Wednesday Night's Breaking News Is Sparking (BNOX) Right Now (Up Approx. 10%)

BNOX is surging green. Watching? Wednesday Night's Breaking News Is Sparking (BNOX) Right Now (Up Approx. 10%) March 9th Dear Reader, BNOX is surging green. Watching? Dropping news last evening, BNOX has hit the ground running and is currently up approximately 10% after hitting an early high of $5.15 this morning. Could more be on the way? Check out the news here: Bionomics Reports Promising Full Results Analysis from PREVAIL Phase 2 Study of BNC210 Social Anxiety Disorder (SAD) - Both doses of BNC210 as an acute treatment resulted in reductions in anxiety across multiple phases of the public speaking challenge - Results achieved statistical significance in post-hoc analysis of the full data set and in relevant subpopulations - Favourable safety, tolerability and PK findings are consistent with a fast-acting non-sedating anxiolytic profile - The company is planning an End of Phase 2 (EoPh2) meeting to discuss BNC210’s late-stage SAD program 2H 2023 - Webcast and conference call scheduled for Thursday, March 9, 2023 at 8:00 AM EST (Friday, March 10, 2023 at 12:00 AM AEDT) ADELAIDE, Australia, March 08, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel allosteric ion channel modulators for serious central nervous system (CNS) disorders with high unmet medical need, today announced the release of a comprehensive analysis of the data from its Phase 2 PREVAIL study to evaluate the efficacy and safety of BNC210, a novel α7 nicotinic acetylcholine receptor negative allosteric modulator, for the acute treatment of Social Anxiety Disorder (SAD). These data support late-stage development of BNC210 in SAD. ... “PREVAIL revealed BNC210’s potential as a non-sedating anxiolytic for the acute treatment of SAD. These results follow positive findings in a panic attack model and in patients with generalized anxiety disorder, further support clinical proof of concept in anxiety disorders and de-risk BNC210’s continuing development,” remarked Spyros Papapetropoulos MD, PhD, President and Chief Executive Officer of Bionomics. “We look forward to meeting with the FDA in the coming months to discuss our clinical path forward for this exciting new therapeutic candidate.” “The full analysis of the data indicates that patients receiving BNC210 show reduced distress compared to placebo. Given the observed effect size in PREVAIL, there is reason to believe that a subsequent trial with a larger sample size could achieve its primary endpoint,” commented Dr. Murray Stein, MD, MPH. Dr. Stein continued, “The finding that a statistically significant separation from the placebo occurred when the two dose levels and the anticipation and performance phases were combined is important. Both anticipation and performance are very relevant to understand clinically, so there would be a lot of value in combining these phases as a key data output in future trials.”  [Read the full article here.]( On top of this awesome news is BNOX trades above [multiple lines]( of potential support. And with a 200-Day Simple Moving Average over $7.00, there could be significant room for BNOX to move vertically before running into potential resistance. Drop everything and get BNOX on radar now. ----- Let's dive in with a quick recap. For Tuesday's opening bell, I delivered a new Nasdaq breakout idea. Making a strong 2-day surge from an open of $1.61 to a $1.90 high, it put together an approximate 18% move which may only be the start. It'll be important to keep it on radar because the last 2 times I alerted it, it ran big over the span of a few weeks. But in the meantime, we need to focus on another Nasdaq breakout idea. This company is aiming their focus at large underserved markets with [over 25 million patients]( in the US alone suffering from Social Anxiety Disorder ("SAD") and Post Traumatic Stress Disorder ("PTSD"). To put it in perspective, the global [SAD treatment market]( size is projected to reach $13.9Bn by 2027 while the [PTSD treatment market]( size is projected to reach $26.1Bn by 2031. And with the alarmingly high frequency of anxiety and sadness around the world from recent difficulties stemming from the pandemic and more, they may be in the right space at the right time to create a treatment that could utterly be game-changing (globally). Based on a float of fewer than 6Mn shares, an explosive chart history with multiple $1.00+ intraday moves, a new CEO/President in charge, and it closed above multiple lines of potential support Wednesday, this Nasdaq Biopharma profile could be a ripe breakout target. For Thursday, March 9th, this profile requires immediate attention: Bionomics Limited (BNOX) Bionomics is a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (CNS) disorders with high unmet medical need. Bionomics 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). Beyond BNC210, Bionomics 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. And based on several potential catalysts, BNOX could become a near term breakout target. Check them out: No. 1 - Low Float Could Provide Significant Volatility Potential On Daily Basis No. 2 - An Explosive Chart History With Several Massive Intraday Rips No. 3 - New President/CEO Is Critical Milestone For The Leadership Team No. 4 - Could Momentum Be Building? BNOX Closes Wednesday Above Key Lines Of Potential Support But more on those in a second... BNOX's Focused CNS Pipeline Bionomics is developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (“CNS”) disorders with high unmet medical need. Ion channels serve as important mediators of physiological function in the CNS and the modulation of ion channels influences neurotransmission that leads to downstream signaling in the brain. The α7 nicotinic acetylcholine (“ACh”) receptor (“α7 receptor”) is an ion channel that plays an important role in driving emotional responses and cognitive performance. Utilizing their expertise in ion channel biology and translational medicine, they are developing orally active small molecule negative allosteric modulators (“NAMs”) and positive allosteric modulators (“PAMs”) of the α7 receptor to treat anxiety and stressor-related disorders and cognitive dysfunction, respectively. BNOX's expertise and approach have been validated through their June 2014 research collaboration and license agreement with Merck & Co. for their α7 receptor PAM program, which targets a receptor that has garnered significant attention for treating cognitive deficits. This partnership enables them to maximize the value of their ion channel and develop transformative medicines for patients suffering from cognitive disorders such as Alzheimer’s disease. BNC210 Bionomics is advancing its lead product candidate, BNC210, an oral, proprietary, selective NAM of the α7 receptor, for the acute treatment of Social Anxiety Disorder (“SAD”) and chronic treatment of Post-Traumatic Stress Disorder (“PTSD”). There remains a significant unmet medical need for the over 22 million patients in the United States alone suffering from SAD and PTSD. BNC210 Holds the Potential to Addresses the Shortcomings of Existing Therapies There is a significant need for improved therapeutics for SAD and PTSD with improved efficacy and response rates, fewer side effects and a faster onset of action, which we believe may be achieved by targeting a different mechanism of action. α7 PAM Program with Merck In June 2014, Bionomics entered into a research collaboration and license agreement with Merck to develop α7 receptor Positive Allosteric Modulators (PAMs) targeting cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions. The Merck collaboration currently includes two candidates which are PAMs of the α7 receptor that are in early-stage Phase 1 safety and biomarker clinical trials for treating cognitive impairment. Pre-Clinical CNS Bionomics’ CNS pipeline includes two earlier stage small molecule discovery programs targeting ion channels and represent additional opportunities for clinical programs and future partnering. These programs are at a similar stage at which the α7 receptor PAM program was licensed under the 2014 Merck License Agreement. The first of these programs has developed two patented series of small molecule Kv3.1/3.2 potassium channel activators for the potential treatment of cognitive deficits and negative symptoms/social withdrawal in schizophrenia and autism spectrum disorders. The second program has developed three patented series of small molecule inhibitors with functional selectivity for Nav1.7 and Nav1.8 voltage gated sodium ion channels for the potential treatment of chronic pain without the liability of addiction associated with opioid treatment. Bionomics Highlights - Targeting Social Anxiety Disorder (SAD), Post-Traumatic Stress Disorder (PTSD) and cognitive dysfunction associated with Alzheimer’s disease, schizophrenia and other CNS conditions - Large underserved markets with over 25 million patients in the US alone suffering from SAD and PTSD and no new FDA approved therapies in nearly two decades - BNC210 (negative allosteric modulator of the α7 nicotinic acetylcholine receptor) - Clinical proof of concept in Generalized Anxiety Disorder (GAD2) and panic attack model - In Phase 2 PREVAIL trial with FDA Fast Track designation for acute treatment of SAD - In Phase 2b ATTUNE trial with FDA Fast Track designation for treatment of PTSD - Partnerships & Collaborations - Strategic partnership with Merck for treatment of cognitive deficits in Alzheimer’s and other CNS disorders Sources: [Company Website.]( [Company Presentation.]( ----- As mentioned above, BNOX has several potential catalysts to soak in right now. Check them out: No. 1 BNOX Potential Catalyst - Low Float Could Provide Significant Volatility Potential On Daily Basis According to the [Yahoo Finance]( website, BNOX has a low float. The website reports this profile to have approximately 5.44Mn shares in its float. Why is that important? It's important on one crucial level. Volatility. Could positive 2023 company news help provide a near term spark? ----- No. 2 BNOX Potential Catalyst - An Explosive Chart History With Several Massive Intraday Rips Take a look at BNOX's 6-month chart real quick: At first glance, it doesn't look like a pretty chart. But, look closer. On multiple occasions over the previous 6 months, BNOX has gone on killer intraday rips of a $1.00+. Here's a few examples (runs from open to high of day): #1. 10/27/22 - $1.50 intraday #2. 11/4/22 - $1.48 intraday #3. 11/9/22 - $1.96 intraday #4. 1/26/23 - $1.60 intraday And in the past few days alone... BNOX surged from a $3.31 open to a $7.71 high Tuesday for a 132% intraday run. Now, are we saying BNOX will make that same type of move Thursday? No. Nothing is certain. But, it is important to take note of this profile's chart history and low float (under 6Mn shares). ----- No. 3 BNOX Potential Catalyst - New President/CEO Is Critical Milestone For The Leadership Team Bionomics appoints Spyridon “Spyros” Papapetropoulos as President and Chief Executive Officer Experienced biotech executive to lead the next phase of growth ADELAIDE, Australia, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO), (Bionomics or the Company) a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced that it has appointed Spyridon “Spyros” Papapetropoulos, M.D. as President and Chief Executive Officer (CEO), effective 5 January 2023. ... Spyros is an experienced biopharmaceutical executive, a recognized neuroscientist/neurologist, and change agent with a 25-year career focused on CNS disorders. He held various positions of increasing responsibility at CNS-focused start-up/small, medium specialty and large biopharma companies. Since 2020, he has been the Chief Medical Officer of Vigil Neuroscience Inc, a Nasdaq-listed biopharmaceutical company developing a pipeline of neuroimmune targeted therapeutics for the treatment of neurodegenerative disorders. Prior to joining Vigil, he served as Chief Development Officer, and SVP, Head of Development at Acadia Pharmaceuticals Inc., CEO at SwanBio Therapeutics, and EVP of Research & Development and Chief Medical Officer at Cavion. Before Cavion, he held senior/executive positions at Biogen Inc., Allergan plc, Pfizer Inc., and Teva Pharmaceuticals Inc. Spyros has filed multiple INDs and has overseen a broad spectrum of CNS biopharmaceutical development programs (small molecules, biologics, gene therapy), leading to successful regulatory filings (>20 INDs and multiple NDAs/BLAs) and new product launches worldwide. Spyros received his MD and PhD in Greece from the University of Patras, School of Medicine and before joining the biopharmaceutical industry served as faculty at the Department of Neurology of the University of Miami, School of Medicine. Dr. De Souza commented, “Bionomics is at a key inflection point in its development and potential transition from an early-stage development organization to a later stage clinical development and commercial organization as we await the data from our two ongoing Phase 2 clinical trials of BNC210 for the acute treatment of social anxiety disorder and chronic treatment of post-traumatic stress disorder by year end 2022 and mid-2023, respectively. Having led the Company turn around over the past three years, I am delighted to hand over the reins to Spyros to leverage his extensive experience in leading R&D and commercial organizations in both the private and public sector and small biotech and large pharmaceutical companies to continue to progress the pipeline and in doing so, build value for patients and shareholders. I will continue to be closely involved with Bionomics in my oversight role as Non-Executive Chairman of the Board.” Dr. Papapetropoulos added, “I am delighted to be joining Bionomics as President, CEO and Director and building upon the great strides the Company has made under Errol’s leadership. The psychiatric and neurological disorders which Bionomics is targeting represent large, unsolved medical challenges for which patients need new options. I look forward to working with the Board, the management team and Bionomics employees in leading the Company as we prepare for its next stage of growth.” ... [Read the full article here.]( ----- No. 4 BNOX Potential Catalyst - Could Momentum Be Building? BNOX Closes Wednesday Above Key Lines Of Potential Support Let's go back to [BNOX's 6-month chart]( real quick. I've highlighted a handful of key lines of potential support to pay close attention to in the link above. First off, BNOX is currently trading above these key lines of potential support: - 5-Day Exponential Moving Average (EMA) - 13-Day EMA - 50-Day Simple Moving Average (SMA) But here's the one to pay close attention to right now since it was tested this week: its 200-Day SMA. On Tuesday, BNOX, trading above those 3 key lines mentioned above, ran all the way up to its 200-Day SMA before being promptly turned away. As you can see, there is a ton of potential room to move from its current trading levels to what may be its next line of potential resistance in its 200-Day SMA. If potential support continues to grow at those 3 key levels I mentioned above, it could slowly become the foundation to allow BNOX to try and test that 200-Day SMA resistance again in the near term. And if that happens, it would obviously be a significant move from current trading levels. On top of that, [StockTA.com]( is reporting a very bullish EMA situation for BNOX. The site shares that not only is BNOX trading above both its 5-Day and 13-Day EMA's, its 5-Day EMA is also trading above its 13-Day EMA in very bullish manner. Make sure to keep an eye on all these lines moving forward. ----- BNOX Recap - These Potential Catalysts Could Provide A Major Breakout Spark No. 1 - Low Float Could Provide Significant Volatility Potential On Daily Basis No. 2 - An Explosive Chart History With Several Massive Intraday Rips No. 3 - New President/CEO Is Critical Milestone For The Leadership Team No. 4 - Could Momentum Be Building? BNOX Closes Wednesday Above Key Lines Of Potential Support ----- Coverage is officially initiated on BNOX. When time permits, do this: Get BNOX on your radar now. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Ownership of FI has now moved to a single individual. Disclosure: I am not a lic-ensed fina-ncial adviser. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. Fierce full disclosure is to be read and fully understood before using Fierce's website, or joining Fierce's email or text list. 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