New NASDAQ Alert [Inside]

AwesomeStocks Don’t want emails from us anymore? Click [here]( to unsubscribe. Hello! New Alert: Bionomics Limited (Nasdaq: BNOX) BNOX is our new NASDAQ high volatility alert. BNOX has a history of experiencing significant upside in a short period of time and a chart setup suggesting the potential for increased gains. BNOX is a NASDAQ listed “clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (“CNS”) disorders with high unmet medical need”. BNOX is “advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD)”. According to the National Alliance on Mental Illness, “Anxiety disorders are the most common mental health concern in the United States. Over 40 million adults in the U.S. (19.1%) have an anxiety disorder.” Social Anxiety Disorder, sometimes called social phobia, is an “anxiety disorder characterized by extreme fear or anxiety in one or more social settings”. According to the NIH, an “estimated 7.1% of U.S. adults had social anxiety disorder in the past year”. As the company further explains: “BNC210 is a negative allosteric modulator of the α7 nicotinic acetylcholine receptor under development for the treatment of Social Anxiety Disorder (SAD) and PTSD.” Importantly: “BNC210 has been given the FDA Fast Track designation for treatment of PTSD and other trauma and stressor related disorders and for acute treatment of SAD and other anxiety related disorders.” In addition, BNOX has a “strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions”. Furthermore: “Bionomics’ pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need.” BNOX has announced multiple accomplishments recently. In September, the company announced: “Bionomics Announces Update on the α7 Nicotinic Acetylcholine Receptor (nAChR) Positive Allosteric Modulator (PAM) Collaboration with MSD” Here are the highlights from this press release: - “Bionomics has collaborated with MSD to identify novel α7 nAChR PAMs suitable for the treatment of cognitive disorders like Alzheimer’s Disease” - “Based on the learnings from Bionomics’ candidate BNC375, additional candidates have been developed with improved drug like and pharmacological properties that are currently in Phase 1 safety, tolerability, pharmacokinetics and biomarker studies” Here are some of the company’s comments from this press release: “Bionomics has a long-standing collaboration with MSD to identify novel α7 nAChR PAMs suitable for the treatment of cognitive disorders that address the limitations seen with nAChR agonists, such as lack of selectivity against related ligand-gated ion channels, desensitization of the receptor with sustained exposure, and an inverted U-shaped dose response function,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “We are excited to see the progress being made in our collaboration with MSD.” In addition, the company announced potentially big news: “Bionomics Announces Positive Topline Results from the Phase 2b ATTUNE Clinical Trial of BNC210 in Patients with Post-Traumatic Stress Disorder (PTSD)” Here are the highlights from this press release: - “ATTUNE trial met its primary endpoint showing BNC210 treatment led to a statistically significant reduction in total PTSD symptom severity at 12 weeks.” - “Statistically significant secondary endpoints showed improvements in depressive symptoms and sleep.” - “BNC210 was well-tolerated with a safety profile supporting chronic administration.” - “Company plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the registrational path for BNC210 in PTSD.” Here are the company’s comments from this press release: "We are excited about the results of the ATTUNE trial that delivered a positive dataset with treatment effects considerably higher than currently approved therapies. We believe these results will enable FDA discussions for the registrational path of BNC210 in PTSD, which in an indication with high unmet need", said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. "I am thankful to the patients, their families, and the clinical teams who participated and contributed to this study. These results, together with the results from earlier this year in social anxiety disorder, and the recently completed Phase 3-enabling End-of-Phase 2 meeting with the FDA on social anxiety disorder, positions BNC210 as a compelling late-stage experimental therapeutic for multiple prevalent neuropsychiatric diseases with high unmet need." Importantly, as the company explains: “"There is great unmet medical need for safe and effective treatments for the large population of patients suffering with PTSD worldwide. Despite the clinical heterogeneity of PTSD, the results of ATTUNE demonstrated broad benefits with BNC210 across a number of symptoms. This a promising step forward for patients with PTSD, where the majority do not achieve clinical remission with current therapies and there have been no newly approved therapies in the past 20 years." commented Murray B. Stein M.D., M.P.H., Distinguished Professor of Psychiatry and Public Health at the University of California San Diego and Staff Psychiatrist at the Veteran Affairs San Diego Healthcare System, and a consultant to Bionomics.” Furthermore, the company also announced: “Bionomics Announces Successful End-of-Phase 2 Meeting with the FDA and Solidifies Plans to Initiate the Registrational Program for BNC210 in Social Anxiety Disorder” Here are the highlights from this press release: - “Positive outcome of End-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA) in September 2023 enables advancement of BNC210 into Phase 3 studies in Social Anxiety Disorder” - “Company confirms agreement with the FDA on Phase 3 clinical program and alignment on nonclinical toxicology studies required for registration” - “Company is on track for first patient dosed in the Phase 3 program planed for Q1’24” Here are some of the company’s comments from this press release: “We are grateful for FDA’s support and guidance and very pleased to reach an agreement on key elements of Phase 3 design and other nonclinical components required for registration”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “The FDA meeting outcomes provide external and independent validation of our position on the strength and Phase 3-enabling nature of the PREVAIL dataset. BNC210’s unique clinical profile seen in multiple anxiety disorders including SAD, Generalized Anxiety Disorder and in a panic model, was recently significantly enhanced by the positive results in Post-Traumatic Stress Disorder. BNC210, which has Fast-Track designation from the FDA for the acute treatment of SAD, has the potential to address a significant unmet need for the 17 million Americans suffering from SAD who currently don’t have fast acting and safe treatment options.” Most recently, the company announced: - “Bionomics Presents Detailed Data on the Validity and Reliability of the Subjective Units of Distress Scale at the 2023 American College of Neuropsychopharmacology Annual Meeting” Earlier this morning, the company also announced: - “Bionomics to Present at Biotech Showcase™ 2024” BNOX could be in a position to experience increased growth. Make sure to do your own due diligence. Sources: [NAMI]( [ADAA]( [ADAA2]( [NIH]( [MHA]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [PR7]( [Website]( [Chart]( Happy Trading! AwesomeStocks Note: We encourage all traders and investors to develop personal trading rules that you can follow and that work for you. Always protect your downside and note that we alert extremely volatile short-term opportunities. Before investing in securities, you should always consult with your financial, tax and legal advisor and never invest money you cannot afford to lose. DISCLAIMER You should read and understand this disclaimer in its entirety before joining the website or email/blog list of AwesomeStocks.com (the “Publisher”). The information (collectively the “Advertisement”) disseminated by email, text or other method by the Publisher including this publication is a paid commercial advertisement and should not be relied upon for making an investment decision or any other purpose. 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