NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that it is terminating two
ongoing clinical studies evaluating domagrozumab (PF-06252616) for the
treatment of Duchenne muscular dystrophy (DMD): a Phase 2 safety and
efficacy study (B5161002) and an open-label extension study (B5161004).
The Phase 2 study (B5161002), did not meet its primary efficacy
endpoint, which was to demonstrate a difference in the mean change from
baseline in 4 Stair Climb (in seconds) following one year of treatment
with domagrozumab as compared to placebo in patients with DMD. Further
evaluation of the totality of evidence including secondary endpoints did
not support a significant treatment effect. The decision comes after a
thorough review of data available at the time of the primary analysis,
which evaluated all study participants after one year of treatment, as
well as those participants who were in the trial beyond one year. The
studies were not terminated for safety reasons. Pfizer will continue to
review the data to better understand any insights they may provide, and
will share results with the scientific and patient community.
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Press Release Archive
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that it is terminating two
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today the primary results from the
Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, which
showed tafamidis significantly reduced the hierarchical combination of
both all-cause mortality and frequency of cardiovascular-related
hospitalizations compared to placebo over a 30-month period (P=0.0006)
in patients with wild-type or variant (hereditary) transthyretin amyloid
cardiomyopathy (ATTR-CM).1 ATTR-CM is a rare, fatal, and
underdiagnosed condition associated with progressive heart failure for
which there are no approved pharmacologic treatments.2,3
NEW YORK & TOKYO--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and
CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced amendments to
the protocols for two registrational Phase 3 trials, ARCHES and EMBARK,
designed to evaluate the safety and efficacy of XTANDI®
(enzalutamide) in men with hormone-sensitive prostate cancer (HSPC).
These amendments accelerate timelines for the anticipated primary
completion dates of both trials.
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts on Monday, August 27, 2018 at 9:00 a.m. EDT. The purpose of the call is to review the Tafamidis data presentation at the ESC Congress 2018 organized by the European Society of Cardiology.
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.1 XELJANZ is the first and only oral therapy and Janus kinase (JAK) inhibitor to be approved for this patient population.
Pfizer Inc. (NYSE: PFE) reported financial results for second-quarter 2018 and raised 2018 financial guidance for Adjusted diluted EPS(2).
Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal Products for Human Use in May 2018.1
Pfizer today announced it will increase its commitment to U.S. manufacturing with a $465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan. This U.S. investment will strengthen Pfizer’s capability to produce and supply critical, life-saving injectable medicines for patients around the world.
Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product.
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA, compared to those receiving placebo. Tanezumab is part of an investigational class of pain medications known as nerve growth factor (NGF) inhibitors and in addition to OA pain, is being evaluated for chronic low back pain (CLBP) and cancer pain (due to bone metastases).
NEW YORK & PHILADELPHIA--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) and Spark Therapeutics (NASDAQ:ONCE) announced today that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting. The factor IX prophylaxis efficacy data obtained in the lead-in study will serve as the within-subject control group for those patients that enroll into the next part of the Phase 3 study, which will evaluate the investigational gene therapy fidanacogene elaparvovec for the treatment of hemophilia B. The interventional portion of this pivotal Phase 3 study will enroll patients who have completed at least six months in the lead-in study. Fidanacogene elaparvovec is the official United States Adopted Name (USAN) and will become the Recommended International Nonproprietary Name (INN) for the therapy formerly known as SPK-9001 and PF-06838435.
TOKYO & Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes XTANDI the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC. XTANDI was first approved by the FDA in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel, and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC.
Pfizer Inc. (NYSE:PFE) today announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. These changes will be effective at the beginning of the company’s 2019 fiscal year.
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.1 XELJANZ is the first and only oral Janus kinase (JAK) inhibitor to be approved in the European Union (EU) for the treatment of adults with active PsA. In 2017, XELJANZ in combination with MTX was approved in the EU for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.2
The board of directors of Pfizer Inc. today declared a 34-cent third-quarter 2018 dividend on the company’s common stock, payable September 4, 2018, to shareholders of record at the close of business on August 3, 2018. The third-quarter 2018 cash dividend will be the 319th consecutive quarterly dividend paid by Pfizer.
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO) inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), a type of chemotherapy.
Pfizer today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy. The results demonstrated a positive trend in the hazard ratio favoring the IBRANCE combination, although this trend did not reach statistical significance. Overall survival is a secondary endpoint of the PALOMA-3 trial and, as such, the trial design was not optimized to detect a statistically significant difference in OS.
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, July 31, 2018. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Second Quarter 2018 Performance Report, to be issued that morning.
Pfizer Inc. announced today it will extend its donation of the antibiotic Zithromax® (azithromycin) to the International Trachoma Initiative through 2025, building on the company’s 20-years of work to help eliminate the world’s leading infectious cause of blindness. Approximately 163 million people are at risk of developing the disease and this recommitment ensures that Pfizer, through the International Trachoma Initiative (ITI), will continue to provide trachoma endemic countries with donated antibiotics that are a critical component of the global strategy to eliminate this neglected tropical disease (NTD).
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population.
Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists. The information contained in each press release was accurate at the time of issuance, and Pfizer assumes no responsibility for updating the information to reflect subsequent developments.
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