Pasithea Therapeutics Corp Stock Price, News & Analysis

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).

Pasithea Therapeutics (NASDAQ: KTTA) announced on November 25, 2025 that the ALS Association awarded a Hoffman ALS Clinical Trial Award grant of approximately $1 million to support a Phase 1 study of PAS-004 in ALS patients.

The funded study will enroll 12 patients across three sequential dose cohorts with about 28 weeks of follow-up. Endpoints include safety, tolerability, ALS Functional Rating Scale–Revised (ALSFRS-R) changes and neurofilament light chain (NfL) levels. Pasithea notes prior efficacy in the SOD mouse model and that PAS-004 is already in clinic for neurofibromatosis and advanced cancers with a promising safety profile.

Pasithea Therapeutics (Nasdaq: KTTA) announced completion of Cohort 7 (37 mg) in its Phase 1 PAS-004 trial on Nov 24, 2025, reporting positive safety, PK, and PD data.

Key findings: zero treatment-related adverse events during the DLT period; Safety Review Committee cleared escalation to Cohort 8 (45 mg); PK showed linear, dose-proportional behavior with AUC 6,690 ng·h/mL, Cmax 313 ng/mL, Cmin 260 ng/mL, and Cmax/Cmin ratio <2; PD showed ~80% pERK inhibition near Cmax and >60% pERK inhibition at Cmin (24 hr), supporting continuous MAPK pathway suppression over a 24-hour dosing cycle.

Pasithea Therapeutics (Nasdaq: KTTA) reported positive tablet pharmacokinetic (PK) data from its ongoing Phase 1/1b study of PAS-004 in adult NF1 patients on Nov 21, 2025. Key findings: linear, dose-proportional PK across 4mg and 8mg tablets; steady‑state Cmax/Cmin <2 with Cmax and Cmin above the cellular IC50; and a long half‑life (~57 hours). Cohort PK: 4mg AUC 1,120 ng·h/mL, Cmax 58.1 ng/mL, Cmin 37.6 ng/mL; 8mg AUC 2,290 ng·h/mL, Cmax 118 ng/mL, Cmin 75.4 ng/mL. Tablet exposures were ~3x higher (dose‑normalized) than capsule, with the 8mg tablet AUC/Cmax slightly exceeding the 22mg capsule and showing reduced interpatient variability and similar Tmax.

Pasithea Therapeutics (Nasdaq: KTTA) reported positive interim Phase 1 data for oral MEK inhibitor PAS-004 in MAPK-driven advanced solid tumors, disclosed through a data cutoff of Nov 10, 2025. Key findings include an unconfirmed monotherapy partial response (–31.9%) in a BRAF V600E melanoma patient on Cohort 4A (15mg) who remains on study >11 months, and a second BRAF V600E patient with durable stable disease >6 months (Cohort 6, 30mg).

Other highlights: initial Disease Control Rate of 71.4% in BRAF-mutated tumors (5 of 7), overall 42.8% DCR in 21 evaluable patients, favorable safety with no DLTs or discontinuations, and pharmacokinetics showing dose-proportionality and AUC ~5,480 ng·h/mL at 30mg.

Pasithea Therapeutics (Nasdaq: KTTA) activated a new U.S. clinical trial site at the University of Alabama at Birmingham (UAB) for its ongoing Phase 1/1b open-label study of PAS-004 in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable, incompletely resected, or recurrent plexiform neurofibromas.

The global Phase 1/1b trial is designed to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004; enrollment at the UAB site is expected to begin immediately following activation (announced Nov 4, 2025). Pasithea will also serve as Platinum Sponsor of the NF Caregivers Symposium hosted at UAB on Nov 8, 2025.

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.