Pfizer Stock Price, News & Analysis

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.

Pfizer Inc. (NYSE: PFE) will present at two upcoming healthcare conferences. Chief Scientific Officer Mikael Dolsten will speak at Citi's 17th Annual BioPharma Conference on September 7, 2022, at 10:30 a.m. EDT, while Chief Financial Officer David Denton will present at the Wells Fargo 2022 Healthcare Conference on September 8, 2022, at 9:10 a.m. EDT. Investors can access the live webcasts and subsequent replays on Pfizer's investor relations website. Forward-looking statements discussed may involve risks that could materially impact actual results.

Pfizer and BioNTech announced that the CHMP has recommended conditional marketing authorization for their Omicron BA.1-adapted bivalent COVID-19 vaccine for individuals 12 years and older. This 30-µg booster dose combines mRNA from the original vaccine and mRNA for the Omicron BA.1 variant. The vaccine demonstrated improved immunogenicity, showing a 9-fold increase in neutralizing titers against the Omicron strain compared to the original vaccine. If approved, doses will be available to EU member states within days, supporting upcoming vaccination campaigns.