Name: Tovorafenib (DAY101) in RAF-altered pediatric low-grade glioma requiring first-line systemic therapy: Generic, brand name and therapeutic class of product
Published: 2026-09-17T18:16:08-04:00

Manufacturer: Day One Biopharmaceuticals

“Manufactured for: Day One Biopharmaceuticals, Inc., Brisbane CA 94005” (opens the source at this quote in a new tab)

“Day One Biopharmaceuticals, Inc., now part of Servier Group, today announced that it has completed enrollment in the FIREFLY-2 clinical trial” (opens the source at this quote in a new tab)

Nonproprietary name, brand name, and US labeler

“OJEMDA (tovorafenib) tablets, for oral use” (opens the source at this quote in a new tab)
“OJEMDA (tovorafenib) for oral suspension” (opens the source at this quote in a new tab)
“Initial U.S. Approval: 2024” (opens the source at this quote in a new tab)

Development codes

“Tovorafenib, previously known as DAY101, TAK-580, MLN2480, BSK1369 and BIIB024 at various points during development (these names appear in this submission), is an oral, central nervous system (CNS)-penetrant, selective small-molecule, Type II rapidly accelerated fibrosarcoma (RAF) inhibitor.” (opens the source at this quote in a new tab)

Therapeutic class

“OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.” (opens the source at this quote in a new tab)

“OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.” (opens the source at this quote in a new tab)

Origin: acquisition of rights from Takeda

“Day One also announced today that it acquired Takeda’s rights to develop and commercialize DAY101 (formerly TAK-580) worldwide, including certain rights previously licensed by Takeda from Sunesis Pharmaceuticals.” (opens the source at this quote in a new tab)
“Takeda retains license to develop and commercialize DAY101 in certain rare disease indications.” (opens the source at this quote in a new tab)

Ex-US licensing agreement with Ipsen

“Day One will maintain exclusive global development and U.S. commercial rights for tovorafenib.” (opens the source at this quote in a new tab)
“Under the terms of the agreement, Ipsen will be responsible for the regulatory and commercial activities for tovorafenib in all territories outside of the U.S. Day One will receive an upfront payment of approximately $111 million, which includes approximately $71 million in cash as well as a $40 million equity investment at a premium and up to approximately $350 million in additional launch and sales milestone payments.” (opens the source at this quote in a new tab)

Acquisition of Day One Biopharmaceuticals by Servier

“Servier, an independent international pharmaceutical group governed by a foundation, today announced the successful completion of the tender offer to acquire all of the issued and outstanding shares of common stock of 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, for $21.50 per share.” (opens the source at this quote in a new tab)
“As a result of the Merger, Day One will become a wholly owned subsidiary of Parent. With completion of the Merger, the transaction will represent a total equity value of approximately $2.5 billion.” (opens the source at this quote in a new tab)

EU marketing authorisation holder

“Ipsen (the Applicant) has acquired the rights from Day One Biopharmaceuticals, Inc. to register and commercialize tovorafenib in countries other than the United States (US).” (opens the source at this quote in a new tab)