Biohaven Ltd.: Troriluzole in SCA Could Be Next Beneficiary of Recent FDA Reversals; PT to $20 (+$5)

研报英文原文证据摘录

Biohaven Ltd.: Troriluzole in SCA Could Be Next Beneficiary of Recent FDA Reversals; PT to $20 (+$5)

Deutsche Bank

Research

Rating Company Date

Buy Biohaven Ltd. 25 June 2026

North America Reuters Bloomberg Rating Buy

United States BHVN.N BHVN US Price target (USD) 20.00 Price at 24 Jun 26 14.96

52-week range 18.11 – 7.79

Health Care

Biotechnology Valuation & Risks

Troriluzole in SCA Could Be Next Beneficiary

of Recent FDA Reversals; PT to $20 (+$5) DavidResearchHoang,AnalystM.D., Ph.D.

+1-212-250-1184

Key Takeaways

Sam Beck In recent weeks, we have seen positive FDA reversals on several regulatory filings Research Associate

for REPL, QURE, and RGNX from the post-Makary/Prasad regime, leading to +1-929-354-4311

significant rallies in these names, which we believe bodes well for BHVN’s NDA

for troriluzole (Vyglxia) in SCA. Recall, the abovementioned names had come

under pressure after the FDA abruptly changed their guidance in relation to filings

for rare diseases, issuing CRLs or onerous guidance for more clinical trial data. In Key changes

Nov. 2025, the FDA issued a CRL for BHVN’s troriluzole in SCA, criticizing Price target (USD) 15 20 33%

flaws/biases of real-world evidence (RWE) and external control studies, which Source: Deutsche Bank

was at odds with positive feedback provided by the agency in Mar. 2024. The

rejection triggered a 40% selloff in the stock and forced a restructuring/pipeline

prioritization effort by BHVN (which admittedly was needed anyway). Given what

appears to be a more hospitable FDA under Acting Commissioner Kyle Diamantas

since Makary’s resignation in May, we believe it is possible that BHVN could align

on a regulatory path forward for troriluzole in SCA without conducting extensive

additional studies.