Astellas Pharma: FDA Grants Fast Track Designation For ASP0367/MA-0211 - Quick Facts

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that the FDA has granted Fast Track designation for the development of ASP0367/MA-0211 as a potential treatment for primary mitochondrial myopathies. There is no FDA-approved treatment for primary mitochondrial myopathies, a rare disease with a high unmet medical need.

Astellas Pharma said ASP0367 will be entering a phase II / III study (MOUNTAINSIDE) to validate the efficacy and safety in PMM patients. The Fast Track designation is anticipated to accelerate the clinical development of ASP0367.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story


Latest Markets Videos


    Founded in the late 1990s by Andrew Mariathasan in New York, with the goal of covering Wall Street for a new generation of investors, RTTNews has expanded steadily over the years to become a trusted provider of content for a wide array of subjects across several platforms. RTT's Financial Newswire is relied upon by some of the world's largest financial institutions, including banks, brokerages, trading platforms and financial exchanges.

    Learn More