Dynavax rises as EMA backs marketing application for HEPLISAV-B

 

• The European Medicines Agency's advisory group, CHMP, has adopted a positive opinion, recommending the marketing authorization of Dynavax Technologies' (NASDAQ:DVAX) HEPLISAV-B for the active immunization against hepatitis B virus infection (HBV) in adults 18 years of age and older.
• The European Commission is expected to make a final decision on the marketing application in Q1 2021. If approved, Dynavax would receive marketing authorization for HEPLISAV-B in all EU member states.
• https://seekingalpha.com/news/3643604-dynavax-rises-4-ema-backs-marketing-application-for-heplisav-b

Covid vax from Sanofi, GSK won't be ready until late 2021

 

• Sanofi (NASDAQ:SNY) and GlaxoSmithKline (NYSE:GSK), two of the world's biggest vaccine makers, have delayed advanced trials of their potential coronavirus vaccine after it produced an "insufficient" response in older adults.
• They now say their jab won't be ready until late next year, and will commence a new second-phase study with a more concentrated antigen in February.
• In another setback for vaccine developers, Australia canceled an order for 51M doses of a COVID shot being developed by CSL (OTCPK:CSLLY) and the University of Queensland.
• The Pfizer/BioNTech vaccine looks set for U.S. emergency authorization after the endorsement of an outside panel of experts.
• https://seekingalpha.com/news/3643603-vaccine-from-sanofi-gsk-wont-be-ready-until-late-2021

4D Molecular Therapeutics prices upsized IPO at $23

 

• A gene therapy company 4D Molecular Therapeutics (FDMT) has priced its upsized IPO of 8.4M shares of common stock (from 7M) at $23.00/share, for expected gross proceeds of $193.2M.
• Underwriters' over-allotment is an additional 1.26M shares.
• Trading kicks off today.
• Goldman Sachs, BofA Securities and Evercore are acting as book-running managers.
• Closing date is December 15.
• https://seekingalpha.com/news/3643606-4d-molecular-therapeutics-prices-upsized-ipo-23

EMA backs Merck's Keytruda as first-line treatment in colorectal cancer

 

• The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Merck's (NYSE:MRK) Keytruda, an anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
• The European Commission is expected to make a final decision on the marketing authorization in Q1 2021. 
• MSI is defined by the National Cancer Institute as a change that occurs in the DNA of certain cells, such as tumor cells, in which the number of repeats of microsatellites is different from the DNA when it was inherited.
• https://seekingalpha.com/news/3643641-ema-backs-mercks-keytruda-first-line-treatment-in-colorectal-cancer

European advisory group backs ViiV's Rukobia in HIV-1

 

• The European Medicines Agency's advisory group CHMP has issued a positive opinion recommending approval of ViiV Healthcare's Rukobia (fostemsavir) 600 mg extended-release tablets for the treatment of HIV-1 infection.
• Final marketing authorization from the European Commission is anticipated in the coming months. Fostemsavir was approved by the US FDA on July 2, 2020 and further regulatory applications have been submitted worldwide.
• ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).
• https://seekingalpha.com/news/3643646-european-advisory-group-backs-viivs-rukobia-in-hivminus-1-infection

Prevail Therapeutics starts gene therapy study for type of dementia

 

• Prevail Therapeutics (NASDAQ:PRVL) initiates dosing in Phase 1/2 PROCLAIM trial evaluating PR006, an investigational AAV9 gene therapy delivering the GRN gene, for the treatment of frontotemporal dementia patients with GRN mutations (FTD-GRN).
• The trial with up to 15 subjects will investigate the safety and tolerability of PR006 as well as key biomarkers and exploratory efficacy endpoints. Biomarker and safety analysis on a subset of patients enrolled in the trial is expected in 2021.
• The investigational gene therapy has been granted US & Europe Orphan Drug designation for FTD and Fast Track designation for FTD-GRN.
• PR006 is designed to increase levels of a protein called progranulin in the brains of FTD-GRN patients by delivering a healthy GRN gene via an AAV9 vector. Progranulin, up-regulated in a range of neuroinflammatory conditions, is believed to play a key role in FTD.
• https://seekingalpha.com/news/3643647-dosing-underway-in-prevail-therapeutics-gene-therapy-study-for-type-of-dementia

Euro advisory group backs Bristol Myers' Inrebic in myelofibrosis

 

• The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Bristol Myers Squibb's (NYSE:BMY) Inrebic (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
• The European Commission will review the recommendation and final decision is expected within 67 days of receipt of the CHMP opinion.
• The decision will be applicable to all EU member states and Iceland, Norway and Liechtenstein.
• https://seekingalpha.com/news/3643650-european-advisory-group-backs-bristol-myers-inrebic-in-myelofibrosis