Traws Pharma Shares Slide 17% After MHRA Delays Mid-Stage Flu Trial
TRAW•Traws Pharma announced that the MHRA postponed its planned mid-stage human challenge trial of tivoxavir marboxil, sending shares down 17% in premarket trading. The company said it is evaluating next steps for the program while advancing alternative long-acting candidates designed without mutagenic concerns.
1. MHRA Postpones Mid-Stage Trial
Traws Pharma said that the UK MHRA issued an unfavorable assessment of its planned human challenge trial for influenza candidate tivoxavir marboxil, deferring study start while the company evaluates next steps. The announcement triggered a 17% drop in premarket trading, reflecting investor concerns over the programme's timeline.
2. Regulatory Hurdles and FDA Hold
This development mirrors an earlier clinical hold by U.S. regulators in February, when the FDA raised mutagenicity data concerns on the same candidate. Both actions have added uncertainty to the asset’s development path and increased scrutiny on Traws Pharma’s safety profile submissions.
3. Progress on Alternative Candidates
Despite setbacks, the company is advancing backup drug candidates designed to deliver long-acting antiviral effects without the mutagenic issues that challenged tivoxavir marboxil. These parallel programmes aim to sustain the company’s influenza pipeline while addressing regulatory safety requirements.
