Welcome to our dedicated page for Enveric Biosciences news (Ticker: ENVB), a resource for investors and traders seeking the latest updates and insights on Enveric Biosciences stock.
Introduction
Enveric Biosciences Inc is a biotechnology company at the forefront of developing novel neuroplastogenic small-molecule therapeutics aimed at treating complex psychiatric disorders such as depression, anxiety, and addiction. The company leverages advanced research techniques and clinical insight to pioneer therapeutic approaches that promote neuroplasticity and offer potential breakthroughs in mental health treatment. In an era where effective and safe psychiatric interventions are in high demand, Enveric Biosciences stands out for its focused strategy of developing drugs that address the underlying neural mechanisms involved in these disorders.
Core Therapeutic Programs
At the heart of Enveric Biosciences’ research is a commitment to innovative drug development. The company’s lead program, EB-003, represents a first-in-class approach designed to enhance neuroplasticity without inducing hallucinogenic effects. This novel mechanism is important because it provides a fresh perspective on how to engage the brain’s adaptive capacity to recover from mental health disorders. Alongside EB-003, the company is developing EB-002, formerly known as EB-373, which is a next-generation synthetic prodrug of the active metabolite psilocin. This compound is being rigorously studied as a treatment for various psychiatric conditions, offering a more controlled and potentially safer alternative compared to traditional hallucinogen therapies.
Therapeutic Approach and Scientific Rationale
Enveric Biosciences’ approach is built on the premise that enhancing the brain's neuroplasticity can provide significant therapeutic benefits in treating mental health issues. Their research is driven by the concept that neuroplasticity—the ability of the brain to reorganize and form new neural connections—plays a critical role in recovery from psychiatric disorders. By using small molecules specifically engineered to modulate neural pathways, the company aims to restore balance in neural circuits without triggering unwanted side effects such as hallucinations. This innovative strategy differentiates Enveric from many other biopharma companies that have historically relied on more traditional mechanisms of action for psychiatric medications.
Research and Development Focus
The company operates in an environment that demands continuous innovation and rigorous scientific exploration. Its research and development efforts are centered around several key pillars:
- Mechanism-based Innovation: Emphasizing the molecular underpinnings of neuroplasticity, the company seeks to harness biological pathways that can induce lasting changes in brain structure and function.
- Safety and Efficacy: With a focus on minimizing adverse effects, the therapeutic agents are developed to achieve the desired neuroplastic response without compromising patient safety.
- Clinical Insight: Ongoing studies and experiments underscore a robust commitment to translating laboratory insights into clinically meaningful outcomes for patients suffering from severe psychiatric conditions.
Industry Position and Competitive Landscape
Within the biotechnology and biopharmaceutical landscape, Enveric Biosciences occupies a unique position. The company differentiates itself by combining the disciplines of neuroscience and medicinal chemistry to create therapies that are both scientifically innovative and clinically relevant. Its focus on neuroplasticity and the development of agents such as EB-003 and EB-002 provides a distinctive value proposition in the crowded field of psychiatric therapeutics. Competitors in this niche tend to emphasize traditional pharmacological approaches that do not always capture the nuanced complexities of neuroplasticity. Therefore, the company’s research-driven model and innovative therapeutic strategies mark it as a notable player for those with an interest in scientifically advanced treatment modalities for mental health disorders.
Operational Excellence and Strategic Focus
Enveric Biosciences integrates a highly specialized scientific framework with operational rigor to maintain excellence in drug development. The company’s operations are deeply aligned with contemporary trends in neuroscience research, and it employs rigorous methodologies to validate the efficacy and safety of its therapeutic candidates. The systematic design and development process underscore the importance of translational research where laboratory findings are successfully bridged to clinical applications. With a well-defined research pipeline, the company adheres to robust quality controls and industry standards, ensuring that each phase of development is executed with precision. This systematic approach not only enhances the scientific credibility of its programs but also builds a foundation of trust and reliability within the scientific community and among potential investors.
Enveric Biosciences (NASDAQ: ENVB), a biotechnology company focused on neuroplastogenic therapeutics, announced the issuance of two U.S. patents (Nos. 12,133,856 and 12,138,276) for its EVM301 series molecules, bringing the total to 11 patents. These patents cover novel psilocybin derivative compounds and their pharmaceutical formulations. Enveric's lead candidate, EB-003, targets anxiety, depression, and addiction disorders, showing potential for promoting neuroplasticity without hallucinogenic effects. Additionally, two other patents (Nos. 12,065,404 and 12,077,498) were issued for EVM201 series prodrugs, protecting novel tryptamine derivatives. Enveric has licensed its EVM201 series to MycoMedica Life Sciences and announced out-licensing deals with MycoMedica and Aries Science & Technology, positioning Enveric to focus on EB-003 development and establish potential future income streams.
Enveric Biosciences (NASDAQ: ENVB) announced positive results from preclinical pharmacokinetic studies of EB-003, demonstrating favorable oral bioavailability and brain penetration without hallucination-like behavior in rat and dog models. The studies showed dose-proportional oral bioavailability and a significant brain/plasma ratio of 5-6 in rats, higher than previously observed in mice (~1.5). No clinical signs of hallucination were observed in either species. The company plans to submit an Investigational New Drug (IND) application to the FDA in the second half of 2025 for this potential treatment of depression, anxiety, and other psychiatric disorders.
Enveric Biosciences (NASDAQ: ENVB) reported Q3 2024 financial results and corporate updates. The company made progress with EB-003, its lead neuroplastogenic molecule for mental health disorders, confirming oral bioavailability and brain exposure in preclinical studies. The company reported a net loss of $2.1 million ($0.24 per share) compared to $2.8 million ($1.30 per share) in Q3 2023. Cash-on-hand was $3.1 million. Enveric secured licensing agreements with Aries Science & Technology for radiation dermatitis treatment and with MycoMedica Life Sciences for EB-002. The company plans to submit an IND application for EB-003 in H2 2025.
Enveric Biosciences (NASDAQ: ENVB) has signed a licensing agreement with MycoMedica Life Sciences for its EVM201 program, including drug candidate EB-002, a synthetic prodrug for treating neuropsychiatric disorders. The agreement includes potential milestone payments up to $62 million plus tiered single-digit royalties on future sales. MycoMedica receives exclusive global rights and will assume responsibility for all development phases. This strategic move allows Enveric to focus on advancing EB-003, their novel non-hallucinogenic neuroplastogen drug candidate, while maintaining potential future revenue streams from EB-002. The company plans to file an Investigational New Drug application for EB-003 in 2025.
Enveric Biosciences (NASDAQ: ENVB) announces the expansion of patent protection for its EVM301 portfolio through five new US patents and three patent application allowances. The company now holds nine total US patents covering its drug candidate library. The patents cover various tryptamine derivative molecules, including carboxylated, aminated, prenylated, glycosylated, nitrilated, and halogenated derivatives. The company's lead candidate, EB-003, targeting treatment-resistant depression and anxiety, is in preclinical development with planned IND filing in 2025. The compound shows potential for promoting neuroplasticity without inducing hallucinations.
Enveric Biosciences (NASDAQ: ENVB) has announced positive results from preclinical safety and pharmacology studies for its lead drug candidate, EB-003. The in vitro studies confirmed EB-003's selective activity with desired serotonergic neuroreceptors and showed a low potential for undesirable cardiovascular, respiratory, and neurological reactions or drug-to-drug interactions.
Key findings include:
- No significant off-target interactions detected
- No meaningful activity against hERG or 5-HT2B, targets related to cardiovascular adverse drug reactions
- No activity against the M1 muscarinic acetylcholine receptor, related to CNS adverse drug reactions
These results, combined with previously reported antidepressant, anxiolytic, and neuroplastogenic properties in animal models, enhance confidence in EB-003's potential. Enveric plans to begin in vivo toxicology and safety pharmacology activities in Q4 2024, with an expected IND application filing by Q3 2025 and clinical development initiation by the end of 2025.
Enveric Biosciences (NASDAQ: ENVB) presented data on its lead candidate, EB-003, at the European Behavioral Pharmacology Society Biennial Workshop in Banff, Canada. The preclinical research highlights EB-003's anxiolytic and anti-depressant properties without inducing hallucinations, a favorable profile compared to other DMT analogs. The study involved behavioral outcomes in mice, showing positive results in models for anxiety and depression. Key measures included head twitch response (HTR), marble burying, and sucrose preference. Enveric aims to file an IND application for EB-003 by Q3 2025 and start clinical trials by the end of 2025. The presentation was delivered by Peter Facchini, Ph.D., Chief Innovation Officer.
Enveric Biosciences (NASDAQ: ENVB) presented data on its lead product candidate, EB-003, at the 7th Neuropsychiatric Drug Summit. EB-003 is a non-hallucinogenic, neuroplastogenic DMT analog that has shown positive outcomes in animal models of anxiety and depression. The presentation highlighted:
1. Preclinical data demonstrating EB-003's effectiveness in reducing anxiety and depression in mouse models.
2. Research on head twitch response (HTR), a behavioral proxy for hallucinogenic effects in humans.
3. Recent data confirming EB-003's oral bioavailability and ability to produce brain exposure at therapeutically relevant levels.
Enveric plans to file an Investigational New Drug (IND) application for EB-003 by Q3 2025 and initiate clinical development by the end of 2025. The company believes EB-003 is highly differentiated from similar drugs in development and has potential to be a significant value driver.
Enveric Biosciences (NASDAQ: ENVB), a biotechnology company focusing on neuroplastogens for neuropsychiatric disorders, will present at the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024. CEO Joseph Tucker, Ph.D., will deliver a virtual presentation on September 9 at 7:00 AM ET, discussing:
- Development of novel neuroplastogenic small-molecule therapeutics for depression, anxiety, and addiction disorders
- Recent data on lead candidate EB-003, confirming oral bioavailability and significant brain exposure
- Enveric's strategy to maximize value from assets developed using their AI-backed drug discovery engine
Investors can register for the conference at https://hcwevents.com/annualconference/
Enveric Biosciences (NASDAQ: ENVB) and Aries Science & Technology announced the issuance of Patent No. 12,059,393 to Enveric's subsidiary, Akos Biosciences, for a topical product aimed at treating radiation dermatitis. This condition affects approximately two million cancer patients annually, with a market opportunity estimated at $400 million. The patent issuance follows a Licensing Agreement between Aries and Akos for the clinical development of the CBD-based lotion. Aries is forming a subsidiary to advance this opportunity, with Dr. Hari Harikumar nominated as Chairman-elect. Under the agreement terms, Enveric could receive up to $61 million in milestone payments and tiered royalties ranging from 2.5% to 10% on future sales.
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