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. (NASDAQ: SRNE) announced a second more potent preclinical antibody candidate, while Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) released preliminary readout for its antibody cocktail in treating non-hospitalized COVID-19 patients.

On the FDA approval front, Eton Pharmaceuticals Inc. (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: ZSAN) shares wilted on a deficiency review letter for the NDA for its migraine patch. Selecta Biosciences Inc. (NASDAQ: 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. (NASDAQ: ATXI), a Fortress Biotech (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: 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. (NYSE: 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.