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FiveHundredCents
wrote a post12/27/2021 17:57
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The Week Ahead In Biotech (Dec.26-Jan. 1): Xeris FDA Decision, Pending Clinical Readouts In Focus In Final Week Of Year

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

$BiondVax制药(BVXV.US)$ rallied strongly after it announced in-licensing of nano-sized COVID-19 antibody.

$Allakos(ALLK.US)$ 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 $Xeris Pharmaceuticals(XERS.US)$ 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

$Anavex Life Sciences(AVXL.US)$: 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

$Vanda Pharmaceuticals(VNDA.US)$: results of Phase 3 study off tradipitant in gastroparesis

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