Biohaven Gets FDA Priority Review of Troriluzole

Biohaven: NDA Review Of Troriluzole Isn't Only 2025 Catalyst On Deck
Biohaven's NDA for Troriluzole was accepted by the FDA, potentially leading to approval in Q3 2025. Click here to find out why BHVN stock is a Strong Buy.
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 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.
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
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 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 ...
Investor's Business Daily on MSN13h
Biohaven Just Hurdled An FDA Setback — And Its Moving Lines
Biohaven stock hurdled its 50-day and 200-day lines Tuesday after the FDA granted its SCA treatment a speedier review time.
ENDPOINTS NEWS13h
Bio­haven lands pri­or­i­ty re­view on sec­ond-chance ap­pli­ca­tion for neu­rode­gen­er­a­tive drug
FDA grants priority review for Biohaven's troriluzole for spinocerebellar ataxia after real-world data submission. Decision ...
Biohaven: Highly Priced Biotech With Broad Pipeline But No Revenues
Biohaven boasts a robust pipeline with late-stage molecules, but a Hold rating reflects its high market cap and uncertain ...
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 ...
Why Biohaven Stock Triumphed on Tuesday
News of a big and important regulator's move was the electricity that powered Biohaven (NYSE: BHVN) stock to an 11%-plus gain ...
BioPharma Dive16h
Merck KGaA pursuing Springworks; BridgeBio wins EU drug OK
The German drugmaker confirmed acquisition talks, but cautioned a deal may not materialize. Elsewhere, Biohaven got priority review on a key drug and Third Harmonic restructured.
Business Insider29d
Biohaven announces 2025 anticipated milestones
Troriluzole: Troriluzole is a novel glutamate ... two key regulators of muscle and fat metabolism. Biohaven is studying taldefgrobep in a global Phase 3 expansion study in Spinal Muscular ...