Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
CDC Recommends COVID-19 Boosters For Kids Ages 5-11
The U.S. Centers for Disease Control and Prevention recommended the COVID-19 vaccine booster for children ages 5 to 11 years after at least five months after the initial Pfizer Inc (NYSE:PFE) - BioNTech SE (NASDAQ:BNTX) vaccination series.
The extra dose is one-third of those kids 12 years old and above receive.
FDA Places Clinical Hold On Foghorn Therapeutics Early Stage Blood Cancer Trial
The FDA has instituted a clinical hold on Foghorn Therapeutics Inc's (NASDAQ:FHTX) Phase 1 dose-escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia and myelodysplastic syndrome.
The FDA initiated the partial clinical hold following the report of a recent death that occurred in a subject with potential differentiation syndrome.
The FDA has requested a review of the safety database, risk mitigation strategies, and clinical activity breakdown across dose levels.
FHTX shares closed 24.9% lower at $8.60 during after-hours trading.
Bayer Intents To Bow Out From CAR-T Therapy Pact With Atara
Atara Biotherapeutics Inc (NASDAQ:ATRA) received notification that Bayer AG's (OTC:BAYRY) intends to end the exclusive worldwide licensing agreement for mesothelin-directed CAR T-cell therapies.
The collaboration included the funding and development of ATA3271, allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for high mesothelin-expressing tumors.
ATRA shares closed 14.3% lower at $4.42 during after-hours trading.
Europe's Advisory Committee Backs Sanofi's Xenpozyme For Rare Metabolic Disease
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Sanofi SA's (NASDAQ:SNY) Xenpozyme (olipudase alfa) for non-central nervous system manifestations of acid sphingomyelinase deficiency.
The positive opinion is based on ASCEND and ASCEND-Peds trials data that Xenpozyme showed robust and clinically relevant improvement in lung function and reduced spleen and liver volumes.
Mirati Submits European Application For Adagrasib In KRAS-Mutated Lung Cancer
Mirati Therapeutics Inc (NASDAQ:MRTX) has submitted a marketing application to the European Medicines Agency for adagrasib in non-small cell lung cancer patients harboring the KRASG12C mutation who have received at least one prior systemic therapy.
The adagrasib FDA application is being reviewed for accelerated approval for the same indication.
Click here to access Benzinga's FDA Calendar.
Insider Trading
OKYO Pharma (NASDAQ:OKYO): Reports in Form 4 filing CEO buys 12.5K shares at an average price of $4/share.
Aprea Therapeutics Inc (NASDAQ:APRE): Reports in Form 4 filing chairman Christian Schade buys 37,500 shares at an average price of $0.64/share.
Exicure Inc (NASDAQ:XCUR): Reports in Form 4 filing 4, a director bought 1.47 million shares at an average price of 19 cents/share.
Shares are trading 26.3% higher at 15 cents during the premarket session on the last check Friday.
Clinical Readout/Presentations
Chinook Therapeutics Inc (NASDAQ:KDNY): Live conference call and webcast to discuss the presentations at the ERA Congress 2022 and provide program updates.
Ocuphire Pharma Inc (NASDAQ:OCUP): Masked safety data from Phase 2b APX3330 trial at Clinical Trials at the Summit.
Soleno Therapeutics Inc (NASDAQ:SLNO): Long-term safety of Diazoxide Choline Extended-Release in Prader-Willi Syndrome at the 2022 European Congress of Endocrinology.
Vera Therapeutics Inc (NASDAQ:VERA): New data from Phase 2a JANUS trial of atacicept in IgA nephropathy and post-hoc analysis of Phase 2 APRIL-SLE study of atacicept in systemic lupus erythematosus at the European Renal Association – European Dialysis and Transplant Association Congress.
Aurinia Pharmaceuticals Inc (NASDAQ:AUPH): Voclosporin data in lupus nephritis at the European Renal Association Congress.
Offerings
Evofem Biosciences Inc (NASDAQ:EVFM) intends to offer and sell shares of its common stock (or pre-funded warrants) and warrants in an underwritten public offering.
Price and volume are yet to be determined.
Shares are slipping 42.8% at 63 cents during the premarket trading.
