An Open-Label, Phase 2 Study Evaluating the Safety of Mosliciguat in Combination With Inhaled Treprostinil in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.

Start Date23 Dec 2025

Sponsor / Collaborator

Pulmovant, Inc.

NCT07185321

/ Active, not recruitingPhase 1

An Open-Label, Phase 1 Study to Investigate the Absolute Bioavailability and the Absorption, Metabolism, and Excretion of [14C]-Mosliciguat in Healthy, Adult Males

This is a single-center, Phase 1, open-label, 3-period, fixed-sequence study to investigate the bioavailability, absorption, metabolism, excretion and the safety of mosliciguat administered to healthy male adults.

Start Date10 Jun 2025

Sponsor / Collaborator

Pulmovant, Inc.

NCT06635850

/ Active, not recruitingPhase 2

A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Start Date29 Oct 2024

Sponsor / Collaborator

Pulmovant, Inc.

100 Clinical Results associated with Mosliciguat

100 Translational Medicine associated with Mosliciguat

100 Patents (Medical) associated with Mosliciguat

Literatures (Medical) associated with Mosliciguat

01 Jun 2025·CLINICAL PHARMACOKINETICS

Pharmacokinetics and Lung Deposition After Administration of Inhaled Mosliciguat (BAY 1237592): Results from Randomized Phase I Studies in Healthy Men

Article

Author: Buetehorn, Ulf ; Nikkho, Sylvia M ; Nagelschmitz, Johannes ; Saleh, Soundos ; Mundry, Tobias ; Holzschuh, Stephan

BACKGROUND AND OBJECTIVE:

Mosliciguat is the first soluble guanylate cyclase activator designed for dry powder inhalation. It is currently under development for the treatment of pulmonary hypertension; the inhaled route of administration delivers the drug to the pulmonary vasculature with the aim of improving pulmonary hemodynamics. We conducted three phase I trials in healthy male volunteers to characterize the pharmacokinetic profile of mosliciguat, focusing on lung deposition after inhalation with a low-resistance device in a lactose carrier-based dry powder formulation.

METHODS:

Study 1 was a randomized, open-label, four-way crossover study (Part 2) comparing the pharmacokinetics of mosliciguat by inhalation (1000 μg), inhalation (1000 μg) with charcoal block, in oral solution (1000 μg), and intravenously (100 μg). (The oral and intravenous doses were selected in Part 1 of the study.) Study 2 was an 8-day, randomized, single-blind, placebo-controlled, multiple-dose escalation study of once-daily inhaled mosliciguat (480, 1000, and 2000 μg). Study 3 was a 2-week, multiple-dose, randomized, placebo-controlled, single-blind study of once-daily inhaled mosliciguat 1000 μg.

RESULTS:

In Study 1 (Part 2) the absolute bioavailability of inhaled mosliciguat was 18.8% without charcoal block and 16.3% with charcoal block. The absolute bioavailability of oral mosliciguat was 23.1%. Pharmacokinetic parameters showed low-to-moderate inter-subject variability. Time to maximum plasma concentration (t_max) was 2.0 h after inhalation and 1.0 h after oral administration; half-life was 15.1 and 4.4 h, respectively. Based on accumulation ratios in Study 2, the area under the concentration-time curve (AUC) and maximum plasma concentration (C_max) increased by 45-51% and 15-21%, respectively, across doses at day 8. In Study 2 the half-life of inhaled mosliciguat with multiple dosing was 57.4 and 42.3 h at doses of 1000 and 2000 µg, respectively. Data showed moderate variability in AUC and C_max (geometric coefficients of variation, 26.6% and 24.7%, respectively, in study 3 on day 1). Trough levels showed accumulation ratios of 1.7-2.1 in Study 2 (day 8) and 2.5 in Study 3 (day 14). In all three studies, mosliciguat was well tolerated, without major systemic effects on heart rate or blood pressure.

CONCLUSIONS:

Inhaled mosliciguat had a longer t_max and half-life than oral mosliciguat. Accumulation data suggest formation of a mosliciguat depot in the lungs and continuous transfer to the systemic circulation, with an indication of an increase in accumulation ratio with longer duration of treatment.

Respiratory research

Inhaled mosliciguat (BAY 1237592): targeting pulmonary vasculature via activating apo-sGC

Article

Author: Weimann, Gerrit ; Nikkho, Sylvia M ; Delbeck, Martina ; Kraemer, Thomas ; Truebel, Hubert K F ; Hahn, Michael G ; Becker-Pelster, Eva M ; Mondritzki, Thomas ; Marquardt, Tobias ; Sandner, Peter ; Stasch, Johannes-Peter ; Tinel, Hanna ; Kopf, Johannes ; Dietz, Lisa ; Schuhmacher, Joachim ; Pires, Philippe V ; Nagelschmitz, Johannes ; Hüser, Jörg ; Wunder, Frank

Abstract:

Background:

Oxidative stress associated with severe cardiopulmonary diseases leads to impairment in the nitric oxide/soluble guanylate cyclase signaling pathway, shifting native soluble guanylate cyclase toward heme-free apo-soluble guanylate cyclase. Here we describe a new inhaled soluble guanylate cyclase activator to target apo-soluble guanylate cyclase and outline its therapeutic potential.

Methods:

We aimed to generate a novel soluble guanylate cyclase activator, specifically designed for local inhaled application in the lung. We report the discovery and in vitro and in vivo characterization of the soluble guanylate cyclase activator mosliciguat (BAY 1237592).

Results:

Mosliciguat specifically activates apo-soluble guanylate cyclase leading to improved cardiopulmonary circulation. Lung-selective effects, e.g., reduced pulmonary artery pressure without reduced systemic artery pressure, were seen after inhaled but not after intravenous administration in a thromboxane-induced pulmonary hypertension minipig model. These effects were observed over a broad dose range with a long duration of action and were further enhanced under experimental oxidative stress conditions. In a unilateral broncho-occlusion minipig model, inhaled mosliciguat decreased pulmonary arterial pressure without ventilation/perfusion mismatch. With respect to airway resistance, mosliciguat showed additional beneficial bronchodilatory effects in an acetylcholine-induced rat model.

Conclusion:

Inhaled mosliciguat may overcome treatment limitations in patients with pulmonary hypertension by improving pulmonary circulation and airway resistance without systemic exposure or ventilation/perfusion mismatch. Mosliciguat has the potential to become a new therapeutic paradigm, exhibiting a unique mode of action and route of application, and is currently under clinical development in phase Ib for pulmonary hypertension.

News (Medical) associated with Mosliciguat

06 Feb 2026

·www.globenewswire.com

Roivant Announces Positive Phase 2 Results for Brepocitinib in Cutaneous Sarcoidosis (CS) and Reports Financial Results for the Third Quarter Ended December 31, 2025

Brepocitinib 45 mg significantly improved cutaneous sarcoidosis disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 P<0.0001). Brepocitinib demonstrated rapid, deep and sustained improvements across all other efficacy endpoints measured with consistent safety profilePriovant plans to progress CS to a pivotal program with a Phase 3 study starting in calendar year 2026 following engagement with the FDA, representing the third indication with a pivotal program for brepocitinib New Drug Application (NDA) was submitted to the FDA for brepocitinib in dermatomyositis (DM). Topline data from Phase 3 studies in non-infectious uveitis (NIU) are expected in the second half of calendar year 2026. Roivant continues to actively explore other indications for brepocitinibIMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) fully enrolled, with topline data expected in the second half of calendar year 2026; topline data from the proof-of-concept trial in cutaneous lupus erythematous (CLE) expected in the second half of calendar year 2026 Mosliciguat Phase 2 trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) fully enrolled, with topline data expected in the second half of calendar year 2026LNP litigation continues to progress, with favorable summary judgment decision in U.S. Moderna case affirming Genevant's view of section 1498: the significant majority of liability belongs in the current case against Moderna. Jury trial in the U.S. Moderna case scheduled for March 2026 and first major hearings in international proceedings expected in the first half of calendar year 2026 Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million, extending Immunovant’s cash runway to the launch of IMVT-1402 in Graves’ disease (GD)Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.5 billion as of December 31, 2025, supporting cash runway into profitabilityRoivant will host a live conference call and webcast at 8:00 a.m. ET on Friday, February 6, 2026, to discuss positive Phase 2 results for brepocitinib in CS and report its financial results for the third quarter ended December 31, 2025 BASEL, Switzerland and LONDON and NEW YORK, Feb. 06, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis (CS) and reported its financial results for the third quarter ended December 31, 2025. "2025 was a transformative year for Roivant, driven by the quality of our clinical execution and its resulting data. We are entering 2026 with early momentum across our late stage pipeline with ambitions of another groundbreaking year. The positive data for brepocitinib in CS represents a breakthrough for the field, generating clinically meaningful outcomes for patients in need in the first ever positive placebo-controlled trial for any therapy in CS," said Matt Gline, CEO of Roivant. "Together with this data, I’m proud of our continued execution elsewhere in our pipeline, including with today's announcement of the NDA filing for brepocitinib in dermatomyositis and the completion of enrollment in multiple large studies setting the stage for the year ahead." BEACON Study Results The BEACON study enrolled 31 patients across 15 sites in the United States, randomized 3:2:2 to once daily brepocitinib 45 mg, 15 mg, or placebo with a 16-week treatment period. The brepocitinib 45 mg arm comprised the most treatment-refractory group, with the highest percentage of patients with longstanding disease, damage, and difficult-to-treat plaque-predominant morphology. Despite this, patients in the 45 mg arm achieved meaningful clinical improvement compared to placebo, including 100% response rates on multiple endpoints. Brepocitinib 15 mg patients also improved considerably, with numerically similar improvement to the 45 mg arm on lower-bar endpoints and evidence of dose-dependent benefit seen on higher bar endpoints and patient reported outcomes. Placebo patients experienced almost no improvement, consistent with natural disease course. On the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity score (CSAMI-A), brepocitinib 45 mg achieved a 22.3-point mean improvement at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 P<0.0001). Statistically significant separation was observed as early as Week 4 and maintained at all timepoints thereafter. One hundred percent of brepocitinib 45 mg patients achieved at least a 10-point improvement on CSAMI-A compared to 14% of placebo patients, and 62% of brepocitinib 45 mg patients achieved CSAMI-A <5 (functional remission), compared to 0% of placebo patients. Treatment ArmMean CSAMI-A Changefrom Baseline at Week 16Achievement of CSAMI-A ≥10-point Reduction at Week 16Achievement ofCSAMI-A < 5 (FunctionalRemission) at Week 1645 mg (n = 13)-22.3100%62%15 mg (n = 11)-22.273%46%Placebo (n = 7)-0.714%0%45 mg vs. placebo∆ -21.6; P<0.0001∆ 86%; P=0.0002∆ 62%; P=0.014715 mg vs. placebo∆ -21.5; P<0.0001∆ 58%; P=0.0498∆ 46%; P=0.1013 On the Investigator’s Global Assessment (IGA), 69% of brepocitinib 45 mg patients achieved the gold standard two-point improvement to Clear (0) / Almost Clear (1), compared to 0% of placebo patients (Δ 69% P=.0047). Brepocitinib 45 mg also demonstrated statistically significant improvement over placebo on key patient reported outcomes, including the King’s Sarcoidosis Questionnaire (KSQ) Skin Domain, the Skindex-16, and the Patient’s Global Impression of Change (PGI-C). On PGI-C, 100% of patients receiving the 45 mg dose reported improvement from baseline, compared to 29% of placebo patients (Δ 71% P=.0014). Brepocitinib was well tolerated during the study treatment period, with no Serious Adverse Events (SAEs) and all Adverse Events (AEs) graded mild or moderate in severity. Brepocitinib has been evaluated in more than 1,500 patients and subjects, with an observed safety profile consistent with approved JAK1 and TYK2 inhibitors. Priovant plans to progress CS to a pivotal program with a Phase 3 study starting in calendar year 2026 following engagement with the FDA, representing the third indication with a pivotal program for brepocitinib. “The BEACON study is a watershed moment for the sarcoidosis field, and most importantly, for our patients,” said Dr. Misha Rosenbach, MD, Professor of Dermatology and Rheumatology and Director of the Cutaneous Sarcoidosis Program at the Hospital of the University of Pennsylvania. “This is an incredible milestone for a historically neglected disease – the study drug showed a clear difference in patients who received the medication compared to placebo, both from the patient and the physician perspective, and appeared to be well tolerated. This is the sort of data you dream of seeing when you look at trial results – and I would call this a transformational moment for sarcoidosis.” Recent Developments Priovant: In February 2026, Priovant announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis (CS). Brepocitinib 45 mg significantly improved CS disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 P<0.0001). Brepocitinib demonstrated rapid, deep and sustained improvements across all other efficacy endpoints measured with consistent safety profile. New Drug Application (NDA) was submitted to the FDA for brepocitinib in dermatomyositis (DM). Topline data from Phase 3 studies in non-infectious uveitis (NIU) are expected in the second half of calendar year 2026.Immunovant: Potentially registrational trial for IMVT-1402 in difficult-to-treat rheumatoid arthritis (D2T RA) fully enrolled, with topline data expected in the second half of calendar year 2026. All other clinical development timelines remain on track for IMVT-1402 across announced indications, including potentially registrational trials in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE). Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million, extending Immunovant’s cash runway to the launch of IMVT-1402 in GD.Pulmovant: Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) fully enrolled, with topline data expected in the second half of calendar year 2026.Genevant: Favorable summary judgment decision in U.S. Moderna case affirms Genevant's view of section 1498: the significant majority of liability belongs in the current case against Moderna. Jury trial in U.S. Moderna case scheduled for March 2026 and international proceedings continue with first major hearings expected in the first half of calendar year 2026.Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.5 billion as of December 31, 2025, supporting cash runway into profitability. Major Upcoming Milestones Priovant plans to progress CS to a pivotal program with a Phase 3 study starting in calendar year 2026 following engagement with the FDA, representing the third indication with a pivotal program for brepocitinib. Topline data from the Phase 3 trial of brepocitinib in NIU are expected in the second half of calendar year 2026. Roivant continues to actively explore other indications for brepocitinib.Immunovant expects to report topline data from the potentially registrational trial of IMVT-1402 in D2T RA and proof-of-concept trial of IMVT-1402 in CLE in the second half of calendar year 2026. Immunovant anticipates sharing topline data from both of its Phase 3 studies to evaluate batoclimab as a treatment for active moderate to severe thyroid eye disease (TED) in the first half of calendar year 2026. In calendar year 2027, topline data are expected across potentially registrational trials of IMVT-1402 in GD and MG.Pulmovant expects to report topline data from the ongoing Phase 2 trial of mosliciguat in PH-ILD in the second half of calendar year 2026.Genevant LNP litigation continues to progress, with summary judgment phase in the U.S. Moderna case ongoing and jury trial in the U.S. Moderna case scheduled for March 2026. First major hearings in international proceedings expected in the first half of calendar year 2026. Discovery phase of Pfizer/BioNTech case is ongoing. Third Quarter Ended December 31, 2025 Financial Summary Cash Position and Marketable Securities As of December 31, 2025, the Company had consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $4.5 billion. Research and Development Expenses Research and development (R&D) expenses increased by $23.8 million to $165.4 million for the three months ended December 31, 2025, compared to $141.6 million for the three months ended December 31, 2024. This increase was primarily driven by an increase in program-specific costs of $11.3 million and share-based compensation of $8.4 million. The $11.3 million increase in program-specific costs was primarily driven by increases of $5.7 million related to mosliciguat and $5.3 million related to brepocitinib, reflecting the progression of our programs. The $8.4 million increase in share-based compensation expense, which is an unallocated internal cost, was primarily driven by incremental share-based compensation expense as a result of the exchange of certain vested equity granted under the Priovant Holdings, Inc. (“Priovant”) 2021 Equity Incentive Plan for RSL common shares (the “Exchange Offer”). Non-GAAP R&D expenses were $146.7 million for the three months ended December 31, 2025, compared to $131.2 million for the three months ended December 31, 2024. General and Administrative Expenses General and administrative (G&A) expenses increased by $33.5 million to $175.1 million for the three months ended December 31, 2025, compared to $141.5 million for the three months ended December 31, 2024. This increase was primarily due to an impairment loss of $17.1 million related to the relocation of the U.S. corporate headquarters of Roivant Sciences, Inc. and an increase of $17.5 million in share-based compensation expense, primarily driven by the Priovant Exchange Offer. These increases were partially offset by a decrease of $5.3 million in personnel-related expense, primarily due to the conclusion of one-time cash retention awards under the Cash Bonus Program. Non-GAAP G&A expenses were $71.0 million for the three months ended December 31, 2025, compared to $71.1 million for the three months ended December 31, 2024. Income from discontinued operations, net of tax Income from discontinued operations, net of tax was $327.0 million for the three months ended December 31, 2024 and reflects the gain on sale of subsidiary interests resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon in October 2024, partially offset by Dermavant’s net losses. Loss from continuing operations, net of tax Loss from continuing operations, net of tax was $313.7 million for the three months ended December 31, 2025, compared to $208.9 million for the three months ended December 31, 2024. On a basic and diluted per common share basis, loss from continuing operations, net of tax was $0.38 and $0.22, respectively, for the three months ended December 31, 2025 and 2024. Non-GAAP loss from continuing operations, net of tax was $167.0 million for the three months ended December 31, 2025, compared to $143.7 million for the three months ended December 31, 2024. ROIVANT SCIENCES LTD.Selected Balance Sheet Data(unaudited, in thousands) December 31, 2025 March 31, 2025Cash, cash equivalents and restricted cash$1,488,770 $2,725,661Marketable securities 3,051,708 2,171,480Total assets 5,225,368 5,436,940Total liabilities 251,144 249,742Total shareholders’ equity 4,974,224 5,187,198Total liabilities and shareholders’ equity 5,225,368 5,436,940 ROIVANT SCIENCES LTD.Condensed Consolidated Statements of Operations(unaudited, in thousands, except share and per share amounts) Three Months EndedDecember 31, Nine Months EndedDecember 31, 2025 2024 2025 2024 Revenue$1,999 $9,018 $5,740 $21,483 Operating expenses: Cost of revenues 700 259 965 706 Research and development (includes $18,123 and $9,685 of share-based compensation expense for the three months ended December 31, 2025 and 2024 and $40,218 and $30,128 for the nine months ended December 31, 2025 and 2024, respectively) 165,380 141,595 482,867 405,175 General and administrative (includes $86,874 and $69,386 of share-based compensation expense for the three months ended December 31, 2025 and 2024 and $228,778 and $165,670 for the nine months ended December 31, 2025 and 2024, respectively) 175,072 141,545 452,216 444,318 Total operating expenses 341,152 283,399 936,048 850,199 Gain on sale of Telavant net assets — — — 110,387 Loss from operations (339,153) (274,381) (930,308) (718,329)Change in fair value of investments (21,592) 21,314 (130,968) (42,287)Change in fair value of liability instruments 24,416 (2,147) 47,704 (1,632)Interest income (43,266) (61,851) (136,929) (203,751)Other (income) expense, net (8,342) 2,816 8,560 7,877 Loss from continuing operations before income taxes (290,369) (234,513) (718,675) (478,536)Income tax expense (benefit) 23,332 (25,568) 34,976 (1,147)Loss from continuing operations, net of tax (313,701) (208,945) (753,651) (477,389)Income from discontinued operations, net of tax — 327,020 — 373,030 Net (loss) income (313,701) 118,075 (753,651) (104,359)Net loss attributable to noncontrolling interests (47,810) (51,306) (150,886) (138,853)Net (loss) income attributable to Roivant Sciences Ltd.$(265,891) $169,381 $(602,765) $34,494 Amounts attributable to Roivant Sciences Ltd.: Loss from continuing operations, net of tax$(265,891) $(157,639) $(602,765) $(338,691)Income from discontinued operations, net of tax — 327,020 — 373,185 Net (loss) income attributable to Roivant Sciences Ltd.$(265,891) $169,381 $(602,765) $34,494 Basic and diluted net (loss) income per common share: Basic and diluted loss from continuing operations$(0.38) $(0.22) $(0.88) $(0.46)Basic and diluted income from discontinued operations$— $0.45 $— $0.51 Basic and diluted net (loss) income per common share$(0.38) $0.23 $(0.88) $0.05 Weighted average shares outstanding: Basic 696,859,682 722,716,168 686,052,379 731,318,202 Diluted 696,859,682 722,716,168 686,052,379 731,318,202 ROIVANT SCIENCES LTD.Reconciliation of GAAP to Non-GAAP Financial Measures(unaudited, in thousands) Three Months EndedDecember 31, Nine Months EndedDecember 31, Note 2025 2024 2025 2024 Loss from continuing operations, net of tax $(313,701) $(208,945) (753,651) (477,389)Adjustments: Research and development: Share-based compensation(1) 18,123 9,685 40,218 30,128 Depreciation and amortization(2) 548 728 2,010 2,147 General and administrative: Share-based compensation(1) 86,874 69,386 228,778 165,670 Depreciation and amortization(2) 142 1,083 700 3,267 Impairment loss from relocation of Roivant Sciences, Inc.’s headquarters(3) 17,098 — 17,098 — Gain on sale of Telavant net assets(4) — — — (110,387)Other: Change in fair value of investments(5) (21,592) 21,314 (130,968) (42,287)Change in fair value of liability instruments(6) 24,416 (2,147) 47,704 (1,632)Estimated income tax impact from adjustments(7) 21,058 (34,786) 23,174 (38,976)Adjusted loss from continuing operations, net of tax (Non-GAAP) $(167,034) $(143,682) $(524,937) $(469,459) Three Months EndedDecember 31, Nine Months EndedDecember 31, Note 2025 2024 2025 2024Research and development expenses $165,380 $141,595 $482,867 $405,175Adjustments: Share-based compensation(1) 18,123 9,685 40,218 30,128Depreciation and amortization(2) 548 728 2,010 2,147Adjusted research and development expenses (Non-GAAP) $146,709 $131,182 $440,639 $372,900 Three Months EndedDecember 31, Nine Months EndedDecember 31, Note 2025 2024 2025 2024General and administrative expenses $175,072 $141,545 $452,216 $444,318Adjustments: Share-based compensation(1) 86,874 69,386 228,778 165,670Depreciation and amortization(2) 142 1,083 700 3,267Impairment loss from relocation of Roivant Sciences, Inc.’s headquarters(3) 17,098 — 17,098 —Adjusted general and administrative expenses (Non-GAAP) $70,958 $71,076 $205,640 $275,381 Notes to non-GAAP financial measures: (1) Represents non-cash share-based compensation expense. (2) Represents non-cash depreciation and amortization expense. (3) Represents a loss on impairment of the operating lease right-of-use asset and leasehold improvements for the former U.S. corporate headquarters of Roivant Sciences, Inc., following relocation to a new office space and execution of an agreement to sublease the former office space during the three months ended December 31, 2025. (4) Represents a gain on the sale of Telavant net assets to Roche due to achievement of a one-time milestone in June 2024. (5) Represents the unrealized (gain) loss on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. (6) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the loss (gain) relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (7) Represents the estimated tax effect of the adjustments. Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Friday, February 6, 2026, to report its financial results for the third quarter ended December 31, 2025, and provide a corporate update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit https://roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: InvestorsKeyur Parekhkeyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com

Clinical ResultPhase 3Phase 2Financial StatementNDA

11 Dec 2025

·investor.roivant.com

Roivant Highlights Continued Pipeline Progress and Outlook for Company’s Next Phase of Growth at 2025 Investor Day

Roivant enters new phase of corporate journey with 3+ launches, 4+ NDA/BLA filings, 8+ pivotal and 3+ proof-of-concept study readouts expected over the next three years Highlighting clinical execution, Roivant announces positive updates to timing guidance across four key programs: Brepocitinib NDA filing in dermatomyositis (DM) now expected in early calendar year 2026; commercial preparation underway with launch expected early in calendar year 2027 Brepocitinib Phase 3 trial in non-infectious uveitis (NIU) fully enrolled with topline data now expected in the second half of calendar year 2026 Brepocitinib proof-of-concept trial in cutaneous sarcoidosis (CS) fully enrolled with topline data now expected in the first half of calendar year 2026 IMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) topline data now expected in calendar year 2026 Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million, extending Immunovant’s cash runway to the launch of IMVT-1402 in Graves’ disease (GD); Roivant cash balance continues to support runway into profitability All other pipeline programs remain on track with previously communicated timelines Roivant will host our Investor Day today at 8:00 a.m. ET to discuss our progress and next chapter in detail Brepocitinib NDA filing in dermatomyositis (DM) now expected in early calendar year 2026; commercial preparation underway with launch expected early in calendar year 2027 Brepocitinib Phase 3 trial in non-infectious uveitis (NIU) fully enrolled with topline data now expected in the second half of calendar year 2026 Brepocitinib proof-of-concept trial in cutaneous sarcoidosis (CS) fully enrolled with topline data now expected in the first half of calendar year 2026 IMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) topline data now expected in calendar year 2026 BASEL, Switzerland and LONDON and NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today is hosting an Investor Day in New York City. Roivant leadership will highlight key pipeline updates and provide an update on the Company’s strategy for long-term value creation. “We are at transformational moment for Roivant. We have a unique opportunity to execute on three major potential products, each of which represents a pipeline-in-a-product opportunity, each with multiple blockbuster-potential indications. I’m proud of the clinical execution across our teams, and we have accelerated timing guidance for topline readouts in three significant programs. We have an opportunity for three meaningful first-in-class commercial launches over the next three years,” said Matt Gline, CEO of Roivant. “First among them is brepocitinib in DM, where the Phase 3 data generated earlier this year represents a significant step forward for patients in need. We remain well-positioned to generate shareholder value, and we are excited to share updates across our late-stage pipeline and long-term strategy at our Investor Day today.” Program-Specific Highlights and Updates Brepocitinib Preparation for commercial launch of brepocitinib in DM is underway; NDA filing expected in early calendar year 2026 with potential commercial launch early in calendar year 2027 Phase 3 trial for brepocitinib in NIU is fully enrolled ahead of schedule with topline data expected in the second half of calendar year 2026, previously expected in the first half of calendar year 2027 Proof-of-concept trial for brepocitinib in CS is fully enrolled ahead of schedule with topline data expected in the first half of calendar year 2026, previously expected in the second half of calendar year 2026 IMVT-1402 Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million, extending Immunovant’s cash runway to the launch of IMVT-1402 in GD Potentially registrational trial for IMVT-1402 in D2T RA topline data now expected in calendar year 2026; previously expected Period 1 data in calendar year 2026 and topline data in calendar year 2027 All other clinical development timelines remain on track, including potentially registrational trials in GD, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE) Mosliciguat Enrollment in the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track; Pulmovant plans to report topline data in the second half of calendar year 2026 Pulmovant also expects to imminently initiate a Phase 2 study (n=20) evaluating mosliciguat in combination with inhaled treprostinil in patients with PH-ILD Genevant In the US Moderna litigation, a jury trial has been scheduled for March 2026. Awaiting court scheduling in the Pfizer/BioNTech litigation Initial court hearings and rulings in the ex-US Moderna litigation expected in calendar year 2026 Investor Day Webcast Information Roivant will host an Investor Day in New York City at 8:00 a.m. ET on Thursday, December 11, 2025. The event will be webcasted for those unable to attend in person. To access the webcast, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the event. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of JAK1 and TYK2 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit https://roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: Investors Keyur Parekh keyur.parekh@roivant.com Media Stephanie Lee stephanie.lee@roivant.com

Phase 3Phase 2

17 Sep 2025

·investor.roivant.com

Roivant and Priovant Announce Positive Phase 3 VALOR Study Results for Brepocitinib in 52-Week Placebo-Controlled Trial in Dermatomyositis (DM)

Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006), even with nearly twice as many patients coming off background steroids on brepocitinib 30 mg compared to placebo More than two thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major response (TIS≥60) Consistent dose response was seen between 30 mg and 15 mg dose arms, establishing 30 mg dose as optimal in this setting Safety profile was consistent with previous clinical trials of brepocitinib and NDA filing is planned for calendar 1H 2026 Roivant will host an investor call to discuss these updates today, September 17, 2025, at 8:00 a.m. EDT BASEL, Switzerland and LONDON and NEW YORK and DURHAM, N.C., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM). On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean TIS of 46.5 compared to 31.2 for placebo (p=0.0006). A statistically significant difference between brepocitinib 30 mg and placebo on mean TIS was seen at all time points, including as early as week 4. This result represents the first ever positive outcome for a 52-week placebo-controlled trial in DM, and the first ever positive registrational trial for a targeted therapy in DM. “Dermatomyositis is an incredibly debilitating autoimmune disease for patients, and we urgently need novel, approved efficacious therapies,” said Dr. Ruth Ann Vleugels, M.D., M.P.H., M.B.A., Heidi and Scott C. Schuster Distinguished Chair in Dermatology, Founding Director of the Autoimmune Skin Disease Center and Connective Tissue Disease Clinics at Brigham and Women's Hospital and Program Director for the Dermatology-Rheumatology Fellowship at Harvard Medical School. “The VALOR study’s success represents a groundbreaking moment for the dermatomyositis field, and the results reinforce brepocitinib’s potential to serve as a deeply impactful treatment option for a substantial number of dermatomyositis patients once approved.” Brepocitinib also demonstrated clinically meaningful and statistically significant improvement over placebo on all nine key secondary endpoints. Dose-dependent response between brepocitinib 30 mg and brepocitinib 15 mg was seen consistently across the primary and secondary endpoints. Approximately 75% of patients entered the VALOR study on background steroids, with a mean baseline dose of 12.2 mg/day in the brepocitinib 30 mg arm and 11.3 mg/day in the placebo arm. Of these patients on background steroids, 62% of brepocitinib 30 mg patients achieved a steroid dose ≤2.5 mg/day by the end of the study (compared to 34% for placebo) and 42% of brepocitinib 30 mg patients were able to come off steroids altogether (compared to 23% for placebo). Even against this backdrop, clinical improvement in the brepocitinib 30 mg arm was rapid, deep, lasting and broad, both in absolute terms and relative to placebo: Brepocitinib demonstrated clinically meaningful and statistically significant improvement relative to placebo on the CDASI (skin), MMT-8 (motor strength) and HAQ-Disability Index (patient questionnaire around daily living activities requiring functional muscle strength, like getting dressed or walking up five steps). More than two-thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major response (TIS≥60); of patients who entered the trial with moderate-to-severe skin disease, 44% on brepocitinib 30 mg achieved cutaneous clinical remission by week 52, compared to 21% on placebo. Both TIS and CDASI achieved statistically significant separation from placebo as early as week 4 and sustained that separation at every assessment out to one year; median time to a TIS≥40 response was approximately 8 weeks. The observed brepocitinib 30 mg safety profile was consistent with previous brepocitinib clinical trials. Adverse events of special interest (AESIs), which included malignancy, cardiovascular events, and thromboembolic events, did not occur with greater frequency in the brepocitinib 30 mg arm than the placebo arm. “We are thrilled with the results of the VALOR study, and I would like to thank all of the patients, investigators, and study site staff who contributed to this important research achievement,” said Ben Zimmer, Priovant CEO. “We are excited to continue working towards the rapid approval of brepocitinib in dermatomyositis and our broader goal of developing brepocitinib as a transformational therapy for multiple highly morbid autoimmune diseases where the need for novel efficacious therapies is greatest.” “The VALOR study is a hallmark example of what Roivant does best: identify a high value program with a differentiated mechanism of action, focus on creative development plans in indications like DM with high unmet need, and deliver on clinical execution excellence,” said Mayukh Sukhatme, Roivant President and Chief Investment Officer. “I am extremely proud of Roivant’s continued track record with VALOR as the 12th consecutive positive Phase 3 study for the company – an unparalleled achievement and a testament to Roivant’s unrelenting focus on clinical strategy and execution.” Priovant plans to file an NDA for brepocitinib in dermatomyositis in the first half of 2026. About Dermatomyositis Dermatomyositis (DM) is a multi-organ idiopathic inflammatory condition that affects approximately 50,000 adults in the United States. DM is characterized by debilitating muscle weakness and skin lesions. DM-related muscle weakness causes significant impairment to daily living activities, such as walking up stairs, carrying groceries, and getting dressed. Dermatomyositis rashes often affect large portions of a patient's body including the scalp and are often disfiguring and painful. No targeted therapies are approved for DM, and a majority of patients require high-dose chronic oral corticosteroids. About the VALOR Study VALOR was the longest and largest interventional DM study ever conducted, enrolling 241 subjects globally. Subjects were randomized 1:1:1 to brepocitinib 30 mg, brepocitinib 15 mg and placebo, with one-year of double-blind treatment. The primary endpoint was the difference at week 52 between brepocitinib and placebo in mean Total Improvement Score (TIS), a composite endpoint of multiple measures of DM disease activity. Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. EDT on Wednesday, September 17, 2025, to discuss the Phase 3 results for brepocitinib in dermatomyositis. To access the conference call by phone, please register online using this registration link. The presentation and webcast details are available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About Priovant Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a dual selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis, and an NDA submission is planned for the first half of 2026. Brepocitinib is also being evaluated in non-infectious uveitis (Phase 3) and cutaneous sarcoidosis (Phase 2). About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit https://roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: Investors Keyur Parekh keyur.parekh@roivant.com Media Stephanie Lee stephanie.lee@roivant.com Priovant Daniel Herz Roiphe daniel.herz-roiphe@priovant.com

Clinical ResultPhase 3Phase 2

100 Deals associated with Mosliciguat

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary hypertension due to interstitial lung disease	Phase 2	United States	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	Japan	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	Argentina	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	Australia	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	Belgium	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	Brazil	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	Canada	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	Czechia	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	France	Pulmovant, Inc.	17 Jan 2025
Pulmonary hypertension due to interstitial lung disease	Phase 2	Germany	Pulmovant, Inc.	17 Jan 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2025	Phase 1	Hypertension, Pulmonary NO-nonresponsive pts with PVR≥5 Wood units	38	Mosliciguat 4mg	lavlohopcy(lvjuzlkmoi) = n=2; 5.3% gyisiyfncg (dcyluhnsko ) View more	Positive	16 May 2025
NCT03754660 (ATMOS, GlobeNewswire) Manual	Phase 1	Hypertension, Pulmonary	38	Mosliciguat 1.0 mg	caxizxcyaq(pkcyphxuko) = ltdmmemeqb pkfbfxcxqy (qpvnetpxyj )	Positive	10 Sep 2024
NCT03754660 (ATMOS, GlobeNewswire) Manual	Phase 1	Hypertension, Pulmonary	38	Mosliciguat 2.0 mg	caxizxcyaq(pkcyphxuko) = ybqviqsrvr pkfbfxcxqy (qpvnetpxyj )	Positive	10 Sep 2024

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