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Tovorafenib (DAY101)

RAF-altered pediatric low-grade glioma requiring first-line systemic therapy

Also known as TAK-580
Regulatory submission
Not announced
Launch
Not announced
Last updated
155 sources

Company-reported prevalence

Tovorafenib

Overview

FieldValue
DrugOjemda (tovorafenib)
IndicationRAF-altered pediatric low-grade glioma requiring first-line systemic therapy
DiseasePediatric low-grade glioma (pLGG), including BRAF-altered and RAF-altered pLGG
CompanyDay One Biopharmaceuticals, Inc., part of Servier since April 2026 (global development rights and United States commercial rights; acquired worldwide rights from Takeda in 2019); Ipsen (regulatory and commercial rights in all territories outside the United States since July 2024); Takeda (retains a license in certain rare disease indications)
Documents searchedDay One Biopharmaceuticals website: home, pipeline, tovorafenib, Ojemda, and patient resources pages (accessed October 2026); Ojemda product websites for patients and health care professionals (accessed October 2026); Day One Biopharmaceuticals press releases dated April 23, 2024, November 2025, and January 11, 2026; Day One Biopharmaceuticals and Servier press release dated May 8, 2026; Servier press release dated April 23, 2026; Day One Biopharmaceuticals Form 10-K for 2025 (February 2026); Day One Biopharmaceuticals presentations (February 2026 and March 2026); Day One Biopharmaceuticals fourth quarter 2025 results announcement (February 2026); SEC full-text search of Day One Biopharmaceuticals filings for "addressable pool", "newly diagnosed with BRAF-altered pLGG", "eligible for front-line systemic therapy", and "per 100,000 in the United States" (2021 to 2026); Ipsen press releases dated July 25, 2024 and April 22, 2026; Ipsen update on the Joint Clinical Assessment (June 2026); Ipsen first half 2026 results press release (July 2026); Ipsen Japan approval announcement (September 2026)
Data as ofOctober 14, 2026
Prepared byAI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

Eligible population (United States): Day One Biopharmaceuticals and Servier press release, May 2026

“Pediatric low-grade gliomas (pLGG) are the most common brain tumor with an estimated US incidence of 1,100” (opens the source at this quote in a new tab)

Cited source: 2.1 Ryall 2020; 2.2 Ipsen 2024

Day One Biopharmaceuticals and Servier (2026) press release, May 8, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Number treated (first-line and relapsed or refractory treatment decisions): Day One Biopharmaceuticals corporate presentation, February 2026

“~1,100 R/R pLGG ~1,100 1L pLGG Estimated Annual Treatment Decisions” (opens the source at this quote in a new tab)

“~2,200 Total Treatment Decisions Annually” (opens the source at this quote in a new tab)

Cited source: 2.3 Day One Biopharmaceuticals 2026

Day One Biopharmaceuticals (2026) corporate presentation, February 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Prevalence: Day One Biopharmaceuticals Form 10-K for 2025, February 2026

“We partnered with an epidemiology firm to perform SEER and CBTRUS registry analysis that estimates the prevalence, as of January 1, 2017, in the United States for BRAF-altered patients with pLGG under the age of 25 to be 26,000.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Day One Biopharmaceuticals (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
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Incidence (all pLGG): Day One Biopharmaceuticals Form 10-K for 2025, February 2026

“While pLGG is the most common brain tumor diagnosed, representing approximately 30% of all childhood brain tumors, the annual estimated incidence of pLGG is 1.3 to 2.1 per 100,000 in the United States.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Day One Biopharmaceuticals (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
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Prevalence (share of pLGG that is BRAF-altered): Day One Biopharmaceuticals Form 10-K for 2025, February 2026

“Potential for tovorafenib, a type-II RAF inhibitor, to be a high-impact targeted therapeutic in pLGG where approximately 70% of tumors are BRAF-altered pLGG in the United States.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Day One Biopharmaceuticals (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
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Europe

Eligible population (Europe): Day One Biopharmaceuticals and Servier press release, May 2026

“Europe incidence of 700 children per year who are eligible for front-line systemic therapy.” (opens the source at this quote in a new tab)

Cited source: 2.1 Ryall 2020; 2.2 Ipsen 2024

Day One Biopharmaceuticals and Servier (2026) press release, May 8, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Incidence (BRAF-altered pLGG): Ipsen press release, April 2026

“More than 800 children are diagnosed with BRAF altered pediatric low-grade glioma (pLGG) each year in the EU.” (opens the source at this quote in a new tab)

Cited source: 2.2 Ipsen 2024

Ipsen (2026) press release, April 22, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Global

No evidence found.

Other countries and regions

No evidence found.

Geography not stated

Incidence (BRAF-altered pLGG under the age of 25): Day One Biopharmaceuticals Form 10-K for 2025, February 2026

“Based on incidence results published in academic journals, we estimate that approximately 1,100 patients under the age of 25 are newly diagnosed with BRAF-altered pLGG every year.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Day One Biopharmaceuticals (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
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Eligible population (recurrent, progressive, or refractory pLGG): Day One Biopharmaceuticals Form 10-K for 2025, February 2026

“The estimated addressable pool of recurrent, progressive, or refractory patients with pLGG for tovorafenib is approximately between 2,000 to 3,000 per year at steady state.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Day One Biopharmaceuticals (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
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Prevalence (share of pLGG driven by RAF alterations): Day One Biopharmaceuticals Form 10-K for 2025, February 2026

“Over the last decade, it has been found that between 50% and 60% of pLGGs are driven by abnormal signaling due to alterations in RAF, approximately 85% to 90% of which are a gene fusion known as KIAA1549-BRAF.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Day One Biopharmaceuticals (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
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Prevalence (share of pLGG with BRAF V600E mutation): Day One Biopharmaceuticals Form 10-K for 2025, February 2026

“In addition, between 5% and 17% of children with pLGGs have tumors with a BRAF V600E activating mutation.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Day One Biopharmaceuticals (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
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Sources the company cites

Ryall 2020

Reference as the company lists it

“Ryall S, et al. Acta Neuropathol Commun. 2020;8(1):30.” (opens the source at this quote in a new tab)

Day One Biopharmaceuticals and Servier (2026) press release, May 8, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Passage carrying the nearest figure

“Tumors of the central nervous system (CNS) are the most frequent solid tumors in children, with approximately 5.4-5.6 diagnoses per 100,000” (opens the source at this quote in a new tab)

“Within this group, pediatric-type low-grade gliomas (pLGG) are the most frequent, accounting for approximately 30% of all childhood brain tumors” (opens the source at this quote in a new tab)

Ryall 2020, quoted passage highlighted (opens the full-size image in a new tab)
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Ipsen 2024

Reference as the company lists it, press release, April 22, 2026

“Estimates of annual incidence and prevalence for addressable patient population in E.U. 4 + U.K. are based on Ipsen calculations from publicly available data (Eurostat, <25yo population; Global Burden of Disease 2019; Desandes et al. Incidence and survival of children with central nervous system primitive tumors in the French National Registry of Childhood Solid Tumors. Neuro Oncol. 2014 Jul;16(7):975-83. doi: 10.1093/neuonc/not309; Qaddoumi et al. Outcome and prognostic features in pediatric gliomas: a review of 6212 cases from the Surveillance, Epidemiology, and End Results database. Cancer. 2009 Dec 15;115(24):5761-70. doi: 10.1002/cncr.24663)” (opens the source at this quote in a new tab)

Ipsen (2026) press release, April 22, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Reference as the company lists it, press release, May 8, 2026

“Estimates of annual incidence and prevalence for addressable patient population in E.U. 4 + U.K. are based on Ipsen calculations from publicly available data (Eurostat, <25yo population; Global Burden of Disease 2019; Desandes et al. Incidence and survival of children with central nervous system primitive tumors in the French National Registry of Childhood Solid Tumors. Neuro Oncol. 2014 Jul;16(7):975-83. doi: 10.1093/neuonc/not309; Qaddoumi et al. Outcome and prognostic features in pediatric gliomas: a review of 6212 cases from the Surveillance, Epidemiology, and End Results database. Cancer. 2009 Dec 15;115(24):5761-70. doi: 10.1002/cncr.24663)” (opens the source at this quote in a new tab)

Day One Biopharmaceuticals and Servier (2026) press release, May 8, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Passage carrying the figure

Not quoted: Unpublished company calculation from Eurostat population data, the Global Burden of Disease 2019 study, Desandes 2014, and Qaddoumi 2009; the calculation and its result are not published.

Day one biopharmaceuticals 2026

Reference as the company lists it

“Based on internal analysis of available U.S. claims data over a rolling 12-month period. Incidence verified by independent third party.” (opens the source at this quote in a new tab)

Day One Biopharmaceuticals (2026) corporate presentation, February 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Passage carrying the figure

Not quoted: Internal company analysis of United States claims data; no published document or address.

References

  1. Day One Biopharmaceuticals (2026) corporate presentation, February 2026 (opens in a new tab)
  2. Day One Biopharmaceuticals (2026) Form 10-K for 2025 (opens in a new tab)
  3. Day One Biopharmaceuticals and Servier (2026) press release, May 8, 2026 (opens in a new tab)
  4. Ipsen (2026) press release, April 22, 2026 (opens in a new tab)
  5. Ryall 2020 (opens in a new tab)