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

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 (MRKmolnupiravir.

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) is to report 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) is to present results of Phase 3 study off tradipitant in gastroparesis.

Second-Half Data Releases

  • Adagene Inc. (ADAG) is to report results from ongoing dose escalation of ADG126 monotherapy in solid tumors.

Fourth-Quarter Releases

  • Corbus Pharmaceuticals Holdings, Inc. (CRBP) is to present topline data from the National Institutes of Health-sponsored Phase 2 study of lenabasum in systemic lupus erythematosus.
  • Vir Biotechnology, Inc. (VIR) is to report initial VIR-111, its HIV vaccine candidate, immunology data.
  • Avalo Therapeutics, Inc. (AVTX) is to release topline Phase 1b data for AVTX-002 in moderate to severe Crohn's disease patients.

December Releases

  • Taysha Gene Therapies, Inc. (TSHA) is to report 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) is to release topline results from Part A of the Phase 3 ATTRibute-CM trial of Acoramidis for transthyretin amyloid cardiomyopathy.

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