Pfizer Stock Price, News & Analysis

ViiV Healthcare has received FDA approval for Cabenuva (cabotegravir, rilpivirine), the first long-acting HIV treatment specifically for virologically suppressed adolescents. The regimen allows for treatment as infrequent as six times a year, offering a crucial alternative to daily oral therapy. This approval highlights ViiV's commitment to addressing unmet needs in adolescent HIV care. The regimen's efficacy is supported by adult data and an interim analysis of the MOCHA study. However, adverse reactions were reported in 61% of adolescent participants, with injection site pain being the most common.

The FDA has expanded the emergency use authorization for Pfizer and BioNTech's COVID-19 vaccine, allowing a second booster dose for adults aged 50 and older who have had a first booster. This also includes individuals 12 years and older with certain immunocompromises. The additional dose is to be given at least four months after the first booster. Immunogenicity data show significant increases in antibody levels post-second booster, suggesting improved protection against COVID-19 variants, particularly for vulnerable populations. The same formulation as prior doses will be used.

Pfizer announced positive results from the ELEVATE UC 52 trial, a Phase 3 study of etrasimod for ulcerative colitis. It met co-primary endpoints of clinical remission at weeks 12 and 52, alongside achieving all key secondary endpoints. The study involved 433 patients who had previously failed other therapies. Etrasimod showed a safety profile consistent with prior studies, and further results will justify future regulatory filings. Pfizer aims to initiate these filings later this year, positioning etrasimod as a potentially groundbreaking treatment option.

ViiV Healthcare announces US FDA approval for an updated label for Cabenuva, allowing treatment initiation directly with injections, bypassing the optional oral lead-in phase. This change enhances the user experience for HIV patients, streamlining the process of starting the first and only complete long-acting HIV treatment regimen. The label update is based on clinical trial results showing comparable safety and efficacy for both initiation methods. Cabenuva is indicated for virologically suppressed adults, reinforcing ViiV's commitment to innovative HIV therapies.

ViiV Healthcare announced the US FDA approval to update the label for Cabenuva, facilitating a streamlined initiation process for its long-acting HIV treatment. This update allows patients to start directly with injections, omitting the previously required oral lead-in regimen, after demonstrating comparable safety and efficacy between both initiation methods. Cabenuva, the only complete long-acting treatment for HIV-1, is approved for use in virologically suppressed adults. This approval is based on FLAIR trial results affirming effective treatment outcomes without the oral lead-in.

Pfizer Inc. (NYSE:PFE) has received Breakthrough Therapy Designation from the FDA for its RSV vaccine candidate, RSVpreF, aimed at preventing lower respiratory tract disease in individuals aged 60 and older. This designation follows promising results from a Phase 2a study assessing the vaccine's safety and efficacy. The ongoing Phase 3 trial, RENOIR, continues to evaluate RSVpreF's effectiveness in older adults. Currently, there are no existing vaccine options for RSV in this demographic, highlighting a critical healthcare need.

Pfizer (NYSE: PFE) announced positive topline results from its Phase 3 ELEVATE 12 study of etrasimod, an oral medication for ulcerative colitis (UC). The study met its primary endpoint with significant clinical remission at week 12 compared to placebo, alongside achieving all key secondary endpoints. The safety profile aligns with prior Phase 2 studies, suggesting etrasimod's potential as a breakthrough treatment for UC patients unresponsive to current therapies. Full results are set for publication, with further data from another study expected by the end of Q1.

Pfizer Inc. (NYSE: PFE) will host a conference call with investment analysts on May 3, 2022, at 10 a.m. EDT to discuss its First Quarter 2022 Performance Report.

Investors can listen to the call through the company's webcast or by phone, dialing (833) 708-1779 in the U.S. and Canada or (602) 585-9859 internationally, using passcode “050322”. A replay will be available on the Pfizer website within 24 hours.

Pfizer (NYSE: PFE) has partnered with UNICEF to provide up to 4 million treatment courses of its COVID-19 oral medication, PAXLOVID™, to 95 low- and middle-income countries starting in April 2022. This initiative aims to enhance global access to COVID-19 treatment, with the courses being offered at a not-for-profit price for lower-income countries. Pfizer anticipates producing up to 120 million treatment courses by the end of 2022, depending on global demand. The agreement aligns with Pfizer's commitment to equitable access amidst the ongoing pandemic.