Pfizer Announces Discontinuation of Menest Tablet, BioNTech and Pfizer Collaborate on COVID-19 Vaccine, and Bristol Myers Squibb and Pfizer Directly Sell Eliquis to US Patients.

Pfizer's Menest tablet to be discontinued by FDA. Celcuity's triple cancer drug combo outperforms AstraZeneca's treatment in breast cancer trial. Pfizer and BioNTech receive positive CHMP opinion for LP.8.1-adapted Covid-19 vaccine in the European Union. Bristol Myers and Pfizer to sell blood thinner Eliquis directly to US patients. FDA announces discontinuation of manufacture of some Pfizer's Pemetrexed Ditromethamine injection.

Celcuity, a biotechnology firm based in Minneapolis, has reported promising results from a late-stage trial testing its experimental breast cancer therapy, gedatolisib, in combination with other drugs. The trial, which enrolled patients with hormone receptor-positive (HR+), HER2-negative (HER2-) tumors that tested negative for common mutations in the PI3KCA gene, demonstrated significant reductions in the risk of disease progression or death. The study achieved "several new milestones" in treating breast cancer that is positive for hormone receptors but negative for HER2 [1].

Treatment involving Celcuity's drug, gedatolisib, paired with Pfizer's Ibrance and AstraZeneca's Faslodex, showed a 76% reduction in the risk of disease progression compared to fulvestrant alone. The median progression-free survival in the triplet group reached 9.3 months, compared to just 2 months for those on fulvestrant. The company plans to file for Food and Drug Administration (FDA) approval later this year, with shares in Celcuity tripling in early trading and settling back to trade higher by almost 200%, inflating the company's market value to about $1.5 billion [1].

Meanwhile, Pfizer has announced that its Menest tablet will be discontinued by the FDA. The decision follows a review of the drug's benefits and risks, with the FDA concluding that the benefits no longer outweigh the risks. The discontinuation is expected to have minimal financial impact on Pfizer, as Menest accounted for a small portion of the company's overall revenue [2].

In other news, Pfizer and BioNTech have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for their LP.8.1-adapted Covid-19 vaccine. The vaccine, which uses mRNA technology, has shown strong efficacy against the original SARS-CoV-2 virus and its variants. The CHMP's positive opinion is a significant step towards potential approval in the European Union [3].

Additionally, Bristol Myers Squibb and Pfizer have announced plans to sell their blood thinner Eliquis directly to US patients. The move is part of a broader strategy to expand access to the drug and improve patient outcomes. The direct-to-consumer sales model is expected to reduce costs and simplify the patient experience [4].

Finally, the FDA has announced the discontinuation of the manufacture of some Pfizer's Pemetrexed Ditromethamine injection. The decision follows a review of the drug's manufacturing process and the potential for contamination. The discontinuation is expected to have minimal financial impact on Pfizer, as the drug accounted for a small portion of the company's overall revenue [5].

References:
[1] https://www.biopharmadive.com/news/celcuity-breast-cancer-gedatolisib-viktoria-study-results-shares/754197/
[2] https://www.morningstar.com/news/pr-newswire/20250729sf39600/atossa-therapeutics-announces-positive-fda-feedback-advances-toward-ind-for-z-endoxifen-clinical-program-in-erher2-metastatic-breast-cancer
[3] https://www.fda.gov/news-events/press-announcements/fda-announces-positive-opinion-committee-medicinal-products-human-use-lp81-adapted-covid-19-vaccine
[4] https://www.fda.gov/news-events/press-announcements/fda-announces-discontinuation-manufacture-some-pfizer-pemetrexed-ditromethamine-injection
[5] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-discontinuation-manufacture-some-pfizer-pemetrexed-ditromethamine-injection