Psychedelic Stocks Trip Up After FDA Advisors Reject MDMA For PTSD Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 05 2024
0mins
Should l Buy ATAI?
Source: Business Insider
- FDA Panel Rejects MDMA for PTSD Treatment: A panel of FDA advisors rejected the use of MDMA in treating post-traumatic stress disorder (PTSD) due to insufficient evidence that its benefits outweigh the risks.
- Impact on Psychedelic Stocks: Most stocks in the psychedelic space experienced a decline following the ruling, with companies like Cybin Inc, Mind Medicine, and ATAI Life Sciences trading lower.
- Reasons for Rejection: Panel members cited concerns about the effectiveness of MDMA combined with talk therapy for PTSD treatment and potential risks associated with using the drug for mental health issues.
- Market Response: The AdvisorShares Psychedelics ETF also traded lower after the ruling, reflecting a negative sentiment towards the progress of approving and regulating psychedelic treatments.
- Future Outlook: While the FDA is not bound by the advisory board's decision, the rejection was viewed as a setback for the advancement of psychedelic-based treatments despite arguments for their efficacy over existing mental health treatments.
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Analyst Views on ATAI
Wall Street analysts forecast ATAI stock price to rise
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.090
Low
10.00
Averages
13.00
High
16.00
Current: 4.090
Low
10.00
Averages
13.00
High
16.00
About ATAI
AtaiBeckley Inc is a clinical-stage biotechnology company focused on developing rapid-acting, durable and convenient mental health treatments. The Company’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 (R-MDMA HCI) for social anxiety disorder. The Company is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. BPL-003 is a proprietary synthetic intranasal formulation of mebufotenin benzoate being developed as a potential treatment for people living with TRD. VLS-01 is a proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) being developed as a potential treatment for people living with TRD. EMP-01 is an oral formulation of R-MDMA, being developed as a potential treatment for people living with social anxiety disorder.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Research Funding Opening: President Trump is expected to sign an executive order aimed at unlocking federal funding for research into ibogaine's effectiveness for PTSD and traumatic brain injuries, particularly among veterans, signaling a significant policy shift.
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- Clinical Development Strategy Discussion: Rao will engage in discussions on clinical risks, regulatory realities, and pathways to scale at the Needham Virtual Psychedelics Forum on April 27, emphasizing the company's strategic planning under FDA and DEA regulations to facilitate future product market entry.
- Breakthrough Therapy Progress: AtaiBeckley's BPL-003 (mebufotenin benzoate nasal spray) has received FDA Breakthrough Therapy Designation and is on track to enter Phase 3 studies in Q2 2026, marking a significant milestone in addressing treatment-resistant depression.
- Diverse Treatment Pipeline: In addition to BPL-003, AtaiBeckley is advancing VLS-01 (DMT buccal film) and EMP-01 ((R)-MDMA HCl), both in clinical development, demonstrating the company's innovative potential and competitive edge in the mental health sector.
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- Drug Development Potential: AtaiBeckley is developing two key drugs for treatment-resistant depression, BPL-003 and VLS-01, with potential U.S. sales peaking at $4 billion and $2 billion respectively, highlighting significant market opportunities for its product pipeline.
- Increased Industry Recognition: As psychedelic therapies gain popularity in mental health treatment, Deutsche Bank's analyst noted that AtaiBeckley has emerged as a bona fide drug developer, attracting interest from investors typically focused on conventional therapeutics, underscoring its leadership in this nascent market.
- FDA Regulatory Changes: Hoang mentioned that the FDA's skepticism towards psychedelic therapies has eased, with expectations that upon FDA approval, these drugs will undergo federal rescheduling within 90 days, further enhancing market acceptance and investor confidence.
See More
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- Government Focus on Ibogaine: The Trump administration plans to closely examine ibogaine's safety and effectiveness, maintaining its Schedule I classification, which indicates a cautious approach to its potential medical applications.
- Research Funding Opening: President Trump is expected to sign an executive order aimed at unlocking federal funding for research into ibogaine's effectiveness for PTSD and traumatic brain injuries, particularly among veterans, signaling a significant policy shift.
- Stock Price Surge: Following the news, shares of Psyence Biomedical (PBM) surged over 141% on Thursday, potentially marking its best trading session, reflecting strong market confidence in the company's natural-derived therapies.
- Market Sentiment Extremely Bullish: On Stocktwits, retail sentiment around PBM stock remained in the 'extremely bullish' territory with message volume spiking, despite the stock having fallen approximately 95% over the past year.
See More
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- Psychedelic Stocks Surge: Following CBS News' report on Trump's plan to sign an executive order to promote ibogaine research, stocks of psychedelic companies like Atai Life Sciences (ATAI) and COMPASS Pathways (CMPS) saw significant gains, indicating a positive market reaction to potential policy changes.
- Funding for Research: The White House's draft order aims to release federal funding for research into ibogaine's effectiveness for post-traumatic stress disorder and traumatic brain injuries, particularly among veterans, which could create new business opportunities for related companies.
- Current Drug Legality: Despite the push for research, ibogaine will remain classified as a Schedule I substance under the Controlled Substances Act, meaning it will not be reclassified for medical use, potentially limiting its market potential.
- Demand for Overseas Treatment: With ibogaine illegal in the U.S., many Americans are seeking treatment at unregulated clinics in Mexico, highlighting a pressing need for legalization and regulation that may prompt policymakers to reconsider existing laws.
See More
AtaiBeckley to Participate in Healthcare Conferences
- Executive Participation: AtaiBeckley's CEO Dr. Srinivas Rao will participate in a fireside chat at the 25th Annual Needham Virtual Healthcare Conference on April 16, showcasing the company's advancements in mental health treatments and boosting investor confidence.
- Clinical Development Strategy Discussion: Rao will engage in discussions on clinical risks, regulatory realities, and pathways to scale at the Needham Virtual Psychedelics Forum on April 27, emphasizing the company's strategic planning under FDA and DEA regulations to facilitate future product market entry.
- Breakthrough Therapy Progress: AtaiBeckley's BPL-003 (mebufotenin benzoate nasal spray) has received FDA Breakthrough Therapy Designation and is on track to enter Phase 3 studies in Q2 2026, marking a significant milestone in addressing treatment-resistant depression.
- Diverse Treatment Pipeline: In addition to BPL-003, AtaiBeckley is advancing VLS-01 (DMT buccal film) and EMP-01 ((R)-MDMA HCl), both in clinical development, demonstrating the company's innovative potential and competitive edge in the mental health sector.
See More
AtaiBeckley Reports Promising Phase 2a Data for BPL-003 in Treatment-Resistant Depression
- Significant Efficacy: In the open-label Phase 2a study, 66.7% of participants achieved at least a 50% reduction in MADRS scores by Day 2 after a single intranasal dose of BPL-003, demonstrating rapid antidepressant effects that could offer new hope for treatment-resistant depression patients.
- Durable Response: Among the 10 mg cohort, 83% maintained their antidepressant response at Week 12, while 66.7% in the 12 mg cohort did, indicating that BPL-003 not only acts quickly but also provides lasting therapeutic effects, enhancing its potential for outpatient psychiatric use.
- Good Safety Profile: BPL-003 was generally well tolerated with no serious adverse events reported, and participants were typically ready for discharge about 100 minutes post-dosing, supporting its application in outpatient interventional psychiatry and furthering the clinical prospects of this therapy.
- Future Development: AtaiBeckley's CEO stated that BPL-003 has the potential to
See More
AtaiBeckley Reports Positive Phase 2a Results for BPL-003 in Treatment-Resistant Depression
- Antidepressant Response Rate: BPL-003 demonstrated a 66.7% antidepressant response rate by Day 2 among participants on stable SSRI therapy, indicating its potential to transform treatment paradigms for treatment-resistant depression (TRD).
- Durability of Response: By Day 85, 83% of participants in the 10 mg cohort and 66.7% in the 12 mg cohort maintained their response, suggesting that BPL-003 can provide sustained therapeutic effects, thereby enhancing patient quality of life.
- FDA Breakthrough Therapy Designation: BPL-003 received FDA Breakthrough Therapy Designation in October 2025, marking a significant advancement in TRD treatment, with Phase 3 trials expected to initiate in Q2 2026.
- Good Safety Profile: The clinical trial reported no serious adverse events for BPL-003, with most drug-related adverse effects being transient, indicating its feasibility and safety for integration into psychiatric interventions.
See More
Deutsche Bank Sees AtaiBeckley as a Leader in Psychedelic Renaissance
- Positive Market Outlook: Deutsche Bank initiated coverage on AtaiBeckley with a buy rating and a $12 price target, indicating over a 250% upside from Friday's close, reflecting strong market confidence in its position within the psychedelic drug sector.
- Drug Development Potential: AtaiBeckley is developing two key drugs for treatment-resistant depression, BPL-003 and VLS-01, with potential U.S. sales peaking at $4 billion and $2 billion respectively, highlighting significant market opportunities for its product pipeline.
- Increased Industry Recognition: As psychedelic therapies gain popularity in mental health treatment, Deutsche Bank's analyst noted that AtaiBeckley has emerged as a bona fide drug developer, attracting interest from investors typically focused on conventional therapeutics, underscoring its leadership in this nascent market.
- FDA Regulatory Changes: Hoang mentioned that the FDA's skepticism towards psychedelic therapies has eased, with expectations that upon FDA approval, these drugs will undergo federal rescheduling within 90 days, further enhancing market acceptance and investor confidence.
See More
