The Week Ahead In Biotech (Dec. 19-25): Amgen And Aquestive Regulatory Decisions Key Events Of Holiday-Shortened Week

Biotech stocks reversed course and advanced solidly in the week ending Dec. 17, as an increase in risk aversion pushed investors to buy into defensive stocks. The sector also drew strength from some positive stock-specific news.

Among the regulatory decisions for the week, the Food and Drug Administration gave the green light to argenx SE's ARGX efgartigimod for the treatment of generalized myasthenia gravis.

AstraZeneca plc AZN and Amgen, Inc. AMGN announced an FDA nod for their Tezspire as a treatment option for severe asthma for those aged 12 years and older. Bristol-Myers Squibb Company's BMY Orencia was approved for the prophylactic treatment of acute graft-versus-host disease.

Calliditas Therapeutics AB (publ) CALT scored an FDA win for Tarpeyo, the first-approved treatment to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression.

Galera Therapeutics, Inc. GRTX was among the biggest gainers in the space following a positive late-stage readout.

Novavax, Inc. NVAX gained about 30% for the week amid an uptick in vaccine news coverage. Friday, the company announced that the WHO has authorized its COVID-19 vaccine.

Genenta Science S.p.A. GNTA, Bionomics Limited BNOX and Immix Biopharma, Inc. IMMX were among the biotech listings this week.

In a key development, JPMorgan Chase & Co. JPM announced it is moving its all-important healthcare conference, originally planned to be held in San Francisco, to a virtual format following a drop in attendees due to concerns over a spike in omicron cases.

Related Link: 2 Mid-Cap Biopharma Stocks BofA Securities Recommends For 2022

Here are the key biopharma catalysts for the unfolding week:

PDUFA Dates

Amgen's Otezla supplemental new drug application seeking approval for it as a treatment for mild- to moderate plaque psoriasis in adults has a PDUFA action date of Sunday, Dec. 19.

Aquestive Therapeutics, Inc.'s AQST has a tryst with the FDA on Thursday, Dec. 23, when the drug regulator is due to announce its verdict on the company's Libervant, a non-invasive treatment for epileptic seizures which involves the placement of a soluble film inside the cheek to administer medication.

IPOs

IPO Pricing 4

Langhorne, Pennsylvania-based NexGel, Inc. NXGL has filed a preliminary prospectus with the SEC for offering 2.066 million units, with each unit consisting of one common share and one warrant to purchase one share of its common stock. Each warrant contained in a unit has an exercise price of $6.825 per share.

The company, which manufactures high water content, electron beam cross-linked, aqueous polymer hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug delivery and cosmetics, has applied for listing its shares and warrants on the Nasdaq under the symbols NXGL and NXGLW, respectively.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates