Welcome to our dedicated page for Pfizer news (Ticker: PFE), a resource for investors and traders seeking the latest updates and insights on Pfizer stock.
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 (NYSE: PFE) will host webcasts featuring key discussions with its leadership at the 39th Annual J.P. Morgan Healthcare Conference, occurring virtually. CEO Albert Bourla will participate in a fireside chat on January 12, 2021, at 10:00 a.m. EST. Angela Hwang, Group President of Pfizer Biopharmaceuticals Group, is set to join a COVID-19 Vaccines Keynote Panel on January 13, 2021, at 12:45 p.m. EST. Archived copies of the webcasts will be available on Pfizer's investor website following their conclusion.
Pfizer (PFE) and OPKO Health (OPK) announced that the FDA has accepted the filing of the Biologics License Application (BLA) for somatrogon, a long-acting growth hormone for treating pediatric growth hormone deficiency (GHD). The FDA's target decision date is in October 2021. Results from a Phase 3 trial demonstrated somatrogon met primary endpoints, showing higher annual height velocity compared to daily somatropin. The therapy offers potential benefits by reducing the need for daily injections. Somatrogon has received Orphan Drug designation in the U.S. and EU.
Pfizer and BioNTech announced an agreement to supply an additional 100 million doses of their COVID-19 vaccine, COMIRNATY®, to the EU in 2021. This expands total doses to 300 million, following an earlier deal.
CEO Albert Bourla emphasized the commitment to rapid vaccine distribution as the virus continues to pose significant public health risks. The vaccine is produced in European manufacturing sites and is authorized for emergency use but not FDA-approved. Pfizer and BioNTech project potential supply of up to 1.3 billion doses worldwide by the end of 2021.
Pfizer (NYSE:PFE) announced that the FDA has accepted the supplemental New Drug Application (sNDA) for LORBRENA® (lorlatinib) as a first-line treatment for ALK-positive metastatic non-small cell lung cancer (NSCLC). The decision is based on data from the pivotal CROWN study and falls under the Real-Time Oncology Review program, with a PDUFA goal date in April 2021. LORBRENA targets tumor mutations and addresses brain metastases, which affect up to 40% of patients. The CROWN trial demonstrated improved progression-free survival compared to XALKORI® (crizotinib).
Pfizer and BioNTech announced a new agreement with the U.S. government to supply an additional 100 million doses of their COVID-19 vaccine, bringing the total to 200 million doses. The U.S. will pay $1.95 billion for this order, with delivery expected by July 31, 2021. At least 70 million doses are to be delivered by June 30, 2021. The vaccine, authorized for emergency use, is provided free to eligible U.S. residents. The companies aim to ensure widespread vaccine access to combat the pandemic.
Pfizer (NYSE: PFE) is hosting a conference call for investors on February 2, 2021, at 10 a.m. EST to discuss its Fourth Quarter and Full Year 2020 Performance Report. This call aims to provide insights into the company's financial results and operational updates. Investors can listen to the live webcast and access the Performance Report via www.pfizer.com/investors. Pre-registration for the call is recommended. Participants can also dial in using the numbers provided, with the password 'Fourth Quarter Earnings' for access.
The European Commission has granted conditional marketing authorization (CMA) for Pfizer and BioNTech's COVID-19 vaccine, COMIRNATY, for individuals aged 16 and older. This follows a positive opinion from the EMA's Committee for Medicinal Products. The CMA is valid across all 27 EU member states, aiming to combat the COVID-19 pandemic. Notably, the vaccine demonstrated a 95% efficacy rate in a pivotal Phase 3 trial involving over 44,000 participants. The rollout of 200 million doses is set to begin immediately, with production at sites in Germany and Belgium.
Pfizer and BioNTech announced a positive opinion from the EMA's CHMP recommending conditional marketing authorization for their COVID-19 vaccine (BNT162b2) for individuals 16 and older. This CMA allows for expedited approval in response to serious public health threats. The positive recommendation is based on Phase 3 clinical study data, which supports the vaccine's efficacy against COVID-19. If authorized by the European Commission, the vaccine will be available across all EU member states. The vaccine is already authorized for emergency use in over 15 countries.
Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) announced that the CDC's Advisory Committee on Immunization Practices recommended the use of their COVID-19 vaccine for individuals 16 and older under an Emergency Use Authorization (EUA). This follows a previous recommendation for high-priority healthcare workers and long-term care residents. With the FDA's authorization on December 11, 2020, the first vaccine shipments from Pfizer's Kalamazoo, MI site are set to be distributed nationwide. Pfizer aims to vaccinate millions by the end of 2021.
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