Pfizer Inc. reports developments across its global biopharmaceutical business, including prescription medicines, vaccines, biosimilars, sterile injectables, and oncology therapies. Recurring news covers financial results and guidance, commercial portfolio changes within Biopharma, dividend declarations, capital allocation priorities, and product access initiatives for established medicines such as Eliquis.
Company updates also address clinical and regulatory activity across Pfizer's pipeline and marketed products. Recent themes include oncology data presentations, Phase 3 results for ELREXFIO in relapsed or refractory multiple myeloma, PADCEV combination regulatory activity in bladder cancer, VYNDAMAX patent litigation settlements, and shareholder meeting communications.
Pfizer Inc. (NYSE: PFE) announced that the FDA has accepted for review a New Drug Application for etrasimod, targeting moderately-to-severely active ulcerative colitis (UC). This follows positive results from two Phase 3 trials (ELEVATE UC 52 and UC 12) demonstrating significant clinical remission compared to placebo. The FDA decision is expected in the second half of 2023, with EMA review anticipated in early 2024. Etrasimod, an oral S1P receptor modulator, aims to provide a new therapeutic option for the 3.8 million people affected by UC.
Pfizer Inc. (NYSE: PFE) will host a conference call for investment analysts at 10 a.m. EST on January 31, 2023, to discuss its Fourth Quarter and Full Year 2022 Performance Report. Investors and the public can access the webcast and Performance Report through Pfizer's investor relations website. Participants must register in advance. The call can be listened to by dialing 800-456-4352 (U.S.) or 785-424-1086 (international) with the passcode '51512'. A transcript and replay will be available for 90 days.
Kindeva Drug Delivery and Meridian Medical Technologies have successfully merged, forming a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products. The newly combined entity, Kindeva, will leverage enhanced capabilities across various drug delivery methods, including inhalation and transdermal solutions. Milton Boyer, former CEO of Meridian, now leads Kindeva. This merger consolidates Kindeva's existing strength as a leader in drug-device solutions, having a rich history of innovation since the 1950s.
Pfizer (NYSE:PFE) presented positive results from the Phase 2 MagnetisMM-3 trial of elranatamab at the 2022 ASH Annual Meeting. The study reported a high objective response rate of 61% in patients with relapsed/refractory multiple myeloma (RRMM), with an 84% probability of maintaining this response at nine months. Elranatamab demonstrated early and deep responses, alongside manageable safety, indicating its potential as a transformative treatment in a high-need area. The trial involved 123 heavily pretreated patients, showing promising signs for further studies.
Pfizer Inc. (NYSE: PFE) announced an increase in its quarterly cash dividend to $0.41 per share for the first quarter of 2023. This dividend, which is the 337th consecutive quarterly dividend, will be payable on March 3, 2023, to shareholders on record as of January 27, 2023. Pfizer's CEO Albert Bourla emphasized that this increase reflects the company’s robust financial performance in 2022 and highlights its commitment to returning value to shareholders.
Pfizer and BioNTech announce the FDA's Emergency Use Authorization (EUA) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a third 3-µg dose in the primary vaccination series for children aged 6 months to 4 years. Given the urgent need due to rising COVID-19 cases and respiratory illnesses in young children, vaccine doses will ship immediately upon CDC recommendation. The EUA is supported by clinical data and aims to enhance protection against severe illness in this age group.
Pfizer (NYSE: PFE) announced that the FDA has accepted its Biologics License Application (BLA) for RSV vaccine candidate RSVpreF for individuals aged 60 and older. The priority review status shortens the review process by four months, aiming for a decision by May 2023. This follows the FDA's Breakthrough Therapy Designation granted in March 2022. RSV causes significant morbidity among older adults, with 60,000-120,000 hospitalizations annually in the U.S. The vaccine candidate is supported by a Phase 3 trial involving approximately 37,000 participants, showing promise in addressing this public health challenge.
Pfizer (NYSE: PFE) announced a collaboration with Clear Creek Bio to develop novel papain-like protease (PLpro) inhibitors aimed at treating COVID-19. This partnership will enhance Pfizer's existing COVID-19 product line with potential oral antivirals targeting various viral mechanisms. Both companies will work on identifying a PLpro candidate for clinical development, with Pfizer taking charge of commercialization. Clear Creek will receive an undisclosed upfront payment and potential future royalties based on product sales.
Pfizer Inc. (NYSE: PFE) invites investors to its Near-Term Launches + High-Value Pipeline Day on December 12, 2022, from 1:00 p.m. EST to 6:00 p.m. EST. The event will showcase potential product launches and pipeline programs that are expected to drive revenue growth through 2030. The live video webcast will be accessible via Pfizer's investor website, with an opportunity for audience questions during the Q&A sessions. A transcript and replay of the event will be available online within 24 hours.
On World AIDS Day, the Health Action Alliance and ViiV Healthcare launched the U.S. Business Action to End HIV, a coalition of businesses aimed at eliminating HIV in the U.S. by 2030. Founding members include major companies like CVS Health, Gilead Sciences, and Walgreens. The initiative aligns with the National HIV/AIDS Strategy and seeks to mobilize private sector support to improve access to HIV prevention and treatment. More than 1.2 million people in the U.S. live with HIV, with nearly 35,000 new cases annually.