Compass Pathways, a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, has been named a 2026 Fierce 50 Breakthrough honoree by Fierce Pharma, Fierce Biotech and Fierce Healthcare. The Fierce 50 recognizes 50 individuals and organizations driving advancements in medicine, fostering innovation and shaping the future of biopharma and healthcare.

Compass is leading a profound shift in the development of new treatment options in mental health care – moving beyond daily or frequent administration toward an option that could potentially provide durable efficacy with just a few treatments a year that could be life changing for patients. Supported by robust clinical data from three late-stage trials involving more than 1,000 participants living with treatment-resistant depression (TRD), COMP360 psilocybin, if approved by the U.S. Food & Drug Administration (FDA), has the potential to establish a new standard of care for a condition affecting approximately 4 million people in the U.S. and for which treatment options remain limited. A rolling New Drug Application (NDA) submission and review is underway and commercial launch preparations for TRD are progressing towards an anticipated first-half 2027 launch. Compass also continues to advance its late-stage PTSD program, reflecting the company’s commitment to expanding access to innovative treatments for people living with serious mental health conditions.

"Being named a Fierce 50 honoree is a tremendous honor and a testament to the passion and perseverance of the Compass team," said Kabir Nath, Chief Executive Officer of Compass Pathways. "This recognition reflects our unwavering commitment to advancing innovative treatment options for people living with serious mental health conditions. We are motivated by the courage of patients who continue to seek better outcomes despite limited treatment options. At Compass, we believe patients deserve the possibility of a better future, and we remain focused on advancing our investigational COMP360 synthetic psilocybin with urgency and rigor for those who need it most."

"Now in its fourth year, the Fierce 50 continues to show that progress in this industry doesn’t come from just one place," said Ayla Ellison, editor-in-chief of Fierce Life Sciences and Healthcare. "It’s showing up in the lab, in executive leadership, in community clinics and in advocacy work that never makes headlines. Whether it’s a biotech pushing a new therapy toward patients or a grassroots organization fighting for someone to get the care they need, these honorees remind us that impact takes a lot of different shapes. We’re honored to celebrate all of them."

Chosen by the editors of Fierce Pharma, Fierce Biotech and Fierce Healthcare, this year's Fierce 50 honorees reflect the breadth of talent and vision shaping the biopharma and healthcare industries today. From startups to established organizations, each has made a distinct contribution, whether by advancing scientific discovery, improving the health of communities, expanding access to care or reimagining how healthcare is delivered at a local level or on a global scale.

More information about Compass’ recognition as a Fierce 50 Breakthrough honoree is available here: https://www.fiercepharma.com/fierce-50/compass-pathways

About Compass Pathways

We believe mental health patients deserve the possibility of a better future. Compass Pathways plc (NASDAQ:CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world’s largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing.

Compass is headquartered in London, UK, with a U.S. office in New York.

We are driven by our purpose of unlocking pathways to be – opening futures filled with possibility. Together, we are on an ambitious journey toward enabling people living with mental health conditions to find clarity through self-discovery, because every journey needs a Compass.

About Fierce Pharma

Fierce Pharma is the go-to destination for the news and trends shaping the industry. Our focus daily is on news about approved drugs and every aspect of pharma’s operations as well as the people who move pharma forward. Our coverage also feeds longer-form content, podcasts and events. In staying on top of the news, our journalists have developed a loyal audience. Critically, we explain the news—often complicated technology or business maneuvers—and put it in context that brings it home for our readers and listeners in their work lives.

About Fierce Biotech

Fierce Biotech is the dominant B2B news brand for the industry. Every day, we track the companies, people and ideas reshaping biotech: from the discovery through clinical trials, approvals and commercialization, and the venture funding, partnerships, IPOs and M&A that power it all. That reporting fuels our long-form features, podcasts and events, where deal flow, data and on-the-ground insight come together into the fullest picture of where the industry is headed.

About Fierce Healthcare

At Fierce Healthcare, we deliver the news and analysis that healthcare can't afford to miss. Our newsroom serves the people building, running, and reshaping this industry: hospital executives and physicians, payers, policymakers, researchers and the entrepreneurs betting on what comes next. Wherever healthcare is being disrupted, financed, regulated, or reinvented, we're covering it, with breaking news, exclusive interviews and deep reporting that connects the dots between a boardroom decision and a patient's bedside experience.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our business strategy and goals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for TRD or PTSD; our plans and expectations regarding our clinical trials; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our estimates and expectations our expectations regarding potential commercial launch timelines and our commercial readiness; our efforts and our ability to obtain regulatory approval and adequate coverage and reimbursement; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; that the rolling review process and/or the National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment on an accelerated basis, or at all, may be unsuccessful; the timing and substance of decisions by the Drug Enforcement Administration and states to reschedule COMP360 psilocybin treatment, if approved by FDA, which contains Schedule I controlled substances and must be rescheduled before commercializing COMP360 psilocybin in the U.S.; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading "Risk Factors" in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260902222972/en/

Enquiries

Media: Dana Sultan-Rothman, media@compasspathways.com

Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324