Pfizer Inc. - PFE STOCK NEWS

Pfizer (PFE) and BioNTech (BNTX) released results from a pivotal Phase 2/3 trial of their COVID-19 vaccine for children 5 to 11 years old. The study demonstrated a good safety profile and robust antibody responses after administering a 10 µg dose in a two-dose regimen. The vaccine's immune response was comparable to that seen in older populations. The companies plan to submit these data to the FDA and EMA for Emergency Use Authorization soon, with results for children under 5 expected later this year.

The FDA's Vaccines Advisory Committee has unanimously recommended the Emergency Use Authorization (EUA) for a COMIRNATY booster dose for individuals 65 and older and those at high risk for severe COVID-19. Data presented showed high neutralization titers against SARS-CoV-2 variants post-booster with a mild to moderate reactogenicity profile. Real-world evidence from Israel indicates that booster doses significantly enhance protection, comparable to initial vaccine effectiveness. The FDA is anticipated to make its decision soon, potentially marking COMIRNATY as the first COVID-19 booster authorized in the U.S.

Astellas Pharma and Pfizer announced that XTANDI (enzalutamide) improved overall survival in the Phase 3 ARCHES trial for men with metastatic hormone-sensitive prostate cancer (mHSPC). The study involved 1,150 patients and showed a 34% reduction in the risk of death (HR=0.66; p<0.0001) compared to placebo. Median OS was not reached in either group. Results are set to be presented at the ESMO Congress. This marks the third stage where enzalutamide has shown survival benefits in advanced prostate cancer, enhancing its clinical profile in earlier disease settings.

Pfizer has received marketing authorization from the UK MHRA for CIBINQO (abrocitinib), a once-daily oral JAK1 inhibitor. This drug is approved for treating moderate to severe atopic dermatitis in patients aged 12 and older who require systemic therapy. The authorized doses are 100mg and 200mg. This marks the first marketing authorization globally for abrocitinib, following its PIM designation last year. Pfizer aims to collaborate with NICE and the Scottish Medicines Consortium to ensure patient access to this treatment.

Pfizer Inc. (NYSE: PFE) invites the public to join two webcasts featuring company executives at healthcare conferences. Frank D’Amelio, CFO, will discuss at the Morgan Stanley 19th Annual Global Healthcare Conference on September 14, 2021, at 10:15 a.m. EDT. Angela Hwang, Group President, will speak at the BofA Global Healthcare Conference on September 15, 2021, at 11:45 a.m. EDT. Webcast access and registration details can be found on Pfizer's website, with transcripts available within 24 hours post-event.

Pfizer has initiated the RENOIR Phase 3 clinical trial for its RSV bivalent prefusion F subunit vaccine candidate in adults aged 60 and older. This trial aims to enroll approximately 30,000 participants and assess the vaccine's safety and efficacy against severe respiratory illness caused by RSV, which poses significant risks to older adults. With no current vaccine available, the trial addresses an urgent medical need, particularly as RSV leads to over 14,000 deaths annually in the U.S. among older adults.

Pfizer Inc. (NYSE: PFE) reported that the JADE DARE trial for abrocitinib met its co-primary and key secondary endpoints. This Phase 3 study demonstrated that abrocitinib, when dosed at 200mg daily, was statistically superior to dupilumab (300mg) for treating moderate to severe atopic dermatitis. While the safety profile was consistent with earlier studies, a higher percentage of patients on abrocitinib experienced adverse events. The findings, expected to be presented at a scientific meeting, underline abrocitinib's potential benefits for patients.

Pfizer Inc. (NYSE: PFE) has appointed Aamir Malik as the new Executive Vice President and Chief Business Innovation Officer, effective August 30, 2021. Malik, previously a Managing Partner at McKinsey & Company, will report to CEO Albert Bourla and succeed John Young as he retires after 34 years. In his new role, Malik will be responsible for the company’s strategy, business development, and innovative partnerships globally. Bourla highlighted Malik's extensive experience in driving growth and improving patient care during the announcement.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have signed a letter of intent with Eurofarma Laboratórios SA to manufacture their COVID-19 vaccine, COMIRNATY^®, for distribution in Latin America. Eurofarma will initiate technical transfer and on-site development immediately, with finished dose production expected to exceed 100 million doses annually, beginning in 2022. This collaboration aims to enhance equitable access to vaccines in the region, contributing to a total of 3 billion doses planned for global distribution by year-end 2021.