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2021-12-27

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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":{"ADAG":"天演药业","AVXL":"Anavex Life Sciences Corp.","XERS":"Xeris制药","BBIO":"BridgeBio Pharma, Inc.","TSHA":"Taysha Gene Therapies, Inc.","CRBP":"Corbus Pharmaceuticals Holdings, Inc.","AVTX":"Avalo Therapeutics Inc","VNDA":"万达生物制药","VIR":"Vir Biotechnology, 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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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