Core Insights - Bright Minds Biosciences Inc. announced positive preclinical data for BMB-201, a selective 5-HT2 agonist, showing similar efficacy to morphine in pain models [1][3] - The company aims to position BMB-201 as a non-opioid alternative for neuropathic pain relief, addressing a significant unmet need in pain management [4] Preclinical Study Findings - BMB-201 demonstrated similar efficacy to morphine in nerve ligation pain models, with superior reductions in mechanical allodynia and pain-related behaviors [3] - Higher doses of BMB-201 resulted in marked improvements in pain relief and guarding behavior in female rodents [3] - The drug's efficacy suggests it may provide better pain relief than traditional opioids without the risks of dependency and side effects [3] Next Steps and Development Plans - Following promising preclinical results, Bright Minds plans to advance BMB-201 into clinical trials to further evaluate its safety and efficacy in humans [4] - The company emphasizes the potential of serotonergic therapies in pain management, as BMB-201 represents a novel mechanism of action for modulating pain perception [4][6] Company Overview - Bright Minds Biosciences focuses on developing innovative treatments for neurological and psychiatric disorders, including drug-resistant epilepsy and depression [7] - The company has developed a unique platform of highly selective serotonergic agonists, providing a rich portfolio of new chemical entity programs within neurology and psychiatry [8]

Core Insights - Bright Minds Biosciences (NASDAQ: DRUG) experienced a significant stock price increase, rising 1,445% in a single day to $38, and a staggering 3,950% over the week, with market capitalization jumping from $4 million to nearly $172 million [1][4]. Stock Performance - The stock showed weakness in pre-market trading on October 16, dropping almost 17% after the previous day's surge [2]. - The stock's borrow availability was reported as zero, with a borrow fee rate soaring to 175.86%, indicating high demand for shorting the stock and potential for a short squeeze [5][21]. Market Activity and Regulatory Attention - Bright Minds issued a press statement indicating it was unaware of any material changes in operations that could explain the stock's recent activity, responding to inquiries from the Canadian Investment Regulatory Organization [4]. - The dramatic price movement has drawn attention from regulators, highlighting the unusual market activity surrounding the stock [4]. Short Selling Dynamics - The high borrow fee rate reflects extreme pressure on short-sellers, reminiscent of the GameStop short squeeze in 2021, where similar conditions led to a massive rally [21]. - Portfolio manager observations noted that the rally caught short sellers off guard, leading to significant short covering as the stock price surged [22]. Company Fundamentals - Bright Minds focuses on research and development for treatments targeting serotonin-mediated diseases and is currently conducting a Phase 2 clinical trial for a drug aimed at drug-resistant epilepsy disorders [25]. - The company has not yet generated any revenue, which raises questions about the sustainability of the recent stock price momentum [25].

Company Overview - Bright Minds Biosciences is a biotech company founded in 2017, headquartered in New York, focusing on therapeutics for severe neurological and psychiatric disorders [2] - The company's pipeline includes selective 5-HT receptor agonists aimed at treating epilepsy, pain, and mental health conditions, with its leading candidate BMB-101 targeting serotonin receptors (5-HT2C) [2][3] Recent Stock Performance - Bright Minds Biosciences' stock (NASDAQ: DRUG) surged by 1,445% in a single trading session, with over 100 million shares traded, a significant increase from its typical volume of under 1 million shares [1] - The stock price reached $38.49, up $36.00 from previous levels, with a 52-week range of $0.93 to $38.49 [2] Factors Driving Stock Surge - The surge was influenced by recent M&A activity in the biotech industry, particularly the acquisition of LBPH's lead drug LP352, which is similar to BMB-101, at a substantial premium [4] - Technical factors, including a low float of 2.5 million shares, made the stock susceptible to a short squeeze, further driving up the price as short sellers were forced to cover their positions [5] Clinical Developments - BMB-101 has shown positive results in a completed Phase 1 clinical trial, demonstrating safety and tolerability in healthy participants, with a Phase 2 trial initiated in September 2024 [6] - The company is scheduled to present at several biotech conferences, including BIO-Europe and the AES Annual Meeting, to showcase data on BMB-101's application in treating rare epilepsies [7] Financial Position - Bright Minds Biosciences is financially stable, with sufficient cash to fund operations through 2026, although additional equity financing may be necessary [7]

Group 1 - Bright Minds Biosciences Inc. has confirmed that its management is unaware of any material changes in operations that would explain the recent increase in market activity [1] - The company focuses on developing novel treatments for neuropsychiatric disorders, epilepsy, and pain, utilizing next-generation serotonin agonists [2] - Bright Minds aims to create drugs that retain the therapeutic benefits of psychedelic and serotonergic compounds while minimizing side effects, positioning them as superior to first-generation drugs [2] Group 2 - The Canadian Securities Exchange has neither approved nor disapproved the contents of the news release [3]

Bright Minds Biosciences will present scientific posters about various programs in development, including BMB-101, BMB-201 and BMB-202 Bright Minds Biosciences will participate in BIO Europe partnering event and Chicago Biocapital Summit to present its innovation in neuroscience NEW YORK, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (NASDAQ: DRUG), a pioneering company focused on developing highly selective 5-HT2 agonists for the treatment of drug-resistant epilepsy, depression, and other ...

Bright Minds Biosciences announces Phase 2 Clinical trial to evaluate BMB-101 in a group of drugresistant epilepsy disorders with high unmet needs BMB-101 is a novel highly selective 5-HT2C agonist. Its G-protein biased agonism provides an improved mechanism of action for chronic dosing Financial runway extending into 2026 enabling key data readout Conference call & KOL Event – will be held as a webcast on September 25th at 10:00 ET NEW YORK, Sept. 12, 2024 /PRNewswire/ - Bright Minds Biosciences Inc. (NASD ...

Bright Minds Biosciences Inc. Condensed Interim Consolidated Financial Statements For the nine months ended June 30, 2024 and 2023 (Expressed in Canadian Dollars) 1 | P a g e June 30, September 30, | --- | --- | --- | --- | |---------------------------------|-------|------------------|----------------| | As at | Notes | 2024 (unaudited) | 2023 (audited) | | | | $ | $ | | ASSETS | | | | | Current Assets | | | | | Cash and cash equivalents | 8 | 6,190,244 | 6,747,986 | | Sales tax receivable | | 17,236 | 36,9 ...

To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800- FDA-1088 or www.fda.gov/medwatch. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our product WAKIX. These statements are neither promises nor guar ...

"Following the FDA's decision to grant priority review, we are very pleased with the Agency's timely review and approval of WAKIX for pediatric narcolepsy patients with excessive daytime sleepiness," said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. "EDS is the primary symptom experienced by all patients with narcolepsy and this approval for WAKIX, as the first-and-only FDA-approved non-scheduled treatment option for narcolepsy, makes this important treatment option ...

Title: TGFB2 therapeutic for the treatment of CRC, GBM, and PDAC Abstract: OT-101, an antisense against TGFB2, is being tested in phase 3 clinical trials for pancreatic cancer and glioblastoma. It was previously reported to have robust clinical activity in those indications as well as in melanoma. Here, we explore the potential application of OT-101 in colorectal cancer (CRC) through the analysis of CRC patients treated with OT-101 during its clinical development, as well as through bioinformatic. Intraveno ...