ENVB

Analysis showed no photoreactive potential for EB-003, further derisking its continued development for the treatment of neuropsychiatric disorders including depression, anxiety and PTSD. Phototoxicity testing is a part of preclinical safety assessment evaluating whether a novel pharmaceutical compound could become harmful when exposed to UV light. CAMBRIDGE, Mass., May 19, 2026--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced promising results from preclinical in vitro experiments evaluating the risk for phototoxicity, which indicated no photoreactive potential for EB-003, further derisking its continued development for the chronic treatment of neuropsychiatric disorders. This represents another preclinical safety assessment milestone for Enveric’s neuroplastogen EB-003, the first known compound designed to selectively engage both 5-HT2A and 5-HT1B receptors. EB-003 is intended to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience. Phototoxicity testing is mandated by regulatory agencies like the FDA under the ICH S10 guideline and is performed to evaluate whether a novel pharmaceutical compound could become harmful when exposed to UV light. Some photoactive chemicals can cause exaggerated sunburn-like reactions, rashes or blistering in sun-exposed tissues such as the eyes and skin, limiting the utility of pharmaceutical products. "The demonstration of limited potential for phototoxicity enhances the favorable safety profile of EB-003," said Joseph Tucker, Ph.D., CEO of Enveric Biosciences. "We continue to de-risk EB-003 as we look forward to initiating first-in-human Phase 1 clinical trials and remain committed to meeting the highest standards of safety as we progress towards the clinic." About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallu...

Product Development Highlights: Continued advancement of lead candidate EB-003 with IND-enabling studies progressing toward planned first-in-human clinical trial Reported additional preclinical data for EB-003 demonstrating dual Gq and β-arrestin signaling at 5-HT2A, pathways linked in peer-reviewed studies to antidepressant and anxiolytic effects Corporate and Business Development Highlights: Strengthened intellectual property portfolio with new patent issuances and allowances across EVM301 and EVM401 series Announced the withdrawal by AbbVie, Inc. of the Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric’s issued U.S. Patent No. 12,138,276, which appears relevant to the bretisilocin molecule (GM-2505) acquired by AbbVie, Inc. Presented at and Participated in Panel Discussion at Sachs Associates 9th Annual Neuroscience Innovation Forum During "J.P. Morgan Week 2026" CAMBRIDGE, Mass., May 15, 2026--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today reported financial results for the first quarter ended March 31, 2026, and provided a comprehensive business update. CEO Commentary: "Our progress in the first quarter of 2026 reflects continued execution against our core mission of developing therapeutics capable of addressing the significant unmet need in mental health," said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric Biosciences. "We remain laser focused on advancing EB-003, Enveric’s lead drug candidate in development, toward an IND submission and first-in-human clinical trials." Dr. Tucker continued: "What differentiates Enveric is our commitment to harnessing the therapeutic potential of psychedelic-inspired mechanisms while designing our candidates to eliminate the hallucinogenic effects that limit scalability, safety, and broad patient access. Our growing body of preclinical data continue to support EB-003’s ability to promote neuroplasticity through selective receptor engagement, reinforcing our confidence in its potential to deliver rapid and durable antidepressant and anxiolytic effects." "Since the end of the first quarter, the broader policy environment appears to be increasingly supportive of innovation in mental health. Recent actions,...

Previously reported results support continued development of EB-003 for PTSD and other neuropsychiatric conditions Recent U.S. Executive Order supporting psychedelic-inspired therapies highlights growing focus on PTSD and reinforces opportunity for neuroplastogens such as EB-003 CAMBRIDGE, Mass., May 05, 2026--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today highlighted preclinical data for its lead candidate, EB-003, a dual 5-HT2A and 5-HT1B modulator, in which a single dose of EB-003 significantly reduced context-induced freezing behavior one hour post-dose (p < 0.05). These results indicate a rapid reduction in conditioned fear response in a validated preclinical model of post-traumatic stress disorder (PTSD). President Donald Trump’s April 18, 2026, Executive Order supporting research into psychedelic therapies for mental health conditions, including PTSD, highlights increasing recognition at the federal level of the urgent need for novel treatment approaches. President Trump stated, "In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression." Secretary of Health and Human Services Robert F. Kennedy Jr commented, "At the same time, millions of Americans living with depression, PTSD, addiction and other conditions do not respond to existing treatments." Joseph Tucker, Ph.D., CEO of Enveric Biosciences, stated: "We believe Enveric’s portfolio of neuroplastogenic compounds, such as EB-003, is well positioned to meet the challenges recognized by regulators and provide therapeutic solutions that fit within existing patient treatment approaches while avoiding real-world limitations of delivering traditional hallucinogenic psychedelic therapies, which may require specialized clinical infrastructure." "Enveric’s EB-003 findings in a model of PTSD highlight the potential importance of targeting both neuroplasticity and mood signaling pathways," Dr. Tucker continued. "We believe EB-003’s combined activity at 5-HT2A and 5-HT1B receptors may offer a differentiated approach to promoting neuroplasticity while restoring key signaling pathways involved in emotional regulation and stress response." EB-003 is designed...

Product Development Highlights: Reported positive preclinical results for lead drug candidate EB-003, showing statistically significant improvements in animal models of severe chronic depression and despair and in post-traumatic stress disorder (PTSD) Identified neuroplastogen candidates with potential to promote brain-derived neurotrophic factor (BDNF) signaling, an established therapeutic target for neurodegenerative disease Corporate and Business Development Highlights: Announced the withdrawal of the Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric’s issued U.S. Patent No. 12,138,276, which appears relevant to the bretisilocin (GM-2505) molecule acquired by AbbVie, Inc. Continued to strengthen Enveric’s expansive IP portfolio directed to molecules intended to provide non-hallucinogenic treatment options. Multiple patents and notices of allowance were issued for its EVM301 Series, including a novel family of molecules including melatonin receptor-targeting compounds, and for its EVM401 Series CAMBRIDGE, Mass., March 27, 2026--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today provided a corporate update following the filing of its 10-K on Friday, March 27, 2026, which reported financial results for the fourth quarter and year ended December 31, 2025. CEO Commentary: "The year 2025 was a year of important scientific progress for Enveric as we further strengthened the mechanistic rationale for our lead candidate, EB-003, a non-hallucinogenic neuroplastogen, being developed for the treatment of underserved mental health conditions," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Our research team has continued to produce novel data, confirming EB-003’s dual-mechanism of action and its ability to promote neuroplasticity without hallucinogenic effects in animal models. We are now in the process of completing IND-supporting studies in preparation for submitting an IND application to the FDA, a key milestone that offers the potential to generate value for our stockholders and potentially deliver much-needed innovation to patients with severe and difficult to treat mental health disorders." Dr. Tucker added: "Our excitement around EB-003 has been furt...

In Q3, Enveric continued toward clinical readiness for lead candidate EB-003, targeting neuropsychiatric indications, announcing additional positive data in a preclinical model of PTSD, successful completion of dose range finding studies, and receipt of FDA response to pre-IND meeting request. CAMBRIDGE, Mass., November 14, 2025--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced financial results for the third quarter ended September 30, 2025, and provided a comprehensive business update. CEO Commentary: "The third quarter of 2025 marked another highly productive period as we continue to advance our lead candidate EB-003 towards clinical trials in 2026," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Importantly, we recently received a written response from the U.S. Food and Drug Administration (FDA) to our request for a Pre-Investigational New Drug (pre-IND) Type B meeting for EB-003, which we believe is consistent with our view that the preparations are sufficiently advanced to proceed to IND submission. Driving towards this significant inflection point, we also completed key chemistry, manufacturing, and controls (CMC) milestones, as well as dose range studies that helped to establish a maximum tolerated dose of EB-003." "In addition, our team continued to strengthen the profile of EB-003 across several neuropsychiatric indications, as we showed positive effects in a preclinical model of post-traumatic stress disorder (PTSD). Our research showed significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05) indicating a positive therapeutic effect in a well-established translational rodent model for PTSD." Dr. Tucker continued, "Intellectual property remains a cornerstone of Enveric’s value proposition, and during the third quarter we pursued opportunities to expand and defend our patent estate. Notably, we announced plans to contest a Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric’s issued U.S. Patent No. 12,138,276 entitled, ‘Halogenated Psilocybin Derivatives and Methods of Using.’ The IP in question concerns claims that may be relevant to the Bretisilocin molecule, which was recently acquired by AbbVie...

Move aligns with company’s vision to leverage the Greater Boston biotech hub’s scientific and financial ecosystem and advance EB-003 into first-in-human trial in 2026 CAMBRIDGE, Mass., September 02, 2025--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced the relocation of its corporate headquarters to Cambridge, Massachusetts, 02142. Enveric believes the move will foster stronger collaborations, facilitate top-tier talent recruitment, and enhance visibility within one of the world’s most vibrant life sciences clusters where world-class scientific expertise, leading biopharma companies, premier academic institutions, and a dynamic investor community converge. "Relocating our headquarters to Cambridge represents an important step in Enveric’s growth trajectory," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "The Greater Boston biotech hub offers unparalleled access to scientific innovation, industry leadership, and capital markets. These advantages will be beneficial as we prepare to advance our lead molecule, EB-003, into first-in-human clinical trials and pursue our vision of transforming the treatment landscape for patients living with serious neuropsychiatric conditions." EB-003 is designed to deliver the therapeutic benefits of neuroplastogens while minimizing hallucinatory effects. Enveric recently unveiled that its lead development candidate, EB-003, is believed to be the first representative of a novel potential pharmacological class of neuroplastogens, defined by dual engagement of the 5-HT₂A and 5-HT₁B receptors. With encouraging preclinical data supporting its differentiated profile, the company is advancing EB-003 toward an Investigational New Drug (IND) submission, with first-in-human studies anticipated in 2026. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucin...

Q2 marked a critical inflection point in EB-003 development with mechanism confirmation, therapeutic opportunity expansion, IND-enabling progress, and continued strengthening of Enveric’s differentiated neuroplastogen pipeline and IP platform. Q2 financial results were consistent with overall performance over the previous four quarters, and development costs were in line with budgeted IND-enabling activities. CAMBRIDGE, Mass., August 14, 2025--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced financial results for the second quarter ended June 30, 2025, and provided a comprehensive business update. CEO Commentary "The second quarter of 2025 represented a period of focused execution across all key areas of our business, most notably with the advancement of EB-003, our lead drug candidate," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "We disclosed important new data demonstrating that EB-003 engages both the 5-HT₂A and 5-HT₁B receptors through a dual mechanism of action. We believe this receptor pairing forms the foundation for a novel pharmacological class. With this discovery, we believe EB-003 has emerged as a first-in-class therapeutic candidate with a dual mechanism that represents a unique therapeutic target with real-world clinical utility." "This new pharmacological class is defined by agonism at the 5-HT₁B receptor, which modulates affective tone, impulsivity, and reward pathways, as well as concurrent partial agonism at the 5-HT₂A receptor, which supports cortical neuroplasticity. We believe this novel and unique profile has the potential to promote adaptive rewiring of brain circuits (i.e. neuroplasticity) while stabilizing emotional reactivity, motivational control, and behavioral regulation (i.e., generally psychological stability). It is expected to unlock the therapeutic benefits of serotonin mediated plasticity and guide those effects toward outcomes that are durable, broadly accessible, and clinically relevant for real-world patient populations." "By targeting this specific set of neural receptors, the intent is for EB-003 to recalibrate emotional reactivity, facilitate extinction of maladaptive fear responses, and restore motivational tone. These are m...

Enveric Biosciences (ENVB) announced preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions. These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks >> Read More on ENVB: Disclaimer & DisclosureReport an Issue Psychedelic: atai Life Sciences reports Phase 2a study data on BPL-003 Enveric Biosciences files new provisional patent application VA secretary wants to find answers on psychedelics therapies, Politico says Psychedelic: Atai, Enveric, Incannex and Relmada report quarterly results Psychedelic: Enveric, Filament Health report earnings results

Statistically significant improvements in a preclinical model of severe chronic depression and despair Support for safe, extended, daily oral administration CAMBRIDGE, Mass., May 28, 2025--(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 preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a well-established psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions (statistical p-value < 0.01). These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. "We are encouraged by these statistically significant and biologically meaningful results in a severe chronic depression animal model," said Dr. Joseph Tucker, CEO of Enveric Biosciences. "EB-003 has now demonstrated strong behavioral efficacy and a clean safety profile in several animal models that are relevant to chronic treatment of severe depression. These data points validate the compound’s pharmacological design...

Corporate, Business and Product Development Highlights: Unveiled EVM401 Series with new U.S. Patent for mescaline derivative compounds Added to suite of intellectual property for EB-003, a neuroplastogen targeting undertreated mental health indications Signed two licensing agreements for cannabinoid-COX-2 conjugate compounds, with potential to target joint pathologies, such as osteoarthritis and rheumatoid arthritis Announced closing of $5 million public offering CAMBRIDGE, Mass., May 14, 2025--(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 depression, anxiety, and addiction disorders, today provided a corporate update and reported financial results for the first quarter ended March 31, 2025. "The first quarter of 2025 was highlighted by continued progress in the development of EB-003, our neuroplastogenic molecule that is designed to address difficult-to-treat mental health disorders," said Joseph Tucker, Ph.D., CEO and Director of Enveric. "We continue to focus our development efforts on the completion of the data package to support filing an Investigational New Drug (IND) application for EB-003, which we aim to submit to the FDA by the end of the first quarter of 2026." Dr. Tucker said: "Ongoing development of EB-003 is supported by the data accumulated to date, which have demonstrated oral bioavailability and brain exposure in preclinical studies. Preclinical work has also shown encouraging pharmacology and safety results from in vitro pharmacology studies." Dr. Tucker added: "Enveric continues to expand the portfolio of intellectual property covering our proprietary technologies, including the recent receipt of a Notice of Allowance from the USPTO for claims covering EB-003 composition of matter. We also announced the issuance of a U.S. patent for our EVM401 Series, a collection of mescaline derivative compounds that broadens Enveric’s potential to develop additional neuroplastogenic therapeutics for addiction and neuropsychiatric disorders. Preliminary testing of our EVM401 series and their metabolites has demonstrated differentiated and encouraging patterns of brain receptor binding and/or activation." Dr. Tucker concluded: "As we look ahead to the remainder of 2025 and beyond, we are confid...

Product Development Highlights: Advanced pre-IND and research activities including confirmation of oral bioavailability and significant brain exposure for EB-003, a novel potential first-in-class neuroplastogenic molecule designed to treat severe mental health disorders Announced positive pharmacology and preclinical safety data for EB-003 including targeting of serotonergic receptors, supporting the potential of the neuroplastogenic therapeutic effect Presented data highlighting development of EB-003 at European Behavioral Pharmacology Society Biennial Workshop and 7th Neuropsychiatric Drug Summit Broadened pipeline of potential non-hallucinatory molecules with new U.S. patent for EVM401 Series mescaline derivative compounds Corporate and Business Development Highlights: Conducted business development campaign with multiple classes of promising novel drug candidates Executed out-licensing deal of patented topical product to Aries Science & Technology for development in radiation dermatitis. Completed out-licensing agreement for EVM201 program to MycoMedica Life Sciences Executed two out-licenses to Restoration Biologics for the development and marketing of patented Cannabinoid-COX-2 conjugate compounds in joint disease CAMBRIDGE, Mass., March 31, 2025--(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 depression, anxiety, and addiction disorders, today provided a corporate update following the filing of its 10-K on Friday March 28, 2025 which reported financial results for the fourth quarter and year ended December 31, 2024. "Enveric is entering 2025 with a clear mission – enhance shareholder value by cementing our leadership position in the promising neuroplastogen field with the continued development of EB-003," stated Joseph Tucker, Ph.D., Director and CEO of Enveric. "With EB-003, we believe Enveric is at the forefront of redefining the treatment of severe mental health conditions, an area of medicine that has been without substantial innovation for many years. We are now focused on completing the data package needed to file an Investigational New Drug (IND) application for EB-003. After the completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA), and the filing of the IN...