New NASDAQ Alert [Inside]

AwesomeStocks Don’t want emails from us anymore? Click [here]( to unsubscribe. Hello! New Alert: Atai Life Sciences N.V. (NASDAQ: ATAI) ATAI is our new NASDAQ high volatility alert with a bounce opportunity. ATAI has a history of experiencing significant volatility in a short period of time. ATAI could be presenting a unique opportunity where it has significantly deviated from its 50 day moving average. While an increased gap does not suggest that it will get smaller, it does create the opportunity for upside potential. ATAI has a 50 day moving average of 1.69, more than 28% above Thursday’s close. In addition, ATAI has a RSI of only 38, suggesting the potential for increased upside. In the event that ATAI holds above its recent lows, there exists potential for a rally higher. ATAI is one of the companies that is solving a growing global problem. ATAI is a NASDAQ listed “clinical-stage biopharmaceutical company”. ATAI is “aiming to transform the treatment of mental health disorders”. The company was “founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape”. Millions of people in the U.S. are affected by mental illness each year. According to the National Alliance of Mental Illness “1 in 5 U.S. adults experience mental illness each year”, while “1 in 20 U.S. adults experience serious mental illness each year”. Sadly, mental health problems have skyrocketed globally over the past few years. “Depression is a leading cause of disability worldwide”. The ripple effect that this disease has on people, families, and whole communities is just too devastating. By some estimates, “Depression and anxiety disorders cost the global economy $1 trillion in lost productivity each year”. To make matters even worse, “Depression, anxiety, dementia and similar conditions often are [early symptoms] to more serious neurodegenerative diseases, such as Multiple sclerosis, Alzheimer's disease and Parkinson's disease.” Effective treatments for mental health and related diseases are more needed today than ever before. ATAI is “dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders”. As the company further explains: - “By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients.” The company’s “vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life”. Here are some of the company’s “Clinical Highlights” as announced in their “First Quarter 2024 Financial Results and Corporate Updates” on May 15: “VLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD)” - “VLS-01 is an oral transmucosal film (OTF) formulation of DMT designed to fit within the two-hour in-clinic treatment paradigm successfully established by Spravato®” - “In March 2024, we announced the initiation of dosing in a Phase 1b study that is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT.” - “Results of the Phase 1b study are anticipated in 2H 2024.” - “The Company plans to initiate a randomized, placebo-controlled Phase 2 trial of VLS-01 in TRD patients around YE’24.” “BPL-003: 5-MeO-DMT for TRD as primary indication” - “Beckley Psytech’s BPL-003 is an intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) designed to fit within an approximately two hour in-clinic treatment paradigm.” - “In March 2024, Part 1 of a Phase 2a open-label (OL) study showed that a single administration of BPL-003 resulted in rapid and durable antidepressant effects, with 45% of patients in remission three months after dosing. Acute effects resolved on average in less than two hours, and BPL-003 was found to be well-tolerated, with no serious adverse events reported.” - “In April 2024, Part 2 of the Phase 2a OL study initiated to investigate BPL-003 as an adjunctive therapy to Selective Serotonin Reuptake Inhibitors in TRD patients.” - “A randomized, controlled Phase 2b study of BPL-003 in TRD patients is underway with topline data expected in 2H 2024.” “COMP360: Psilocybin Therapy for TRD as primary indication” - “Compass Pathways’ COMP360 is an oral formulation of synthetic psilocybin that is currently being evaluated in multiple clinical studies.” - “In May 2024, results from an OL Phase 2 study in 22 patients with PTSD showed that COMP360 met its primary safety endpoint and was well tolerated, with no serious adverse events. COMP360 demonstrated a rapid and durable improvement in PTSD symptoms.” - “Week 4 and 12 reductions in the CAPS-5 total score of 29.9 and 29.5, respectively, were observed.” - “The response rate, as defined by patients experiencing a ≥ 15-point improvement on CAPS-5 score, was 81.8% at week 4 and 77.3% at week 12.” - “The remission rate, as defined by CAPS-5 total score of ≤ 20, was 63.6% at week 4 and 54.5% at week 12.” - “The Phase 3 program of COMP360 in TRD patients is composed of two pivotal trials, each with a long-term follow-up component. Pivotal Trial 1 (COMP005) topline data is expected in the fourth quarter of 2024 and Pivotal Trial 2 (COMP006) topline data is anticipated mid-2025.” In addition, ATAI has announced multiple accomplishments recently. In May, the company announced: “atai Life Sciences Reports First Quarter 2024 Financial Results and Corporate Updates” Here are some of the company’s highlights from this press release: - “First participant dosed in Phase 1b trial of VLS-01 with data expected in 2H’24; Phase 2 study in TRD patients anticipated to initiate around YE’24” - “Beckley Psytech’s Phase 2a study of BPL-003 in TRD patients showed rapid and durable antidepressant effects; Phase 2b topline data expected in 2H’24” - “Compass Pathways’ Phase 2 study of COMP360 in PTSD patients demonstrated durable improvement in symptoms; Phase 3 data of COMP360 in TRD patients expected in 4Q’24” - “Co-Founder Florian Brand to step down as CEO as part of a planned transition by YE’24 and to be succeeded by Co-Founder and current Chief Scientific Officer Srinivas Rao, M.D., Ph.D.” - “Cash, marketable securities, and committed term loan funding expected to fund operations into 2026” In addition, the company also announced: “atai Life Sciences Strengthens Board with Appointment of Two New Independent Directors” As the company further explained: - “Scott Braunstein, M.D., is the Chief Executive Officer (“CEO”) and Chairman of Marinus Pharmaceuticals, Inc. He is an operating partner at Aisling Capital and serves on the Board of Directors at both Caribou Biosciences, Inc. and Trevena Inc. Previously, Dr. Braunstein was Chief Operating Officer at Pacira Pharmaceuticals, Inc. and portfolio manager of the JP Morgan Global Healthcare Fund. Dr. Braunstein began his career as a practicing physician at the Summit Medical Group, earning his medical degree from the Albert Einstein College of Medicine and his undergraduate degree from Cornell University.” - “Laurent Fischer, M.D., is the CEO and President of Adverum Biotechnologies and serves on the Board of Directors at Mirum Pharmaceuticals, Inc., Lycia Therapeutics and Teal. Previously, Dr. Fischer was Chairman of CTI Biopharma, CEO of Tobira Therapeutics (subsequently Allergan), and held leadership roles at Jennerex, RXCentric (now part of Allscripts Healthcare Solutions), MedVantx, Dupont Pharmaceuticals, Dupont-Merck, and F. Hoffmann-La Roche. Dr. Fischer earned an undergraduate degree from the University of Geneva and his medical degree from the Geneva Medical School, Switzerland.” Last week, the company announced: “atai Life Sciences Announces Update on Beckley Psytech’s Phase 1/2a Trial of ELE-101 (IV Psilocin) for Major Depressive Disorder, with Initial Results from Phase 1 and First Patients Dosed in Phase 2a” Here are the highlights from this press release: - “ELE-101 is a patent-protected, synthetic formulation of psilocin, designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours.” - “The Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single intravenous (IV) dose of ELE-101 in 6-12 participants with Major Depressive Disorder (MDD). Results are expected in H2 2024.” - “The dose for Phase 2a was selected using preliminary pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1 randomized, double-blind, placebo-controlled, single ascending dose part of the study of ELE-101 in healthy participants, which showed that it was well-tolerated with no serious adverse events. ELE-101 showed a dose-proportional PK profile and a reliable induction of short-duration psychedelic experiences.” ATAI could be presenting an opportunity for increased growth potential. Make sure to do your own due diligence. Sources: [NAMI]( [Hopkins]( [Presentation]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [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. 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