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 positive initial data from its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor, for advanced cancer treatment. The trial, conducted at four U.S. sites, showed promising results in safety, tolerability, pharmacokinetics (PK), and preliminary efficacy.
Key findings include:
- No treatment-related adverse events or dose-limiting toxicities observed
- Long half-life of ~70 hours, supporting once-daily or less frequent oral dosing
- Constant target inhibition while avoiding peak plasma toxicities
- A patient with stage 3 colon cancer achieved prolonged stable disease
The company believes PAS-004 demonstrates a differentiated MEK inhibitor profile, potentially outperforming current inhibitors in safety, dosing frequency, and efficacy for treating neurofibromatosis type 1 (NF1) and other cancer indications.
Pasithea Therapeutics Corp. (NASDAQ: KTTA) has successfully completed long-term chronic toxicity studies for its lead candidate PAS-004, a next-generation macrocyclic MEK inhibitor. The studies, conducted in rats (6 months) and dogs (9 months), confirm the safety profile observed in prior 28-day toxicity studies. Key findings include:
1. Establishment of 0.5 mg/kg as the no adverse effect level (NOAEL) in dogs, the most sensitive species.
2. Consistent safety profile at doses correlating with significant pathway engagement.
3. Similar adverse event profile and equivalent NOAEL for crystalline PAS-004 compared to the original amorphous formulation.
These results support chronic patient dosing and highlight PAS-004's potential as a best-in-class MEK inhibitor for treating neurofibromatosis type 1 (NF1) and other cancer indications. Pasithea plans to share initial interim pharmacokinetic and pharmacodynamic data from its Phase 1 clinical study later this quarter.
Pasithea Therapeutics Corp. (NASDAQ: KTTA) has appointed Dr. Rebecca Brown to its Scientific Advisory Board. Dr. Brown, the Director of the Neurofibromatosis Clinic at The Mount Sinai Hospital, brings extensive expertise in Neurofibromatosis type 1 (NF1) research and treatment. This appointment aligns with Pasithea's development of PAS-004, a next-generation macrocyclic MEK inhibitor for NF1 treatment.
Dr. Brown's experience, particularly in cutaneous and plexiform neurofibromas, will contribute to Pasithea's upcoming Phase 1/2a clinical trial for NF1. She highlighted PAS-004's potential advantages, including a long half-life, superior therapeutic index, cleaner safety profile, and once-daily dosing, which could represent a significant advancement in NF1 treatment.
Pasithea Therapeutics Corp. (NASDAQ: KTTA), a clinical-stage biotech company, will present at the H.C. Wainwright 26th Annual Global Investment Conference in New York City. The company is developing PAS-004, a next-generation macrocyclic MEK inhibitor for treating neurofibromatosis type 1 (NF1) and other cancer indications.
Key points:
- Presentation available online from 7:00 a.m. ET on September 9th, 2024
- Management to conduct 1x1 meetings from September 9-11, 2024
- Conference held at the Lotte New York Palace Hotel
- Registration available at https://hcwevents.com/annualconference/
Pasithea Therapeutics has completed enrollment and initial dosing for the second cohort in its Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor aimed to treat neurofibromatosis type 1 (NF1) and other conditions. The Safety Review Committee (SRC) recommended escalating to the next dose level (4mg) after a positive safety review of the first dose cohort (2mg), which showed no dose-limiting toxicities or clinically relevant adverse events. The trial, involving patients with advanced solid tumors driven by MAPK pathway mutations, aims to assess the safety, tolerability, and pharmacokinetics (PK) of PAS-004. Initial safety and PK data are expected by Q3 2024.
Pasithea Therapeutics announced new preclinical data for PAS-004, revealing its strong inhibition of NRAS mutant cancer cell lines and superior activity in xenograft studies. PAS-004 demonstrated greater efficacy than selumetinib and binimetinib, comparable efficacy to trametinib without plateauing, and achieved over 50% maximal growth inhibition in more cell lines. The data will be presented at the ASCO Annual Meeting on June 1, 2024. PAS-004, a macrocyclic MEK inhibitor, is in clinical trials for neurofibromatosis type 1 (NF1) and other cancers, offering potential advantages in pharmacokinetics, pharmacodynamics, and tolerability.
Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced the acceptance of an abstract for poster presentation at the 2024 ASCO Annual Meeting for their drug PAS-004, a macrocyclic MEK inhibitor targeting neurofibromatosis type 1 (NF1) and other indications. The drug is the first of its kind in human clinical trials, offering extended half-life for improved efficacy.
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