Compass pathways fda approval. Here, we review both programs.
Compass pathways fda approval. Compass Pathways, or COMPASS Pathways, is a British pharmaceutical company developing psychedelics as potential medicines. Jun 24, 2025 · If the benefits wane after six weeks, COMP360 could face two critical setbacks: FDA Approval Uncertainty: While the FDA's Breakthrough Therapy designation is a positive signal, the agency's final decision will hinge on demonstrating durable efficacy. Apr 29, 2025 · “We strive to improve mental healthcare for every person who needs help, and we recognize the challenges to access for underserved populations and the potential for innovative treatments, such as COMP360, to lessen existing disparities, if approved,” said Steve Levine, Chief Patient Officer of Compass Pathways. S. Dec 20, 2023 · Less than a week after the first-ever request for approval of an MDMA treatment landed on the FDA’s desk, Compass Pathways has reported phase 2 safety data from the first clinical trial of 1 day ago · Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the appointment of Dr. Here, we review both programs. “The positive top-line results at week 6 from the COMP005 trial underscore the innovative potential of psilocybin treatment in mental health care for which Compass Pathways continues to pave the Jun 23, 2025 · Compass Pathways reports significant progress in psilocybin research, showing promise for treatment-resistant depression in a pivotal phase 3 trial. Oct 21, 2025 · Has COMPASS Pathways received FDA approval? Track FDA approvals, PDUFA dates, and regulatory milestones for CMPS with the latest event history at MarketBeat. These are the results. Regulatory approvals for the trial have already been given in the UK, the Netherlands and Canada. Apr 22, 2025 · COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). The landmark Phase 3 trial follows the company's announcement of successful Phase 2B Jun 24, 2025 · The stock's current valuation assumes a best-case scenario: durable efficacy, swift FDA approval, and robust pricing power. Immediately, the company’s publicly traded shares dropped 16%. This article will examine various Nov 26, 2019 · In October 2018 the FDA granted a Breakthrough Therapy designation to COMPASS Pathways for its use of psilocybin in addressing treatment-resistant depression (TRD). Nov 10, 2021 · Something strange happened yesterday. placebo. COMPASS Pathways’ share price has Feb 21, 2025 · At the meeting, COMPASS senior manager of advocacy and state government policy Tess Bettler explained that if COMP360 is approved by the FDA, the DEA will be directed to consider rescheduling the drug. 75B TRD market with FDA Breakthrough Therapy designation and Phase 3 efficacy showing -3. Jan 16, 2024 · Compass Pathways enters into research collaboration agreement with Hackensack Meridian Health to develop optimal clinical model for investigational COMP360 psilocybin treatment, if FDA-approved Nov 4, 2024 · Compass Pathways' latest update reveals extended trial timelines, staff cuts, and financial concerns. Aug 23, 2018 · The agency gave the green light to Compass Pathways, a life sciences firm, to perform clinical trials using psilocybin. Jan 12, 2022 · In November, Compass Pathways’ much-anticipated FDA-approved phase 2b clinical trial found that patients who took a single psychedelic dose of psilocybin, the main ingredient in “magic COMPASS Pathways’ ambitious Phase 3 program, meanwhile, is a milestone for both COMPASS Pathways and psychedelic drug development writ large, representing the most mature clinical investigation of a classical psychedelic. Together Psychedelic drug developers like MindMed (MNMD), Compass Pathways (CMPS), Atai Life Sciences (ATAI), and Cybin (CYBN) could learn from the mistakes of Lykos' trial setup and New Drug Application. Key risks include market acceptance 6 days ago · UK biotech Compass Pathways is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient derived from magic mushrooms. Nov 25, 2024 · Phase III COMPASS Pathways is investigating the use of its experimental psilocybin therapy, COMP360, for treating serious mental health conditions like major depressive disorder. Oct 24, 2022 · The trial, run by Compass Pathways, will enroll close to 1,000 subjects and the company is looking to FDA approvals by the end of 2025. We have received FDA Breakthrough Therapy designation and Innovative Licensing and Access Pathway designation for our investigational COMP360 psilocybin for TRD. Jun 10, 2024 · After an unexpected vote at the Food and Drug Administration (FDA) on June 4, shares of psychedelics companies like Compass Pathways, Atai Life Sciences, and Mind Medicine fell sharply. 3rlv7u1cknwj95m5u7xru96ba2gq7k4umtmahisjz4ii8t3