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Pasithea Therapeutics Corp (KTTAW) is a clinical-stage biotechnology company pioneering treatments for central nervous system disorders and RASopathies. This page provides investors and researchers with timely updates on clinical developments, regulatory milestones, and strategic initiatives.
Access verified news about the company’s pipeline progress, including its lead candidate PAS-004 (a macrocyclic MEK inhibitor), trial design updates, and collaborations. Our curated collection features press releases on:
• Clinical trial phases
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• Regulatory submissions
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Bookmark this page for centralized access to Pasithea’s latest advancements in neurofibromatosis, ALS, and schizophrenia research. Check regularly for objective updates on therapeutic innovations and corporate developments shaping the biotechnology landscape.
Pasithea Therapeutics (NASDAQ: KTTA) has announced the activation of two major clinical trial sites in South Korea for its Phase 1/1b study of PAS-004, a next-generation macrocyclic MEK inhibitor. The trial will evaluate the drug's safety, tolerability, and pharmacokinetics in adult patients with neurofibromatosis type 1 (NF1) who have symptomatic and inoperable plexiform neurofibromas.
The activated sites include ASAN Medical Centre and Severance Hospital, which together have access to an estimated 10,000 NF1 patients in South Korea. Professor Lee Beom-Hee from ASAN Medical Center, which has the largest NF1 caseload in South Korea, will lead the trial at their facility. The drug PAS-004 has shown a distinct pharmacokinetic profile and offers a more convenient dosing regimen compared to existing treatments.
Pasithea Therapeutics (NASDAQ: KTTA) has received approval to advance to Cohort 2 in its Phase 1/1b clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 (NF1) patients. The external Safety Review Committee's recommendation follows a successful safety review of Cohort 1, where no dose limiting toxicities were observed in the initial three patients.
The trial will now proceed with Cohort 2, testing an 8mg tablet dosage. The company has already enrolled the first three patients in this cohort, noting strong enrollment demand. Initial interim clinical data from the first two cohorts is expected in Q1 2026.
Pasithea Therapeutics (NASDAQ: KTTA), a clinical-stage biotech company developing PAS-004 (a next-generation macrocyclic MEK inhibitor), has updated its presentation time at the upcoming H.C. Wainwright 27th Annual Global Investment Conference.
CEO Dr. Tiago Reis Marques will deliver the company presentation on Monday, September 8, 2025, at 5:00 PM ET at the Lotte New York Palace Hotel. Management will also be available for one-on-one meetings during the conference, which runs from September 8-10, 2025 in New York City.
Pasithea Therapeutics (NASDAQ: KTTA), a clinical-stage biotech company, will participate in the upcoming H.C. Wainwright 27th Annual Global Investment Conference. The company's CEO, Dr. Tiago Reis Marques, will deliver a presentation on September 10, 2025, at 2:30 PM ET at the Lotte New York Palace Hotel.
Pasithea is currently developing PAS-004, a next-generation macrocyclic MEK inhibitor. Management will be available for one-on-one meetings throughout the conference, which runs from September 8-10, 2025.
Pasithea Therapeutics (NASDAQ: KTTA) has achieved a significant milestone in its clinical development program by completing enrollment and initial dosing of three subjects in Cohort 1 of its Phase 1/1b trial for PAS-004. The trial evaluates a novel once-daily macrocyclic MEK inhibitor in adult patients with neurofibromatosis type 1 (NF1) who have symptomatic and inoperable plexiform neurofibromas.
The company expects to present initial interim safety, tolerability, biomarker, and preliminary efficacy data in Q1 2026. PAS-004 aims to differentiate itself from current FDA-approved therapies that require twice-daily dosing, potentially offering better patient compliance and tolerability advantages.
Pasithea Therapeutics (NASDAQ: KTTA) has closed its previously announced public offering, raising total gross proceeds of approximately $6.3 million. The offering consisted of 3,571,428 shares of common stock (or pre-funded warrants) and accompanying Series C and D warrants at $1.40 per share. The company received $5.0 million from the initial offering and an additional $1.3 million from the immediate exercise of Series D warrants by certain investors.
The Series C warrants have a 5-year term while Series D warrants expire in 18 months, both with an exercise price of $1.40 per share. H.C. Wainwright & Co. served as the exclusive placement agent. The funds will support general corporate purposes, including research, clinical trials, technology development, potential acquisitions, and working capital.