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LONDON & NEW YORK—Compass Pathways plc (Nasdaq: CMPS) said it welcomes a White House executive order aimed at accelerating medical treatments for serious mental illness, praising the move for recognizing the urgency of the mental health crisis and the potential impact of FDA-approved psychedelics.
“We commend the Administration’s Executive Order on psychedelic treatment which recognizes the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have,” said Kabir Nath, CEO at Compass Pathways. Nath said the announcement aligns regulatory urgency with patient need while maintaining “rigorous science.”
Compass said it is conducting what it called the largest and most robust classic psychedelic studies to date using COMP360 synthetic psilocybin. The company reported two positive phase 3 trials in treatment-resistant depression (TRD), describing results as “highly statistically significant and clinically meaningful,” with effects that Compass said begin within one day and durability lasting at least through six months after one or two doses for patients who show a clinically meaningful response.
Compass also said the treatment has a generally well-tolerated and safe profile. It added that a “significant majority” of treatment-emergent adverse events (TEAEs) are mild or moderate, and that the “vast majority” resolve within 24 hours.
The company said it is actively working with the FDA on a rolling submission and review for COMP360 in TRD.
Compass said an estimated four million Americans are living with TRD and 13 million with post-traumatic stress disorder (PTSD). The company said both conditions have seen “critically limited innovation for decades.”
Compass stated that with the executive order including the potential for accelerated regulatory and rescheduling processes, it would be ready to make COMP360 available to patients if the therapy is approved.
Compass said it is also advancing its PTSD pathway. After receiving clearance for its IND in this indication, the company said it is starting a late-stage trial.
Compass Pathways plc is a biotechnology company focused on accelerating patient access to evidence-based innovation in mental health. The company said it is developing COMP360, an investigational synthetic psilocybin treatment, and described it as potentially a first-in-class therapy.
Compass said COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and received Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD.
The company said the press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. It noted that such statements involve risks and uncertainties, including the possibility that clinical trials may be delayed or terminated, that full phase 3 results may differ from preliminary findings, and that regulatory processes may not proceed as expected.
Compass also stated that it does not undertake any obligation to update or revise forward-looking statements except as required by law.
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