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2021-12-30

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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

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week ending&nbsp;Dec. 23, with regulatory decisions, clinical readouts and COVID-19 treatment and vaccine developments&nbsp;dictating sentiment.\nThe week's news was headlined by the Food and Drug Administration issuing emergency use authorizations for two oral COVID-19 antiviral pills.&nbsp;Pfizer, Inc.received authorization for its oral drug Paxlovid on Wednesday, followed by&nbsp;Merck &amp; Co., Inc.'s&nbsp;molnupiravir.\nBiondVax Pharmaceuticals Ltd.rallied strongly after it announced in-licensing of nano-sized COVID-19 antibody.\nAllakos Inc.&nbsp;was among the worst performers of the week after the company's investigational compound&nbsp;flunkedlate-stage studies in inflammation of the digestive tract.\nHere are the key biopharma catalysts for the unfolding week:\nPDUFA Dates\nThe FDA is scheduled to announce its verdict on&nbsp;Xeris Biopharma Holdings, Inc.'s&nbsp;new drug application for Recorlev (levoketoconazole), an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing's syndrome.\nClinical Readouts/Presentations\nYear-end Releases\nAnavex Life Sciences Corp.: 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\nVanda Pharmaceuticals Inc.: results of Phase 3 study off tradipitant in gastroparesis\nSecond-Half Data Releases\nAdagene Inc.: Results from ongoing dose escalation of ADG126 monotherapy in solid tumors\nFourth-quarter Releases\nCorbus Pharmaceuticals Holdings, Inc.: topline data from the National Institutes of Health-sponsored Phase 2 study of lenabasum in systemic lupus erythematosus\nVir Biotechnology, Inc.: initial VIR-111, its HIV vaccine candidate, immunology data\nAvalo Therapeutics, Inc.: opline Phase 1b data for AVTX-002 in moderate to severe Crohn's disease patients expected\nDecember Releases\nTaysha Gene Therapies, Inc.: 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\n2021/Late-2021 Releases\nBridgeBio Pharma, Inc.: topline results from Part A of the Phase 3 ATTRibute-CM trial of Acoramidis for transthyretin amyloid cardiomyopathy (late-2021)\n\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"AVXL":"Anavex Life Sciences Corp.","TSHA":"Taysha Gene Therapies, Inc.","VIR":"Vir Biotechnology, Inc.","CRBP":"Corbus Pharmaceuticals Holdings, Inc.","BBIO":"BridgeBio Pharma, Inc.","AVTX":"Avalo Therapeutics 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FDA is scheduled to announce its verdict on Xeris Biopharma Holdings, Inc.'s new drug application for Recorlev (levoketoconazole), an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing's syndrome.\nClinical Readouts/Presentations\nYear-end Releases\nAnavex Life Sciences Corp.: 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\nVanda Pharmaceuticals Inc.: results of Phase 3 study off tradipitant in gastroparesis\nSecond-Half Data Releases\nAdagene Inc.: Results from ongoing dose escalation of ADG126 monotherapy in solid tumors\nFourth-quarter Releases\nCorbus Pharmaceuticals Holdings, Inc.: topline data from the National Institutes of Health-sponsored Phase 2 study of lenabasum in systemic lupus erythematosus\nVir Biotechnology, Inc.: initial VIR-111, its HIV vaccine candidate, immunology data\nAvalo Therapeutics, Inc.: opline Phase 1b data for AVTX-002 in moderate to severe Crohn's disease patients expected\nDecember Releases\nTaysha Gene Therapies, Inc.: 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\n2021/Late-2021 Releases\nBridgeBio Pharma, Inc.: topline results from Part A of the Phase 3 ATTRibute-CM trial of Acoramidis for transthyretin amyloid cardiomyopathy 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