The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO

Biotech stocks made a steady recovery over the week ended October 2, although Friday's weakness trimmed some of the gains of the week.

Companies working on anti-COVID-19 antibody treatments were in the news during the week. Sorrento Therapeutics Inc. (SRNE) announced a second more potent pre-clinical antibody candidate, while Regeneron Pharmaceuticals Inc. (REGN) released preliminary readout for its antibody cocktail in treating non-hospitalized COVID-19 patients.

On the FDA approval front, Eton Pharmaceuticals Inc. (ETON) received the nod for its Alkindi Sprinkle as a hormone replacement therapy for treating adrenocortical insufficiency in children under 17 years of age. Mesoblast (MESO), however, was in for a disappointment. Its stem cell therapy for acute graft versus host disease was turned down by the regulatory agency.

Zosano Pharma Corp. (ZSAN) shares wilted on a deficiency review letter for the NDA for its migraine patch. Selecta Biosciences Inc. (SELB), which reported an adverse clinical readout, was also among the biggest losers of the week

The week saw five biopharma companies debuting on Wall Street, raising a combined $582.18 million in gross proceeds. Here are the key catalysts for the unfolding week.


  • Heart Failure Society of America, or HFSA, Virtual Annual Scientific Meeting 2020: September 30 – October 6.
  • American Neurological Association, or ANA, 2020 Virtual Meeting: October 4-9.
  • 7th Annual Jefferies Cell Therapy Summit: October 5-6.
  • Chardan Virtual 4th Annual Genetic Medicines Conference: October 5-6.
  • HIV Glasgow 2020: October 5-8.


Avenue Therapeutics Inc. (ATXI), a Fortress Biotech (FBIO) company, awaits FDA nod for intravenous tramadol as a potential alternative that could reduce the use of conventional opioids for treating acute pain. The PDUFA date is scheduled for Saturday, October 10.

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