The Week Ahead In Biotech (Dec.26-Jan. 1): Xeris FDA Decision, Pending Clinical Readouts In Focus In Final Week Of Year

Biopharma stocks eked out modest gains in the week ending Dec. 23, with regulatory decisions, clinical readouts and COVID-19 treatment and vaccine developments dictating sentiment.

The week's news was headlined by the Food and Drug Administration issuing emergency use authorizations for two oral COVID-19 antiviral pills. Pfizer, Inc. PFE received authorization for its oral drug Paxlovid on Wednesday, followed by Merck & Co., Inc.'s MRK molnupiravir.

BiondVax Pharmaceuticals Ltd. BVXV rallied strongly after it announced in-licensing of nano-sized COVID-19 antibody.

Allakos Inc. ALLK was among the worst performers of the week after the company's investigational compound flunked late-stage studies in inflammation of the digestive tract.

Here are the key biopharma catalysts for the unfolding week:

PDUFA Dates

The FDA is scheduled to announce its verdict on Xeris Biopharma Holdings, Inc.'s XERS new drug application for Recorlev (levoketoconazole), an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing's syndrome.

Clinical Readouts/Presentations

Year-end Releases

Anavex Life Sciences Corp. AVXL: Top-line results from the second placebo-controlled AVATAR Phase 2/3 study of Anavex2-73 for the treatment of adult patients with Rett syndrome and top-line results from the placebo-controlled Phase 1 ANAVEX 3-71-001 study evaluating ANAVEX3-71 in humans

Vanda Pharmaceuticals Inc. VNDA: results of Phase 3 study off tradipitant in gastroparesis

Second-Half Data Releases

Adagene Inc. ADAG: Results from ongoing dose escalation of ADG126 monotherapy in solid tumors

Fourth-quarter Releases

Corbus Pharmaceuticals Holdings, Inc. CRBP: topline data from the National Institutes of Health-sponsored Phase 2 study of lenabasum in systemic lupus erythematosus

Vir Biotechnology, Inc. VIR: initial VIR-111, its HIV vaccine candidate, immunology data

Avalo Therapeutics, Inc. AVTX: opline Phase 1b data for AVTX-002 in moderate to severe Crohn's disease patients expected

December Releases

Taysha Gene Therapies, Inc. TSHA: clinical safety and MFM32 functional data for TSHA-120 from the highest dose cohort of 3.5x1014 total vg in giant axonal neuropathy and preliminary clinical safety data and Hex A enzyme activity in the plasma and cerebral spinal fluid for TSHA-101 in GM2 gangliosidosis

2021/Late-2021 Releases

BridgeBio Pharma, Inc. BBIO: topline results from Part A of the Phase 3 ATTRibute-CM trial of Acoramidis for transthyretin amyloid cardiomyopathy (late-2021)

Related Link: How Much Revenue Could Pfizer's Oral COVID-19 Pill Fetch?