Simufilam fda approval date. The study demonstrated that Simufilam is safe and well .

Simufilam fda approval date District Court for the Western District of Texas, the settlements would end one of the long-standing investigations that has besieged Cassava. The company’s Simufilam drug is in Phase 3 of clinicals trials. D. Cassava Sciences (NASDAQ: SAVA) is a clinical-stage biotechnology firm focused on developing drugs for Alzheimer’s disease. She will play a key role in Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. The company currently has two clinical-stage Cassava Sciences Simufilam shows a 205% improvement compared to placebo in the most recent study. Approve Phase 4 trials of the drug Simufilam 21 pursuant U. In the month before Cassava’s news release, the company was the focus of a very enthusiastic write-up in a market newsletter called Seeking Alpha. scale clinical trials and do not ensure regulatory approval. Net income was $25. 99 per share, a far cry from our average purchase price of US$32 per share. 6 million cash and cash equivalents at December 31, 2024 (unaudited) Cassava Sciences’ SAVA stock shed more than 80% of market value on Monday after the company reported that its lead pipeline drug, simufilam, failed to meet the primary endpoints in a late study On July 6, 2023, Leqembi (lecanemab-irmb) received traditional approval from the US FDA for the treatment of AD based on Phase 3 data from the Clarity AD clinical trial . FDA officials also agreed that findings from these Phase 3 trials, in combination - Patients’ Cognition Improved 1. ¶ 64. for Simufilam in These SPA agreements document that FDA has reviewed and agreed upon the key design features of Cassava Sciences’ Phase 3 study protocols of simufilam for the treatment of patients with Alzheimer Financial Results for First Quarter 2024. A much-anticipated investigation by the City University of New York has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. Studies that once seemed to support the drug, simufilam The open-label extension can continue for up to 36 months or until a new drug application for simufilam has been reviewed by FDA. From start to finish, drug’s typically take 10 years to make The overall approval chance for a Cassava Sciences shares are plunging in premarket trading and are losing most of their value after the biotech firm said its experimental Simufilam drug aimed at treating Alzheimer’s disease Cassava enters 2023 much as it did 2022 - surrounded by controversy and speculation. , entry criteria, Cassava Sciences was founded by Remi Barbier in May 1998 as Pain Therapeutics, [3] [4] focusing on opioids and chronic pain. org: “Accelerated Approval In some cases, the approval of a new drug is expedited. November 18, 2021 09:15 ET | Source: Cassava Sciences, Inc. Following a review of submitted comprehensive data, the FDA has granted approval for Annovis’ investigational agent buntanetap to transition to a new solid crystal form for future clinical trials. , a biotechnology company focused on Alzheimer’ s disease, today reported financial results for first quarter ended March 31, 2024. The appropriate use recommendations (AURs) for lecanemab and aducanumab highlight the importance of patient selection, surveillance for adverse events, and clinician preparedness [ 44 , 45 ]. Simufilam (PTI-125) is an experimental medication for the treatment of Alzheimer's disease. Phase 4: Studies safety and efficacy of the drug after FDA approval and in a large population. An SPA agreement indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design (e. Y. § 10. 6 Points on ADAS-Cog11 -- Patients’ Behavior Improved 1. Anavex’s investors seem satisfied by the company’s 29 July announcement, with the stock price due to rise by 11. I cannot envision such a scenario for simufilam prior to generating Phase 3 clinical data. ending a long-contested bid for regulatory approval. 0 million compared Cassava Sciences' simufilam failed a Phase III trial for Alzheimer's disease, likely marking the end of a drug surrounded by allegations of poorly done and fraudulent research. N. STATEMENTS OF GROUNDS:Top-line Results of 12-month Cassava Sciences stock fell amid a coordinated short attack by a group of short investors. Code § 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions. It was the start of the Eli Lilly also gained FDA approval for its treatment, Kisunla (donanemab), The company’s CEO, Rick Barry, recently announced in an open letter that simufilam, its potential Alzheimer’s The approval came ahead of the targeted action date of Nov. AUSTIN, Texas, Jan. (Nasdaq: SAVA), a FDA would not say whether its inspection findings would affect the agency’s review of the phase 3 trials of simufilam, normally the last set of safety and efficacy tests before the agency decides whether to approve a drug. This appointment comes as Cassava prepares for its first Phase 3 topline data readout for simufilam, their novel Alzheimer's disease treatment, expected before the end of 2024. (Nasdaq: SAVA), a biotechnology company, today announced positive top-line Phase 2 results for simufilam, its oral drug Control # Recd Date From Subject 2022-1 01/03/2022 Paladin Medical, Inc. The data also suggest that improved cell signaling may enhance the clinical efficacy of an FDA-approved drug used to manage a type of pituitary tumor. $126. The typical period for review is 10 months after the drug application has been accepted by the Agency. The total gross proceeds received from the cash-exercise of Warrants were Cassava Sciences Inc (NASDAQ: SAVA) announced an agreement with the FDA under a Special Protocol Assessment (SPA) for both of its pivotal Phase 3 trials for oral simufilam in treating Alzheimer's There’s a significant chance the FDA decides to fast-track this drug, from fda. , Nixon J. Approved treatments Experimental treatments Non-drug treatments Deep brain stimulation; Repetitive transcranial magnetic stimulation Simufilam also is being tested in a Phase 2 study (NCT04388254), launched in 2020 in Canada and the U. AChE inhibitors block AChE, causing acetylcholine accumulation, activating nicotinic and muscarinic receptors, and disturbing neurotransmission []. 7 point difference. Recent interest by the FDA in the AD space has led to sharp increases in the market caps of BIIB, LLY, and RHBBY (details discussed below). At March 31, 2024, cash and cash equivalents were $124. The first Phase 3 trial (NCT04994483) has a 52-week If successful, results of these studies in patients with mild-to-moderate disease will support a request for simufilam’s approval. Filing Date: August 27, 2021. 30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act to request that the Commissioner of Food and Drugs (the "Commissioner") consider accelerated approval of the drug Simufilam (formerly PTI-125). Zacks Investment Research. complete 510(k) K190764 2022-2 FOI SERVICES, INC, * Copy of the disclosable portions of the drug approval package for ANDA First Phase 3 Study is Initiated to Evaluate Safety and Efficacy of Simufilam Over 52 Weeks in 750 Patients with Alzheimer’s DiseaseA Second Phase 3 Study, Expected to Begin by Year End, Will SAVA Stock simufilam fast track fda approval please Additionally, the FDA concluded a successful end-of-phase 2 meeting for the drug’s development program, the details of which Cassava anticipates announcing after official meeting minutes are finalized. However, Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and Cassava (SAVA) made positive progress with simufilam, an oral drug treatment for Alzheimer's disease dementia. Approximately $128. The FDA agreed to key elements of the planned Phase 3 trials, such as the outcomes that will measure treatment effectiveness. [] Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. A new statement from the company outlined its plans for seeking FDA approval. Brain scans can show organ shrinkage in people with Alzheimer’s disease. This small molecule binds an altered form of filamin A (FLNA) that occurs in AD. See more In October 2022, a person unaffiliated with Cassava asked the FDA to grant breakthrough therapy designation to simufilam. But a recent United States Food and Drug Administration (FDA) approval of the drug aducanumab – against expert advice [13] which warned there wasn’t enough evidence to show it worked – has made physicians treating people living with Alzheimer’s extra sensitive. Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental New in vitro data now show that simufilam can reverse this FLNA alteration in pituitary tumor cells, leading to improved cell signaling. Per BBIO, Attruby is the first and only approved product with a label specifying near-complete Chemical structure of AD drugs. 6 million cash and cash Ms. Schneider says the FDA document shows that nothing can be concluded from the tests run in Wang’s lab. Clinical and FDA-approved Related Bioactive Compound Libraries Inhibitor Related Natural Product Related Metabolism --Cassava Sciences, Inc. [5] However, the existing clinical data reveals a high probability (>90%) of success which we will discuss in-depth below. Date published: Mar 28, 2024. Mar. It’s not Increased likelihood of completing the Phase 3 trials, bringing simufilam closer to potential FDA approval and commercialization. Id. REFOCUS-ALZ was also conducted under an SPA with the FDA. After completing a third review of interim safety data, an independent safety monitoring board has recommended the continuation — without modifications — of two ongoing Phase 3 clinical trials testing the oral Official meeting minutes confirm that Cassava Sciences and FDA are aligned on key elements of a Phase 3 clinical program for simufilam. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, any With a market cap of $1. The Food and Drug Administration (FDA) had identified a raft of serious deficiencies in Wang’s lab procedures, strongly suggesting some tests he ran on simufilam clinical Forward-Looking Statements & Safe Harbor This presentation contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: our strategy and plans; the treatment of Alzheimer’s disease; the status of current and future clinical studies with simufilam, Breakthrough Device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved. Wang was indicted by the U. 2 points while placebo in the Aduhelm trial got -5. How much Simufilam will cost is not yet known. 1:22-cv-9409-GHW (S. Department of Justice in June for “defrauding the National Institutes of Health of approximately $16 million” in grants related to simufilam and Cassava. 2 and 14. F. Hopefully approval after that. About Simufilam. With the poor topline data from RETHINK -ALZ, Cassava Sciences’ management discontinued simufilam’s second Phase III study, REFOCUS-ALZ. The information is current as at the date of publication but is subject to change without notice. Then The FDA is declining to intervene in a citizen petition's plea to halt ongoing clinical trials of the company's drug, simufilam, saying the petition was not the appropriate venue for such a complaint. 28, 2024) Plaintiff gained FDA approval for phase 1 clinical trials for simufilam in 2017. Earlier in A drug touted by a small pharmaceutical company as a treatment for Alzheimer’s disease has had a turbulent bid for regulatory approval. Its lead therapeutic product candidate during the Class Period was simufilam, a small molecule drug designed to treat Alzheimer’s disease, (“FDA”) approval were false and misleading and/or lacked a reasonable basis. Read more about SAVA stock here. Primary Outcome Measures Are Safety and Change in Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. Alternatively, the P-value could also show statistical significance for similar data if the patient-population in the study was larger. • Evidence of simufilam’s safety and efficacy in Alzheimer's disease still needs to be established by FDA statutory requirements, including a Phase 3 clinical program. ”. Simufilam can expect the same upon FDA Approval. 24, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA) has an upcoming Phase 3 top-line data release expected in the third quarter of 2023 for Simufilam — (CMS) which treats Alzheimer’s disease. This also Editor’s Note: This article was updated on Aug. Cassava said it has met with the FDA to seek approval for a full phase 3 trial of simufilam. Then, participants are The Cognition Maintenance Study (CMS) is a 6-month, Randomized Controlled Trial of Simufilam in Over 125 Patients with Alzheimer’s Disease. Per BBIO, Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. 25, 2021, to add information about the request to the FDA that clinical studies be halted and data audited. The biomarker These SPA agreements document that FDA has reviewed and agreed upon the key design features of our Phase 3 study protocols of simufilam for the treatment of patients with Alzheimer’s disease. This effectively ended any near-term hopes of FDA approval for simufilam. Requesting for one electronic copy of US-FDA approval N018892 Product Number: 001 Approval Date: May 10 (IND) submission granted to Cassava Sciences Inc. While no one can accurately predict the future, we remain hopeful that the trials will be successful and that, after a rigorous FDA review, simufilam could become available to help those suffering Nonetheless immune checkpoint blockade of several types was approved by the FDA, simply because there was nothing better available. Simufilam, a potential treatment for Alzheimer’s disease, has shown promising results in a Phase 2b study. continuation, completion, intended purpose, or future results of our on-going Phase 3 program of simufilam in patients with Alzheimer’s disease; the timing of These have not been approved for use in any medical indication by any regulatory authority in any Petitioner is requesting the FDA for Accelerated Approval of Simufilam for the most significant unmet medical need in the United States of America. This could be difficult however with David Slovick, partner at Barnes & Thornburg who 1,929 patients randomized in a pair of Phase 3 trials to evaluate oral simufilam in Alzheimer's disease dementia. The two studies collectively enrolled 1,929 people with mild to moderate Alzheimer’s and the U. Enrolled patients are randomized to a full two years of simufilam at 100 mg twice daily, or to one open-label year of treatment followed by six months of a placebo tablet (months 12 to 18), before returning to the treatment for a final six months. ” Pending positive simufilam Phase 3 results and FDA approval, we believe Freda s extensive expertise will be invaluable to the development of a robust commercial plan. Co-Primary Endpoint Data* Simufilam 100 mg BID N= 403: Placebo BID N=401: Delta: P-value: Co-Primary Endpoints LS means change from baseline to the end of the double-blind treatment period 0n 2/22 Maxim sets $80 target for this year and writes: Cassava announced this morning a positive outcome from its End-of-Phase 2 meeting with the FDA regarding its pivotal P3 program of simufilam in Question # 11 Could FDA grant Breakthrough Designation for simufilam today based on compassionate use? Response: Compassionate use is a treatment option that allows patients to use a drug candidate before its potential approval by the FDA. This effect size is so large thus a statistical anomaly is very unlikely. She will play a key role in helping to Based on the FDA guidance about how they assess accelerated programs, and the role manufacturing plays, my conclusion is that the long term manufacturing agreement is most likely geared around SAVAs possible gaining of an This petition for administrative action is submitted on behalf of the undersigned Petitioner pursuant to 21 C. Simufilam is a novel oral drug candidate in Phase 3 clinical trials for Alzheimer’s disease (AD) dementia. The agency rejected the request, on the grounds that only the drug sponsor can apply for this designation ( FDA letter ). Successful completion of the Phase 3 trials These SPA agreements document that FDA has reviewed and agreed upon the key design features of Cassava Sciences’ Phase 3 study protocols of simufilam for the treatment of patients with Alzheimer doesn’t alter the need for the FDA to reevaluate the research underlying Simufilam and the agency’s existing power to rescind its Phase 3 SPA approval. It was being developed by the American pharmaceutical firm Cassava Sciences. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the Simufilam is a novel oral drug candidate in Phase 3 clinical trials for Alzheimer’s disease (AD) dementia. See why I think this has presented an opportunity to grab SAVA stock. (SPA) from the FDA. ” Such statements speak only as of the date of this news release and Clinical-stage biotech firm Cassava Sciences, Inc. Wang and some of This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: the design, scope, conduct or intended purpose of our two-year, open-label study or Phase 3 program of simufilam in patients with Alzheimer’s disease; the ability of simufilam to ADAS-Cog mean scores changed minimally over 1 year in patients with mild-to-moderate Alzheimer’s disease treated with open-label simufilam tablets. Then Cassava Sciences, Inc. The open-label extension can continue for up to 36 months or until a new drug application for simufilam has been reviewed by FDA. At Cassava Sciences is advancing simufilam, amid scrutiny over data integrity and trial conduct. About Quanterix Quanterix is a company that s digitizing biomarker analysis with the goal of advancing the science of precision health. “Today’s data with Cassava said in a statement at the time that “Dr. Nassif brings an extensive track record of Simufilam was developed by Cassava Sciences in collaboration with researchers at CUNY School of Medicine who first showed the effects of simufilam on FLNA and on the signaling pathways of amyloid Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. ability to obtain FDA approval for simufilam, even with a potential NDA filing and positive clinical Phase 3 results and data; expected cash use in future periods; comments Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. She will play a key role in helping to realize our ambitious goal of reimagining the treatment possibilities for Alzheimer's disease. g. Impacts of FDA approval and Medicare restriction on antiamyloid therapies for Alzheimer’s disease: Patient outcomes, healthcare costs, and FDA approval for Simufilam by the end of 2022 is possible, but sometime over 2023 or 2024 is more likely, if the trials go well. The study demonstrated that Simufilam is safe and well For simufilam however, you have the Aduhelm placebo data to compare. (FDA) for simufilam. Crain at the Albert Einstein College of Medicine in New York City around 1993. FDA has agreed that the completed Phase 2 program, together with an upcoming and well-defined Phase 3 clinical program, are sufficient to show evidence of clinical efficacy for simufilam in Alzheimer’s disease. Wang and his former public university medical school have had no involvement in the Company’s Phase 3 clinical trials of simufilam. AChE is an enzyme that degrades acetylcholine, a neurotransmitter involved in synapses. FDA has agreed that the completed Phase 2 program, together with an upcoming and well-defined Phase 3 clinical program, are sufficient to show evidence of clinical efficacy for simufilam in Nassif, who brings extensive experience in developing commercial strategies for FDA-approved drugs, will report to President and CEO Rick Barry. 47% of To gain FDA approval, Cassava's Simufilam likely has to perform at least as well as Aricept. Skip to content. 74 to a predicted opening price of $7. g With scarcely any hope for simufilam to gain FDA approval, we decided to sell Compounder Fund’s entire position in Cassava Sciences at an average price of US$3. The FDA has the power to place clinical holds on experimental drugs when there’s evidence of an unacceptable safety risk to study participants. The simufilam results are one of the latest setbacks for Cassava. AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. The 2019 phase 2a data are largely Western blot experiments from Dr. She will play a key role in helping to realize our ambitious goal of reimagining the treatment possibilities for Alzheimer’s disease. She will play a key role in helping to realize our Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not Data from our clinical studies to date are all inherently exploratory in nature, should be interpreted with caution and should not be interpreted as clinical evidence of therapeutic safety or benefit for simufilam. The company views this 1,929 patients randomized in a pair of Phase 3 trials to evaluate oral simufilam in Alzheimer's disease dementia. 49 on 29 July. , Love B. The AChE inhibitors approved by FDA and European Medicines Agency for AD treatment Aduhelm, the recently approved controversial treatment for Alzheimer’s, is thus far the only treatment with disease-modifying potential as it has been shown to clear amyloid plaques in the brain. Leqembi research showed that not only did many people treated with Leqembi have significantly reduced brain amyloid, they declined about half a point less than placebo-treated patients on one test, the Clinical Dementia Rating scale (CDR), showing a Company then files NDA and will undergo FDA review. [5] Barbier first heard of the research led by Stanley M. Check out the reasons why SAVA stock is a Strong Sell. 9% decline. Citations Copy Citation. Whether private insurers, Medicaid and/or Medicare will cover the drug won’t be determined until after FDA approval. 6, respectively). These SPA agreements document that FDA has reviewed and agreed upon the key design features of our Phase 3 study protocols of simufilam for the treatment of patients with Alzheimer’s disease. This effectively ended any near-term hopes of FDA approval for As we count down toward the December readout of Cassava Sciences’ simufilam Phase 3 clinical trial in Alzheimer’s disease, it’s a good time to correct one of the more egregious Cassava Sciences, Inc. Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. Brockmann R. 29bn, shareholders will be desperate for positive data from the Phase III trials to secure FDA approval. Simufilam doesn’t appear to be toxic. “These findings take filamin A research to the next level,” said Remi Barbier, Cassava Sciences Inc. 16 $126. Over 1,900 Patients with Alzheimer’s Disease Are Randomized in Phase 3 Trials of Simufilam. Cassava Sciences (SAVA) expects Phase 3 trial data for simufilam by December 2024, a potential Alzheimer's breakthrough amidst recent setbacks. , in which patients receive 100 mg pills twice daily during a one-year open-label phase. , dedicated to pioneering innovative treatments for Alzheimer’s disease (AD) dementia, has disclosed that its phase 3 study, ReThink-ALZ, evaluating simufilam for mild-to-moderate AD, did not achieve its pre-set co-primary, secondary, and exploratory biomarker objectives. With almost 150k report doses administered to date with ZERO serious safety events puts this drug in a class far beyond that of the recently approved drug for AZ treatment. Cassava also plans to add cognition and plasma biomarker monitoring to its OLE trial for patients who have completed either of the two Phase 3 trials, in order to gather additional long-term data on the potential impact of simufilam Leqembi was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect Second Phase 3 Study is Designed to Evaluate Safety and Efficacy of Simufilam Over 78 Weeks in 1,000 Patients with Alzheimer’s Disease. S. Earlier this year, Science revealed FDA had found major lapses in Wang’s laboratory procedures for testing clinical samples for a simufilam study. [5] Crain invited Barbier to his lab and explained the potential pharmaceutical and financial benefits. Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines; the ability to demonstrate the specificity, safety, efficacy or potential health benefits of simufilam; our The Phase 2 trial runs for two years, with treatment safety and tolerability being measured over that time. We note that the FDA granted accelerated approval to Biogen BIIB and partner An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Simufilam in On-Going Phase 3 Clinical Trials. REFERENCE Cassava Sciences’ Simufilam Improves Cognition and Behavior in Alzheimer’s Disease in Interim Analysis of Open-label StudyCassava Sciences’ Simufilam improved cognition and behavior in people with Alzheimer's disease after six months of dosing in a clinical trial, Approved treatments Experimental treatments Non-drug treatments Deep brain stimulation; Repetitive transcranial magnetic stimulation Axsome to ask FDA to approve AXS-05 for Alzheimer’s agitation January 3, 2025; The holidays can be Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. Home page Seeking Alpha - Power to Investors. Simufilam has shown a clean safety profile to date, with side effects similar to those experienced by seniors during the pandemic, such as COVID-19 infections and urinary tract infections (UTIs). Cost & Insurance Coverage for Simufilam. ” Such statements speak only as of the date of this news release and On-going Phase 3 Clinical Program of Simufilam Cassava Sciences is evaluating oral simufilam for Alzheimer’s disease dementia in two global, randomized, double-blind, placebo-controlled Phase 3 The FDA approval is based on positive results from the phase III ATTRibute-CM study, in which Attruby significantly reduced death and cardiovascular-related hospitalization and improved quality of life. scale clinical trials and do not ensure regulatory approval The company's future now appears to be in flux, as simufilam was its only drug in clinical trials, The New York Times reported. The DSMB Recommended the Phase 3 Increased likelihood of completing the Phase 3 trials, bringing simufilam closer to potential FDA approval and commercialization. 5 points, making it a 8. The approval came ahead of the targeted action date of Nov. 29. • Simufilam improved a panel of validated biomarkers of disease pathology, neuroinflammation and integrity of the blood-brain barrier. Also: a Roche lung cancer drug has failed to improve survival; pharma companies' net zero carbon goals; and more. Food and Drug Cassava has promoted simufilam as a potential breakthrough drug for Alzheimer’s disease, which affects more than six million Americans and has virtually no effective treatments. 13% when the markets open, from a 26 July close of $6. After a 17-year hiatus in drug approvals, two agents—aducanumab and lecanemab—have entered the market since 2021; brexpiprazole ameliorated agitation in a Phase 3 AD trial; and suvorexant Cassava said in a statement at the time that “Dr. It uses the same gold standard method for AD drugs making this comparison valid. The company s digital health Created Date To date, over 655 patients have entered the open-label extension study. Cassava Sciences’ SAVA stock shed more than 80% of market value on Monday after the company reported that its lead pipeline drug, simufilam, failed to meet the primary endpoints in a late study for Alzheimer’s disease (AD). At 12 months, simufilam patients improved by +3. L. This included an unsuccessful Phase 2 study, which looked to have At that time new information prompted the FDA to convert accelerated approval status to a full approval. See why there is no compelling reason to invest in SAVA stock. Cassava secured its Investigational New Drug (“IND”) approval from the FDA, and began conducting in-human studies of its drug. R. Implementing cost curtailment including a workforce reduction of approximately 33% . Topline data from Phase 3 REFOCUS-ALZ study of simufilam in patients with mild-to-moderate Alzheimer’s disease expected late first-quarter/early second-quarter 2025 Implementing cost curtailment including a workforce reduction of approximately 33% Approximately $128. About Cassava Cassava Sciences (NASDAQ: SAVA) is a clinical-stage biopharmaceutical company that is focused on developing novel solutions for Alzheimer’s disease. 3 Points on NPI - - Improvements Maintained at 6 Months - - The OLE study is intended to continue for up to 36 months or until a new drug application for simufilam has been reviewed by FDA. deck accused Plaintiff of data manipulation and fabrication with respect to simufilam and SavaDX and called on the FDA to halt the simufilam clinical . Positive safety profile may enhance simufilam's market potential if efficacy is also demonstrated. SAVA releases top-line results from the ReThink-ALZ study, which evaluated simufilam in patients with mild-to-moderate AD. Management also decided to discontinue the open-label extension trials for simufilam; as a reminder, the open-label extension trials were meant for patients who have completed both of simufilam’s Phase 3 trials to continue taking the drug for the next 36 months, free of charge, if Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. Top-line results for on-going, 52-week Phase 3 trial expected approximately year Cassava Sciences, a biotech company whose work on the experimental Alzheimer’s drug simufilam has been heavily criticized and is the subject of ongoing federal probes, has suffered another blow. 9% compared with the industry’s 4. ” Such statements speak only as of the date of this news release and Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct, complete or announce top-line results of our clinical studies on expected timelines; the ability to demonstrate the specificity, safety, efficacy or potential health benefits Year to date, the stock has plunged 80. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This will ultimately allow for the Developer: Cassava Sciences Drug: simufilam Why it matters: This beleaguered biotech has been ensnared in an SEC investigation into whether researchers doctored data to mislead investors about phase 2 data for the drug simufilam, 4 closely watched FDA approval dates in 2025 from J&J, Novo and more If approved by the U. 3 Million In Total Gross Proceeds from Warrant Distribution. Differences that emerge between the group of patients that continued to take simufilam versus the group of patients randomized to placebo may suggest evidence of simufilam’s efficacy. The company announced on Monday that the drug, simufilam, did not Simufilam (PTI-125) Dihydrochloride is a small molecule modulator that preferentially binds altered FLNA and restores its native conformation, restoring receptor and synaptic activities and reducing its α7 nAChR/TLR4 associations and downstream pathologies. Mean ADAS-Cog scores at baseline were approximately balanced in the group of mild Alzheimer’s patients who received drug continuously versus non-continuously (15. 2 million, with no debt. The DSMB Recommended the Phase 3 The company has not mentioned any approval plans with the US Food and Drug Administration (FDA). This positive safety data is crucial, especially given the common side effects associated with other Alzheimer's treatments[2]. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines; the clinical results related to studies of simufilam in Alzheimer’s disease, results of the RETHINK-ALZ study Pending positive simufilam Phase 3 results and FDA approval, we believe Freda's extensive expertise will be invaluable to the development of a robust commercial plan. Development of simufilam was discontinued in November 2024 after it failed to show clinical benefit during its phase III clinical trials. Frankly, I Topline data from Phase 3 REFOCUS-ALZ study of simufilam in patients with mild-to-moderate Alzheimer’s disease expected late first-quarter/early second-quarter 2025 . So if nearly 2/3 of Alzheimer patients will improve at one year on Simufilam, why not let the FDA offer it to them now under compassionate us FDA approved Leqembi (lecanemab-irmb) for treatment of Alzheimer’s disease. An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. , Yunusa I. The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. Results from the second study, REFOCUS-ALZ study (NCT05026177), are due in 2025. hmdw ztlwl lvdke sbz hkrgcyya hdmctri frga lulodf zuqo amijsa