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.
Overview
Pasithea Therapeutics Corp (NASDAQ: KTTA) is a clinical-stage biotechnology company pioneering research and development in the fields of neuroscience, translational medicine, and drug development. With a strong focus on central nervous system (CNS) disorders, RASopathies, and certain cancer indications, the company is deeply engaged in discovering and developing innovative treatments that address significant unmet medical needs.
Core Business Areas
Pasithea Therapeutics operates at the intersection of advanced neuroscience and drug development. The company has structured its operations around a robust pipeline that includes research into conditions such as Neurofibromatosis Type 1 (NF1), Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Schizophrenia, and other CNS disorders. Additionally, it is developing a novel macrocyclic MEK inhibitor, known as PAS-004, which is positioned as part of a broader strategy to explore treatments for NF1 and other complex indications.
Research, Development and Clinical Trials
The company’s research initiatives leverage cutting-edge translational medicine techniques, aiming to bridge laboratory observations with clinical applications. Through its rigorous clinical trial processes, Pasithea Therapeutics is advancing its developmental pipeline by systematically evaluating safety, tolerability, pharmacokinetics, and biomarker data of its experimental therapies. This structured approach not only exemplifies its commitment to innovation but also highlights its focus on addressing the complexities inherent in CNS disorders and related diseases.
Clinical Trial Strategy and Geographic Footprint
Pasithea Therapeutics has strategically established clinical trial sites across multiple geographies, including both the United States and Eastern Europe, to diversify its patient recruitment and research environment. The expansion into regions such as Romania and Bulgaria illustrates the company’s intent to cultivate a comprehensive understanding of varied population genetics and treatment responses, thereby enhancing the robustness of its clinical data.
Industry Position and Strategic Differentiation
Operating in a highly competitive sector, Pasithea Therapeutics distinguishes itself through its emphasis on integrating advanced neuroscientific concepts with translational research. This allows the company to not only target common CNS disorders but also to venture into rare genetic diseases that require specialized treatment approaches. While the biotechnology arena is fraught with challenges, including complex regulatory environments and evolving competition, the company’s methodical focus on research rigor and diversified clinical trial execution underscores its dedication to addressing unmet medical needs with precision and expertise.
Technological Advances and Methodologies
At the core of its operational methodology, Pasithea Therapeutics employs state-of-the-art technology in molecular biology and pharmacology to drive its drug discovery processes. By leveraging these technologies, the company enhances its capability to pinpoint molecular targets and streamline the transition from bench research to clinical applications. This scientific rigor is central to its strategy of developing next-generation treatments that cater to the sophisticated demands of modern healthcare challenges.
Market Relevance
Despite the inherent challenges associated with early-stage clinical trials, Pasithea Therapeutics has entrenched itself within a niche of highly specialized biotech firms. Its focus on CNS disorders, accompanied by a pipeline that addresses both common and rare conditions, represents a significant value proposition within the biotech sector. Investors and industry analysts often regard such diversified research strategies as reflective of a deliberate approach aimed at balancing innovation with scientific risk management.
Conclusion
Overall, Pasithea Therapeutics Corp embodies the converging interests of advanced biotech research and practical clinical applications. Through its methodical approach to addressing CNS disorders and related diseases, the company maintains a steadfast commitment to scientific excellence, informed by its comprehensive clinical trial strategy and diversified research outlook. This detailed operational narrative provides an in-depth view of how Pasithea Therapeutics navigates the complexities of modern drug development, always rooted in a dedication to rigorous, translational science.
Pasithea Therapeutics (NASDAQ: KTTA) has announced its participation in the upcoming 2025 CAGLA NeauxCancer Conference, a leading global oncology forum scheduled for March 27-29, 2025, in New Orleans.
The company's Vice President of Business Development, Mathew Lazarus, will present on March 28 at 11:00 AM CDT at The Roosevelt Hotel. His presentation will focus on PAS-004, the company's next-generation macrocyclic MEK inhibitor being developed for neurofibromatosis type 1 (NF1) and other cancer indications.
The presentation will include interim data from their ongoing Phase 1 study, covering safety, tolerability, and pharmacokinetic (PK) results in advanced cancer patients with MAPK pathway-driven tumors. Lazarus will also discuss Pasithea's progress in clinical development and their strategy to revolutionize cancer and NF1 treatment.
Pasithea Therapeutics (NASDAQ: KTTA) announced positive safety review recommendations for its Phase 1 clinical trial of PAS-004, advancing to cohort 5 with a 22mg capsule dose. The trial, evaluating a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 (NF1) and other cancers, showed no dose-limiting toxicities in cohort 4A (15mg capsule) patients.
Notably, none of the 14 patients treated with PAS-004 (12 capsule, 2 tablet formulations) experienced rash, a common side effect with competitor MEK inhibitors that often leads to treatment discontinuation. The drug demonstrates a half-life exceeding 60 hours and substantial exposure levels. The ongoing multi-center, open-label study (NCT06299839) evaluates safety, tolerability, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors with RAS, NF1, or RAF mutations.
Pasithea Therapeutics (NASDAQ: KTTA) has expanded its Phase 1 clinical trial for PAS-004, a next-generation macrocyclic MEK inhibitor, by opening three new sites in Eastern Europe. The trial now includes locations in Romania and Bulgaria, operating alongside four existing U.S. sites. The company has completed initial dosing of three patients in Cohort 4A (15mg capsule) and is currently recruiting for Cohort 4B (4mg tablet).
The ongoing trial is a multi-center, open-label, dose-escalation study evaluating PAS-004's safety, tolerability, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors. The company expects to present interim safety and pharmacokinetic data from Cohorts 4A and 4B in Q1 2025.
Pasithea Therapeutics (NASDAQ: KTTA) announced positive safety results from its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The Safety Review Committee recommended advancing to cohort 4 with a 15mg capsule dose, following no dose-limiting toxicities in the first 9 patients. Notably, no rash was observed, which is a common adverse event with competitor MEK inhibitors. The company will add cohort 4b to test a commercial formulation. PAS-004 demonstrates advantages over first-generation MEK inhibitors, including a longer half-life of 70 hours enabling once-daily dosing, and consistent plasma levels at steady-state.
Pasithea Therapeutics Corp. (NASDAQ: KTTA) has announced a $5 million private placement priced at-the-market under Nasdaq rules. The offering includes the sale of 1,219,513 shares of common stock (or pre-funded warrants) with accompanying Series A and short-term Series B warrants at $4.10 per share. Both warrant series have an exercise price of $3.85 per share, with Series A expiring in 5 years and Series B in 18 months.
The closing is expected around September 30, 2024, subject to customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. Pasithea plans to use the net proceeds for working capital and general corporate purposes. The securities are offered under Section 4(a)(2) of the Securities Act and/or Regulation D and have not been registered, limiting their sale in the United States.
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.
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