GSK has announced the advancement of its investigational mRNA seasonal flu vaccine candidate to phase 3 clinical trials following positive phase 2 data. The company's FLUm3HA.b-3NA candidate, designed to target both hemagglutinin (HA) and neuraminidase (NA), demonstrated stronger immune responses against all tested influenza strains compared with licensed standard-dose and high-dose inactivated flu vaccines. The randomized, observer-blind Flu-028 trial enrolled 971 adults aged 18 and older, comparing the optimized B-strain HA candidate with licensed age-appropriate comparators. The optimized candidate generated stronger responses to both influenza A and B strains in younger and older adults respectively, with an acceptable reactogenicity and safety profile. GSK's phase 3 efficacy trial is scheduled to start in September 2026, evaluating the optimized B-strain HA candidate against licensed comparators. This dual-antigen approach represents a significant advance in mRNA flu vaccine development, as it targets both major surface antigens of influenza viruses.
Three pharmaceutical companies announced significant regulatory developments that boosted investor confidence. Caplin Point Laboratories received confirmation of compliance with good manufacturing practices (GMP) from Colombia's National Institute for the Surveillance of Food and Drugs (INVIMA) for its subsidiary's manufacturing unit in Tiruvallur district, Tamil Nadu. The company expects to receive formal certification from INVIMA for oncology drug products including lyophilized powder for injections and tablets. Gland Pharma achieved a clean regulatory inspection with zero Form 483 observations from the US Food and Drug Administration for its VSEZ sterile oncology formulations and API facilities, following an inspection conducted between August 24-September 1, 2026.
The regulatory developments significantly impacted stock prices across all three companies. Caplin Point Laboratories shares surged 8% to close at ₹2,720, extending their year-to-date advance to 51.2%. Gland Pharma shares ended 0.7% lower at ₹2,864.5, despite the positive regulatory news, though the stock has gained 11% in the past month and 67% year-to-date. Nephrocare Health Services shares rose 0.7% to close at ₹688, with the stock gaining 51% year-to-date.
Nephrocare Health Services announced its overseas subsidiary Nephroplus Health Services Kazakhstan LLP entered a sale and purchase agreement to acquire 100% participatory interest in Dialysis Center Almaty LLP for KZT 561.66 million (approximately ₹11.63 crore). The acquisition will make Dialysis Center Almaty an overseas step-down subsidiary, strengthening the company's dialysis services network in international markets and expanding its presence in Kazakhstan. The transaction is subject to downward adjustments as per the share purchase agreement terms.
