Freedom to Heal Act of 2025
Summary
The Freedom to Heal Act of 2025 removes a critical DEA regulatory barrier for Schedule I investigational psychedelic drugs under Right to Try laws. This directly benefits pure-play psychedelic therapy companies $CMPS, $GHRS, and $ATAI by enabling early patient access, revenue generation, and real-world data collection before full FDA approval. The bill is early-stage but has significant tailwind from an April 2026 Executive Order targeting psychedelic therapies for mental health.
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Key Takeaways
- 1.The Freedom to Heal Act creates a DEA registration pathway for physicians to administer Schedule I psychedelic investigational drugs under Right to Try, enabling pre-approval revenue for psychedelic therapy companies.
- 2.Pure-play beneficiaries $CMPS, $GHRS, and $ATAI all show 30-day rallies of 15–53% on deregulatory momentum, with current pullbacks representing technical profit-taking, not fundamental deterioration.
- 3.The bill authorizes zero government funding—all financial impact is from early commercial access; passage probability is above-average due to companion bill and Executive Order support.
Market Implications
The real market data shows a clear pattern: all three pure-play psychedelic tickers surged 15–53% over the 30 days leading to April 30, 2026, driven by the April Executive Order combined with Right to Try anticipation. The 7-day pullbacks ($CMPS -11.9%, $GHRS -4.05%, $ATAI -11.88%) are standard profit-taking after a regulatory rally. These stocks remain well above their 30-day open levels, suggesting structural buying interest. The bill's early-stage status means any committee hearing or markup announcement will trigger the next leg higher. Key catalyst calendar: Senate Judiciary Committee schedule in Q3–Q4 2026. $CMPS at $8.44 is 17% below its recent high of $10.21 and could retest that if the bill advances.
Full Analysis
Intelligence Surface
Cross-referenced against federal contracts, SEC insider filings & congressional trade disclosures
No confirming evidence found yet from contracts, insider trades, or congressional activity
What the bill does
Regulatory exemption: establishes a special DEA registration for physicians to directly administer Schedule I investigational psychedelic drugs to eligible patients under federal Right to Try law, bypassing standard Schedule I research restrictions.
Who must act
Physicians seeking to administer Schedule I investigational psychedelics to eligible patients under Right to Try; requires manufacturer/sponsor documentation and supply agreement.
What happens
Enables COMPASS Pathways to supply its investigational COMP360 psilocybin therapy directly to physicians for eligible patients before full FDA approval, creating an early revenue channel and real-world data collection pathway outside clinical trials.
Stock impact
COMPASS Pathways' primary asset is COMP360 for treatment-resistant depression (TRD). The Right to Try pathway opens a paid-access channel for patients who meet eligibility criteria, generating early per-patient revenue—estimated at $5,000–$15,000 per course—and accelerating real-world evidence gathering that supports eventual FDA approval. This directly monetizes their lead asset during the pre-approval period.
What the bill does
Regulatory exemption: establishes a special DEA registration for physicians to directly administer Schedule I investigational psychedelic drugs to eligible patients under federal Right to Try law, bypassing standard Schedule I research restrictions.
Who must act
Physicians seeking to administer Schedule I investigational psychedelics to eligible patients under Right to Try; requires manufacturer/sponsor documentation and supply agreement.
What happens
Enables GH Research to supply its investigational GH001 (5-MeO-DMT) therapy directly to physicians for eligible patients before full FDA approval, creating an early revenue channel and real-world data collection pathway outside clinical trials.
Stock impact
GH Research is a pure-play psychedelic therapy company developing GH001 for treatment-resistant depression. The Right to Try pathway allows early limited commercialization, generating maiden product revenue while building a treatment record that supports FDA approval. GH001 requires specialized administration protocols, making physician registration a critical enabler. Estimated per-patient revenue of $8,000–$20,000 per course.
Market Impact Score
Connected Signals
Matched on shared policy language across AI analyses, with ticker & timing weight
Mental Health Research Accelerator Act of 2025
Innovative Therapies Centers of Excellence Act of 2025
Freedom to Heal Act of 2025
Veterans Health Administration Novel Therapeutics Preparedness Act
SUPPORT for Patients and Communities Reauthorization Act of 2025
Protecting Health Care and Lowering Costs Act of 2025
ADVANCED TECHNOLOGY INTERNATIONAL: $304M Department of Health and Human Services Contract
Veterans SPORT Act
Related Presidential Actions
Executive orders & memoranda affecting the same sectors or companies
Accelerating Medical Treatments for Serious Mental Illness
This executive order directs the FDA to prioritize review and facilitate 'Right to Try' access for psychedelic drugs, including ibogaine compounds, that have received Breakthrough Therapy designation for serious mental illnesses. It also allocates $50 million from HHS to support state programs advancing these treatments and mandates collaboration between HHS, FDA, VA, and the private sector to increase clinical trial participation and data sharing for these drugs. The Attorney General is further directed to expedite rescheduling reviews for approved Schedule I psychedelic substances.