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Compass Pathways Plc (Nasdaq: CMPS) is a biotechnology company at the forefront of mental health innovation, dedicated to accelerating patient access to evidence-based therapies. Headquartered in London, UK, with offices in New York and San Francisco, Compass is pioneering a new model of psilocybin therapy, specifically targeting treatment-resistant depression (TRD). The company’s flagship product, a proprietary high-purity polymorphic crystalline formulation of synthetic psilocybin known as COMP360, is at the core of their therapeutic approach.
Compass Pathways has made significant strides in mental health care by combining psilocybin treatment with psychological support. This dual approach is designed to provide comprehensive care for patients unresponsive to standard treatments. COMP360 has been designated a 'Breakthrough Therapy' by the U.S. Food and Drug Administration (FDA) and also received the Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD.
The company's research is supported by robust clinical trials. Compass has commenced a Phase 3 clinical program for COMP360, making it the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previous Phase 2b studies have shown that a single 25mg dose of COMP360 can significantly improve depressive symptoms with sustained effects over weeks. In addition to TRD, Compass is exploring the potential of COMP360 for treating post-traumatic stress disorder (PTSD) and anorexia nervosa through ongoing Phase 2 clinical trials.
Recent collaborations with leading healthcare institutions like Hackensack Meridian Health and Journey Clinical are aimed at understanding and optimizing the delivery models for COMP360, should it receive FDA approval. These partnerships also include exploration into therapist training and care reimbursement processes to ensure that the treatment can be integrated smoothly into existing healthcare systems.
Financially, Compass Pathways remains committed to transparency and regular updates to investors through various platforms including their website, social media, and investor relations channels. The company's vision is to create a world where mental well-being is within reach for all.
For the latest news and updates on Compass Pathways, visit www.compasspathways.com.
COMPASS Pathways (Nasdaq: CMPS) has appointed Matthew Owens as its new General Counsel and Chief Legal Officer, effective February 1, 2022. Owens joins from Novartis, where he was the Global Head of Legal, Digital. Concurrently, Lars Wilde, co-founder and Chief Business Officer, will transition to a senior advisory role from January 1, 2022. Under Wilde's leadership, COMPASS raised over $429 million and advanced its psilocybin therapy for mental health, which has received Breakthrough Therapy designation from the FDA.
COMPASS Pathways (Nasdaq: CMPS) announced positive results from its study of COMP360 psilocybin therapy in patients concurrently taking SSRIs. In this phase IIb trial, 19 patients treated with a 25mg dose had comparable outcomes to those who discontinued SSRIs before treatment. 42.1% of participants responded after three weeks, with an average MADRS score reduction of 14.9. Notably, no serious adverse events emerged. COMPASS is now preparing to meet with the FDA to finalize its phase III program planned to start in Q3 2022.
COMPASS Pathways plc (Nasdaq: CMPS) announced the appointment of Michael Falvey as Chief Financial Officer, effective January 1, 2022. He replaces Piers Morgan, who departs at year-end. Falvey has a robust background in finance, having previously led financial strategies at Karyopharm Therapeutics and other growth companies. His expertise will be vital as COMPASS advances its psilocybin therapy for treatment-resistant depression, especially following recent positive Phase IIb clinical trial results. The company has raised over $425 million and aims to transform mental health care.
COMPASS Pathways (Nasdaq: CMPS) announced positive results from its phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD). Additional analyses validated prior findings, showing significant improvements in depression symptoms and overall patient functioning with a 25mg dose compared to 1mg. Outcomes measured at three weeks revealed a -6.6 difference on the MADRS scale (p<0.001). Safety analysis indicated that COMP360 was generally well-tolerated, with most adverse events resolving quickly. The company anticipates starting a pivotal phase III trial in 2022.
COMPASS Pathways plc (Nasdaq: CMPS) announced the granting of its 10th patent, specifically US Patent No 11,180,517, which focuses on treatment-resistant depression (TRD) using crystalline psilocybin. With five patents in the US, the latest patent reinforces the company’s commitment to advancing mental health therapies. COMPASS's COMP360 formulation, recognized as a Breakthrough Therapy by the FDA, has shown statistically significant improvements in depressive symptoms in clinical trials. The company continues to expand its innovative approach to mental health care.
COMPASS Pathways (CMPS) reported positive topline results from its phase IIb trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD), indicating a rapid and sustained response from patients after a single 25mg dose. The company has also initiated a phase II study for PTSD and noted promising outcomes from an investigator-initiated study on cancer-related depression. Financially, COMPASS reported a net loss of $15.8 million for Q3 2021, with cash reserves of $294 million. The acquisition of an IP portfolio and new US patent for crystalline psilocybin were highlighted as advancements.
COMPASS Pathways plc (Nasdaq: CMPS) announced the successful results of its phase IIb clinical trial for COMP360 psilocybin therapy, targeting treatment-resistant depression (TRD). The trial involved 233 patients and achieved its primary endpoint, showing a statistically significant reduction in depressive symptoms with a 25mg dose compared to a 1mg dose, as indicated by a -6.6 points difference on the MADRS scale (p<0.001). The therapy was well tolerated, with over 90% of adverse events being mild or moderate. The company plans to initiate a pivotal phase III trial in 2022.
COMPASS Pathways (Nasdaq: CMPS) announced a Phase II clinical trial of COMP360 psilocybin therapy for PTSD on November 3, 2021. This multicenter study aims to evaluate the safety and tolerability of a single 25mg dose administered with psychological support, enrolling 20 adult participants. Conducted at King’s College London, the trial is part of COMPASS’s efforts to address the 40% of PTSD patients who do not respond to existing treatments. The primary endpoint is safety, with secondary endpoints assessing symptom improvement and quality of life.
COMPASS Pathways (CMPS) announced positive topline results from an open-label study of COMP360 psilocybin therapy for major depression in cancer patients. Conducted by Maryland Oncology Hematology, 50% of participants achieved remission in depression symptoms within one week, maintained for eight weeks. The study involved 30 patients, with an average initial MADRS score of 25.9, which dropped by 19.1 points after treatment. COMP360 therapy was well tolerated with no serious adverse events reported. Further research is anticipated to validate these promising results.
COMPASS Pathways plc (Nasdaq: CMPS) announced on 19 October 2021 that it received its fourth patent from the US Patent and Trademark Office, covering the Form A hydrate of psilocybin. This new patent (US Patent No 11,149,044) includes claims related to crystalline psilocybin and its use in treating major depressive disorder. CEO George Goldsmith emphasized the importance of this innovation for developing effective therapies for patients with treatment-resistant depression, as the company continues its phase IIb clinical trial of psilocybin therapy, COMP360, across Europe and North America.
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