Gilead Sciences Inc. tallied a “clear win,” said Barclays analyst Carter Gould, in the phase III interim analysis showing that the Foster City, Calif.-based company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, yielded 100% efficacy as an HIV blocker for cisgender women.
Preliminary data show Biotron Ltd.’s lead compound BIT-225 met the primary objectives of the phase II BIT225-011 trial, a longitudinal, open-label trial designed to characterize the effect of the compound added to ongoing, suppressive antiretroviral therapy in HIV-1-infected, treatment-experienced patients who achieved only partial immune reconstitution.
Becoming the first pneumococcal conjugate vaccine specifically designed for adults 18 and older, Merck & Co. Inc.’s 21-valent candidate, Capvaxive (V-116), gained U.S. FDA approval on its June 17 PDUFA date. The Rahway, N.J.-based company expects to take significant market share based on positive phase III findings from the Stride-3 trial. Analysts have estimated the product could reach $2 billion in annual global sales.
Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
An expert in hepatitis delta virus said Vir Biotechnology Inc.’s phase II findings with the monoclonal antibody tobevibart and the small interfering ribonucleic acid elebsiran in chronic disease could lead to a “change [in] the entire care cascade and paradigm.” Shares of Vir (NASDAQ:VIR) ended June 5 at $12.66, up $2.08, or 19.7%, on the clinical news.
Annexon Inc.’s stock (NASDAQ:ANNX) climbed 31% June 4 following news that a single infusion of C1q protein complex inhibitor ANX-005 at the 30-mg/kg dose delivered a statistically significant 2.4-fold improvement in Guillain-Barré syndrome patients. Shares closed at $5.99, up $1.41.
Although consensus was not reached on the World Health Organization’s pandemic agreement, the World Health Assembly recognized the progress made by member states to develop a pandemic agreement and to strengthen International Health Regulations (IHR, 2005) during the 77th World Health Assembly meeting held May 27 to June 1 in Geneva.
The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn.
Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S.
In a paper published in the May 17, 2024, online issue of Cell, investigators from the Duke Human Vaccine Institute reported that a sequence of three immunizations in the HVTN-133 trial was sufficient for the development of heterologous or broadly neutralizing antibodies that protected against several strains of HIV.
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