The FDA has issued a CRL to Biohaven regarding the NDA for troriluzole for the treatment of adults with spinocerebellar ataxia.
Biohaven (BHVN) downgraded after FDA setback for VYGLXIA. Learn key risks, pipeline shifts, and what investors should watch next. Click here to read more.
After the FDA rejected its spinocerebellar ataxia treatment, Biohaven missed out on a $150 million payment from Oberland Capital. Now the company is reshuffling its pipeline to stay alive.
Spinocerebellar ataxia type 1 (SCA1) is an inherited neurodegenerative disease involving progressive loss of motor and cognitive function resulting from the death of cerebellar neurons. Watase et al.
Biohaven is proposing troriluzole for the treatment of spinocerebellar ataxia, a group of rare, genetic diseases that lead to the progressive loss of control over movement.
A green light would have made Vyglxia the first and only FDA-approved treatment for spinocerebellar ataxia, a life-threatening neurodegenerative disease characterized by progressive loss of voluntary ...
Earlier this month, Biohaven Ltd. announced it received a Complete Response Letter from the FDA declining approval of its drug candidate VYGLXIA (troriluzole) for spinocerebellar ataxia, prompting the ...
Biohaven (BHVN) stock plunges as the FDA declines to approve its lead drug Vyglxia (troriluzole) targeted at spinocerebellar ataxia. Read more here.
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The U.S. FDA’s complete response letter (CRL) for Biohaven Ltd.’s lead asset, troriluzole, to treat spinocerebellar ataxia has prompted a wave of downstream changes at the company. There will be a ...
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