FDA Shifts to Single Pivotal Trial Requirement for Drug Approvals
FDA plans to require only one pivotal trial for drug approvals instead of two, potentially accelerating development timelines while raising safety and efficacy concerns.
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Stifel Begins Coverage of Tango Therapeutics with Bullish Outlook
Stifel initiates coverage of Tango Therapeutics with a Buy rating and $15 target, citing strong potential for its PRMT5 inhibitor vopimetostat and forecasting $1.2B in peak global revenue by 2035.
UniQure Huntington's Drug Faces FDA Setback, Shares Drop 19%
UniQure stock tumbles as FDA says AMT-130 gene therapy data insufficient for approval. Company seeks urgent Q1 2026 meeting to advance Huntington's disease treatment.
Hims & Hers Expands to Canada with Weight Loss Focus
US telehealth giant Hims & Hers enters Canadian market through Livewell acquisition, targeting obesity crisis with affordable digital healthcare and upcoming generic semaglutide access.
Goldman Sachs Downgrades Halozyme to Sell
HALO faces a post-2030 royalty cliff; Goldman Sachs cuts rating to Sell with $56 target, citing long-term revenue risks.
Goldman Sachs Initiates Sell Rating on MBX Biosciences
Goldman Sachs starts coverage of MBX Biosciences with a Sell rating and $18 price target, citing cautious outlook ahead of key trial data in 2026.