Biohaven ($BHVN) Regulatory Misstatements, Clinical Setbacks, and Drug Approval Risks Case

The court has appointed the lead plaintiff to represent the class.

D. Connecticut

Court

3:25-cv-01120

Case number

03/24/2023

Class period Start

05/14/2025

Class period End

09/12/2025

Lead Plaintiff motion deadline

$BHVN investors filed a claim against Biohaven for misleading the market about the viability and regulatory prospects of its key drug candidates, troriluzole and BHV-7000. 
Following the FDA’s refusal to review the troriluzole application, weak bipolar trial data, and EMA’s rejection, $BHVN dropped a cumulative 63.7%.
$BHVN investors can join this case to be notified about potential recovery.

Case Details:

Between March 24, 2023, and May 14, 2025, Biohaven repeatedly assured investors about the regulatory momentum for troriluzole in treating spinocerebellar ataxia (SCA), despite a Phase 3 trial having failed to meet its primary endpoint. The company submitted the NDA in 2023 and claimed promising post-hoc analyses supported approval. Biohaven also touted the EMA's review of the drug and pushed forward on a parallel filing.

In truth, the data was insufficient. On July 27, 2023, the FDA rejected the NDA outright, citing the failed endpoint. Biohaven's stock fell 22.6%. Despite this, the company resubmitted the application and claimed to expect approval in 2025.

Meanwhile, Biohaven also promoted BHV-7000 for bipolar disorder, highlighting strong early signals and a promising profile. However, on March 3, 2025, the company revealed that BHV-7000 failed to show statistical separation from placebo in its pivotal trial. Shares dropped 13.8%.

Further damage came on April 25, 2025, when the EMA confirmed that Biohaven had withdrawn the troriluzole application. $BHVN sank 15.2%. Then, on May 14, 2025, Biohaven disclosed that the FDA extended the PDUFA deadline and planned an advisory committee meeting—signaling regulatory uncertainty. The stock fell 19.5% the next day.

Based on these events, $BHVN investors filed a claim against Biohaven, alleging the company:
It misled investors about troriluzole's approval prospects despite a failed trial.
It concealed key data limitations in the bipolar disorder program.
Investors believe Biohaven exaggerated the clinical viability and regulatory status of its lead assets to inflate its valuation and delay fallout.

Case Type

US Securities Class Action

Case Status

Lead Plaintiff Appointed

Alleged Offence

Misleading Statements,

Financial Misrepresentation,

Failure to Disclose

Suspected Party

Directors,

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

05/14/2025

Filing date

07/14/2025

Lead Plaintiff Deadline

09/12/2025

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