Core Insights - Several biotech companies experienced significant stock price increases in after-hours trading, driven by clinical updates, strategic shifts, and upcoming catalysts [1] Cassava Sciences (SAVA) - Shares surged 37.1% to $3.18 in after-hours trading, following a regular session close of $2.32, which marked a 1.75% gain [2] - The rally is attributed to renewed interest in the investigational drug simufilam, particularly its potential in treating TSC-related epilepsy, following positive preclinical data [3] - Leadership changes, including the appointment of Dr. Joseph Hulihan as Chief Medical Officer, indicate a strategic pivot in clinical priorities [3] - Future updates on simufilam and the diagnostic candidate SavaDx could serve as near-term catalysts [4] Helius Medical Technologies (HSDT) - Stock rose 15.67% to $18.53 in after-hours trading after a regular session close of $16.02, where it had dropped 33.61% [4] - The rebound followed a $500 million private placement announcement, marking a significant pivot from its core neurotech focus [5] - Helius continues to advance its medical device pipeline, with positive results from the Portable Neuromodulation Stimulator (PoNS) stroke registrational program and plans for FDA submission [6] Werewolf Therapeutics (HOWL) - Shares increased 9.78% to $2.02 in after-hours trading, following a regular session close of $1.84, which was up 23.49% [6] - The company is advancing multiple conditionally activated cytokine therapies through its INDUKINE platform, with lead candidate WTX-124 in a Phase 1/1b trial targeting advanced solid tumors [7] - Participation in the H.C. Wainwright 27th Annual Global Investment Conference highlighted management's timelines for clinical readouts and pipeline progress [8] Aytu BioPharma Inc. (AYTU) - Stock rose 7.63% to $2.68 in after-hours trading after closing at $2.49, up 2.05% [8] - The price action follows the announcement of full-year and Q4 fiscal 2025 results expected on September 23, 2025, which will clarify commercial performance and progress with EXXUA [9] - Aytu maintains a portfolio of pediatric and ADHD-focused therapeutics and has extended its loan agreement with Eclipse to boost liquidity [10] Equillium Inc. (EQ) - Shares increased 10.34% to $1.60 in after-hours trading after closing at $1.45, down 0.68% [10] - The company announced up to $50 million in financing to advance EQ504 into clinical development, with positive feedback from the FDA regarding its regulatory pathway [11] - Its lead candidate, itolizumab (EQ001), is in Phase 3 trials for acute graft-versus-host disease and has completed earlier-stage studies in lupus nephritis and ulcerative colitis [11]

AUSTIN, Texas, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders, such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced management’s participation in the H.C. Wainwright 27th Annual Global Investment Conference being held September 8 – 10, 2025 in New York City. Rick Barry, President and Chief Executive Officer, will ...

AUSTIN, Texas, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, "Cassava", the "Company"), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2025 and provided a business update. Net loss was $44.2 million compared to net income of $6.2 million for the same period in 2024. Net cash used ...

Core Viewpoint - Cassava Sciences, Inc. has appointed Dr. Joseph Hulihan as Chief Medical Officer to lead the clinical development of simufilam for Tuberous Sclerosis Complex (TSC)-related epilepsy [1][3][8] Company Overview - Cassava Sciences, Inc. is a clinical-stage biotechnology company focused on developing investigational treatments for central nervous system disorders, including TSC-related epilepsy [5] - Simufilam is a proprietary oral small molecule believed to modulate the activity of the filamin A protein, which is crucial for neuronal development [5] Appointment of Dr. Joseph Hulihan - Dr. Hulihan has over 25 years of experience in the development of therapeutics for epilepsy and neurological disorders, previously serving as CMO at Marinus Pharmaceuticals and in senior roles at Janssen Pharmaceuticals [2][4] - He is board certified in Neurology and Electroencephalography (EEG) and has been involved in over 25 late-stage neurology-focused clinical trials [2][4] Clinical Development Plans - The clinical program for simufilam as a potential treatment for TSC-related epilepsy is set to begin in the first half of 2026 [4][8] - Dr. Hulihan expressed enthusiasm for simufilam's novel mechanism of action and the upcoming proof-of-concept study [4]

Core Viewpoint - Cassava Sciences, Inc. reported positive preclinical results for simufilam in treating tuberous sclerosis complex (TSC)-related epilepsy, indicating its potential as a novel treatment option [1][2][6] Company Summary - Cassava Sciences is a clinical-stage biotechnology company focused on developing treatments for central nervous system disorders, including TSC-related epilepsy [13] - Simufilam is a proprietary oral small molecule believed to modulate the activity of the filamin A protein, which is crucial for neuronal development [13] - The company plans to initiate a proof-of-concept study for simufilam in TSC-related epilepsy in the first half of 2026 [6][9] Research Findings - The study utilized the Tsc1 conditional knockout (CKO) mouse model, which is recognized for evaluating the effectiveness of therapeutics for TSC-related epilepsy [3][4] - Simufilam demonstrated a beneficial effect on seizure activity, showing a statistically significant correlation between the dose of simufilam and the number of seizures [4] - The results align with previous findings from Yale School of Medicine, reinforcing the potential of simufilam as a first-in-class treatment for TSC-related epilepsy [2][5] Industry Context - Tuberous sclerosis complex affects approximately 50,000 individuals in the US, with epilepsy being the most common condition associated with TSC [12] - Between 80% and 90% of TSC patients experience seizures, and two-thirds have refractory epilepsy, highlighting the urgent need for new treatment options [12] - Current therapies are not fully effective and can lead to serious adverse events, emphasizing the potential market opportunity for simufilam [12]

Core Insights - Cassava Sciences, Inc. presented promising preclinical data on simufilam, showing a significant reduction in seizure activity in a mouse model, which supports its potential as a treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy [1][3][4] - The company plans to initiate human clinical studies in the first half of 2026 to further evaluate simufilam's efficacy in treating TSC-related epilepsy [2][3][10] Preclinical Data - Simufilam reduced seizure frequency by 60% in a mouse model compared to vehicle-treated mice, with significant results (p<0.0001) [7][9] - The effective dose in mice was 20 mg/kg/day, and no adverse effects were observed at doses up to 50 mg/kg/day in rats and 1250 mg/kg/day in mice [7] - The treatment also led to a higher rate of seizure freedom in mice, with 11 out of 32 simufilam-treated mice achieving seizure freedom compared to 3 out of 29 vehicle-treated mice (p=0.0343) [9] Clinical Safety Data - Data from two Phase 3 studies involving 1,929 patients with mild-to-moderate Alzheimer's disease demonstrated a favorable safety profile for simufilam [11][15] - Non-serious adverse events were typically mild and not considered related to simufilam, with no serious adverse events assessed as study-drug related [15] Background on TSC - Tuberous Sclerosis Complex (TSC) affects approximately 50,000 patients in the US, leading to lifelong epilepsy and severe neurological issues [3][12] - Current treatments for TSC-related epilepsy are often ineffective, with nearly two-thirds of patients not responding to antiepileptic drugs [13][14] Future Directions - Additional preclinical studies are planned in collaboration with the TSC Alliance to explore simufilam's mechanism of action and its potential for treating TSC-related epilepsy [10]

Core Insights - Cassava Sciences, Inc. is advancing the development of simufilam for TSC-related epilepsy, with plans to initiate clinical trials in the first half of 2026 following necessary pre-clinical studies and regulatory strategy development [3][6] - The company reported a net loss of $23.4 million for Q1 2025, a significant decrease from a net income of $25.0 million in the same period in 2024, primarily due to the change in fair value of warrant liabilities [6][10] - As of March 31, 2025, Cassava had cash and cash equivalents of $117.3 million, with no debt, indicating a favorable balance sheet for future developments [6][19] Business Update - Cassava has entered a license agreement with Yale University for intellectual property rights related to potential treatments for rare diseases, including TSC-related epilepsy [3][6] - The company has appointed Dr. Angélique Bordey as SVP of Neuroscience and Dr. Jack Moore as SVP of Clinical Development to enhance its team for the new TSC-related epilepsy program [3][6] - The Alzheimer's disease program, which did not meet its co-primary endpoints in Phase 3 studies, will be completely discontinued by the end of Q2 2025 [6][10] Financial Performance - Total operating expenses for Q1 2025 were $24.6 million, compared to $19.9 million in Q1 2024, reflecting increased general and administrative expenses primarily due to legal-related costs [10][17] - Research and development expenses decreased by 16% to $13.7 million in Q1 2025, down from $16.2 million in the same period in 2024, due to the discontinuation of Alzheimer's clinical trials [10][17] - General and administrative expenses rose to $10.9 million in Q1 2025, compared to $3.7 million in Q1 2024, largely due to legal expenses and the absence of insurance recoveries [10][17]

Core Insights - Cassava Sciences, Inc. has appointed Dr. Angélique Bordey as Senior Vice President of Neuroscience to lead research and development efforts, particularly focusing on simufilam for TSC-related epilepsy and other potential indications [1][2][3] Company Overview - Cassava Sciences, Inc. is a clinical-stage biotechnology company that develops investigational treatments for central nervous system disorders, including simufilam for TSC-related epilepsy [7] - Simufilam is a proprietary oral small molecule targeting the filamin A protein [7] Leadership and Expertise - Dr. Bordey brings extensive experience as Vice Chair of the Department of Neurosurgery at Yale School of Medicine and has published over 125 research papers [5][6] - Her research has contributed to a recently granted patent for simufilam's use in treating TSC-related epilepsy, which has led to a licensing agreement with Yale University [3][4] Research Focus - Dr. Bordey will guide the preclinical program to evaluate simufilam as a treatment for TSC-related epilepsy, which is known to be challenging to manage [2][4] - The collaboration with the TSC Alliance and her leadership in the TSC community may facilitate productive study collaborations [3][4]

Core Viewpoint - Cassava Sciences, Inc. announces the retirement of Chief Medical Officer James W. Kupiec, MD, effective May 9, 2025, and the appointment of Jack Moore, PhD, as Senior Vice President of Clinical Development, effective April 28, 2025, to advance the clinical evaluation of simufilam for CNS disorders, including TSC-related epilepsy [1][3][8] Company Leadership Changes - James W. Kupiec, MD, retires after a notable career in Alzheimer's disease drug development, contributing to high-quality clinical trials at Cassava [2] - Jack Moore, PhD, brings extensive experience in CNS drug development and will focus on advancing simufilam in new indications [3][4] Clinical Development Focus - Dr. Moore will be responsible for the clinical evaluation of simufilam, targeting TSC-related epilepsy and exploring additional applications [3][5] - The company aims to identify potential clinical collaborators and study sites as part of its strategy for the TSC program [4] Background of Jack Moore - Jack Moore has a strong background in biopharmaceuticals, with experience in CNS and neurodegenerative diseases, having held leadership roles at major pharmaceutical companies [6] - He holds a PhD in Neuroscience and has a history of engaging with key opinion leaders and patient advocacy groups [7] Company Overview - Cassava Sciences, Inc. is a clinical-stage biotechnology company focused on developing investigational treatments for CNS disorders, including simufilam, which targets the filamin A protein [8]

Company Overview - Cassava Sciences (SAVA) recently faced a significant setback as its phase III study REFOCUS-ALZ for simufilam in mild-to-moderate Alzheimer's disease failed to meet the prespecified co-primary endpoints [1][4] - The study enrolled 1,125 Alzheimer's disease patients who received either simufilam or placebo for 76 weeks, but the drug did not show a significant reduction in cognitive and functional decline compared to placebo [2][3] Study Results - Treatment with simufilam did not achieve significant results on the ADAS-COG12 and ADCS-ADL scales over the 76-week period, nor did it meet any secondary or exploratory biomarker endpoints [2] - Despite the lack of efficacy, simufilam maintained an acceptable safety profile throughout the study [3][4] Program Termination - Following the failure of the REFOCUS-ALZ study, Cassava decided to discontinue the study and will phase out the development of simufilam for Alzheimer's disease by the end of the second quarter [4] - With the termination of this program, Cassava no longer has any late-stage candidates in its pipeline [4] Financial Position - As of December 2024, Cassava reported having $128.6 million in cash and equivalents, raising concerns about its ability to fund future operations [5] Industry Context - The Alzheimer's disease market is characterized by significant challenges in drug development, with many pharmaceutical and biotech companies experiencing setbacks [6] - Currently, there are two FDA-approved drugs for Alzheimer's disease: Leqembi and Kisunla, which target the reduction of amyloid beta plaques in the brain [7][8]