Merck & Co., Inc. (MRK) FDA Sets April 22, 2027 Action Date For Two HIV Drug Applications

Merck (MRK) will present new HIV treatment and prevention data at HIV Glasgow 2026, including Phase 3 results for IDVYNSO and investigational regimens. The FDA has accepted supplemental applications for IDVYNSO, with a target action date of April 22, 2027.

Merck completed adult enrollment in two trials for its investigational monthly HIV-prevention pill, alimatravir. The company presented data on various HIV treatments, including once-daily and once-weekly oral regimens, at the HIV Glasgow conference. Key data include Phase 3 subgroup analyses and patient-reported outcomes for IDVYNSO and islatravir/lenacapavir (ISL/LEN). Merck aims to expand HIV treatment and prevention options.

Merck, Eli Lilly, Novartis, and AstraZeneca allegedly paid millions in bonuses to Russian distributors, including R-Pharm, which faces corruption allegations. Whistleblower reports claim these payments may have facilitated kickbacks to officials for cancer drug contracts, potentially violating the U.S. Foreign Corrupt Practices Act. The companies have not publicly addressed the allegations.

Merck and Moderna's mRNA vaccine, tailored to patients' genetic profiles, reduced melanoma recurrence by 42% in a phase 3 trial when combined with immunotherapy. The vaccine, called intismeran, targets neoantigens in tumor cells, training the immune system to attack them. The study involved 1137 patients, with 82% of those receiving the vaccine and immunotherapy surviving without recurrence after two years, compared to 70% with immunotherapy alone.

Merck (MRK) and Moderna (MRNA) reported that their experimental personalized cancer vaccine, combined with Merck's Keytruda, reduced melanoma recurrence or death risk by 42% in a Phase 3 trial. Merck's Q3 Keytruda sales reached $8.6B, up 6% YoY, but faces patent expiration in 2028. The companies' shares rose on the news, with Merck up 4% and Moderna's value increasing by $30B in one session.

Merck and Moderna's personalized mRNA vaccine for melanoma reduced relapse risk by 42% in a phase 3 trial, with 82.2% of vaccinated patients relapse-free after 2 years. The vaccine targets neoantigens unique to each patient's tumor, but concerns include high costs and potential limitations compared to existing immunotherapies, according to SCIENCE.