Plus   Neg

Genentech: FDA Grants Priority Review For Risdiplam - Quick Facts

Genentech, a member of the Roche Group (RHHBY.PK), announced the U.S. FDA has accepted the New Drug Application and granted priority review for risdiplam, an investigational survival motor neuron-2 splicing modifier for spinal muscular atrophy. Previously, the FDA granted Orphan Drug Designation for risdiplam in 2017, followed by Fast Track Designation. The final FDA decision is expected by May 24, 2020.

If approved, risdiplam would be the first at-home administered medicine for people living with spinal muscular atrophy. Genentech leads the clinical development of risdiplam as part of a collaboration with the SMA Foundation and PTC Therapeutics, Inc. (PTCT).

The FDA's acceptance of the NDA triggers a $15 million milestone payment to PTC by Roche.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Walt Disney Co. plans to lay off 28,000 theme park employees in U.S., as the coronavirus pandemic continues to affect its businesses. The layoff will affect about 67 percent of part-time employees. JPMorgan Chase & Co (JPM) agreed to pay a total of $920 million in penalty to settle U.S. investigations into the company's alleged manipulation of metal and treasuries markets. Elon Musk, the founder and CEO of Space Exploration Technologies, or SpaceX, said the aerospace company is planning to list its space internet venture, Starlink, after many years when revenue growth is smooth and predictable. In a tweet, Musk said, "We will probably IPO Starlink, but only several years in the future when revenue growth is smooth & predictable. Public market does *not* like erratic
Follow RTT