Biohaven Gets FDA Priority Review of Troriluzole

Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for troriluzole for the treatment of adult patients with spinocerebellar ataxia (SCA) and has granted Priority Review.
Troriluzole Priority Review Granted for Spinocerebellar Ataxia
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for troriluzole for the treatment of adults with
Biohaven's troriluzole gains FDA priority review for SCA
NEW HAVEN, Conn. - Biohaven Ltd. (NYSE: BHVN), a biotechnology company with a market capitalization of $3.87 billion, announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for troriluzole,
Biohaven Gets FDA Priority Review of Troriluzole for Spinocerebellar Ataxia
Biohaven has won Food and Drug Administration priority review for its application seeking approval of troriluzole for adults with spinocerebellar ataxia, a group of rare, genetic neurological disorders. Biohaven on Tuesday said a green light would make troriluzole the first and only FDA-approved treatment for the life-threatening disorder.
FDA grants brensocatib priority review for bronchiectasis
The FDA has granted priority review to brensocatib to treat patients with non-cystic fibrosis bronchiectasis, according to a manufacturer-issued press release.If approved, the release said this will be the first treatment for this patient population.
Biohaven’s troriluzole NDA in spinocerebellar ataxia accepted by the FDA
Biohaven (BHVN) announced that the FDA has accepted for review the company’s New Drug Application, or NDA, for troriluzole for the treatment of
Biohaven stock rises following FDA review and Deutsche Bank's buy rating
Shares of Biohaven Ltd. (NYSE: BHVN) climbed 7% as the company announced the FDA's acceptance and Priority Review of its ...
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Insmed: Priority Review For Brensocatib Cements (Limited) Upside Opportunity
Brensocatib, Insmed's lead pipeline candidate for non-CF bronchiectasis, received FDA Priority Review with a target action date of August 12, 2025. This is a potential multi-billion dollar selling ...
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Datopotamab Deruxtecan Granted Priority Review in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating ...
Insmed Gets Speedy FDA Review of Brensocatib for Bronchiectasis
The Bridgewater, N.J., biopharmaceutical company said brensocatib has the potential to become the first and only approved treatment for non-cystic fibrosis bronchiectasis, which causes the lungs' ...
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FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC
Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. The WU-KONG1 Part B study showed a 53.3% objective response ...
Biohaven Ltd.: Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment. Troriluzole demonstrated a 50-70% slowing of SCA disease progression ...