GSK has surged ~46% YTD, far outpacing both the healthcare sector and S&P 500, which is notable considering the spectre of high US tariffs hanging over it. The recent US-UK pharmaceuticals deal, the company's investment plans in the US, and the likelihood of a possible drug pricing agreement with the US government can work for GSK. Supporting these developments is the company's solid financial performance, upgraded outlook and attractive market multiples.
GSK secures FDA approval for Exdensur, the first twice-yearly biologic for treating severe asthma with an eosinophilic phenotype.
The U.S. Food and Drug Administration has approved GSK's add-on drug to treat asthma and a chronic inflammatory sinus condition, the drugmaker said on Tuesday, paving the way for a less frequently dosed treatment option for patients to enter the market.
UK's health regulator on Monday approved GSK's twice-yearly drug for use as an add-on treatment for asthma in patients aged 12 and older, as well as for a chronic inflammatory sinus condition in adults.
GSK gets CHMP backing for Nucala in COPD and depemokimab in asthma, setting up possible Europe approvals in 2026 for IL-5 therapies.
GSK has been impressing me with strong revenue and EPS numbers for the eighth quarter in a row. Also, on December 12, depemokimab, GSK's anti-IL-5 antibody with 6-month dosing, received a positive EMA's CHMP opinion for the treatment of certain patients with severe asthma and CRSwNP. And yesterday, the FDA approved Blujepa for the treatment of uncomplicated urogenital gonorrhea.
GSK wins FDA approval for Blujepa, a new oral antibiotic treatment option for uncomplicated urogenital gonorrhea.
GSK gains FDA Orphan Drug Designation for risvutatug rezetecan, adding momentum to its fast-advancing solid-tumor pipeline.
GSK's stock surge rides on strong Q3 results and raised guidance, as Specialty Medicines momentum offsets U.S. vaccine softness.
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GSK PLC (LSE:GSK, NYSE:GSK) has picked up another regulatory boost for its experimental cancer medicine risvutatug rezetecan, after the US Food and Drug Administration granted the treatment Orphan Drug Designation for small-cell lung cancer. The company said the decision was supported by early data from its phase I ARTEMIS-001 study, where some patients with extensive-stage small-cell lung cancer, a form of the disease that has spread widely and is notoriously hard to treat, showed durable responses.
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