FDA clears three updated COVID-19 vaccines
The FDA approved updated COVID-19 vaccines from Pfizer, Moderna, and Novavax. Moderna also raised $2.6 billion for its cancer drug business.
The U.S. Food and Drug Administration has approved updated versions of three COVID-19 vaccines. The shots from Pfizer and BioNTech, Moderna, and Novavax are tailored to a prominent viral variant the FDA recommended developers target earlier this year.
Pfizer and BioNTech said the FDA cleared a new formulation of their mRNA shot, Comirnaty. Moderna’s mNEXSPIKE and Novavax’s protein-based vaccine Nuvaxovid were also greenlit. All three received the kind of limited approvals given to newer COVID vaccines. These clearances are for all people over 65 and younger people at higher risk of severe illness. The Centers for Disease Control and Prevention has not yet issued a formal recommendation on the vaccines.
Moderna's fundraising for cancer work
Moderna has significantly increased its cash reserves. The company announced it secured $2.6 billion by pricing an "upsized" note offering.
Moderna raised the cash by selling convertible notes due in 2032. It 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. This 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.
Other biotech updates
Shares in Generate Biomedicines fell by double digits. Data for one of its experimental drugs were mistakenly published ahead of a medical meeting in Europe.
According to a filing with the U.S. Securities and Exchange Commission, three embargoed posters on GB-0895, or golukibart, were "inadvertently made publicly available." This happened ahead of a planned presentation at the European Respiratory Society Congress in September. The drug is in testing for patients with asthma and chronic obstructive pulmonary disease. The posters described early-stage results as well as the design of two late-stage studies.
ProFound Therapeutics, a biotech startup formed by Flagship Pioneering, has secured a $35 million commitment from the Gates Foundation. The cash will support efforts to develop treatments for women’s health.
The commitment includes an initial $20 million investment. It will support ProFound's use of artificial intelligence technology to find novel biomarkers and drug targets for preeclampsia and eclampsia. Herbert Virgin, the head of an AI program managed by the Gates Foundation, said both conditions are chronically "underdiagnosed and undertreated."
The FDA also cleared another HIV treatment from drugmaker Gilead Sciences. The company 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.
