Eye Doctor and Fox News Regular Eyed as New Head of FDA Vaccine Division
FDA may pick Dr. Hemmati to lead CBER, which could speed up vaccine and biotech drug approvals, but decision is not final.
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Oppenheimer Sees $1 Billion Potential in Passage Bio’s PBFT02 for FTD
Oppenheimer just started coverage on Passage Bio with an Outperform rating and $30 price target. They call the recent pullback a buying opportunity ahead of key PBFT02 data in H1 2026.
uniQure Stock Soars as FDA's Vinay Prasad Exit Sparks Analyst Upgrades
uniQure stock jumps after Wells Fargo ($60 PT) and RBC ($35 PT) upgrades, driven by Vinay Prasad's FDA exit boosting AMT-130 Huntington's gene therapy outlook.
Vinay Prasad Leaves FDA After High-Profile Clashes Over Gene Therapies
Dr. Vinay Prasad, head of the FDA's vaccines and biologics division, is stepping down at the end of April after a controversial year overseeing approvals for vaccines, gene therapies, and biotech products.
FDA Rejects UniQure’s Huntington’s Gene Therapy Path – Shares Plunge
UniQure's stock falls sharply in premarket trading after the FDA says early data for AMT-130 isn't enough for approval. The company plans more talks for a Phase III trial on this Huntington's disease treatment.
uniQure Stock Tanks on FDA Comments – But Is It Really About AMT-130?
uniQure shares fell about 33% after FDA Commissioner Marty Makary's comments on rare disease drugs. But analysts say his remarks likely targeted another therapy, not uniQure's AMT-130 for Huntington's disease.