Phase 2a data for BPL-003 ‘encouraging' for Atai Life Sciences, says Jefferies
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Atai Life Sciences announces data from Part 2 of Phase 2a study of BPL-003
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Business Wire
6 days ago
- Business Wire
Enveric Biosciences Lead Drug Candidate EB-003 Demonstrates Positive Effects in Preclinical Model of Post-Traumatic Stress Disorder (PTSD)
BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) ('Enveric' or the 'Company'), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, today announced positive results in a preclinical, exposure-based therapeutic model for post-traumatic stress disorder (PTSD). In fear conditioned mice, oral administration of EB-003 significantly decreased context-induced freezing behavior when measured one-hour post-dose (p < 0.05) indicating a positive therapeutic effect with extinction of contextual fear after a single dose. These results were in line with the therapeutic effects observed with MDMA, which was used as a positive control in this study. MDMA is a psychedelic controlled substance that has demonstrated clinical benefit in the treatment of PTSD in human trials, although it is not approved by the FDA. The pairing of electrical shock stimulus with a controlled environment generates context-based traumatic memories leading to freezing behaviors when the subject is re-exposed to the same environment. This well-established translational rodent model, performed by a third-party lab, is designed to induce a potent, trauma-related state of fear using a Pavlovian association paradigm. 'Only a few medications have been approved by the FDA for the treatment of PTSD, including the serotonin reuptake inhibitors (SSRIs) paroxetine and sertraline,' said Joseph Tucker, Ph.D., CEO and Director of Enveric. 'Only 20% to 30% of PTSD patients experience full remission with these drugs and it takes two to three weeks of SSRI administration before clinical and neuronal benefits become apparent. Clearly, there is enormous unmet need in PTSD, which has yet to be addressed with meaningful innovation.' Dr. Tucker added: 'Research has implicated impaired hippocampal neuroplasticity as key underlying features of patients struggling with PTSD. We are very encouraged that a single dose of our lead neuroplastogen, EB-003, facilitated rapid fear extinction in mice.' In light of this new data, EB-003, a next-generation neuroplastogen that may enhance hippocampal neuroplasticity without causing hallucinations, has the potential to significantly improve treatment outcomes for this chronic and debilitating mental health condition, representing a major opportunity in an underserved market. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric's lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans," "expects" or "does not expect," "proposes," "budgets," "explores," "schedules," "seeks," "estimates," "forecasts," "intends," "anticipates" or "does not anticipate," or "believes," or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric's products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric's filings with the Securities and Exchange Commission, including Enveric's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Yahoo
13-07-2025
- Yahoo
Aegis Capital Reaffirms Buy on Atai Life Sciences N.V. (ATAI) with $8 Target
Atai Life Sciences N.V. (NASDAQ:ATAI) is among the . Aegis Capital analysts have reaffirmed their Buy rating on Atai Life Sciences N.V. (NASDAQ:ATAI), with an unchanged price target of $8.00, following the favorable Phase 2b results of the BPL-003 treatment for the company's Treatment Resistant Depression (TRD). Around 193 depression patients, who didn't respond to previous treatment, were part of the Phase 2b trial testing three doses: 0.3 mg, 8 mg, and 12 mg. Not only the 8mg but also the 12mg dose showcased statistically significant improvement in an FDA-accepted measurement of depression, with a healthy side-effect profile. A close-up of a medical professional providing advice to a patient struggling with opioid use disorder. The research firm believes these robust results strengthen the company's efforts to proceed to a Phase 3 clinical program, which would result in marketing approval. Going forward, Atai Life Sciences N.V. (NASDAQ:ATAI) plans to schedule a post-Phase 2 meeting with the FDA, with the Phase 3 trial expected to begin only at the end of the upcoming year. Another noteworthy development is the company's recent $50 million private capital raise, which involved the sale of 18,264,840 common shares with 25% warrant coverage at the market price. Moves like these highlight Atai Life Sciences N.V. (NASDAQ:ATAI)'s capacity to raise cash when needed. Atai Life Sciences N.V. (NASDAQ:ATAI) is a German clinical-stage biopharmaceutical company that researches, develops, and markets mental health treatments in the United States, Germany, and Canada. With a market capitalization of $587.639 million, the company is committed to healing mental health disorders. While we acknowledge the potential of ATAI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
11-07-2025
- Yahoo
Aegis Capital Reaffirms Buy on Atai Life Sciences N.V. (ATAI) with $8 Target
Atai Life Sciences N.V. (NASDAQ:ATAI) is among the . Aegis Capital analysts have reaffirmed their Buy rating on Atai Life Sciences N.V. (NASDAQ:ATAI), with an unchanged price target of $8.00, following the favorable Phase 2b results of the BPL-003 treatment for the company's Treatment Resistant Depression (TRD). Around 193 depression patients, who didn't respond to previous treatment, were part of the Phase 2b trial testing three doses: 0.3 mg, 8 mg, and 12 mg. Not only the 8mg but also the 12mg dose showcased statistically significant improvement in an FDA-accepted measurement of depression, with a healthy side-effect profile. A close-up of a medical professional providing advice to a patient struggling with opioid use disorder. The research firm believes these robust results strengthen the company's efforts to proceed to a Phase 3 clinical program, which would result in marketing approval. Going forward, Atai Life Sciences N.V. (NASDAQ:ATAI) plans to schedule a post-Phase 2 meeting with the FDA, with the Phase 3 trial expected to begin only at the end of the upcoming year. Another noteworthy development is the company's recent $50 million private capital raise, which involved the sale of 18,264,840 common shares with 25% warrant coverage at the market price. Moves like these highlight Atai Life Sciences N.V. (NASDAQ:ATAI)'s capacity to raise cash when needed. Atai Life Sciences N.V. (NASDAQ:ATAI) is a German clinical-stage biopharmaceutical company that researches, develops, and markets mental health treatments in the United States, Germany, and Canada. With a market capitalization of $587.639 million, the company is committed to healing mental health disorders. While we acknowledge the potential of ATAI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.