Pfizer Inc. - PFE STOCK NEWS

Pfizer announced positive results from the Phase 3 trial of its investigational pentavalent meningococcal vaccine, MenABCWY, demonstrating safety and immunogenicity non-inferior to existing licensed vaccines. The trial met all primary and secondary endpoints, providing broad serogroup coverage. Pfizer plans to submit a Biologics License Application to the FDA in Q4 2022, which, if approved, could simplify the vaccination schedule for approximately 52 million adolescents in the U.S. and improve meningococcal disease protection.

Pfizer Inc. (NYSE: PFE) will hold a conference call on September 21, 2022, at 4:30 p.m. EDT, focusing on oral GLP-1 data from the European Association for the Study of Diabetes 2022. Investors can join the webcast via Pfizer's investor site, and are encouraged to register in advance. Participants can also listen by calling 800-456-4352 (U.S. and Canada) or 785-424-1086 (international), with passcode “70409”. A transcript and replay will be available for 90 days on the investor site.

Pfizer Inc. (NYSE: PFE) has initiated a pivotal Phase 3 clinical trial for its mRNA-based influenza vaccine, enrolling approximately 25,000 healthy adults in the U.S. This study aims to evaluate the vaccine's efficacy, safety, and immunogenicity. With influenza annually causing up to 710,000 hospitalizations and 52,000 deaths in the U.S., the need for improved vaccines is critical. mRNA technology may allow better strain matches and more rapid production, potentially enhancing vaccine effectiveness.

Pfizer (NYSE: PFE) has expanded its collaboration with Strata Oncology for the Strata PATH trial, which will now include treatment for new micrometastatic patient cohorts. Pfizer will provide several FDA-approved cancer therapies, including Braftovi® and Lorbrena®, for patients with early-stage cancer showing micrometastatic disease. The trial aims to evaluate the safety and efficacy of these therapies on a broader patient population. This initiative underscores the potential of precision oncology in advancing cancer treatment.

Pfizer and BioNTech have received a conditional marketing authorization recommendation from the EMA's CHMP for their bivalent Omicron BA.4/BA.5 COVID-19 vaccine for individuals 12 years and older. The vaccine combines components targeting both the original SARS-CoV-2 and Omicron subvariants, designed to elicit a strong immune response. If approved by the European Commission, distribution will commence immediately to support EU vaccination efforts this fall. Previous data showed a superior immune response against Omicron subvariants compared to the existing vaccine.

Pfizer Inc. (NYSE: PFE) announced that the FDA accepted the New Drug Application (NDA) for ritlecitinib for treating alopecia areata in adults and adolescents. The FDA decision is expected in Q2 2023, while the EMA's Marketing Authorization Application (MAA) decision is anticipated in Q4 2023. Ritlecitinib is a new oral treatment aimed at regrowing hair, showing statistically significant results in clinical trials. Alopecia areata affects approximately 6.8 million people in the U.S. and around 147 million globally.

Pfizer Inc. (NYSE:PFE) announced that its investigational GBS vaccine, GBS6, has received Breakthrough Therapy Designation from the FDA. This designation aims to expedite the development of GBS6, aimed at preventing invasive Group B Streptococcus disease in newborns. The decision is based on interim analysis from an ongoing Phase 2 trial in pregnant women. If approved, GBS6 could significantly reduce neonatal diseases, addressing a critical public health need. GBS6 targets the six main GBS serotypes, accounting for 98% of global cases.