Pfizer Inc. (NYSE: PFE) shares took a small step back on Monday despite announcing positive results from a late-stage trial. The pullback seems to be the product of overall market sentiment as opposed to these results.
The company announced that its Phase 3 study evaluating its pipeline candidate tafamidis for the treatment of transthyretin cardiomyopathy (ATTR-ACT) met its primary endpoint.
In 2011, tafamidis was granted orphan drug designation for transthyretin cardiomyopathy in both the European Union and United States. In June 2017, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to tafamidis for transthyretin cardiomyopathy.
The ATTR-ACT study was designed to assess clinically meaningful outcomes for the use of tafamidis as a treatment for patients with transthyretin cardiomyopathy, a rare, fatal and underdiagnosed condition associated with progressive heart failure.
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The average life expectancy for people with transthyretin cardiomyopathy is three to five years from diagnosis. The prevalence of transthyretin cardiomyopathy is presently unknown; however, it is estimated that less than 1% of people with the disease are diagnosed. Currently, there are no approved pharmacological medications specifically indicated for treating transthyretin cardiomyopathy.
Brenda Cooperstone M.D., senior vice president and chief development officer, Rare Disease, Pfizer Global Product Development, commented:
These topline results are important for people with transthyretin cardiomyopathy and bring us one step closer to realizing the potential for a new treatment for those in desperate need. Pfizer Rare Disease has been at the forefront of improving the understanding of transthyretin cardiomyopathy, and we thank the patients who participated in the trial and their families, as well as the physicians and investigational sites that contributed to this important study. We look forward to sharing the detailed results of the study with the cardiovascular community and discussing these data with health authorities to determine an appropriate regulatory path forward.
Shares of Pfizer were last seen down about 1% at $35.08, with a consensus analyst price target of $40.26 and a 52-week range of $31.67 to $39.43.
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