Welcome to our dedicated page for Pasithea Therapeutics news (Ticker: KTTAW), a resource for investors and traders seeking the latest updates and insights on Pasithea Therapeutics stock.
Pasithea Therapeutics Corp. (Nasdaq: KTTA, KTTAW) generates frequent news as a clinical-stage biotechnology company centered on PAS-004, a next-generation macrocyclic oral MEK inhibitor. Coverage of KTTA and KTTAW news often focuses on clinical trial progress in neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), MAPK pathway-driven advanced cancers and ALS, as well as capital markets and regulatory developments that shape the company’s trajectory.
Investors following Pasithea’s news can expect detailed updates on its Phase 1 and Phase 1/1b studies, including safety, pharmacokinetic and pharmacodynamic data, dose-escalation decisions, and early signs of clinical activity such as partial responses or disease control rates in advanced cancer patients. The company also reports on the activation of new clinical trial sites in regions such as the United States, South Korea and Australia for NF1-PN, and on grant-funded initiatives like the Hoffman ALS Clinical Trial Award supporting a Phase 1 PAS-004 study in ALS patients.
Beyond clinical results, Pasithea news includes financing events such as public offerings of common stock and at-the-market programs, with stated uses of proceeds for research, clinical trials, technology development, licensing and potential acquisitions. Regulatory and governance items disclosed through press releases and SEC filings, including proxy proposals, stock incentive plan amendments and responses to Nasdaq listing notices, also feature in the news flow.
For readers tracking KTTA and KTTAW, this news stream offers insight into how Pasithea advances PAS-004 across NF1-PN, oncology and ALS, how it manages its capital structure, and how regulatory milestones may influence its development plans. Regularly reviewing these updates can help contextualize the company’s clinical data, trial timelines and corporate actions over time.
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).
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.