Welcome to our dedicated page for Pasithea Therapeutics news (Ticker: KTTA), a resource for investors and traders seeking the latest updates and insights on Pasithea Therapeutics stock.
Pasithea Therapeutics Corp. reports news centered on PAS-004, its next-generation macrocyclic MEK inhibitor, and the company’s clinical-stage biotechnology operations. Recurring updates cover NF1-associated plexiform and cutaneous neurofibromas, advanced cancer, ALS-related research, FDA designations, clinical development strategy and medical leadership.
Company news also includes capital actions, investor conference presentations and public-company matters tied to common stock and warrant securities. Pasithea’s releases frame the business around drug-development progress, regulatory designations and financing activity supporting research, preclinical work and clinical trials.
Pasithea Therapeutics (NASDAQ:KTTA) amended the clinical protocol for its Phase 1/1b PAS-004 trial in NF1 patients with symptomatic inoperable, incompletely resected or recurrent plexiform neurofibroma.
Changes add higher dose levels (24mg, 32mg), allow longer treatment up to 18 months, expand imaging and CN measurements, and support a planned interim NF1 data update in Q4 2026.
Pasithea Therapeutics (NASDAQ:KTTA) will exhibit at the Children's Tumor Foundation 2026 NF Conference, held June 26-30, 2026 in Denver, Colorado.
The company plans to engage with the NF1 clinical and academic community following recent FDA Fast Track and Rare Pediatric Disease designations for its lead NF1 candidate PAS-004.
Pasithea Therapeutics (NASDAQ: KTTA) announced that the FDA has granted Orphan Drug Designation to PAS-004, a next-generation macrocyclic MEK inhibitor, for treating Amyotrophic Lateral Sclerosis (ALS).
The designation offers potential tax credits, certain FDA fee exemptions, and up to seven years of market exclusivity after approval. Pasithea previously received a $1 million ALS Association grant in November 2025 to study PAS-004 in ALS.
Pasithea Therapeutics (NASDAQ: KTTA) appointed Kartik Krishnan, M.D., Ph.D. as Chief Medical Officer, effective May 1, 2026. Dr. Krishnan will lead clinical development and medical strategy for PAS-004, a macrocyclic MEK inhibitor in development for NF1-associated plexiform and cutaneous neurofibromas.
He brings over 20 years of clinical development experience and prior roles at Genentech, Amgen, BioMarin, and others, including work on cobimetinib (approved MEK inhibitor) and pediatric clinical training.
Pasithea Therapeutics (NASDAQ: KTTA) announced the U.S. FDA granted Rare Pediatric Disease Designation to PAS-004 for treatment of Neurofibromatosis type 1 (NF1) on April 20, 2026. The designation could make Pasithea eligible for a Priority Review Voucher (PRV); disclosed PRV sales have ranged from $150–$205 million in the last 12 months.
PAS-004 already holds Orphan Drug and Fast Track designations and is in a Phase 1/1b multicenter dose-escalation trial (NCT06961565) in adults with symptomatic NF1 plexiform neurofibromas.
Pasithea Therapeutics (NASDAQ: KTTA) announced the FDA granted Fast Track designation to PAS-004 for treatment of NF1-associated plexiform neurofibromas (PN) causing significant morbidity on April 1, 2026. The designation enables frequent FDA communications and rolling review and may allow accelerated approval or priority review if criteria are met. The company is conducting a Phase 1/1b dose-escalation trial (NCT06961565).
Pasithea Therapeutics (Nasdaq: KTTA) will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference in a virtual session on Thursday, February 26, 2026 at 4:00 PM ET. CEO Tiago Reis Marques will deliver a 30-minute presentation in Track 2 and management will be available for one-on-one investor meetings.
The presentation will be webcast live and archived for a limited time on the company’s Investors > Events page; a replay will be available after the live event. Registration for the conference is required to join meetings.
Pasithea Therapeutics (NASDAQ: KTTA) updated timelines for PAS-004 clinical programs and reported a $60 million gross public offering completed December 2025 to fund operations through at least H1 2028. The company completed enrollment of 12 adult NF1-PN patients across four dose cohorts (4, 8, 12, 18 mg) in Part A and plans to present safety, tolerability, PK and six-month efficacy data in H2 2026. For the advanced cancer Phase 1 study, Pasithea expects longer-term follow-up from Cohort 4–8 (15–45 mg) in Q2 2026. Prior results included a partial response and a 71.4% disease control rate in efficacy-evaluable BRAF-mutated tumors.
Pasithea Therapeutics (Nasdaq: KTTA) closed a public offering of 80,000,000 common shares (or pre-funded warrants) at $0.75 per share, generating gross proceeds of approximately $60 million on December 2, 2025.
The offering was led by healthcare-dedicated investors including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners and Squadron Capital Management, with H.C. Wainwright & Co. as exclusive placement agent.
The company said it intends to use net proceeds for general corporate purposes — including ongoing research, preclinical studies, clinical trials and potential acquisitions — and expects the funding to extend its cash runway through at least the first half of 2028.
Pasithea Therapeutics (Nasdaq: KTTA) priced a public offering of 80,000,000 shares (or pre-funded warrants) at $0.75 per share, expected to close on or about December 1, 2025, with gross proceeds of approximately $60 million before fees. The offering was led by healthcare investors including Vivo Capital and Janus Henderson Investors, with H.C. Wainwright & Co. as placement agent.
The company said net proceeds will be used for general corporate purposes and that pro forma cash will extend the cash runway through at least the first half of 2028. Securities are offered under an effective Form S-1 (File No. 333-291611).