Today, a brief rundown of news involving the Food and Drug Administration and Moderna, as well as updates from Generate Biomedicines, ProFound Therapeutics and Gilead Sciences that you may have missed.
The Food and Drug Administration has approved updated versions of three COVID-19 vaccines tailored to a prominent viral variant. Pfizer and partner BioNTech said Thursday the FDA cleared a new formulation of their mRNA shot, Comirnaty, aimed at the “XFG” variant the FDA recommended developers target earlier this year. The agency also greenlit Moderna’s mNEXSPIKE and Novavax’s protein-based vaccine Nuvaxovid. All three were granted the kind of limited approvals given to newer COVID vaccines, which involve clearances for all people over 65 and younger people at higher risk of severe illness. The Centers for Disease Control and Prevention hasn’t yet issued a formal recommendation on the vaccines.— Delilah Alvarado
Moderna has also significantly upped its cash reserves, pricing an “upsized” note offering that secured $2.6 billion, the company announced Thursday. Moderna raised the cash by selling convertible notes due in 2032, and intends to use the proceeds to help build its cancer drug business and repay debt. Shares have fallen about 10% since Moderna revealed the note offering, which came shortly after the success of a closely watched cancer vaccine in a Phase 3 trial. Moderna added $45 billion in market value the day those results were disclosed.— Jonathan Gardner
Shares in Generate Biomedicines fell by double digits after data for one of its experimental drugs were mistakenly published ahead of a medical meeting in Europe. According to a Wednesday filing with the U.S. Securities and Exchange Commission, three embargoed posters on GB-0895, or golukibart, which is in testing for patients with asthma and chronic obstructive pulmonary disease, were “inadvertently made publicly available” ahead of a planned presentation at the European Respiratory Society Congress in September. The posters described early-stage results as well as the design of two late-stage studies.— Gwendolyn Wu
ProFound Therapeutics, a biotech startup formed by Flagship Pioneering, has secured a $35 million commitment from the Gates Foundation to develop treatments for women's health. The cash includes an initial $20 million investment and will support efforts by ProFound to use artificial intelligence technology to unearth novel biomarkers and drug targets for preeclampsia and eclampsia. Both conditions are chronically “underdiagnosed and undertreated,” said Herbert Virgin, the head of an AI program managed by the Gates Foundation.— Delilah Alvarado
The FDA on Friday cleared another HIV treatment from drugmaker Gilead Sciences. The company on Thursday gained an OK for Bixlenvo, a medicine combining Gilead’s bictegravir and lenacapavir into a single tablet. The drug is now available for use in people whose HIV has been suppressed by other treatments. According to Gilead, Bixlenvo is the only drug of its kind cleared for use in those on “complex" regimens who can’t take other one-pill treatments. The clearance was based on late-stage study results published this year in The Lancet and Lancet HIV. — Delilah Alvarado
