Pfizer Inc. - PFE STOCK NEWS

Pfizer Inc. (NYSE: PFE) announced the enrollment of the first participants in a new study examining the coadministration of its 20-valent pneumococcal conjugate vaccine (20vPnC) alongside a booster dose of the Pfizer-BioNTech COVID-19 Vaccine. This trial, involving 600 adults aged 65 and older, aims to assess safety and immune responses over a six-month follow-up. Participants will be randomized into three groups: one receiving both vaccines, one receiving 20vPnC plus a placebo, and another receiving the COVID-19 vaccine booster plus placebo.

Pfizer and BioNTech have entered a new agreement with the European Commission to supply 900 million doses of the COVID-19 vaccine COMIRNATY® to the EU, with an optional additional 900 million doses. This follows a prior commitment of 600 million doses for 2021. Deliveries are set to start in December 2021 and continue into 2023, potentially totaling 2.4 billion doses. Both companies emphasize the importance of ongoing vaccinations due to the continued spread of COVID-19 and are committed to adapting their vaccine for emerging variants.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) announced that the FDA has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals aged 12 to 15, making it the first vaccine authorized for this age group in the U.S. This decision follows a Phase 3 trial with 2,260 participants showing 100% efficacy and good tolerance of the vaccine. Monitoring for long-term safety will continue for two years post-vaccination. The CDC's Advisory Committee will shortly discuss recommendations for this age group.

Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the FDA for their mRNA COVID-19 vaccine for individuals aged 16 and older. This submission supports their ongoing Emergency Use Authorization (EUA) since December 2020, during which over 170 million doses have been delivered in the U.S. The BLA aims for full regulatory approval, with data submitted on a rolling basis. The companies also seek to expand the EUA to include ages 12 to 15, followed by a supplemental BLA once data for this age group is available.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) signed a Memorandum of Understanding with the IOC to donate COVID-19 vaccine doses to athletes participating in the Tokyo 2020 Olympic and Paralympic Games, starting July 23, 2021. Initial doses are set for delivery by the end of May. The agreement ensures that vaccine doses provided will not detract from national supply agreements. IOC President emphasized the donation's role in promoting safety and solidarity. Pfizer's Chairman stated that the initiative represents a unifying moment post-pandemic, while BioNTech's CEO highlighted the importance of vaccines for a successful Games.

Pfizer Inc. (NYSE: PFE) reported a 45% increase in revenues for Q1 2021, reaching $14.58 billion, driven by strong sales of its COVID-19 vaccine BNT162b2, which contributed $3.5 billion. Adjusted diluted EPS rose to $0.93, reflecting an operational growth fueled by various therapeutic products. Pfizer has raised its 2021 revenue guidance to between $70.5 and $72.5 billion, previously at $59.4 to $61.4 billion, primarily due to improved expectations from BNT162b2. The company's dividend strategy remains robust, maintaining a consistent payout for the 12th consecutive year.

Astellas Pharma announced that the European Commission approved XTANDI™ (enzalutamide) for treating metastatic hormone-sensitive prostate cancer (mHSPC). This approval follows the Phase 3 ARCHES trial, which demonstrated a 61% reduction in the risk of radiographic progression or death when enzalutamide was combined with androgen deprivation therapy. XTANDI is now the only oral treatment available in the EU for this type of advanced prostate cancer, providing a crucial therapeutic option. The approval does not affect Astellas' financial forecasts for the current fiscal year ending March 31, 2022.

Pfizer (NYSE: PFE) is set to present at the 7th Annual Truist Securities 2021 Life Sciences Summit on May 5, 2021, at 1:50 p.m. EDT. The discussion will feature Charles Triano, Senior Vice President of Investor Relations. Investors and the public can access the live webcast and archived recordings on Pfizer's investor relations website starting today. Pfizer focuses on delivering innovative therapies and vaccines to enhance patient lives and collaborates globally to improve healthcare access. More information can be found at www.pfizer.com/investors.

Pfizer Inc. (NYSE: PFE) has acquired Amplyx Pharmaceuticals, which specializes in therapies for life-threatening diseases in immunocompromised patients. The key focus of this acquisition is Amplyx's lead compound, Fosmanogepix (APX001), designed to treat invasive fungal infections. With over 1.5 million global cases annually and a high mortality rate, Fosmanogepix targets drug-resistant fungal strains, introducing a potentially novel therapeutic class. This acquisition follows Pfizer’s previous investment in Amplyx, aiming to enhance its anti-infective portfolio.