Seelos Therapeutics Receives FDA Fast Track Designation for Intranasal Racemic Ketamine (SLS-002)
Seelos Therapeutics, Inc. (SEEL)
Last seelos therapeutics, inc. earnings: 5/21 05:12 pm
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Source: GlobeNewswire
NEW YORK, Nov. 18, 2019 (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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its new, investigational intranasal racemic ketamine program, SLS-002, for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD). “The decision by the FDA to grant Fast Track designation to SLS-002 underscores the significant unmet medical need for patients with Acute Suicidal Ideation and Behavior in Major Depressive Disorder,” said Raj Mehra, PhD, Chairman and CEO of Seelos. “We will be working diligently in close collaboration with the FDA to finalize the protocol for the proof of concept study and future clinical development.” Tim Whitaker, MD, Head of R&D at Seelos added, “While I was a psychiatrist workin
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Sec Filings
- 11/22/24 - Form NT
- 11/22/24 - Form 8-K
- 11/14/24 - Form SC
- SEEL's page on the SEC website