Seelos Therapeutics Inc (NASDAQ:SEEL) announced Friday that its drug SLS-005 (trehalose) has been granted a Rare Pediatric Disease Designation (RPDD) for the treatment of Sanfilippo syndrome by the US Food and Drug Administration (FDA).
RPDD is an incentive program created under the Federal Food, Drug and Cosmetic Act and is meant to encourage the development of new therapies to prevent and treat rare pediatric diseases, the company said.
The FDA will award priority review vouchers to sponsors of drug candidates that meet those criteria, which allows a company to obtain priority review without having met the application requirements.
Shares in New York surged more than 31% to stand at $0.98.
In April, trehalose was granted Orphan Disease Designation (ODD) for the treatment of Sanfilippo syndrome by the FDA as well. ODD allows companies developing a drug access to various incentives such as tax credits for qualified clinical testing.
The drug is being developed as a treatment for patients with Type A and B versions of Sanfilippo syndrome, a childhood disorder that triggers fatal brain damage.
Seelos is currently designing a study of trehalose in Europe after receiving feedback from the European Medicines Agency in March.
New board member
Separately, the company announced the appointment of pharmaceutical and biotechnology veteran Judith Dunn to its board of directors.
Dunn previously served various roles over eight years at Swiss multinational healthcare company F. Hoffman-La Roche AG, including vice president, global head of clinical development and principal medical group leader, neuroscience.
Before that, she worked as the executive medical director of CNS clinical development as Sepracor Inc and spent eight years in a variety of roles at Pfizer Inc.
“It’s our privilege and honor to have Judy on our board as she brings a unique combination of clinical and regulatory experience from Roche and Pfizer in both Psychiatry and Neurology,” CEO Raj Mehra said in a statement. “She will be an invaluable resource to Seelos.”
In addition to her industry experience, Dunn has served as an entrepreneur in residence at Atlas Venture since June 2018, the independent board member of Evolution Research Group since August 2018, a member of the NYC Mayor’s Advisory Council on Life Sciences since December 2016 and a member of the Digital Health Breakthrough Network Advisory Board since 2017.
—Updated to include share price and information from Seelos' press release on Judith Dunn joining the company's board—
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