Pfizer - PFE STOCK NEWS

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.

IDEAYA Biosciences (IDYA) has collaborated with Pfizer (PFE) to enhance clinical trials evaluating the combination of darovasertib and crizotinib in patients with metastatic uveal melanoma (MUM) and cMET-driven tumors. The Phase 2 trial could enable registration, with promising preliminary data showing robust activity. IDEAYA plans to provide an update on clinical data in mid-2022 and will seek FDA guidance for trial design. This partnership aims to elevate treatment standards for patients with high unmet needs and potentially expand to other cancer types.

Pfizer Inc. (NYSE: PFE) has successfully completed the acquisition of Arena Pharmaceuticals for $100 per share, totaling approximately $6.7 billion. This strategic move aims to enhance Pfizer's capabilities in treating immuno-inflammatory diseases, leveraging Arena's promising pipeline, including etrasimod. Etrasimod is being developed for conditions such as ulcerative colitis and Crohn's Disease. The acquisition is anticipated to advance Pfizer’s Inflammation and Immunology therapeutic area.

Pfizer has commenced the Phase 2/3 EPIC-PEDS study to assess the safety and efficacy of PAXLOVID™ in children with COVID-19. This follows promising data from the EPIC-HR study, showing an 89% reduction in hospitalization or death risk in high-risk adults. The pediatric study aims to enroll around 140 participants under 18, focusing on those weighing at least 20 kg. PAXLOVID is already authorized in over 50 countries, with more than 1.5 million courses delivered and expectations of 30 million by July. The company remains committed to equitable access through tiered pricing and increased production capabilities.