<div id="readability-page-1"><ul><li>Magic Mushrooms, Hard Cash: Compass Pathways’ Trial Win, Fast Raise</li></ul><p>Compass Pathways <span>NASDAQ: CMPS<span></span></span> executives outlined plans for a potential U.S. regulatory filing and commercial launch preparation for its investigational psilocybin therapy, COMP360, during a recent fireside chat. Chief Executive Officer Kabir Nath and Chief Commercial Officer Lori Englebert discussed upcoming clinical milestones, the company’s approach to a rolling regulatory submission, and key operational issues they see as central to access at launch, including federal and state rescheduling timelines.</p><div><p><span></span><span>Get <strong>Compass Pathways</strong> alerts:</span></p></div><h2>Regulatory timeline and next clinical catalyst</h2> <p>Nath said the company shared a recent COMP360 dataset with the FDA and has scheduled a meeting intended to align with the agency on a “rolling submission and rolling review” approach. He said Compass plans to present a proposed sequence for submitting modules (including CMC and preclinical components) while the agency begins reviewing clinical data already submitted. </p><p>Nath identified the next major data release as 26-week results from the COMP006 study, which he said remains on track for early Q3. He described those long-term data as the final piece expected to be integrated into the overall clinical submission package. </p><p>Assuming alignment with the FDA, Nath said the company anticipates completing an NDA submission in the back part of the year. He also noted that COMP360 has Breakthrough Therapy designation, which he said “largely tends to mean priority review,” and suggested that an accepted filing and PDUFA date could place a potential approval decision “sometime end of the year into next year,” while emphasizing that exact regulatory timing would depend on discussions with the agency.  </p><h2>Why the 26-week COMP006 data matter</h2> <p>Asked about the importance of the upcoming long-term readout, Nath said the FDA will be focused on durability—how long one or two doses last—alongside safety and whether there is any waning of effect. He said prior long-term observations from COMP005 have not indicated new safety issues or loss of effect, but that COMP006 will be important to confirm that pattern. </p><p>Nath characterized the long-term data as supportive from a regulatory standpoint, but particularly important for labeling considerations, including how dosing might be reflected (for example, whether treatment is positioned as one or two doses).  </p><h2>Commercial focus: access, rescheduling, and site readiness</h2> <p>Englebert framed the commercial opportunity around treatment-resistant depression (TRD), differentiating it from the broader major depressive disorder (MDD) market. She said MDD affects 23 million patients, with about 13 million treated using more than 50 MDD-indicated FDA-approved products, while TRD is about 4 million patients. She added that fewer than 200,000 TRD patients are being treated with TRD-indicated products, citing current options such as SPRAVATO as well as procedures like ECT and TMS, which she described as “high patient burden” approaches. </p><p>Englebert said the company’s “North Star” is broad and equitable access, and she highlighted two areas of focus to support access at launch: </p><ul>   <li><strong>Federal and state rescheduling:</strong> Englebert said the company expects approximately a 90-day federal rescheduling window after FDA approval and is working to see whether the timeline can be shortened through efficient coordination between the FDA scheduling recommendation and the DEA. She said she does not expect the process to extend beyond 90 days. She also emphasized that state rescheduling is necessary for shipment and prescribing, and said Compass is working toward having about 90% of the U.S. patient population in states that are rescheduled within 30 days after federal DEA action. Englebert said the company estimates it is currently at about 70%–75% under that 30-day state timeline and is working on legislation in other states to accelerate rescheduling.</li>   <li><strong>Site enablement:</strong> Englebert said Compass is focused on ensuring sites can prescribe COMP360 at launch, including education and scientific exchange, REMS training, sales force readiness, and making reimbursement “easy for these sites.”</li> </ul>  <h2>Provider logistics and reimbursement discussions</h2> <p>During the discussion, Nath and Englebert pushed back on the idea that providers are primarily concerned about the length of time patients spend in the office during administration sessions. Nath said the question they hear from providers is when psilocybin will be available, rather than operational debates about session length. </p><p>Englebert said Compass had anticipated the need for reimbursement structures tailored to psychedelic administration and noted that CPT codes related to psychedelics went into effect in January 2024, confirmed by the American Medical Association. She said these codes currently sit in Category III and are intended to capture the support required during the psychedelic experience on an hour-by-hour basis, with the expectation that broader adoption could support a transition to Category I codes over time. Englebert said she has seen “a tiny bit” of usage by IV ketamine providers so far. </p><p>Englebert also said Compass expects that the full six-to-eight hours required to block a room for COMP360 administration would be reimbursed to the site under these codes. She contrasted that with her description of current SPRAVATO workflows, where she said sites may not be able to bill for all time in a day due to gaps between patients. She added that she sees capacity expanding at existing sites and new sites being built as psychedelics approach the market.  </p><h2>Therapy, REMS expectations, and pipeline discussion</h2> <p>On questions about psychotherapy’s role in the treatment model, Nath said Compass has sought to standardize non-drug variables in trials (including training and a standardized playlist) to focus on demonstrating a drug effect with dose response. He said COMP360 administration sessions are largely “inner-directed” and do not involve active therapy during dosing, noting that internal review of transcripts showed “80%+ is silent.” At the same time, he said many patients may benefit from therapy during the broader course of care for TRD. </p><p>Nath said the company expects monitoring during administration to be performed by a licensed healthcare professional trained to manage safety, and he said Compass does not currently expect the label or REMS to specify requirements beyond patient education on what to expect, safety monitoring, and follow-up check-ins. </p><p>Englebert said the company has been directed to look at the SPRAVATO REMS and materials discussed in Lykos advisory committee briefing documents as guideposts for what a potential REMS could look like. </p><p>Compass also discussed its PTSD program. Nath described an open-label study of 22 patients that showed what he called a “very, very strong response” in both response and remission. He said the company did not observe unexpected safety issues or triggering events, and he highlighted patient narratives suggesting some patients reached remission without re-experiencing the initial traumatic event. Nath said a larger PTSD study is being set up, with a CRO selected and site selection underway, but he did not provide timing for data given historically slow PTSD recruitment. </p><p>On financing, Nath said the company raised $150 million following the recent data update and called warrants from a January 2025 financing totaling $200 million. He said the company expects that to provide runway into 2028, which he described as well beyond the anticipated launch.</p><h2>About Compass Pathways <span>NASDAQ: CMPS<span></span></span></h2><p>Compass Pathways <span>NASDAQ: CMPS<span></span></span> is a clinical-stage biotechnology company focused on the development and commercialization of psilocybin therapy for mental health disorders. Founded in 2016 and headquartered in London with additional offices in the United States, Compass Pathways is pioneering the use of synthetic psilocybin combined with psychotherapy to address treatment-resistant depression. The company’s flagship program is a Phase IIb clinical trial evaluating COMP360, its proprietary psilocybin formulation, which has received Breakthrough Therapy designation from the U.S.</p><h2>Read More</h2><ul><li>Five stocks we like better than Compass Pathways</li></ul><p><em>This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.</em></p><h2>Should You Invest $1,000 in Compass Pathways Right Now?</h2><p>Before you consider Compass Pathways, you'll want to hear this.</p><p>MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Compass Pathways wasn't on the list.</p><p>While Compass Pathways currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys.</p><p>View The Five Stocks Here</p>                  </div>

CMPS

<p>Compass Pathways (NASDAQ:CMPS) is preparing for a potential U.S. regulatory filing and commercial launch of its psilocybin therapy, COMP360. CEO Kabir Nath announced plans for a rolling submission to the FDA, with key data from the COMP006 study expected in early Q3. The company aims for an NDA submission later this year, pending FDA alignment. The focus is on treatment-resistant depression (TRD), with efforts to ensure access and site readiness for prescribing COMP360. Compass is also addressing reimbursement structures for psychedelic administration, anticipating CPT codes to support this by January 2024.</p>

Compass Pathways Eyes Rolling FDA Filing for COMP360, Preps TRD Launch Ahead of Q3 Data