and Blood Institute. Steven Nathan, M.D., F.C.C.P. Dr. Steven Nathan is Schar Chair of the Advanced Lung Disease and Lung Transplant Program, Inova Health System and Professor of Education at the University of Virginia. The author of more than 500 publications and co-editor of two books on idiopathic pulmonary fibrosis, Dr. Nathan is internationally recognized for his expertise in advanced lung diseases. Dr. Nathan is a reviewer for multiple journals and is on the editorial board for the journal, Thorax. He has served on multiple committees, including U.S. Food and Drug Administration advisory boards as well as steering committees for clinical trials in IPF and pulmonary hypertension, where he has also served as chair. Dr. Nathan is the recipient of the 2023 American College of Chest Physicians’ 2023 College Medalist Award, and is a member of several professional medical associations, including the American Thoracic Society, the American College of Chest Physicians, and the International Society for Heart and Lung Transplantation. Steve Hays, M.D. Dr. Steven R. Hays is Medical Director of the UCSF Advanced Lung Disease and Lung Transplant Program and Professor of Medicine at the University of California, San Francisco. Under his leadership, the program has grown to one of the nation’s largest transplant centers while consistently achieving superior outcomes, receiving INTERLINK’s Chairman’s Award for Transplant Excellence for three consecutive years. Dr. Hays brings deep clinical expertise across the full spectrum of advanced lung disease, including cystic fibrosis, alpha-1 antitrypsin deficiency, interstitial lung disease, and emphysema. A dedicated clinical investigator, Dr. Hays has served as principal investigator on NIH-funded, industry-sponsored, and investigator-initiated trials. His research portfolio spans lung transplant immunology, chronic lung allograft dysfunction, infectious disease, and transplant digital health. He has authored more than 110 peer-reviewed publications and has been an invited speaker at the American Thoracic Society, the International Society of Heart and Lung Transplantation, and the American Society of Transplantation, among others. He is a Fellow of the American College of Chest Physicians, and a member of the American Thoracic Society and the International Society of Heart and Lung Transplantation, where he serves on the Pulmonary and Infectious Disease Councils. He is a recipient of the American Thoracic Society’s Outstanding Clinician Award and a member of the prestigious UCSF Council of Master Clinicians. Robert Baughman, M.D. Dr. Baughman is Professor Emeritus at the University of Cincinnati. Along with his longtime collaborator Dr. Elyse Lower, he has performed numerous investigator initiated trials of novel treatments for sarcoidosis, including methotrexate, thalidomide, leflunomide, infliximab, rituximab, repository corticotropin injection, pirfenidone, roflumilast, and armodafinil. For sarcoidosis associated pulmonary hypertension, he has conducted trials on bosentan, iloprost, riociguat, tadalafil, selexipag, and inhaled nitric oxide. His publications include over 350 original papers and over 70 review articles and/or book chapters. Additionally, Dr. Baughman has edited multiple books on sarcoidosis and interstitial lung disease. A recognized leader in his field, Dr. Baughman led a multi-national registry of sarcoidosis associated pulmonary hypertension (ReSAPH) and is past president of the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG). About LAM-001 LAM-001 is a proprietary, investigational, once-daily inhaled formulation of sirolimus, also known as rapamycin. LAM-001’s potential as a disease-modifying agent in pulmonary hypertension stems from its ability to inhibit mTOR-mediated pulmonary arterial smooth muscle cell proliferation. The mTOR pathway has been shown to be activated in the pulmonary arterial smooth muscle cells of patients with pulmonary hypertension, and mTOR inhibition with rapamycin has been shown to reverse smooth muscle cell hyperproliferation and attenuate pulmonary vascular remodeling and cardiopulmonary dysfunction in multiple nonclinical models. Additionally, mTOR signaling promotes fibroblast activation, myofibroblast differentiation, and extracellular matrix deposition in injured or inflamed lung tissue, and mTOR inhibition has been shown to exert direct anti-fibrotic activity, reducing collagen accumulation, suppressing profibrotic cytokine signaling, and attenuating parenchymal fibrosis. These effects are particularly relevant in PH-ILD, where vascular remodeling and progressive fibrosis evolve in parallel and amplify pulmonary vascular load. LAM-001 is designed to enhance pulmonary delivery and reduce systemic exposure, offering a promising potential disease-modifying therapy for pulmonary disease. LAM-001 is currently being studied in multiple indications including PH-ILD, a serious and progressive condition affecting an estimated ~86K patients in the U.S. and ~120K in Europe. Based on compelling Phase 2a data presented at the American Thoracic Society (ATS) in May 2026, the company is advancing LAM-001 into a Phase 2b trial in PH-ILD, with initiation planned for mid-2026 and data anticipated in the first quarter of 2028. LAM-001 is also being evaluated in a Phase 2 study in BOS, a serious complication following lung transplantation affecting an estimated ~17K patients in the U.S. and ~11K in Europe. The trial is fully enrolled, with data anticipated in the first quarter of 2027. In late 2026, the company also plans to initiate a Phase 2 study of LAM-001 in SAPH, a severe complication of sarcoidosis with no approved therapy affecting an estimated ~60K patients in the U.S. and Europe. About Quince Therapeutics, Inc. Quince Therapeutics, Inc. is committed to transforming the lives of patients facing serious, underserved diseases by developing disease-modifying therapies to treat their conditions. The company is currently developing LAM-001 for the treatment of PH-ILD, BOS, and SAPH. A Phase 2a study in PH patients has been completed, a Phase 2 clinical study in BOS patients is ongoing, a Phase 2b study in PH-ILD is anticipated to begin in mid-2026, and a Phase 2 study in SAPH is anticipated to begin in late-2026. By pioneering innovative approaches, the company aims to offer new hope and improved quality of life to patients worldwide. Forward Looking Statements Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “aim,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to expectations that the SAB will be instrumental in progressing the development of LAM-001 across multiple pulmonary indications; the design and potential benefits of LAM-001, including as a disease-modifying therapy for pulmonary disease and as a treatment option that may be utilized in conjunction with currently available therapies to achieve better health outcomes; anticipated regulatory and development processes and timelines, including the expected timing to initiate the planned Phase 2b trial of LAM-001 in PH-ILD and the planned Phase 2 trial of LAM-001 in SAPH, the expected timing for data readouts from the ongoing Phase 2 trial of LAM-001 in BOS and the planned Phase 2b trial of LAM-001 in PH-ILD; the Phase 2a data of LAM-001 in PAH and PH-ILD supporting continued development of LAM-001 in PH-ILD and the potential benefit across exercise capacity, pulmonary hemodynamics, cardiac stress and lung function; observed improvements in 6MWD and PVR in the Phase 2a trial potentially suggesting broader effects on cardiopulmonary physiology; the estimated patient populations in the U.S. and Europe for PH-ILD, BOS and SAPH; and the potential advantages of mTOR inhibitors in PH-ILD. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to LAM-001; the ability to obtain and maintain regulatory approval; competition in the company’s industry; the scope, progress and expansion of developing LAM-001; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the company’s ability to attract or retain key management, members of the board of directors and other personnel; the impacts of general macroeconomic and geopolitical conditions on the company’s business and financial position; and other risks and uncertainties described in the section titled “Risk Factors” in the company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on April 10, 2026, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. Contacts Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com 212-915-2577

Phase 2

20 May 2026

·www.biopharmadive.com

Oorja, run by Acceleron veterans, launches to make new fibrosis drugs

Westlake BioPartners headed to Texas for its latest biotechnology venture, launching Oorja Bio with $30 million in Series A funding to make new drugs for cardiopulmonary and fibrotic diseases.The Houston startup announced Tuesday that it would soon begin a Phase 2 clinical trial for ORJ-001, its lead program for idiopathic pulmonary fibrosis. Oorja licensed the drug from NIBEC, a South Korean biotechnology company, as part of a strategy to find assets that could advance in the clinic rapidly, CEO Sujay Kango told BioPharma Dive in an email.Idiopathic pulmonary fibrosis, or IPF, is a rare condition where scar tissue builds up in the lungs, causing chronic cough, shortness of breath and fatigue. Patients can draw from a handful of drugs to manage their conditions: Esbriet, Ofev and the recently approved Jascayd.Esbriet, developed by Roche, slows disease progression by preventing the buildup of scar tissue. Ofev and Jascayd, both made by Boehringer Ingelheim, block some cell-surface receptors linked to fibrosis.None stop the disease completely, and they all carry tolerability issues, prompting other drugmakers to search for better options. One of those companies, Avalyn Pharma, last month raised $300 million in an initial public offering.Oorja is pursuing a different approach with its lead drug, according to Kango. The therapy is designed to restore the function of alveolar epithelial type 2, or AEC2 cells. These cells are found in the tiny air sacs of the lungs and help repair damage when those sacs, or alveoli, are injured. They're also compromised in IPF, suggesting that repairing their abilities might help undo lung scarring.Preclinical research has showed such potential, the company said in a Tuesday statement.In an early human study presented at a medical meeting this week, Oorja also found that ORJ-001 was well-tolerated in healthy volunteers. The company plans to launch a Phase 2 trial later this year.ORJ-001 represents a different regenerative approach that might complement other therapeutic strategies, Kango said.Oorja draws its name from the Sanskrit word for energy, which Kango said reflects our focus on restoring tissue function and promoting repair in serious fibrotic diseases.Kango as well as Chief Medical Officer Janethe Pena both previously worked together at Acceleron Pharma, where they played key roles in the development of a blood pressure drug now known as Winrevair. Merck & Co. acquired Acceleron for more than $11 billion in 2021.We believe the fibrosis field is entering a new era focused on regenerative and disease-modifying approaches that may offer greater benefit for patients, Kango said. '

Drug ApprovalPhase 2AcquisitionCell Therapy

100 Deals associated with Sotatercept

External Link

KEGG	Wiki	ATC	Drug Bank
D09670	-	-	DB12118

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Depressive Disorder	Canada	Merck Canada, Inc.	01 Aug 2024
Pulmonary Arterial Hypertension	United States	Merck Sharp & Dohme LLC	26 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Familial Primary Pulmonary Hypertension	Phase 3	United States	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Argentina	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Australia	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Belgium	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Brazil	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Canada	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Czechia	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	France	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Germany	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Israel	Acceleron Pharma, Inc.	25 Jan 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03496207 \| NCT04576988 (Pubmed \| Expert Opin Drug Saf)	Phase 2/3	Pulmonary Arterial Hypertension	132	Sotatercept 0.7 mg/kg	fcfclfsrly(seqqsjauen): MD = -1150.38 (79.0% CI, -1846.44 to -454.32), P-Value = 0.001 View more	Positive	09 Jun 2026
				Sotatercept 0.3 mg/kg
NCT04811092 (MK-7962-005 \| A011-13 \| HYPERION, CTgov)	Phase 3	Familial Primary Pulmonary Hypertension \| Pulmonary Arterial Hypertension	321	Sotatercept (Sotatercept Plus Background Pulmonary Arterial Hypertension (PAH) Therapy)	adsbffccax(ntkazhbpal) = zxfnyogkul aisrujkunt (fwihuefzts, hvugogidqi - yqfybdesul) View more	-	27 Apr 2026
				Placebo (Placebo Plus Background PAH Therapy)	adsbffccax(ntkazhbpal) = dpcqzdqsaj aisrujkunt (fwihuefzts, qojcsgcelz - dnmhjiubfo) View more
NCT05818137 (MK-7962-020, Pubmed \| JACC Asia)	Phase 3	Pulmonary Arterial Hypertension	46	Sotatercept 0.3-0.7 mg/kg (Pulmonary Arterial Hypertension + Stable background therapy)	byhhanztgg(jwciuzoufi) = vppjgwrbhv gdnbiinqcp (mkrjfumonn, 27.8 - 55.5) View more	Positive	01 Mar 2026
NCT07356778 (SuMILE, Pubmed \| BMJ Open)	Phase 3	Pulmonary arterial hypertension associated with congenital heart disease	36	Sotatercept add-on therapy plus vasodilator-based PAH therapy	eadbvgzero(dybslttsbd) = fizjubjhes jeeykwduyx (nvpobnxlyp ) View more	Positive	01 Mar 2026
				Vasodilator-based PAH therapy alone	bfexhxmrzt(tfsjwqglqx) = dwepjxqewj azasqtyxwq (yjmydcgaux, 103.0) View more
NCT04896008 (ZENITH, BusinessWire) Manual	Phase 3	Pulmonary Arterial Hypertension	172	WINREVAIR (sotatercept-csrk)	dngpfvmfyh(iikzyddftv) = glsyaaqpld pdzaennutx (vdfryxfxea ) View more	Positive	27 Oct 2025
				Placebo	dngpfvmfyh(iikzyddftv) = lfyirvqhba pdzaennutx (vdfryxfxea ) View more
NCT04811092 (HYPERION, Pubmed \| N Engl J Med) Manual	Phase 3	Pulmonary Arterial Hypertension	320	Sotatercept	bcvqbkoksu(cmkdarrufz) = gbudkrkbfi rlanynqjjs (pbymebvbtz ) View more	Positive	23 Oct 2025
				Placebo	bcvqbkoksu(cmkdarrufz) = mggogfcyfl rlanynqjjs (pbymebvbtz ) View more
NCT04896008 (MK-7962-006 \| ZENITH, CTgov)	Phase 3	Familial Primary Pulmonary Hypertension \| Pulmonary Arterial Hypertension	173	Sotatercept (Sotatercept)	gxvugcuqhk(ucgqzeefur) = vsapidgipu npklhiekiu (bxcynrqkig, nerxthvmmz - fyenqfwjyj) View more	-	22 Aug 2025
				Placebo (Placebo)	gxvugcuqhk(ucgqzeefur) = kvzgrorxuz npklhiekiu (bxcynrqkig, eclqvogzet - bhizelqrkn) View more
NCT04796337 (SOTERIA, Pubmed \| Eur Respir J)	Phase 3	Pulmonary Arterial Hypertension Add-on	426	Sotatercept	epawuksvir(pboaxgmgbr) = jrdspwmhss gfsdrerdzs (ibomwkzpli ) View more	Positive	01 Jul 2025
NCT04811092 (HYPERION, PipelineReview) Manual	Phase 3	Pulmonary Arterial Hypertension	320	WINREVAIR	mbtipixtxt(akmoqdbigq) = WINREVAIR added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo. ndyifkozlc (sjbaexfwgo ) Met	Positive	24 Jun 2025
				placebo
NCT04576988 (STELLAR, Pubmed \| Adv Ther)	Phase 3	Pulmonary Arterial Hypertension	-	Sotatercept plus background therapy (BGT)	hhabcevogx(zsvnsidcim) = ycgogclavj rktvupbclg (xpfccwwokp ) View more	Positive	17 Jun 2025
				Placebo plus background therapy (BGT)	ibcprfluxf(ddkgpocroa) = eyylxmpwtx fwzxtownqn (jgfvapbayt )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis