Core Insights - Celcuity Inc. is participating in the 8th Annual Evercore Healthcare Conference from December 2-4, 2025, in Miami, Florida [1] - CEO Brian Sullivan will have a fireside chat on December 3, 2025, at 7:30 a.m. ET, with a live webcast available [2] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for multiple solid tumor indications [3] - The lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTor pathway [3] - Ongoing clinical trials include VIKTORIA-1, which has completed enrollment for both PIK3CA wild-type and mutant cohorts, and VIKTORIA-2, which is currently enrolling patients [3] - A Phase 1/2 trial, CELC-G-201, is evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3]

C4 Therapeutics ( CCCC ) reported a GAAP EPS loss of -$0.44 for 3Q25. A figure that missed analyst estimates by about $0.03. Revenue, on the other hand, came in at $11.23 million, beating expectations by $4.95 million. It's a bit of niceI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave m ...

Core Insights - Scilex Holding Company has successfully closed the second tranche of its strategic investment in Datavault AI, acquiring shares valued at approximately $583.3 million based on the closing price of Datavault's common stock [1][5]. Company Overview - Scilex is focused on acquiring, developing, and commercializing non-opioid pain management products for treating acute and chronic pain, as well as neurodegenerative and cardiometabolic diseases [3][4]. - The company has several commercial products, including ZTlido® for neuropathic pain, ELYXYB® for acute migraine treatment, and Gloperba® for gout flare prophylaxis [3][4]. Product Development - Scilex has three product candidates in development: - SP-102, a viscous gel for lumbosacral radicular pain, which has completed Phase 3 studies and received Fast Track status from the FDA [4]. - SP-103, a next-generation lidocaine topical system for acute pain, which has recently completed a Phase 2 trial [4]. - SP-104, a low-dose naltrexone for fibromyalgia treatment, is also under development [6]. Strategic Investment - The strategic investment in Datavault AI involves the purchase of a pre-funded warrant for 263,914,094 shares of Datavault AI common stock, with the transaction being approved by Datavault's stockholders [5]. - Both companies plan to enhance collaboration to drive growth in Real World Asset tokenization starting in 2026 [5]. Datavault AI Overview - Datavault AI specializes in AI-driven data experiences and asset monetization, offering solutions across various industries, including biotech, fintech, and healthcare [7]. - The company’s platform includes technologies for audio transmission and high-performance computing, enabling secure monetization and data analytics [7].

Company Performance - Biofrontera Inc. experienced a price drop to $0.05, marking a decrease of approximately 36.07%, potentially due to market dynamics or operational challenges [2][8] - IAC Inc. saw its stock decline to $0.60, a 33.31% drop, attributed to the recent spin-off of its subsidiary, Angi Inc., and subsequent market adjustments [3][8] - OmniAb, Inc. had its stock price fall to $0.08, a decrease of 44.83%, indicating investor concerns over growth prospects or market competition [4][8] - S&W Seed Company experienced a price drop to $0.11, reflecting a 48.59% decrease, possibly due to its decision to voluntarily delist from The Nasdaq Capital Market [5] - MingZhu Logistics Holdings Limited saw a significant decline to $0.17, an 83.53% drop, related to operational challenges and market competition in the logistics sector [6] Market Trends - The price movements of these companies reflect a combination of company-specific developments, sectoral challenges, and broader market trends [7]

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Financial Data and Key Metrics Changes - The net loss for fiscal year 2025 was $2 million, a significant improvement from a net loss of approximately $599 million in fiscal year 2024, resulting in a loss of $0.01 per share compared to a loss of $5 per share [32] - Revenue for fiscal year 2025 totaled $829 million, driven primarily by licensing and collaboration agreements, with $697 million from Sarepta Therapeutics [32][33] - Total operating expenses increased to approximately $731 million in fiscal year 2025 from $605 million in fiscal 2024, primarily due to higher R&D and SG&A costs [35] Business Line Data and Key Metrics Changes - The FDA approval of Redemplo marked a major milestone, being the first FDA-approved siRNA medicine for familial chylomicronemia syndrome (FCS) [7][8] - Redemplo achieved an unprecedented reduction in triglycerides by approximately 80% from baseline as early as one month, with 50% of patients at the 25-mg dose achieving triglyceride levels below 500 mg per deciliter [24] - The company has made progress with Zodasiran, initiating the Yosemite phase III clinical trial for homozygous familial hypercholesterolemia (HoFH) [11][12] Market Data and Key Metrics Changes - There are an estimated 6,500 people in the U.S. living with genetic or clinical FCS, and approximately 750,000 patients with persistent chylomicronemia at high risk for acute pancreatitis [10][25] - The One Redemplo pricing model is set at $60,000 annually, aimed at providing consistent pricing across current and future indications [25] Company Strategy and Development Direction - The company is focusing on the cardiometabolic space, with ongoing development programs for Zodasiran and ArrowDiamond PA, targeting large populations without proper treatment options [14][15] - Arrowhead aims to have 20 individual drug candidates in clinical trials by the end of 2025, with a balanced pipeline of wholly owned and partnered programs [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial launch of Redemplo and the positive feedback received from healthcare professionals and patient societies [24][25] - The company anticipates that the commercial sales of Redemplo will not have a substantial impact on financial statements in fiscal year 2026, but believes its cash runway is sufficient to extend into fiscal year 2028 [39] Other Important Information - Arrowhead received a $200 million upfront payment from Novartis for a licensing agreement and is eligible for up to $2 billion in future milestone payments [18][37] - The company has expanded its clinical pipeline in CNS with AROMAPT, targeting tauopathies including Alzheimer's disease [15] Q&A Session Summary Question: Can you discuss the plan to show benefit in terms of acute pancreatitis for Plozasiran? - Management indicated that shots at three and four were powered for triglyceride reduction, with a reasonable chance to show a difference in acute pancreatitis, but emphasized that shots at five are specifically designed to demonstrate benefit in acute pancreatitis [45][46] Question: Can you provide more details on the upcoming data for obesity programs? - Management confirmed that initial data from the AROINHBE program will be shared in early January, with a focus on safety and biomarker data, while ARO-ALK7 will provide limited data focused on monotherapy safety [50][52] Question: What are the estimates on acute pancreatitis events accrual based on patient baseline characteristics? - Management noted that it is difficult to estimate the number of events due to the new criteria being used, but they expect to have a sufficient number of events based on the percentage of patients with a history of pancreatitis enrolled in the study [56] Question: Can you discuss the differentiation of the ArrowMapT program from J&J's failed anti-tau antibody? - Management highlighted that ArrowMapT targets intracellular tau, potentially reducing both intracellular and extracellular tau levels, unlike J&J's approach which primarily targets extracellular tau [62] Question: What is the visibility on launching a CBOT study? - Management indicated that they expect to have a clearer idea by summer regarding the data from ongoing studies, which will inform the timeline for launching pivotal studies [65]

Group 1 - Ideaya Biosciences, Inc. (IDYA) is a precision medicine oncology company that went public in May 2019, raising $57.5 million by issuing 5.75 million shares at $10 per share [1] - The current stock valuation of Ideaya Biosciences is $35 per share, indicating significant appreciation since its IPO [1] - The investing group Haggerston BioHealth, led by biotech consultant Edmund Ingham, provides insights and analysis on over 1,000 companies in the biotech, healthcare, and pharma sectors [1] Group 2 - Haggerston BioHealth offers catalysts for investors to monitor, along with buy and sell ratings, product sales forecasts, and integrated financial statements [1] - The group also conducts discounted cash flow analysis and market-by-market analysis for major pharmaceutical companies [1]

Core Insights - Ideaya Biosciences, Inc. (IDYA) is a precision medicine oncology company that went public in May 2019, raising $57.5 million by issuing 5.75 million shares at $10 per share, with the current stock valued at $35 per share [1] Group 1 - Ideaya Biosciences focuses on precision medicine within the oncology sector [1] - The company has been supported by a biotech consultant with over 5 years of experience in the biotech, healthcare, and pharma industries [1] - The investing group Haggerston BioHealth provides insights and forecasts for major pharmaceutical companies, including product sales and integrated financial statements [1]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Core Viewpoint - Bright Minds Biosciences, Inc. is focused on developing highly selective 5-HT2 agonists for treating drug-resistant epilepsy, depression, and other CNS disorders, and is participating in key upcoming healthcare events [1][2]. Company Overview - Bright Minds Biosciences is a biotechnology company dedicated to creating innovative treatments for neurological and psychiatric disorders, with a pipeline that includes novel compounds targeting critical brain receptors [2]. - The company aims to address conditions with high unmet medical needs, including epilepsy and depression, by delivering breakthrough therapies that can significantly improve patients' lives [2]. Product Development - Bright Minds has developed a unique platform of highly selective serotonergic agonists that exhibit selectivity at various serotonergic receptors, resulting in a rich portfolio of new chemical entity (NCE) programs within neurology and psychiatry [3]. Upcoming Events - The company will participate in the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, at 11:30 am ET [1]. - Additionally, Bright Minds will be present at the 2025 American Epilepsy Society Annual Meeting during the Scientific Exhibit Session on December 7, 2025, from 2 pm to 5 pm ET [1].