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Investing.com - Biohaven Pharmaceutical Holding (NYSE:BHVN) shares fell approximately 25% in premarket trading Monday, despite Raymond James reiterating its Strong Buy rating and $75.00 price target on the stock. The current price of $15.53 represents a significant discount to analysts’ targets, with InvestingPro data showing the stock is trading 72% below its 52-week high of $54.98.
The selloff appears to be in sympathy with uniQure’s announcement that the FDA reversed its position regarding the submission of AMT-130, a gene therapy for Huntington’s disease, according to Raymond James. InvestingPro analysis indicates BHVN’s stock price movements are quite volatile, with a high beta of 3.45, which helps explain today’s outsized reaction.
The research firm emphasized key differences between the two situations, noting that Biohaven’s troriluzole application is being reviewed by FDA’s CDER Neurology I division, while uniQure’s therapy falls under CBER jurisdiction, representing distinct regulatory pathways.
Raymond James highlighted that unlike uniQure’s pre-filing feedback, Biohaven has already submitted its New Drug Application for troriluzole in Spinocerebellar Ataxia (SCA), which the FDA accepted and granted priority review status.
The firm also noted that troriluzole, an oral prodrug of riluzole (an approved ALS treatment) with a "benign safety profile," represents a fundamentally different proposition than uniQure’s gene therapy requiring brain surgery for delivery. While Biohaven holds more cash than debt on its balance sheet and maintains a healthy current ratio of 3.82, investors seeking deeper insights into BHVN’s financial health can access the comprehensive Pro Research Report available on InvestingPro.
In other recent news, Biohaven Pharmaceutical Holding has seen significant developments concerning its troriluzole drug candidate. The U.S. Food and Drug Administration (FDA) has decided not to hold an advisory committee meeting for the review of Biohaven’s New Drug Application for troriluzole, a treatment for Spinocerebellar Ataxia (SCA). This decision was communicated to Biohaven after the FDA had initially planned to convene such a meeting. The FDA’s decision implies that the advisory meeting is not necessary for their regulatory decision-making process. Additionally, UBS adjusted its price target for Biohaven to $26, reflecting updated projections for the troriluzole timeline, while maintaining a Buy rating. On a different note, BTIG raised its price target for Biohaven to $60, citing the potential of Biohaven’s SCA treatment VYGLXIA and its favorable outlook with the FDA. These developments highlight the ongoing interest and evaluations surrounding Biohaven’s drug candidates.
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