Protocols

Cel-Sci shares jump after FDA lifts hold; New upstart is looking for Euro marketing pacts with biotech

Jim Mullen

⇨ Shares at microcap biotech Cel-Sci $CVM jumped 36% after the biotech announced that the FDA has lifted the clinical hold on its Phase III study of Multikine for head and neck cancer. Researchers have recruited 928 frontline patients for this study. The primary endpoint is a 10% increase in overall survival.

⇨ Here’s a new option for biotechs to take a look at. A group that includes ex-Biogen CEO Jim Mullen has formed a new company — cleverly named Vicarius — which is looking to do deals where it undertakes the European marketing for new drugs. This is one possible alternative to going it alone or outlicensing European marketing rights for some loess-than-ideal returns.

Amarin says it will move to complete its big Phase III REDUCE-IT cardiovascular outcomes study for Vascepa after an independent review of the data. Results are expected in Q2 or Q3 of next year.

⇨ New York-based Fortress Biotech is ramping up a new subsidiary company — Aevitus Therapeutics — focused on developing gene therapies for complement-mediated diseases. The biotech says it will use AAV delivery tech from an unnamed university for its work.



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