Pfizer Inc. - $PFE STOCK NEWS

The FDA has granted full approval for TIVDAK® for the treatment of recurrent or metastatic cervical cancer. TIVDAK is the first antibody-drug conjugate with positive overall survival data for patients with previously treated disease. The approval is based on results from a Phase 3 study showing an overall survival benefit compared to chemotherapy. The safety profile of TIVDAK was consistent with known information, with no new safety issues identified. Common adverse reactions included decreased hemoglobin, peripheral neuropathy, and conjunctival adverse reactions. The approval of TIVDAK brings new treatment options for patients with advanced cervical cancer and addresses the high unmet need in this patient population.

Genmab A/S and Pfizer Inc. announced that the U.S. FDA has approved TIVDAK® for recurrent or metastatic cervical cancer treatment, converting its accelerated approval to a full approval. This is the first ADC with positive overall survival data in this patient population. The approval is based on Phase 3 data showing a 30% risk reduction in death compared to chemotherapy.

Pfizer (PFE) Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting
Pfizer Inc. (NYSE: PFE) is presenting more than 50 abstracts and 11 oral presentations at the annual ASCO meeting, showcasing its robust portfolio of approved and pipeline therapies and highlighting Pfizer's efforts to accelerate breakthrough medicines in Oncology. Key research includes data from the LORBRENA CROWN study and Phase 3 ECHELON-3 study of ADCETRIS, demonstrating overall survival benefit for a type of lymphoma. Pfizer will also present Phase 1 data for several priority pipeline therapies across different tumor areas.

Pfizer's BEQVEZ gene therapy for hemophilia B has been approved by the FDA, providing a one-time treatment option for adults. The therapy has shown significant reduction in bleeds post-treatment compared to standard care, potentially avoiding years of treatment burden. Pfizer is also launching an innovative warranty program to ensure durability of patient response to treatment.

Pfizer Inc. (NYSE: PFE) declares a $0.42 dividend per share for the second quarter of 2024, marking the 342nd consecutive quarterly dividend paid by the company. The dividend is payable on June 14, 2024, to shareholders of record as of May 10, 2024.

Pfizer's EMBLAVEO® receives approval from the European Commission for treating serious infections caused by multidrug-resistant bacteria, including metallo-β-lactamase-producing bacteria. The antibiotic combination is the first of its kind in the EU and offers hope to patients facing treatment options. The approval is based on successful Phase 3 studies showing efficacy, safety, and tolerability in treating Gram-negative bacterial infections.

Pfizer Inc. (NYSE: PFE) announces its virtual-only 2024 Annual Meeting of Shareholders, providing shareholders with comparable rights to an in-person meeting. Shareholders can access the meeting online, ask questions, and vote. The meeting details and registration information are available on the company's website. Shareholders can participate in real-time discussions and submit questions in advance. Both registered and beneficial shareholders can vote during the meeting, with some beneficial owners needing to pre-register. Guests can listen to the meeting without a control number. A replay of the webcast will be available for one year.

Pfizer Inc. announced positive top-line immunogenicity and safety data from the Phase 3 clinical trial of ABRYSVO in adults aged 18 to 59 at risk of severe RSV disease. The vaccine showed non-inferior immune response compared to older adults, with well-tolerated and consistent safety profiles. Pfizer aims to seek regulatory approval for ABRYSVO in the 18 to 59 age group, potentially addressing a significant unmet medical need.

ALTIVIA appoints Scott Barnum as Director of Manufacturing and Dean Hale as Corporate Engineering Manager. Both bring extensive experience in the chemicals industry and will contribute to ALTIVIA's growth and operational excellence.