Lenacapavir Sodium

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 Modernas mNEXSPIKE and Novavaxs 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 hasnt yet issued a formal recommendation on the vaccines. Delilah AlvaradoModerna 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 GardnerShares 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 WuProFound 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 AlvaradoThe FDA on Friday cleared another HIV treatment from drugmaker Gilead Sciences. The company on Thursday gained an OK for Bixlenvo, a medicine combining Gileads 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 cant 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 '

The US FDA has approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), a once-daily single-tablet regimen (STR) for HIV-1 treatment in virologically suppressed adults — including, for the first time, those on complex multi-tablet regimens who could not previously use an STR. Gilead Sciences (Nasdaq: GILD) said the combination is the smallest oral STR and the first approved STR option for virologically suppressed patients on complex regimens who are unable to use existing STRs because of factors including historical resistance or tolerability. Bixlenvo is indicated as a complete regimen for adults with HIV-1 RNA below 50 copies per mL on a stable antiretroviral regimen, with no known or suspected resistance to either component. Initiation requires a two-day loading period with Sunlenca (lenacapavir) co-administered alongside Bixlenvo, after which Bixlenvo is taken alone once daily. Contraindications include co-administration with dofetilide and strong CYP3A inducers. Approval rested on two Phase III trials — ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) — both evaluating virologic suppression maintenance at Week 48 after switching to Bixlenvo. ARTISTRY-1 enrolled a notably treatment-experienced population: median age 60 years, median 28 years on antiretroviral therapy, 67% with nucleoside reverse transcriptase inhibitor (NRTI) resistance, and 81% on complex regimens due to resistance. Both trials reported comparable efficacy to prior regimens and no new safety signals; the most common adverse reactions were headache (4%), nausea (3%), and diarrhea (2%). ARTISTRY-1 results were published in The Lancet and ARTISTRY-2 in Lancet HIV. Bictegravir is an integrase strand transfer inhibitor (INSTI) that blocks insertion of viral cDNA into the host genome. Lenacapavir, a first-in-class capsid inhibitor also marketed as Sunlenca, disrupts capsid-dependent processes across multiple stages of the HIV lifecycle — nuclear import, uncoating, and virion assembly — with no cross-resistance to other approved antiretroviral classes. The approval adds another option to an increasingly competitive HIV switch market that includes ViiV Healthcare's Dovato (dolutegravir/lamivudine), long-acting injectable Cabenuva (cabotegravir/rilpivirine), and Merck's recently approved Idvynso (doravirine/islatravir). Bixlenvo is differentiated by its ability to simplify treatment for some heavily treatment-experienced patients currently requiring complex multi-tablet regimens. Spot something wrong? Report an issue with this article