StreetInsider.com News Articles

Pasithea receives FDA orphan drug designation for ALS treatment PAS-004

Tue, 02 Jun 2026 07:02:30 -0400

Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to PAS-004 for treating Amyotrophic Lateral Sclerosis.

The FDA grants Orphan Drug Designation to therapies intended for diseases affecting fewer than 200,000 people in the United States. The designation provides potential benefits including eligibility for tax credits for qualified clinical trials, exemption from certain FDA fees, and the potential for seven years of market exclusivity following approval.

PAS-004 is described as a next-generation macrocyclic MEK inhibitor. "This designation further supports our efforts to explore the potential of PAS-004 in ALS and other serious diseases

Pasithea receives FDA orphan drug designation for ALS treatment PAS-004

Tue, 02 Jun 2026 07:02:30 -0400

Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to PAS-004 for treating Amyotrophic Lateral Sclerosis.

PAS-004 is described as a next-generation macrocyclic MEK inhibitor. "This designation further supports our efforts to explore the potential of PAS-004 in ALS and other serious diseases

Pasithea Therapeutics Announces Orphan Drug Designation by FDA of PAS-004 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Tue, 02 Jun 2026 07:02:00 -0400

Orphan Drug Designation is intended to support the development of therapies for rare diseases affecting fewer than 200,000 people in the United States

MIAMI, June 02, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PAS-004 for the treatment of Amyotrophic Lateral Sclerosis (ALS).

“ALS remains a devastating neurodegenerative disease with limited treatment options and significant unmet medical need,” said Dr. Tiago Reis Marques, Chief

Pasithea Therapeutics Announces Orphan Drug Designation by FDA of PAS-004 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Tue, 02 Jun 2026 07:02:00 -0400

Orphan Drug Designation is intended to support the development of therapies for rare diseases affecting fewer than 200,000 people in the United States

“ALS remains a devastating neurodegenerative disease with limited treatment options and significant unmet medical need,” said Dr. Tiago Reis Marques, Chief

Form 10-Q Pasithea Therapeutics For: Mar 31

Fri, 15 May 2026 16:35:00 -0400

si-local-file:///var/storage/secattach/20260515/26506578.html

Form 10-Q Pasithea Therapeutics For: Mar 31

Fri, 15 May 2026 16:35:00 -0400

si-local-file:///var/storage/secattach/20260515/26506578.html

Form SCHEDULE 13G/A Pasithea Therapeutics Filed by: AMERIPRISE FINANCIAL INC

Fri, 15 May 2026 10:21:00 -0400

si-local-file:///var/storage/secattach/20260515/26501480.html

Form SCHEDULE 13G/A Pasithea Therapeutics Filed by: AMERIPRISE FINANCIAL INC

Fri, 15 May 2026 10:21:00 -0400

si-local-file:///var/storage/secattach/20260515/26501480.html

Form 4 Pasithea Therapeutics For: May 01 Filed by: Schneiderman Daniel H