RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (United States)

Structure/Sequence

Molecular FormulaC17H12Cl2F3N7O2S

InChIKeyVWMJHAFYPMOMGF-ZCFIWIBFSA-N

CAS Registry1096708-71-2

Clinical Trials associated with Tovorafenib

NCT07206849

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Tovorafenib in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor Alterations in the Mitogen-Activated Protein Kinase (MAPK) Pathway

The goal of this study is to determine the efficacy of the study drugs tovorafenib to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (MAPK) that this drug targets.
The main question the study aims to answer is whether tovorafenib can prolong the life of patients diagnosed with HGG, including DIPG.

Start Date01 Nov 2026

Sponsor / Collaborator

Nationwide Children's Hospital

[+1]

CTIS2024-516896-34-00

/ RecruitingPhase 1/2IIT

Phase I/II combination umbrella trial in progressive/relapsed/refractory pediatric low-grade glioma (pLGG) (EPILOGUE)

Start Date17 Jun 2026

Sponsor / Collaborator

Universitätsklinikum Heidelberg

NCT06965114

/ RecruitingPhase 1/2IIT

A Phase 1 Study of Combination Tovorafenib (DAY101) and Rituximab Treatment in Relapsed or Refractory Classical Hairy Cell Leukemia and Phase 2 Randomized Study Comparing Tovorafenib (DAY101) and Rituximab With Cladribine and Rituximab for Front-Line Treatment of Classical Hairy Cell Leukemia

This phase I/II trial tests the safety, side effects, and effectiveness of tovorafenib in combination with rituximab in patients with classical hairy cell leukemia (cHCL) that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory) and compares the effect of tovorafenib and rituximab to current standard treatment of cladribine and rituximab in cHCL patients that have not yet received treatment. Tovorafenib blocks certain proteins made by the mutated BRAF gene, which may help keep cancer cells from growing. It is a type of kinase inhibitor. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cladribine damages the cell's deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Giving tovorafenib in combination with rituximab may be safe and tolerable and more effective than cladribine with rituximab in treating patients with untreated, recurrent or refractory cHCL.

Start Date29 May 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Tovorafenib

100 Translational Medicine associated with Tovorafenib

100 Patents (Medical) associated with Tovorafenib

Literatures (Medical) associated with Tovorafenib

01 Jun 2026·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Understanding Pharmacokinetic-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2024 to Better Manage the Risk of Drug Interactions With Concomitant Medications: A Review of Clinical Data From New Drug Applications

Review

Author: Owens, Katie ; Argon, Sophie ; Yu, Jingjing ; Ragueneau-Majlessi, Isabelle ; Wang, Yan

Objective:

This analysis aimed to provide a mechanistic understanding and an evaluation of the clinical relevance of pharmacokinetic drug-drug interactions (DDIs) associated with drugs approved by the Food and Drug Administration in 2024.

Methods:

Drug metabolism, transport, and absorption-based DDI data available in New Drug Applications (NDAs) of small molecular drugs approved (n = 34) was analyzed. The mechanism and clinical outcome of these interactions were characterized based on in vitro, in silico, and clinical data.

Results:

As objects, 11 drugs were identified as clinical substrates. Of these, 7 drugs were substrates of CYP3A, 3 of CYP2C9, one of CYP1A2, and one of CYP2C8, including the sensitive substrates vanzacaftor (CYP3A) and vorasidenib (CYP1A2). As precipitants, 6 drugs (acoramidis, cefepime/enmetazobactam, givinostat, lazertinib, mavorixafor, and resmetirom) were clinical inhibitors of CYP enzymes (2C8, 2C9, 2D6, 2E1, and 3A), with mavorixafor being a CYP2D6 strong inhibitor. Two drugs (elafibranor and tovorafenib) showed weak induction of CYP3A. Regarding transporter data, 3 drugs were substrates of transporters, including seladelpar (BCRP and OAT3), sulopenem (OAT3), and vadadustat (OAT1/3), and 8 drugs (arimoclomol, danicopan, givinostat, lazertinib, mavorixafor, resmetirom, vadadustat, and vazacaftor/tezacaftor/deutivacaftor) were inhibitors of transporters. All clinical DDIs with AUC changes ≥ 2-fold triggered labeling recommendations. Several DDIs with an AUC change <2 also had labeling recommendations, pertaining most often to the concomitant use of drugs with a narrow therapeutic index.

Conclusions:

Mechanistic DDI insights from newly approved therapies can be extrapolated to inform the management of commonly co-administered drugs, supporting a safer and more effective use of new drug products in the context of polypharmacy.

01 Apr 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Harnessing retinoic acid metabolism-related genes to identify lung adenocarcinoma subtype and establish a risk model for predicting prognosis and drug therapy response

Article

Author: Xu, Li ; Zhang, Weichu ; Zheng, Danting

BACKGROUND:

The metabolism of retinoic acid (RA) is associated with the progression of lung adenocarcinoma (LUAD), but the relationship between RA metabolism-related genes (RAMRGs) and LUAD prognosis remains unclear.

OBJECTIVES:

The goal of this study was to develop and validate a prognostic model based on RAMRGs for LUAD patients.

METHODS:

LASSO-Cox and multivariate Cox regression analyses were undertaken, with data from TCGA-LUAD used to identify RAMRGs to create a prognostic model and data from the GEO-LUAD cohort utilized to validate the model. The predictive ability of the model was further evaluated using the nomogram. In addition, functional enrichment analysis, immunological characteristics analysis, and sensitivity analysis of chemotherapy drugs were performed.

RESULTS:

A novel prognostic model containing 10 RAMRGs (CCDC17, CLCA1, CYP17A1, FETUB, IGF2BP1, IGFBP1, KCNB2, NTSR1, RPE65, and VGF) was established. The reliable prediction performance of this model in LUAD patients was verified. The DEGs in high-risk and low-risk groups were involved in neural activity of ligand-receptor interaction, Neutrophil extracellular trap formation, and metabolism of xenobiotics by cytochrome P450. The low-risk group had a higher abundance of aDCs, iDCs, Mast_cells, and Neutrophils, and had a higher chance of benefiting from immunotherapy. In both groups, TP53 showed the highest mutation rates, with the high-risk group exhibiting a higher rate than the low-risk group (60 % vs. 39 %). In addition, Dabrafenib, ARQ-680, Vemurafenib, BGB-283, and MLN-2480 were potential therapeutic drugs for LUAD.

CONCLUSION:

RAMRGs serve as useful biomarkers to predict prognosis in LUAD patients, and may guide the immunotherapy regimen.

26 Dec 2025·Neuro-Oncology Practice

Clinical experience with tovorafenib in adults with treatment-refractory high- and low-grade gliomas

Article

Author: Devkota, Anirudra ; Schreck, Karisa C ; Bagley, Stephen J ; Welch, Mary R ; Ioannou, Maria ; Holdhoff, Matthias ; Justin, Jordan T ; Ozer, Byram H ; Mehta, Setu ; Romo, Carlos G

Abstract:

Background:

BRAF alterations are common in pediatric low-grade gliomas (LGG) and a subset of high-grade gliomas (HGG) in adults and children. BRAF-targeted therapy can be effective at preventing tumor growth, though resistance commonly emerges in HGG. Recently, tovorafenib was FDA approved for recurrent or refractory LGG with BRAFV600 alterations or BRAF rearrangements. While the trial showed it is effective for children with LGG previously treated with BRAF or MEK inhibitors, the safety in adults and efficacy in HGG is unknown.

Methods:

A cohort of appropriate patients was identified through routine clinical care. This research was conducted in accordance with IRB regulations with a waiver of written consent.

Results:

Seven adults (5 HGG, 2 LGG) who received tovorafenib were identified. All patients had received prior BRAF-targeted therapy, and all patients with HGG had received prior radiation and temozolomide as well. Three individuals (2 HGG, 1 LGG) experienced stable disease or better for 4 or more months. Median duration of treatment was 8 weeks (range 3 weeks to 10 months). Two individuals experienced CTCAE grade 4 intratumoral hemorrhage (1 HGG, 1 LGG). Two patients remain on therapy at 4 and 10 months of treatment (1 HGG, 1 LGG).

Conclusion:

Our experience with tovorafenib indicates some limited efficacy in HGG in combination with other standard treatments. These observations demonstrate the need for further clinical trials in patients with HGG to understand potential clinical utility, either earlier in the disease course or in combination with other therapies.

174

News (Medical) associated with Tovorafenib

28 Jul 2026

·www.globenewswire.com

Bicara Therapeutics Announces Appointments of Jeremy Bender and Christy Oliger to Board of Directors

BOSTON, July 28, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the appointments of Jeremy Bender, Ph.D., MBA and Christy Oliger to its Board of Directors. Dr. Bender, who most recently served as Chief Executive Officer at Day One Biopharmaceuticals through its acquisition by Servier in 2026, brings more than 20 years of corporate strategy and operating experience in biotechnology to Bicara. Ms. Oliger brings more than 30 years of commercial and operating experience in global biopharmaceutical organizations, having most recently served as Senior Vice President of the Oncology Business Unit at Genentech. "We are delighted to welcome Jeremy and Christy to our Board of Directors at this pivotal time for Bicara. Together, they bring deep commercial, strategic, and operational expertise that will be invaluable as we continue our evolution from a clinical-stage organization to one focused on successfully delivering ficerafusp alfa to patients,” said Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics. “Each of these distinguished professionals has an established track record of guiding innovative biopharmaceutical companies through critical stages of growth, including pipeline development, corporate strategy, and commercialization. Their perspectives will strengthen our Board as we advance our portfolio, execute on our long-term vision, and continue building Bicara into a mature biopharmaceutical organization.” In addition, Kiran Mazumdar-Shaw has retired from Bicara’s Board of Directors. "As one of our founding Board members, Kiran has been instrumental in shaping Bicara from its earliest days. Her impact extends beyond the initial seed capital that helped launch the company, but also the strategic guidance and steadfast support that has enabled Bicara to advance ficerafusp alfa into the clinic and reach the important milestone of a registration-enabling clinical study,” said Mike Powell, PhD, Chairman of Board of Bicara Therapeutics. “On behalf of the Board, management team, and Bicara employees, I want to thank Kiran for her vision, leadership, and indelible contributions to Bicara.” About Jeremy Bender, Ph.D., MBADr. Bender most recently served as Chief Executive Officer, President and a member of the Board of Directors of Day One Biopharmaceuticals, Inc. from September 2020 to April 2026, where he led the company through its evolution into a commercial-stage oncology company, including the approval and launch of OJEMDA® for pediatric low-grade glioma and the company's approximately $2.5 billion acquisition by Servier in 2026. Prior to joining Day One, Dr. Bender was Vice President of Corporate Development at Gilead Sciences, Inc., a pharmaceutical company, from March 2018 to September 2020. Prior to that, he was Chief Operating Officer of Tizona Therapeutics, Inc. from July 2015 to March 2018 and Chief Business Officer of Sutro Biopharma, a biotechnology company specializing in cancer and autoimmune therapeutics, from October 2012 to July 2015. Prior to joining Sutro Biopharma, Inc., he was Vice President of Corporate Development at Allos Therapeutics Inc., a biotechnology company focused on cancer treatments, from January 2006 to September 2012. Dr. Bender began his career in the life sciences practice at Boston Consulting Group, a management consulting company. Dr. Bender also sits on the boards of Mereo BioPharma Group plc and Aura Biosciences, Inc. From October 2023 to June 2024, Dr. Bender also served as a director of Fusion Pharmaceuticals, Inc., a biopharmaceutical company. Dr. Bender holds a B.S. in Biological Sciences from Stanford University, a Ph.D. in Microbiology and Immunology from the University of Colorado, and an MBA from the MIT Sloan School of Management. About Christy OligerMs. Oliger is recognized for building industry leading capabilities and teams and was the Senior Vice President, Business Unit Head for Oncology and Genentech from 2017-2020, managing a portfolio of 15 products, contributing U.S. revenue exceeding $13 billion, delivering launches in lung cancer, breast cancer, chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), melanoma and leading an organization of more than 800 people. Prior to this role, Ms. Oliger served as Senior Vice President and Business Unit Head, Neurology, Rare Disease, Infectious disease where she was responsible for building the teams and driving successful launches in multiple sclerosis (MS) (Ocrevus®), hemophilia (Hemlibra®) and spinal muscular atrophy (SMA) (Evrysdi®), together the most significant growth drivers in the U.S. business. Prior to these roles, she spent three years as Global Head of Portfolio and Project Management where her team was responsible for the Late-Stage Portfolio Committee comprised of a late-stage development portfolio of greater than 300 projects across multiple therapeutic areas. Christy began her career in life sciences at Schering Plough, a pharmaceutical company. In addition to Bicara, Christy also currently sits on the boards of Vera Therapeutics, Karyopharm Therapeutics, and Replimune Inc. She previously served as a director at Nuvalent Inc. prior to acquisition by GSK, Sierra Oncology prior to acquisition by GSK, Reata Pharmaceuticals prior to acquisition by Biogen, Rayze Bio prior to acquisition by BMS, and Lava Oncology prior to acquisition by Xoma Therapeutics. She holds a B.A. in Economics from University of California, Santa Barbara. About Bicara Therapeutics Bicara is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara has built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This approach was deployed in the development of Bicara’s lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor (EGFR) directed monoclonal antibody bound to a human transforming growth factor beta (TGF-β) ligand trap. By combining these two clinically validated targets, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment (TME). Ficerafusp alfa directs the TGF-β inhibitor into the immediate TME through the binding of EGFR on tumor cells, which Bicara believes will lead to deep and durable responses and an increase in overall survival, while reducing the potential adverse effects previously associated with systemic TGF-β inhibition. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all contain identifying words. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding Bicara’s strategy, business plans and focus; the clinical development of ficerafusp alfa, including planned and ongoing clinical trials; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability; Bicara’s ability to scale and prepare for potential commercialization of ficerafusp alfa; the potential for U.S. regulatory approval and launch of ficerafusp alfa; and anticipated contributions of members of Bicara’s Board of Directors. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks relating to Bicara’s research and development activities; Bicara’s ability to execute on its business plans and strategy, including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to the clinical development of ficerafusp alfa; the Company’s dependence on third parties; risks related to the Company’s financial condition and need for additional funds in order to commercialize ficerafusp alfa, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Bicara’s intellectual property protections; and risks related to the competitive landscape for ficerafusp alfa; as well as other risks described in “Risk Factors,” in Bicara’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Bicara’s subsequent filings with the U.S. Securities and Exchange Commission (SEC). In addition, any forward-looking statements represent Bicara’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Bicara intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. Contacts InvestorsRachel Frank IR@bicara.com MediaTim PalmerTim.Palmer@bicara.com

Executive ChangeAcquisition

15 Jul 2026

·www.einpresswire.com

PNOC Foundation Appoints Biopharma Executive Jeremy Bender to Its Board of Directors

Biopharma leader and longtime PNOC collaborator Jeremy Bender, brings firsthand experience turning pediatric brain cancer research into approved treatments SAN FRANCISCO, CA, UNITED STATES, July 15, 2026 / EINPresswire.com / -- Jeremy Bender , Ph.D., MBA, a senior biopharmaceutical executive with more than 25 years of drug development and corporate leadership experience, has joined the Board of Directors of PNOC Foundation, the national fundraising partner for the Pediatric Neuro-Oncology Consortium (PNOC). Bender most recently served as CEO of Day One Biopharmaceuticals (NASDAQ: DAWN), where he led the team that worked directly with PNOC's scientific leadership on the clinical trials behind the FDA's accelerated approval of tovorafenib (OJEMDA™)—a targeted therapy for BRAF-altered pediatric low-grade glioma and the first FDA approval for a pediatric brain cancer treatment in more than 50 years. Day One was subsequently acquired by Servier Pharmaceuticals in April 2026. "Working alongside PNOC's researchers on clinical trials of tovorafenib gave me a firsthand view of the success that can be achieved when committed people and organizations collaborate to create new medicines for children living with cancer," said Bender. "Joining the board is an opportunity to help sustain and expand the work that gives children with brain tumors new potential therapies and hope for a brighter and longer future." Prior to Day One, Bender served as Vice President of Corporate Development at Gilead Sciences, leading transactions totaling more than $10 billion. He holds a Ph.D. in Microbiology and Immunology from the University of Colorado School of Medicine, an MBA from MIT Sloan, and a B.S. in Biological Sciences from Stanford University. He and his wife, Melissa, have been longstanding philanthropic supporters of PNOC Foundation. "Jeremy has been part of PNOC's story in a real way—as a clinical partner and as a supporter," said Bruce Campbell, PNOC Foundation Co-Founder. "His experience taking a treatment from trial to FDA approval, in direct collaboration with the PNOC team, brings a depth of understanding that is rare and invaluable." Bender's appointment further strengthens the board driving PNOC Foundation's Lose No Child campaign, a global push to ensure no child loses their life to a brain tumor. ABOUT PNOC FOUNDATION: PNOC Foundation is a platinum-rated non-profit dedicated to supporting advancements in childhood brain cancer research. PNOC Foundation’s vision is to lose no child to brain cancer, and to improve the quality of life for those fighting and surviving pediatric brain cancer. Since its inception in 2012, PNOC has pushed beyond older paradigms and historic trial designs, expanding nationally and globally to accelerate clinical trial completion and find cures faster. Through their cooperative open-source network, PNOC is fostering worldwide collaboration with the world’s leading pediatric brain tumor specialists. PNOC has grown from a 7-member group along the West Coast to a global consortium with 43 participating sites, funded largely by philanthropy. Visit https://www.pnocfoundation.org/ for more information. Adam Eversole, Director of Development PNOC Foundation +1 513-673-1170 adam@pnocfoundation.org Visit us on social media: LinkedIn Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Executive ChangeDrug Approval

14 Jul 2026

·www.biospace.com

Ligand Completes Acquisition of XOMA Royalty, Creating a Portfolio of More than 200 Biopharmaceutical Royalty Assets

Acquisition adds seven commercial products including VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), and MIPLYFFA® (arimoclomol), and more than 100 development and commercial-stage assets, creating long-term opportunities to drive growth Ligand to provide updated 5-year outlook during Investor Day on December 8, 2026 JUPITER, Fla., July 14, 2026 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced it has completed its acquisition of XOMA Royalty Corporation (“XOMA Royalty”), a biotechnology royalty aggregator, for $39.00 per share of common stock in cash, for a total equity value of approximately $739 million. XOMA Royalty stockholders also received one non-transferable Contingent Value Right (“CVR”) per share entitling the holder to receive a portion of 75% of the net proceeds that may result from certain pending litigation at XOMA Royalty. “At Ligand, we are focused on building a diversified portfolio of high-value royalty assets tied to innovative medicines that have the potential to improve patient outcomes around the world,” said Todd Davis, CEO of Ligand. “Over the past several years, we have executed a disciplined strategy to expand, diversify and strengthen our royalty portfolio, and the acquisition of XOMA Royalty meaningfully advances that vision. This transaction adds exposure to high-quality commercial and development-stage assets and enhances our ability to generate durable, long-term shareholder value, marking an important milestone in our evolution as a leading biopharmaceutical royalty aggregator.” This acquisition strengthens Ligand’s royalty portfolio by adding seven commercial products, including Roche’s VABYSMO® (faricimab-svoa), Servier’s OJEMDA™ (tovorafenib), and Zevra Therapeutics’ MIPLYFFA® (arimoclomol). Additionally, it includes 14 late-stage development programs, featuring Takeda’s mezagitamab and certain assets from Takeda’s externalized asset portfolio, such as osavampator, volixibat, and OHB-607, along with more than 100 assets in various stages of development. As a result, Ligand’s portfolio has more than doubled in size, now comprising over 200 commercial, clinical, and preclinical stage royalty assets. The closing of the transaction met Ligand’s original timeline expectations. The transaction is expected to be immediately accretive and to add approximately $0.50 and $1.50 per share to Ligand’s projected 2026 and 2027 adjusted earnings per share 1 , respectively. Ligand will provide an updated 5-year outlook during the Company’s Investor Day on December 8, 2026. In connection with the completion of the transaction, XOMA Royalty common stock ceased trading on The Nasdaq Global Market. Advisors Stifel served as lead financial advisor, Citi served as financial advisor, Paul Hastings LLP served as legal advisor, and Collected Strategies served as strategic communications advisor to Ligand. Leerink Partners served as lead financial advisor, H.C. Wainwright & Co. served as financial advisor, and Gibson, Dunn & Crutcher LLP served as legal advisor to XOMA Royalty. About Ligand Ligand is a leading royalty aggregator, partnering with biopharmaceutical companies to finance and advance late-stage clinical development programs. Ligand owns and manages one of the largest and most diversified portfolios of biopharmaceutical royalties in the industry, with economic interests in more than 200 development and commercial-stage assets. Ligand funds high-value programs in exchange for long-term economic interests, aligning capital with clinical and commercial success. Ligand’s royalty portfolio is designed to deliver consistent and predictable revenue streams across a broad range of therapeutic assets. Ligand also licenses its proprietary technologies, Captisol® and NITRICIL™, to support drug development and formulation across its global partner network. For more information, visit or follow Ligand on X and LinkedIn . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including information about, among other topics, Ligand’s acquisition of XOMA Royalty, Ligand’s and XOMA Royalty’s products pipeline and the substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; the risk that XOMA Royalty stockholders may receive no payment with respect to the CVRs; disruption from the transaction making it more difficult to maintain business and operational relationships, including the ability to attract and retain highly qualified management and other clinical and scientific personnel; negative effects of this announcement or the completion of the acquisition on the market price of Ligand’s common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the acquisition of XOMA Royalty’s business; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Ligand’s business and prospects, adverse developments in Ligand’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment, tariffs and other trade policies or economies generally; future business combinations or disposals; uncertainties regarding the commercial success of commercialized and/or pipeline products; risks associated with drug development; Ligand’s reliance on collaborative partners for milestone payments, royalties, materials revenue, contract payments and other revenue projections, which may not be received; the uncertainties inherent in research and development, including the ability of Ligand’s partners to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical trials conducted by Ligand’s partners; whether and when drug applications may be filed in any jurisdictions for pipeline products for any potential indications by Ligand’s partners; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such products will be commercially successful; and decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of such products. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the businesses of Ligand and XOMA Royalty described in the “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” (in the case of Ligand) and “Forward Looking Statements” (in the case of XOMA Royalty) sections of their respective Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed by either of them from time to time with the U.S. Securities and Exchange Commission (the “SEC”), all of which are available at . These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ligand assumes no obligation to, and does not intend to, update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. Ligand gives no assurance that it will achieve its expectations. Contacts Investors: Melanie Herman investors@ligand.com (858) 550-7761 Media: Nick Lamplough/Jude Gorman Ligand-CS@collectedstrategies.com (917) 885-1013 1 The financial outlook, expectations and other forward-looking statements provided by Ligand for 2026 and beyond reflect Ligand's judgment based on the information available at the time of this release. Please see the Forward-looking Statements section in this release for factors that may impact Ligand's ability to meet expectations. In reliance upon Item 10(e)(1)(i)(B) of Regulation S-K, reconciliations of forward-looking core adjusted earnings per diluted share for 2027 is not provided because of the unreasonable effort associated with providing such reconciliations due to the variability in the occurrence and the amounts of certain components thereof. For the same reasons, we are unable to address the significance of the unavailable information, which could be material to future results.

100 Deals associated with Tovorafenib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15266

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
BRAF fusion or rearrangement postive low-grade glioma	United States	Day One Biopharmaceuticals, Inc.	23 Apr 2024
BRAF V600 mutation low-grade glioma	United States	Day One Biopharmaceuticals, Inc.	23 Apr 2024
Low grade glioma	United States	Day One Biopharmaceuticals, Inc.	23 Apr 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	NDA/BLA	Canada	Ipsen Biopharmaceuticals, Inc.	01 Oct 2025
BRAF V600E mutation-positive low grade glioma	Phase 2	-	Day One Biopharmaceuticals, Inc.	01 Nov 2026
Brain metastases	Phase 2	-	Day One Biopharmaceuticals, Inc.	01 Nov 2026
Diffuse Intrinsic Pontine Glioma	Phase 2	-	Day One Biopharmaceuticals, Inc.	01 Nov 2026
High grade glioma	Phase 2	-	Day One Biopharmaceuticals, Inc.	01 Nov 2026
WHO Grade III Mixed Glioma	Phase 2	-	Day One Biopharmaceuticals, Inc.	01 Nov 2026
Hairy Cell Leukemia	Phase 2	United States	National Cancer Institute	29 May 2026
Refractory Langerhans Cell Histiocytosis	Phase 2	United States	National Cancer Institute	28 Mar 2024
Refractory Langerhans Cell Histiocytosis	Phase 2	Australia	National Cancer Institute	28 Mar 2024
Refractory Langerhans Cell Histiocytosis	Phase 2	Canada	National Cancer Institute	28 Mar 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04775485 (FIREFLY-1, Company_Website) Manual	Phase 2	BRAF V600 mutation low-grade glioma BRAF Fusion \| BRAF Rearrangement	137	Tovorafenib (efficacy analyses)	osmzjunpne(hykhxcyfhs) = cnrbyychri wmaurcihnm (gxzgacnqzx ) View more	Positive	27 Feb 2026
NCT04775485 (FIREFLY-1, Company_Website) Manual	Phase 2		137	Tovorafenib (safety data)	-	Positive	27 Feb 2026
NCT04775485 (FIREFLY-1, GlobeNewswire) Manual	Phase 2	BRAF V600 mutation low-grade glioma \| BRAF fusion or rearrangement postive low-grade glioma BRAF Mutation \| BRAF Fusion	137	OJEMDA (tovorafenib)	ynnaexbprb(tfgktgdpmb) = lrafzowqwf dsddendwhk (udysbqxyzq ) View more	Positive	24 Nov 2025
NCT04775485 (FIREFLY-1, GlobeNewswire) Manual	Phase 2		137	OJEMDA (tovorafenib) (Exploratory analyses：entered a treatment-free observation period)	ysoipmjdil(brdtzzzkkx) = bphrntelml txsqquxpoc (goagxjwywo ) View more	Positive	24 Nov 2025
NCT04985604 (CTgov)	Phase 2	Relapsed Solid Neoplasm \| BRAF Fusion Glioma \| Urothelial Carcinoma of the Urinary Bladder ... View more	23	Tovorafenib (Melanoma Cohort)	bvmgnubagi = kdmpbponni fzdynlwogc (kjhqdblsxp, becqaaikfs - oyrdcwfsmf) View more	-	02 Oct 2025
NCT04985604 (CTgov)	Phase 2		23	Tovorafenib (Tissue Agnostic Cohort)	bvmgnubagi = udbnwflayj fzdynlwogc (kjhqdblsxp, ohjvsmfobg - anykyggqnv) View more	-	02 Oct 2025
NCT03429803 \| NCT04775485 \| NCT05760586 (ASCO2025)	Phase 1/2	Locally Advanced Malignant Solid Neoplasm \| Advanced Malignant Solid Neoplasm \| BRAF V600 mutation low-grade glioma ... BRAF View more	167	Tovorafenib	tobomrkyez(hogxllybbp) = ajdqgcslta sjxhemadks (vzgcchttoq, 0.4 - 2.2)	-	30 May 2025
NCT04775485 (FIREFLY-1, ASCO2025)	Phase 2	BRAF V600 mutation low-grade glioma BRAF-altered	137	Tovorafenib	cmhrbtkaps(txjnsyfblv) = nkvgtdomuv watcweqhso (wxoyhinfvc ) View more	-	30 May 2025
NCT04985604 (ESMO2024)	Phase 2	Solid tumor \| Melanoma recurrent	-	Tovorafenib 600 mg	fwvllkpnib(nayjjmmqpy) = 39% nofaovjqyk (bsldjrbkbw ) View more	-	14 Sep 2024
NCT03429803 (ASCO2024) Manual	Phase 1	Low grade glioma MAPK pathway activated	35	Tovorafenib 530 mg/m2	jaalibyaqc(uydvrcnuop) = wdwemohtys alyidkostd (ndereosenh ) View more	Positive	24 May 2024
NCT04775485 (FIREFLY-1, FDA_CDER) Manual	Phase 2	BRAF V600 mutation low-grade glioma \| BRAF fusion or rearrangement postive low-grade glioma BRAF Rearrangement \| BRAF V600E	137	OJEMDA	xxkwaliayb(kkzllmuaro) = ekfyotktzb jrkixygolu (havbzecuam, 40 - 63) View more	Positive	23 Apr 2024
NCT04775485 (FIREFLY-1, SNO2023)	Phase 2	Low grade glioma BRAF	136	Tovorafenib 420 mg/m2	myxsnzngzl(mznjujwvgw) = qydxywbujp hysgqqhcbt (kyfykfkefi )	Positive	10 Nov 2023
NCT04775485 (FIREFLY-1, SNO2023)	Phase 2	Low grade glioma BRAF	136	MAPK inhibitor therapy	myxsnzngzl(mznjujwvgw) = jhdknkquwn hysgqqhcbt (kyfykfkefi )	Positive	10 Nov 2023
NCT04775485 (FIREFLY-1, SNO2023)	Phase 2	Optic Nerve Glioma BRAF V600E mutation	77	Tovorafenib 420 mg/m2 weekly	qkhzkezzci(paoihlblwd) = xwqoeqywcy tbsnznpasc (sasivcpgjg ) View more	Positive	10 Nov 2023

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