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 Oct. 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 preclinical 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.

Conferences

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

PDUFA Dates

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, Oct. 10.

See Also: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

Adcom Calendar

A joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will review Alkermes Plc's ALKS NDA for olanzapine/samidorphan oral tablets for the proposed indications of schizophrenia and bipolar I disorder. The committees will discuss the efficacy, safety, and benefit-risk profile of the combo treatment. The meeting is scheduled between 10 a.m. ET and 4 p.m. ET on Friday.

Clinical Readouts

Neurocrine Biosciences Inc. NBIX will present at the ANA 2020 meeting new data from a post-hoc, sub-group analysis of Phase 3 data for Ongentys as an add-on to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.

Merck & Co. Inc. MRK will present at the HIV Glasgow 2020 96-week results from efficacy and safety analyses of data from the Phase 2b study of islatravir in adults with HIV-1 infection who had not previously received antiretroviral treatment. Additionally, Merck will share results from Phase 1/1b studies of MK-8507 for once-weekly oral administration in combination with islatravir.

IPOs

Silver Spring, Maryland-based Aziyo Biologics Inc. has filed with the SEC a preliminary prospectus for an initial public offering of 2.94 million shares at an estimated price range of $16-$18. The regenerative medicine company proposes to list its shares on the Nasdaq under the ticker symbol AZYO.

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