Bristol Myers licenses for Evotec molecule for $20M; FDA approves Impel's migraine nasal spray Trudhesa
Bristol Myers Squibb has exercised its option with Evotec for EVT8683, a small molecule created by the German biotech to target a specific “cellular stress response.”
The companies have obtained clearance to start human trials, close to 4.5 years after initiating a partnership.
According to an Evotec statement, “the programme targets a key cellular stress response mechanism which has the potential to deliver disease-modifying treatments for several devastating neurodegenerative diseases.”
Evotec CSO Cord Dohrmann commented in a statement: “We are very excited to bring a first drug candidate which originated from Evotec’s iPSC discovery platform into the clinic.”
Through this opt-in, Bristol Myers will pay Evotec $20 million and lead further development and commercialization.
Impel announces FDA approval of Trudhesa in nasal spray form for migraines
Seattle, WA-based biotech Impel NeuroPharma said today that the FDA approved Trudhesa nasal spray for the treatment of migraines, with or without aura in adults. Trudhesa was previously known as INP104. The commercial launch of the drug is planned for early next month.
Adrian Adams, chairman and CEO of Impel, said in a statement: “The approval of Trudhesa marks the culmination of more than a decade of research and advanced engineering. We are grateful for all the patients and investigators who participated in our clinical trials.”
This approval comes only a few months after Impel launched its IPO in April, raising $80 million and pricing its shares at $15 apiece.
The NDA for the spray included the results of a Phase III, open-label, pivotal safety study known as STOP 301. More than 5,650 migraine attacks were treated over 24 or 52 weeks during the study.
Impel will host a conference call regarding Trudhesa’s FDA approval on September 7th.