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.
Roivant Sciences and Pfizer have launched Priovant Therapeutics to focus on developing innovative therapies for autoimmune diseases. Priovant is advancing brepocitinib, a dual inhibitor of TYK2 and JAK1, showing statistically significant results in five Phase 2 studies. A Phase 3 trial for dermatomyositis (VALOR) has commenced, and top-line results from an ongoing Phase 2b study in systemic lupus erythematosus (SLE) are expected in the second half of 2023. Pfizer retains a 25% equity stake in Priovant and has licensed rights for both brepocitinib and ropsacitinib.
Pfizer and BioNTech announced positive results from their study of two Omicron-adapted COVID-19 vaccine candidates, a monovalent and a bivalent one. These candidates exhibited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg doses, respectively. The bivalent vaccine demonstrated a 9.1 and 10.9-fold increase against the same variant. Both candidates showed a favorable safety profile, and data will be discussed with regulatory authorities for potential emergency use authorization.
Pfizer Inc. (NYSE: PFE) is hosting a conference call on July 28, 2022, at 10 a.m. EDT to discuss its Second Quarter 2022 Performance Report. Investors and the public can access the event via webcast on Pfizer's investor website. To listen by phone, dial 800-456-4352 in the U.S. or 785-424-1086 internationally, using the password 'PFEQ222'. A transcript and replay will be available online within 24 hours after the call.
Pfizer continues its commitment to improving patient lives through innovative health care solutions.
Pfizer (NYSE: PFE) announced a $0.40 cash dividend for Q3 2022, marking the 335th consecutive quarterly dividend. This dividend will be payable on September 6, 2022, to shareholders on record as of July 29, 2022. Pfizer continues its commitment to return value to shareholders through consistent dividend payments.
Pfizer has announced a €90.5 million ($95 million) investment in Valneva, acquiring an 8.1% stake in the company. This investment is aimed at supporting the development of VLA15, a Lyme disease vaccine candidate, with the Phase 3 study set to begin in Q3 2022. Pfizer will also update the collaboration agreement with Valneva, increasing Valneva's contribution to 40% of shared development costs. The total potential milestone payments to Valneva remain at $168 million, with royalties adjusted to a tiered range of 14% to 22%.
Pfizer Inc. and BioNTech SE have received FDA emergency use authorization for their COVID-19 vaccine, now available for children aged 6 months to 4 years. The 3-µg dose showed a strong immune response and a favorable safety profile similar to the placebo in a Phase 2/3 clinical trial involving 4,526 children. The trial demonstrated immunogenicity comparable to older age groups, meeting regulatory non-inferiority criteria. The vaccine rollout is anticipated to begin following CDC recommendations, ensuring free access for U.S. residents.
Pfizer's EPIC-SR study of PAXLOVID, targeting standard-risk COVID-19 patients, did not achieve its primary endpoint of sustained symptom relief. However, secondary analyses indicated a nominally significant 62% reduction in COVID-related medical visits. The company will halt enrollment in the EPIC-SR trial, focusing instead on high-risk populations due to low hospitalization rates. Data from this study will be included in the upcoming NDA submission to the FDA. Despite these challenges, Pfizer maintains that PAXLOVID's efficacy and safety profile is supported by data across multiple studies.
Pfizer, MorphoSys, and Incyte announced a clinical trial collaboration to explore the immunotherapeutic combination of Pfizer's TTI-622 with MorphoSys's Monjuvi and lenalidomide for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not eligible for autologous stem cell transplantation. Pfizer will lead a multicenter Phase 1b/2 study, which is set to take place in North America, Europe, and Asia-Pacific. The initiative addresses significant unmet medical needs in DLBCL treatment and follows promising preclinical data regarding TTI-622's potential efficacy.
Pfizer (NYSE: PFE) has successfully acquired ReViral, a clinical-stage biopharmaceutical company specializing in antiviral therapeutics for respiratory syncytial virus (RSV), for up to $525 million. This acquisition enhances Pfizer's anti-infective pipeline with promising candidates like sisunatovir, which has shown significant efficacy in clinical studies. The potential annual revenue for these programs could exceed $1.5 billion. This strategic move underscores Pfizer's commitment to advancing innovative therapies for serious infectious diseases.
Pfizer Inc. (NYSE: PFE) will host a webcast on June 16, 2022, featuring Mikael Dolsten, Chief Scientific Officer, at the Storebrand Conference: Invest in the Future. The event starts at 11:40 a.m. CEST (5:40 a.m. EDT). Investors can access the live presentation and register through www.pfizer.com/investors. A transcript and replay will be available within 24 hours post-event for 90 days. Pfizer emphasizes its commitment to health advancements and innovation, impacting global healthcare.