Pfizer Inc. - PFE STOCK NEWS

Pfizer Inc. (NYSE: PFE) announced a $120 million investment in four clinical-stage biotech companies as part of its Pfizer Breakthrough Growth Initiative (PBGI). This initiative aims to invest up to $500 million in biotechnology firms developing clinical-stage assets aligned with Pfizer's focus areas, including oncology and rare diseases. Initial investments include ESSA Pharma ($10M), Trillium Therapeutics ($25M), Vedanta Biosciences ($25M), and Homology Medicines ($60M). Pfizer aims to leverage its resources to drive innovative therapies for patients.

Pfizer Inc. (NYSE: PFE) announced the dosing of the first participant in the Phase 3 CIFFREO study, investigating gene therapy candidate PF-06939926 for Duchenne muscular dystrophy (DMD). The trial aims to enroll 99 boys aged 4 to 7 across 15 countries, focusing on the efficacy and safety of the treatment. The primary outcome is the change in North Star Ambulatory Assessment score after one year. With no approved treatments currently available for DMD, the trial represents a significant milestone for patients and families affected by this condition.

ImaginAb Inc. has signed a multi-year, non-exclusive license agreement with Pfizer (NYSE: PFE) to provide the 89Zr CD8 Immuno-PET agent, aimed at imaging CD8 T cells in cancer patients. This partnership is expected to enhance drug efficacy identification, potentially shortening clinical trial durations and reducing costs. ImaginAb will supply clinical doses and offer technical support, receiving license fees and manufacturing payments in return. This agreement builds on a prior alliance focused on 89Zr CD8 Immuno-PET technology development.

Dewpoint Therapeutics has partnered with Pfizer (NYSE: PFE) to develop treatments for myotonic dystrophy type 1 (DM1), a rare genetic disorder. Dewpoint will receive an upfront payment and could earn up to $239 million in milestone payments if targets are met. Additionally, Dewpoint is set to receive royalties on any approved therapies. DM1 affects one in 8,000 to 20,000 individuals, leading to serious health issues. The collaboration aims to leverage biomolecular condensates to find novel solutions in treating this debilitating disease.

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.