As previously disclosed, the studies did not meet pre-specified co-primary, secondary, or exploratory biomarker endpoints The paper provides a detailed analysis of the RETHINK-ALZ and REFOCUS-ALZ studies and confirms simufilam’s favorable safety profile in these studies Exploratory post-hoc analyses offer informative insights AUSTIN, Texas, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational ...

AUSTIN, Texas, Dec. 23, 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 that it has reached a definitive agreement to resolve the previously disclosed consolidated securities class action litigation pending in the United States District Court for the Western District of T ...

Cassava Sciences Inc. (NASDAQ:SAVA) received a formal letter from the U.S. Food and Drug Administration (FDA) related to the company’s trial for simufilamFollowing previously reported communications with the FDA regarding Cassava’s investigational new drug application and proposed proof-of-concept clinical trial for simufilam in tuberous sclerosis complex (TSC)-related epilepsy, the company confirmed a full FDA clinical hold.The SEC filing highlighted that the company has to provide the FDA with additional ...

本文源自：金融界AI电报 Cassava Sciences股价下跌，此前该公司表示，美国食品药品管理局已叫停其抗癫痫药物临床试验。该 股周四盘后下跌15%，至2.41美元。截至周四收盘，该股今年已累计上涨21%。FDA已对这家总部位于 得克萨斯州奥斯汀的制药公司的新药临床试验申请和simufilam拟议临床试验发出临床试验暂停指令。 Simufilam原本计划用于测试治疗结节性硬化症相关的癫痫。FDA正要求Cassava提供进一步信息，包括 更多的临床前数据以及对试验方案设计的修改。Cassava表示，计划处理FDA指出的事项，但不再预计 能按原计划在2026年上半年启动simufilam的临床试验。 ...

Core Viewpoint - Cassava Sciences, Inc. has reported significant financial improvements and advancements in its research and development efforts, particularly focusing on simufilam as a potential treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy, with plans for a proof-of-concept study in H1 2026 [4][10]. Financial Results - The net loss for Q3 2025 was $10.8 million, or $0.22 per share, a notable decrease from a net loss of $27.9 million, or $0.58 per share, in Q3 2024 [2][10]. - Cash and cash equivalents stood at $106.1 million as of September 30, 2025, down from $128.6 million at the end of 2024, with an estimated cash range of $92 to $96 million expected by year-end 2025 [3][9]. - Research and development expenses for Q3 2025 were $4.0 million, a 78% decrease from $17.7 million in Q3 2024, primarily due to the completion of the Alzheimer's disease development program [10][19]. - General and administrative expenses were $7.9 million in Q3 2025, down 39% from $12.9 million in Q3 2024, attributed to reduced legal costs and absence of severance costs from the prior year [10][19]. Business Updates - Cassava is advancing simufilam as a potential treatment for TSC-related epilepsy, with positive preclinical results indicating a 60% reduction in seizure frequency in a mouse model [6][10]. - The company has strengthened its strategic capabilities by appointing experienced neuroscience leaders and expanding its Board of Directors [5][10]. - A collaboration with the TSC Alliance is underway to initiate a proof-of-concept study for simufilam in TSC-related epilepsy, expected to begin in the first half of 2026 [4][10]. Industry Context - Tuberous Sclerosis Complex (TSC) affects approximately 50,000 people in the US, with epilepsy being a common condition among TSC patients, occurring in 84% of cases [10][11]. - Current therapies for TSC-related epilepsy are often ineffective and associated with serious adverse events, highlighting the need for novel treatments like simufilam [11][12].

Core Viewpoint - Cassava Sciences, Inc. has appointed Ms. Dawn C. Bir to its Board of Directors, which is seen as a strategic move as the company prepares to initiate its first clinical study for simufilam in Tuberous Sclerosis Complex (TSC)-related epilepsy in the first half of 2026 [1][3]. Company Overview - Cassava Sciences, Inc. is a biotechnology company focused on developing investigational treatments for central nervous system disorders, including TSC-related epilepsy [4]. - The company's lead product, simufilam, is an oral small molecule believed to modulate the activity of the filamin A protein, which plays a role in neuronal development [4]. Appointment of Dawn C. Bir - Dawn C. Bir is a seasoned biopharmaceutical executive with a history of contributing to the growth and commercialization of biotechnology companies [2]. - Her previous roles include Interim President and CEO of Geron Corporation and Executive Vice President and Chief Commercial Officer at Reata Pharmaceuticals, where she was instrumental in the company's acquisition by Biogen [2][3]. - The Board believes that Ms. Bir's experience in building shareholder value and her relationships with market stakeholders will be beneficial as Cassava advances its clinical programs [3]. Strategic Importance - The appointment of Ms. Bir is considered pivotal for Cassava as it seeks to enhance its strategic capabilities in preparation for the upcoming clinical study [3]. - Ms. Bir expressed her commitment to delivering transformative therapies for TSC-related epilepsy and is eager to collaborate with the management team to guide business and clinical strategies [3].

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]

Core Insights - Cassava Sciences, Inc. is a biotechnology company focused on developing investigational treatments for central nervous system disorders, particularly Tuberous Sclerosis Complex-related epilepsy [1][4] - The company will participate in the H.C. Wainwright 27 Annual Global Investment Conference scheduled for September 8-10, 2025, in New York City [1][2] Company Overview - Cassava Sciences is based in Austin, Texas, and is developing a proprietary oral small molecule called simufilam, which is believed to modulate the activity of the filamin A protein, impacting neuronal development [4] - The company aims to address various CNS disorders with its investigational treatments [4] Conference Details - Rick Barry, the President and CEO of Cassava, will present at the conference on September 8, 2025, at 5 PM ET [2] - A replay of the webcast will be available on the Cassava Investor's website for approximately 90 days post-event [2]

Core Insights - Cassava Sciences, Inc. reported a net loss of $44.2 million for Q2 2025, a significant decline from a net income of $6.2 million in the same period of 2024 [2][13] - The company is advancing its investigational treatment simufilam for Tuberous Sclerosis Complex (TSC)-related epilepsy, with a proof-of-concept study planned for H1 2026 [5][9] - Cassava has appointed experienced neuroscience professionals to guide the clinical development of simufilam, enhancing its research capabilities [6][8] Financial Performance - Net cash used in operations for the first half of 2025 was $16.3 million, with expectations of $47 to $51 million for the second half, including a $31.25 million estimated loss contingency related to securities litigation [2][13] - Cash and cash equivalents stood at $112.4 million as of June 30, 2025, down from $128.6 million at the end of 2024 [13][22] - Research and development expenses decreased by 66% to $5.1 million in Q2 2025, primarily due to the phase-out of the Alzheimer's disease program [13][20] Business Developments - The company initiated a new program focused on TSC-related epilepsy, supported by positive preclinical studies showing a 60% reduction in seizure frequency in animal models [3][5] - Cassava has established collaborations with Yale University and the TSC Alliance to further its research on simufilam [9][12] - The appointment of Dr. Joseph Hulihan as Chief Medical Officer and other neuroscience leaders is expected to strengthen the clinical development strategy for simufilam [6][8] Market Context - TSC affects approximately 50,000 people in the US, with 80% to 90% of patients experiencing seizures, highlighting a significant unmet medical need for effective treatments [11][12] - Current therapies for TSC-related epilepsy are not fully effective and are associated with serious adverse events, indicating a potential market opportunity for simufilam [11][12]

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]