Pfizer Stock Price, News & Analysis

ViiV Healthcare, majority-owned by GlaxoSmithKline (GSK), presented groundbreaking research at CROI 2022, emphasizing long-acting HIV treatments. Key findings highlighted include:

• Cabenuva administered every two months shows sustained efficacy in virologically suppressed adults.
• Dovato demonstrates long-term efficacy over 144 weeks compared to TAF-based treatments.
• Insights from the MOCHA study reveal adolescent perspectives on long-acting injectables.

These results reinforce ViiV's commitment to innovative HIV treatment and prevention.

Pfizer and BioNTech have initiated a rolling submission to amend the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include children aged 6 months to 4 years, at the request of the FDA. This application seeks authorization for two 3 µg doses as part of a planned three-dose series. With over 10.6 million pediatric COVID-19 cases in the U.S., this vaccine could be the first available for children under 5. The companies aim to submit additional data for a third dose in the coming months, enhancing protection against current and future variants.

Pfizer Inc. (NYSE: PFE) announces the appointment of William Pao, M.D., Ph.D., as Executive Vice President and Chief Development Officer, effective March 21, 2022. Dr. Pao, previously at Roche, will lead Pfizer's Global Product Development, overseeing the clinical advancement of innovative medicines. He succeeds Rod MacKenzie, who is retiring after 35 years. Dr. Pao's extensive experience in drug development is expected to enhance Pfizer's focus on breakthrough therapies and vaccines.

Cabenuva has received FDA approval for administration as few as six times a year for virologically suppressed adults with HIV-1, addressing treatment adherence challenges. This long-acting regimen combines cabotegravir and rilpivirine, initially approved in January 2021 for once-monthly dosing. The recent approval for every-two-month dosing was supported by the ATLAS-2M trial, showing comparable efficacy to monthly dosing. This innovation may significantly enhance patient experience and adherence, representing a noteworthy step forward in HIV treatment.

Pfizer and Ionis Pharmaceuticals announced the termination of the clinical development program for vupanorsen (PF-07285557), an investigational antisense therapy aimed at cardiovascular risk reduction and severe hypertriglyceridemia. Despite meeting its primary endpoint of reducing non-HDL cholesterol and triglycerides in a Phase 2b study, the results were insufficient to justify further development. Additionally, vupanorsen was linked to dose-dependent liver fat increases and elevated liver enzymes. Pfizer will return development rights to Ionis, which licensed vupanorsen in November 2019.

Pfizer (NYSE: PFE) announced that the European Commission has approved LORVIQUA (lorlatinib) for treating adults with ALK-positive advanced non-small cell lung cancer (NSCLC) previously untreated with an ALK inhibitor. This decision was based on the Phase 3 CROWN trial, demonstrating a 72% reduction in the risk of disease progression or death compared to XALKORI (crizotinib). The trial also reported a confirmed objective response rate of 76%, highlighting LORVIQUA's efficacy in patients with brain metastases.

Pfizer announced that the European Medicines Agency's CHMP has recommended conditional marketing authorization for PAXLOVID™ to treat COVID-19 in adults not requiring supplemental oxygen. If approved, it would be the first oral COVID-19 treatment recommended in the EU. The recommendation is based on clinical trial data showing PAXLOVID reduced the risk of hospitalization or death by 89% when administered within three days of symptom onset. Pfizer aims to produce up to 120 million treatment courses and is committed to equitable access worldwide.

Pfizer and BioNTech have commenced a clinical trial for an Omicron-based COVID-19 vaccine, evaluating safety and immunogenicity in 1,420 healthy adults aged 18-55. This study will assess various dosing regimens of the existing vaccine alongside the Omicron variant candidate. With the ongoing risk of waning vaccine effectiveness against emerging variants, the companies aim to provide longer-lasting protection. The trial is part of an extensive strategy to address evolving COVID-19 challenges while maintaining production capabilities of the current vaccine.

Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) received a Complete Response Letter (CRL) from the FDA concerning their Biologics License Application for somatrogon, a once-weekly treatment for pediatric growth hormone deficiency (GHD). Pfizer will collaborate with the FDA to address the feedback. Despite the setback, somatrogon has gained approvals in several countries, including Japan, Canada, and Australia. The European Commission decision is expected soon. The companies remain committed to advancing somatrogon and addressing unmet medical needs in GHD.