The Week Forward In Biotech: The Vaccine Updates, Drug Shows, And FDA Selections That Will Transfer The Markets
Biotech shares superior within the week ended Nov. 13 amid a vaccine information flow-induced rally that additionally lifted the broader market.The week began with optimistic tidings from Pfizer Inc. (NYSE: PFE) and its German companion BioNTech SE – ADR (NASDAQ: BNTX), which reported optimistic interim Part 3 information for his or her collectively developed mRNA vaccine in opposition to the COVID-19 coronavirus.An replace from rival vaccine developer Moderna Inc (NASDAQ: MRNA) on reaching the mandated variety of instances for its first interim evaluation additionally generated optimism.5 Prime Therapeutics Inc (NASDAQ: FPRX) rallied over 300% through the week, with the upside primarily attributable to a optimistic mid-stage readout for its investigational drug in a abdomen most cancers examine.Supernus Prescribed drugs Inc (NASDAQ: SUPN), in the meantime, got here beneath strain after the FDA rejected its ADHD drug.Earnings information move continued, however the week was silent on the IPO entrance. A number of conferences bought underway through the week, giving biopharma corporations an opportunity to point out new information on merchandise they’re investigating.Listed below are the important thing catalysts for the week from Nov. 13.Conferences * American Academy of Ophthalmology, or AAO, 2020 Digital assembly: Nov. 13-15 * American Affiliation for the Examine of Liver Illnesses, or AASLD, The Liver Assembly, Digital Expertise: Nov. 13-16 * Guggenheim Healthcare Talks, Concept Discussion board, 2nd Annual Neuro/Immunology Day: Nov. 16 * Stifel 2020 Digital Healthcare Convention: Nov. 16-18 * Jefferies Digital London Healthcare Convention: Nov. 17-19 * Wolfe Analysis Digital Healthcare Convention: Nov. 18-19 * Connective Tissue Oncology Society, or CTOS, Digital Annual Assembly: Nov. 18-21 * SVB Leerink Oncology Day: Nov. 19 * 2020 Society for Neuro-Oncology, or SNO, Digital Assembly: Nov. 19-21PDUFA Dates The FDA is about to rule on Alkermes Plc’s (NASDAQ: ALKS) NDA for ALKS 3831 in schizophrenia and bipolar I dysfunction. (Sunday)Additionally on Sunday, the destiny of Adamis Prescribed drugs Corp’s (NASDAQ: ADMP) Zimhi, an investigational therapy for opioid overdose, is to be determined by the FDA.Mylan NV (NASDAQ: MYL) awaits the FDA’s nod for its ANDA for dimethyl fumarate, a generic model of 1 made by Biogen Inc (NASDAQ: BIIB) to deal with a relapsing type of a number of sclerosis. (Monday)The FDA has set a PDUFA date of Nov. 16 for Bristol-Myers Squibb Co’s (NYSE: BMY) BLA for liso-cel as a therapy choice for sufferers with relapsed or refractory giant B-cell lymphoma after not less than two prior therapies. (Monday)Eiger BioPharmaceuticals Inc (NASDAQ: EIGR) awaits a decisive second with the FDA on Nov. 20 with respect to its NDA for Lonfarnib in progeria and progeroid laminopathies. (Friday)Medical Readout/Information Shows AAO Assembly Shows Lineage Cell Therapeutics Inc (NYSE: LCTX): up to date interim outcomes from the continuing Part 1/2a examine of its lead product candidate OpRegen in dry age-related macular degeneration. (Sunday); the corporate has additionally scheduled a name with key opinion leaders Tuesday, 4 pm ET, to debate the information.AASLD Shows Albireo Pharma Inc (NASDAQ: ALBO): new information from a Part 3 examine of odevixibat in progressive familial intrahepatic cholestasis (Sunday)Inventiva ADR Representing Ord Shs (NASDAQ: IVA): new information from the NATIVE Part 2b medical trial evaluating lanifibranor for NASH, specializing in the efficacy of lanifibranor in type-2 diabetic sufferers and its optimistic impact on key plasma biomarkers (Sunday)Akero Therapeutics Inc (NASDAQ: AKRO): further information evaluation from the Part 2a BALANCED examine of efruxifermin in non-alcoholic steatohepatitis (Sunday)Dicerna Prescribed drugs Inc (NASDAQ: DRNA): Up to date Part 1 information for RG6346 in HBV an infection (Monday)CymaBay Therapeutics Inc (NASDAQ: CBAY): a late-breaking presentation highlighting outcomes from the ENHANCE Part 3 examine of seladelpar in sufferers with major biliary cholangitis (Monday)Associated Hyperlink: 7 Shares That Might Profit From Pfizer’s COVID-19 Vaccine That Requires Chilly Chain Storage SNO Assembly Shows VBI Vaccines Inc (NASDAQ: VBIV): information from Half B of the continuing Part 1/2a examine of VBI-1901, its most cancers vaccine immunotherapeutic candidate, in recurrent glioblastoma (Thursday)Kintara Therapeutics Inc (NASDAQ: KTRA): replace on Part 2 research of VAL-083 in MGMT-unmethylated Recurrent Glioblastoma Multiforme (Thursday)Plus Therapeutics Inc (NASDAQ: PSTV): new interim information from the continuing NIH-sponsored ReSPECT Part 1 medical trial evaluating its lead investigational asset, Rhenium NanoLiposome in sufferers with recurrent glioblastoma (Thursday)CTOS Shows Karyopharm Therapeutics Inc (NASDAQ: KPTI): information from the Part 3 portion of the SEAL examine of Xpovio in superior dedifferentiated liposarcomaCogent Biosciences Inc (NASDAQ: COGT): last medical information from its Part 1/2 examine of PLX9486 in gastrointestinal stromal tumorsStandalone Information Readouts Avrobio Inc (NASDAQ: AVRO) will announce at its Digital R&D Day scheduled for Tuesday further particulars on its new Hunter syndrome program, whereas additionally sharing new information on its three medical packages, together with preliminary medical information from its Gaucher illness program.Pfizer and BioNTech count on security information milestone to be achieved within the third week of November and plan for emergency use authorization shortly after.Moderna might launch interim Part 3 readout for its coronavirus vaccine candidate, given it has mentioned it has reached the mandated variety of instances for evaluation.Earnings Monday Vascular Biogenics Ltd (NASDAQ: VBLT) (earlier than the market open) Jaguar Well being Inc (NASDAQ: JAGX) (earlier than the market open) Celsion Company (NASDAQ: CLSN) (earlier than the market open)Tuesday Trinity Biotech plc (NASDAQ: TRIB) (earlier than the market open) PAVmed Inc (NASDAQ: PAVM)Wednesday Edap Tms SA (NASDAQ: EDAP) (after the shut)Thursday Precipio Inc (NASDAQ: PRPO) (after the shut)Friday Burning Rock Biotech Ltd (NASDAQ: BNR) (earlier than the market open)IPOs San Diego, California-based Maravai Lifsciences Holding, Inc. is planning to promote in an preliminary public providing 50 million shares of its frequent inventory at a worth vary of $24-$27. The corporate, which gives essential merchandise to allow the event of drug therapies, diagnostics, novel vaccines and assist analysis on human illnesses, mentioned its shares can be listed on the Nasdaq beneath the ticker image MRVI.Sotera Well being Firm,, a sterilization, lab testing and advisory companies firm, has filed a prospectus with the SEC to supply 46.6 million shares of its frequent inventory, that are to be priced between $20 and $23. The Broadview Heights, Ohio-based firm has utilized for itemizing its shares on the Nasdaq beneath the ticker image SHC.IPO Quiet Interval Expiry Foghorn Therapeutics Inc. (NASDAQ: FHTX)See extra from Benzinga * Click on right here for choices trades from Benzinga * Moderna Achieves COVID-19 Case Quantity For First Interim Readout: What’s Subsequent? * What Pfizer’s Coronavirus Vaccine Information Means For Moderna(C) 2020 Benzinga.com. Benzinga doesn’t present funding recommendation. All rights reserved.