RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Rare Pediatric Disease (United States), Priority Review (United States), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC17H12Cl2F3N7O2S

InChIKeyVWMJHAFYPMOMGF-ZCFIWIBFSA-N

CAS Registry1096708-71-2

Clinical Trials associated with Tovorafenib

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 Date27 Jun 2026

Sponsor / Collaborator

National Cancer Institute

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 Mar 2026

Sponsor / Collaborator

Nationwide Children's Hospital

ChiCTR2600117584

/ Not yet recruitingPhase 2IIT

Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab-Tuvorilimab for Advanced Gallbladder Cancer

Start Date01 May 2025

Sponsor / Collaborator

Xinhua Hospital

100 Clinical Results associated with Tovorafenib

100 Translational Medicine associated with Tovorafenib

100 Patents (Medical) associated with Tovorafenib

Literatures (Medical) associated with Tovorafenib

01 Jan 2026·CNS DRUGS

New and Emerging Therapies for Patients with Low-Grade Glioma

Review

Author: Peters, Katherine B

Both pediatric and adult patients can develop low-grade glioma (World Health Organization [WHO] grade 2), a type of primary brain tumor that can impact neurologic function and limit one's ability to thrive and survive. Traditionally, the treatment of low-grade gliomas mirrored recommendations for patients with higher-grade gliomas, such as glioblastoma. The diagnosis and categorization of primary brain tumors, including low-grade gliomas, were transformed in 2021 with an update of the World Health Organization classification system for pediatric and adult diffuse gliomas. In the pediatric population, there is recognition that a majority of low-grade gliomas have alterations in the mitogen-activated protein kinase (MAPK) pathway (BRAF mutations and rearrangements and other alterations in genes in this pathway); whereas in the adult population, mutations in isocitrate dehydrogenase (IDH), a key enzyme of the Krebs cycle, define diffuse low-grade glioma, namely oligodendroglioma and astrocytoma. Parallel to the advancements in diagnosis and tumor classification, the treatment has advanced to develop targeted therapies for patients with diffuse low-grade glioma. This review will highlight the molecular and genetic underpinnings of these tumors and how targeted therapeutic strategies led to the US Food and Drug Administration's approvals of combination therapy with dabrafenib and trametinib for pediatric patients with BRAF V600E mutant low-grade glioma; tovorafenib, a pan-RAF inhibitor, for pediatric BRAF mutant glioma; and vorasidenib, an inhibitor of mutant IDH1/2 enzymes, for patients with mutant IDH low-grade glioma. Integration of these targeted therapies into currently accepted treatment paradigms remains to be fully understood, along with the long-term impact on patient quality of life and prognosis.

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.

01 Dec 2025·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Identification of different lung adenocarcinoma subtypes in combination with antidiuretic hormone-related genes and creation of an associated index to predict prognosis and guide immunotherapy

Article

Author: Dai, Hong ; Lv, Yuankai ; Zheng, Hao ; Cai, Xiaoping

BACKGROUND:

Lung adenocarcinoma (LUAD) is one of the most aggressive and rapidly lethal tumor types. Previous studies have demonstrated the involvement of antidiuretic hormone (ADH)-related genes in cancer. However, the role of ADH-related genes in LUAD remains unclear. Therefore, investigating the characteristics of these genes in LUAD is essential.

METHODS:

Differentially expressed genes (DEGs) associated with ADH in LUAD were identified using the STRING database. Consensus clustering was performed, and a protein-protein interaction network was constructed for the DEGs between subtypes. Genes extracted from the PPI network underwent univariate, LASSO, and multivariate Cox regression analyses to develop a predictive model for LUAD. A nomogram integrating clinical data and risk scores was created, and its prognostic power for overall survival (OS) in LUAD patients was evaluated. Additionally, LUAD patients were analyzed for targeted therapies, immune landscape, functional enrichment, and mutation profiles. Finally, qRT-PCR was used to examine the expression of signature genes in LUAD cells.

RESULTS:

Based on ADH-related DEGs, LUAD patients were stratified into two clusters (Cluster 1 and Cluster 2) with distinct survival outcomes. A predictive model incorporating nine feature genes was subsequently constructed using DEGs from these two subtypes. The receiver operating characteristic curve demonstrated the model's prognostic accuracy in predicting OS in LUAD patients. Compared to the high-risk group, patients in the low-risk group exhibited higher immune infiltration levels and immunophenoscore, along with lower tumor immune dysfunction and exclusion scores. Enrichment analysis revealed that immune response pathways and ligand-receptor interactions were the primary functional categories distinguishing the high- and low-risk groups. The low-risk group showed a significantly lower gene mutation burden. Drug sensitivity analysis identified several potential targeted therapies, including Dabrafenib, ARQ-680, Vemurafenib, BGB-283, MLN-2480, and GDC-0994, which might act on hub genes. qRT-PCR validation confirmed that DNAH12 was significantly downregulated in tumor tissues, while DKK1, DLX2, IGFBP1, NTSR1, RPE65, and VGF were markedly upregulated.

CONCLUSION:

This study provided potential prognostic biomarkers for LUAD and might facilitate the development of effective immunotherapy strategies for LUAD patients.

137

News (Medical) associated with Tovorafenib

12 Jan 2026

·www.biospace.com

Day One Announces Preliminary 2025 OJEMDA™ Net Product Revenue And Provides 2026 Net Product Revenue Guidance

Preliminary 2025 net product revenue of $155.4 million, representing 172% year-over-year growth; OJEMDA 2026 U.S. net product revenue projected to be $225 - $250 million Company to present on corporate progress and priorities for 2026 during J.P. Morgan Healthcare Conference, January 12th at 5:15 pm PT (8:15 pm ET) BRISBANE, Calif., Jan. 11, 2026 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the release of preliminary unaudited 2025 OJEMDA™ net product revenue, cash and investments at year-end and provided 2026 OJEMDA net product revenue guidance ahead of the company’s scheduled presentation tomorrow at the 44th Annual J.P. Morgan Healthcare Conference at 5:15 pm PT (8:15 pm ET). “Following remarkable commercial and clinical progress in 2025 and the strategic acquisition of Mersana and our new pipeline program Emi-Le (emiltatug ledadotin), we’re entering 2026 poised to deliver on our mission and on our growth aspirations,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “I’m thrilled by the steady uptake of OJEMDA in relapsed or refractory pLGG, and by the opportunities for future patient impact we expect from the clinical data for OJEMDA in front line pLGG and for Emi-Le and DAY301. Our solid financial position will continue to enable us to invest in future programs that have strong potential to become important new medicines.” 2025 OJEMDA Commercial Performance OJEMDA net product revenue was approximately $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively (unaudited) ~37% QoQ growth compared to Q3 2025; ~172% YoY growth vs. 2024, driven by momentum in patient demand, with prescription volumes increasing to 1,394 during the fourth quarter 2026 OJEMDA U.S. net product revenue is projected to be between $225 million and $250 million, representing 53% year-over-year growth at the midpoint 2026 Corporate Priorities and Key Milestones OJEMDA Deliver on 2026 OJEMDA net product revenue guidance, with a focus on increasing persistency and driving new patient starts to support continued OJEMDA adoption as standard of care (SOC) in 2L pediatric low-grade glioma (pLGG) Extend the OJEMDA commercial opportunity beyond the U.S. with global expansions via our partner Complete enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pLGG in the first half of 2026, enabling a mid-2027 data readout and a potential approval in 2028 PIPELINE Advance Emi-Le program by delivering Phase 1 clinical data by mid-2026 and progressing toward registration Provide initial data from the Phase 1a clinical trial for DAY301, a PTK7-targeted antibody drug conjugate (ADC), in the second half of 2026 Corporate Update As of December 31, 2025, prior to the acquisition of Mersana, Day One had approximately $441.1 million of cash, cash equivalents, and short-term investments (unaudited). The 2025 net product revenues and cash, cash equivalents and short-term investments position included in this release are preliminary and are therefore subject to adjustment. The preliminary net product revenue results are based on management’s initial analysis of operations for the year ended December 31, 2025. The Company expects to issue full financial results for the fourth-quarter and full-year 2025 in February 2026. J.P. Morgan Presentation Details Dr. Jeremy Bender, chief executive officer, will present during the 44 th Annual J.P. Morgan Healthcare Conference on Monday, January 12 at 5:15 pm PT (8:15 pm ET). A live audio webcast of the presentation will be available by visiting the Events & Presentations section of the Company’s website at An archived replay of the webcast will be available for 30 days following the live presentation. About Day One Biopharmaceuticals Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One. Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™), DAY301, and following the recently announced acquisition of Mersana Therapeutics, Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) targeting the B7-H4 protein in clinical development to treat the rare cancer adenoid cystic carcinoma (ACC). Day One is based in Brisbane, California. For more information, please visit or find the Company on LinkedIn or X . Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s ability to grow revenue from OJEMDA, plans to develop and commercialize cancer therapies and its pipeline and the impact of Emi-Le and DAY301, and statements regarding its net product revenues, cash, cash equivalents and short-term investments. Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including risks related to the ability to realize the anticipated benefits of the Mersana 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; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the consummation of the acquisition on the market price of Day One’s common stock and/or operating results; significant transaction costs; unknown liabilities, Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, government shutdowns, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law. DAY ONE MEDIA media@dayonebio.com DAY ONE INVESTORS LifeSci Advisors, PJ Kelleher pkelleher@lifesciadvisors.com

Phase 1AcquisitionFinancial StatementADCPhase 3

08 Jan 2026

·www.globenewswire.com

Day One Completes Acquisition of Mersana Therapeutics

Acquisition expands Day One’s pipeline with clinical-stage antibody drug conjugate (ADC) emiltatug ledadotin (Emi-Le) targeting rare cancer adenoid cystic carcinoma (ACC) Jan. 06, 2026 -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the successful close of its acquisition of Mersana Therapeutics, Inc., (NASDAQ: MRSN) (“Mersana”) following completion of all conditions of the tender offer to acquire all outstanding shares of Mersana at a price of $25 per share in cash, plus one non-tradable contingent value right (“CVR”) per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash. “This acquisition of Mersana is a strategic fit with Day One’s mission and ambitions, allowing us to continue to expand into adult oncology while maintaining a focus on rare cancers. With promising early clinical data, Emi-Le represents a potentially transformative advancement in the treatment of ACC, and we will leverage our distinct capabilities to rapidly develop the asset and pursue registration to reach patient communities who have no approved therapies today,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Building on the strong momentum of OJEMDA in the market and our continually progressing pipeline, this acquisition strengthens our overall position to expand our impact on patient communities while delivering sustainable business growth.” Through this acquisition, Day One has added a second novel ADC to the company’s clinical pipeline. Emi-Le (emiltatug ledadotin) represents an innovative and differentiated ADC directed against B7-H4, a well-characterized target in certain cancers including adenoid cystic carcinoma (ACC), a challenging rare cancer usually arising within the salivary gland with a clear unmet medical need. For additional background on Emi-Le and the acquisition, please read the announcement press release and view Day One’s investor presentation. Day One has acquired all outstanding shares of Mersana common stock at a price of $25 per share in cash, plus one non-tradable CVR per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash, for total consideration of up to $55.25 per share in cash. The CVR is payable subject to certain terms and conditions of achievement of specified milestones. The tender offer expired as scheduled at one minute following 11:59 p.m., Eastern Time, on January 5, 2026 (the “Expiration Date”). The depositary for the tender offer, Computershare Trust Company, N.A., advised Day One that, as of the Expiration Date, a total of 3,029,135 shares of Mersana common stock were validly tendered and not validly withdrawn pursuant to the tender offer, representing 60.57% of the outstanding shares of Mersana common stock and satisfying the minimum condition to consummate the tender offer. All of the conditions of the tender offer having been satisfied, Day One accepted for payment all such tendered shares, and following a statutory merger under Section 251(h) of the Delaware General Corporation Law on January 6, 2026, Mersana became a direct wholly owned subsidiary of Day One. All remaining shares of Mersana common stock that were not tendered in the tender offer were converted into the right to receive the same per share consideration as shares that were tendered in the tender offer, as described above. With the completion of the acquisition, Mersana’s common stock will cease to trade on the Nasdaq stock exchange prior to market open on January 6, 2026 and Mersana’s common stock will be delisted from Nasdaq. Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One. Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. Day One’s pipeline includes tovorafenib (OJEMDA™), DAY301, and following the January 2026 acquisition of Mersana Therapeutics, Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) targeting the B7-H4 protein in clinical development to treat the rare cancer adenoid cystic carcinoma (ACC). Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and LinkedIn Home Page (linkedin.com/company/dayonebio) as a means of disseminating or providing notification of, among other things, news or announcements regarding its business or financial performance, investor events, press releases, and earnings releases, and as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. The content above comes from the network. if any infringement, please contact us to modify.

AcquisitionADC

08 Jan 2026

·www.pharmaceutical-technology.com

Day One concludes Mersana Therapeutics acquisition

Day One has incorporated a second new antibody-drug conjugate into its clinical development pipeline. Credit: Love Employee / Shutterstock.com. Day One Biopharmaceuticals has concluded its acquisition of Mersana Therapeutics after meeting all the tender offer conditions. The tender offer expired on 5 January 2026. The transaction involved purchasing all outstanding shares of Mersana at $25 per share in cash, along with one non-tradable contingent value right (CVR) per share. The CVR entitles shareholders to potential milestone payments of up to $30.25 per CVR in cash. The deal was first announced in November 2025 and had a total equity value of approximately $129m at closing, with the overall deal valued at up to $285m. With this deal, Day One has incorporated a second new antibody-drug conjugate (ADC) into its clinical development pipeline. Emi-Le (emiltatug ledadotin) is an advanced ADC directed against B7-H4, a known target in various cancers, including adenoid cystic carcinoma (ACC), which primarily affects salivary glands. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Following satisfaction of all conditions, Day One accepted these shares for payment. With the completion of a statutory merger under Section 251(h) of Delaware General Corporation Law on 6 January 2026, Mersana became Day One’s direct wholly owned subsidiary. Day One CEO Jeremy Bender said: “This acquisition of Mersana is a strategic fit with Day One’s mission and ambitions, allowing us to continue to expand into adult oncology while maintaining a focus on rare cancers. “With promising early clinical data, Emi-Le represents a potentially transformative advancement in the treatment of ACC, and we will leverage our distinct capabilities to rapidly develop the asset and pursue registration to reach patient communities who have no approved therapies today.” “Building on the strong momentum of OJEMDA in the market and our continually progressing pipeline, this acquisition strengthens our overall position to expand our impact on patient communities while delivering sustainable business growth.” In June 2024, Day One entered the field of ADCs through an exclusive licensing agreement with MabCare Therapeutics for its ADC MTX-13.

License out/inAcquisitionADC

100 Deals associated with Tovorafenib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15266

R&D Status

Approved

10 top approved records.

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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
Hairy Cell Leukemia	Phase 2	United States	National Cancer Institute	27 Jun 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
Bladder Cancer	Phase 2	United States	Day One Biopharmaceuticals, Inc.	15 Jul 2021
Bladder Cancer	Phase 2	Australia	Day One Biopharmaceuticals, Inc.	15 Jul 2021
Bladder Cancer	Phase 2	Belgium	Day One Biopharmaceuticals, Inc.	15 Jul 2021
Bladder Cancer	Phase 2	Canada	Day One Biopharmaceuticals, Inc.	15 Jul 2021
Bladder Cancer	Phase 2	France	Day One Biopharmaceuticals, Inc.	15 Jul 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


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)	jrmdfsqbiw(qdxoxpemkz) = wcqlbnywdp xiqotavjds (hksgctduhj ) View more	Positive	24 Nov 2025
NCT04775485 (FIREFLY-1, GlobeNewswire) Manual	Phase 2		137	OJEMDA (tovorafenib) (Exploratory analyses：entered a treatment-free observation period)	kdfdhieunh(vxypvjzsrm) = vjyfugryie askncpumez (thlusajbsj ) 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)	gxftdsxflt = saprkksetg jrmhcnrvbj (idlnoozzry, ryapwfzilo - dmzctygdye) View more	-	02 Oct 2025
NCT04985604 (CTgov)	Phase 2		23	Tovorafenib (Tissue Agnostic Cohort)	gxftdsxflt = lldzncnnby jrmhcnrvbj (idlnoozzry, myntpjqvyq - ryrdbeiszv) View more	-	02 Oct 2025
NCT04775485 (FIREFLY-1, ASCO2025)	Phase 2	BRAF V600 mutation low-grade glioma BRAF-altered	137	Tovorafenib	qogenlnodx(fyexyrvenl) = elwefjjfwa nltlvnptcn (orxlofhnlu ) View more	-	30 May 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	cvcmajewnv(ihuntbgigl) = tuheykgwch pcdycrrgus (errphtuajs, 0.4 - 2.2)	-	30 May 2025
NCT04985604 (ESMO2024)	Phase 2	Solid tumor \| Melanoma recurrent	-	Tovorafenib 600 mg	vvfbzpvefg(loakodjyxz) = 39% bphliznusc (vidlmrtvox ) View more	-	14 Sep 2024
NCT03429803 (ASCO2024) Manual	Phase 1	Low grade glioma MAPK pathway activated	35	Tovorafenib 530 mg/m2	rxopexobis(pqwiodybqh) = gzpjeclhkq rrfwgenxdf (wbtnkpwgbs ) 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	qnlzzmnbje(dftvjwsvaw) = itqxkhiuem vbsayqhppk (pnopmduabq, 40 - 63) View more	Positive	23 Apr 2024
NCT04775485 (FIREFLY-1, SNO2023)	Phase 2	Optic Nerve Glioma BRAF V600E mutation	77	Tovorafenib 420 mg/m2 weekly	mhuqjvagct(ppatjqzuqy) = ekuxrpxhxe kephwdpzur (ncnvmqvynn ) View more	Positive	10 Nov 2023
NCT04775485 (FIREFLY-1, SNO2023)	Phase 2	Low grade glioma BRAF	136	Tovorafenib 420 mg/m2	evqhxnampk(nuyqjvbylq) = ypsgjmrxcp lchjwzvpkn (eoavwjymck )	Positive	10 Nov 2023
NCT04775485 (FIREFLY-1, SNO2023)	Phase 2	Low grade glioma BRAF	136	MAPK inhibitor therapy	evqhxnampk(nuyqjvbylq) = vzfqiujevf lchjwzvpkn (eoavwjymck )	Positive	10 Nov 2023
NCT04775485 (FIREFLY-1, ASCO2023) Manual	Phase 2	Low grade glioma	77	Tovorafenib 420 mg/m2	cicyrjmsdt(uueakwqwai) = omvoyjozhs gelpalijdb (cogwhniibv ) View more	Positive	31 May 2023

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