Seelos Therapeutics Receives Rare Pediatric Disease Designation for SLS-005 (Trehalose) in Sanfilippo Syndrome

Rhea-AI Summary

Seelos Therapeutics (Nasdaq: SEEL) has announced that the FDA granted Rare Pediatric Disease Designation (RPDD) to its therapy SLS-005 for Sanfilippo syndrome. This designation incentivizes the development of treatments for rare pediatric diseases, which could lead to priority review vouchers (PRVs) for future applications. Additionally, SLS-005 also received Orphan Disease Designation from the FDA. These designations are part of the FDA's efforts to encourage innovation in the treatment of rare conditions.

Positive

• FDA granted Rare Pediatric Disease Designation for SLS-005, potentially leading to priority review vouchers.
• SLS-005 also received Orphan Disease Designation from the FDA, enhancing its development prospects.

Negative

• None.

News Market Reaction – SEEL

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+31.08% News Effect

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NEW YORK, May 15, 2020 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has been granted Rare Pediatric Disease Designation (RPDD) for SLS-005 in Sanfilippo syndrome from the U.S. Food and Drug Administration (FDA).

RPDD is an incentive program created under the Federal Food, Drug, and Cosmetic Act (FD&C Act) created to encourage the development of new therapies for the prevention and treatment of certain rare pediatric diseases.

Seelos was also recently granted Orphan Disease Designation from the FDA for SLS-005 in Sanfilippo syndrome.

About Rare Pediatric Disease Designation (RPDD)

Under section 529 of the FD&C Act, the FDA will award priority review vouchers (PRVs) to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section.

The PRV entitles the holder to utilize the voucher alone or in conjunction with addition incentive programs to obtain priority review for a subsequent human drug application. The subsequent application would not have to meet the requirements for a priority review, the voucher may be utilized by the entity who is granted the voucher and, is also transferrable and may be sold to another entity. Transfer of the voucher requires FDA notification within 30 days of the transfer of ownership.

Industry guidance on this program may be found here: https://www.fda.gov/media/90014/download

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 12th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

FAQ

What is the significance of the Rare Pediatric Disease Designation granted to Seelos Therapeutics (SEEL)?

The Rare Pediatric Disease Designation for SLS-005 may lead to priority review vouchers, incentivizing its development for Sanfilippo syndrome.

What therapy received the Orphan Disease Designation from the FDA for Seelos Therapeutics?

SLS-005 received the Orphan Disease Designation for its potential treatment of Sanfilippo syndrome.

How does the Rare Pediatric Disease Designation impact the development of therapies by SEEL?

It provides incentives such as priority review vouchers that can expedite the approval process for new therapies.