Sumifilam

Shares in Cassava Sciences fell more than 20% to $2.20 when the markets opened Tuesday from a Monday closing price of $2.78.\n Cassava Sciences has given up on simufilam in Alzheimer’s disease. Months after seeing one phase 3 trial fail, the biotech is planning to stop development altogether after chalking up another late-stage flop.Texas-based Cassava discontinued the second study, ReFocus-ALZ, when it reported the first failure late last year. But with all the patients completing 52 weeks of follow-up, and many making it to the 76-week assessments, before Cassava pulled the plug, ReFocus-ALZ still offered the biotech a final chance to show simufilam may be effective against Alzheimer’s.Instead, the failure of the trial sealed simufilam’s fate. Cassava said ReFocus-ALZ missed its prespecified co-primary, secondary and exploratory biomarker endpoints. The co-primary endpoint data left no room for optimistic interpretations. On ADAS-COG12, where lower numbers mean less cognitive impairment, scores rose by 4.97 and 5.26 points in the two simufilam cohorts and by 4.70 points in the placebo group. Similarly, on ADCS-ADL, where higher numbers mean less functional impairment, scores fell by 6.27 and 6.43 points on simufilam arms and by 5.32 points on placebo.  The failures on the co-primary endpoints and broader dataset led Cassava CEO Rick Barry to conclude the trial “showed no treatment benefit for patients.” Barry was blunt about the data and the next steps.“These results were unambiguous,” Barry said. “Cassava will discontinue all efforts to develop simufilam for Alzheimer’s disease and we expect to phase out the program by the end of Q2 2025.”Having recently entered a license agreement, Cassava has begun preclinical studies to assess simufilam as a potential treatment of tuberous sclerosis complex-related epilepsy. While the biotech is investing in those studies, it is maintaining its “ongoing strategic expense management efforts,” Barry said. Cassava ended last year with $128.6 million in cash and cash equivalents.Shares in Cassava fell more than 20% to $2.20 when the markets opened Tuesday from a Monday closing price of $2.78.

Plus, news about Relmada Therapeutics and Mural Oncology: Cassava Sciences finally stops work on Alzheimer’s drug: After a Phase 3 study of simufilam failed in November, Cassava said it was discontinuing a second Phase 3 trial. On Tuesday, the company said that trial failed, too, and it would stop work on simufilam in Alzheimer’s by the end of June. The drug did not meet primary, secondary or exploratory biomarker endpoints. “These results were unambiguous,” CEO Rick Barry said in a press statement. The SEC last year accused the drug’s co-developer Hoau-Yan Wang, a CUNY School of Medicine professor, of manipulating clinical trial results. Former CEO Remi Barbier and SVP of neuroscience Lindsay Burns paid more than $40 million to settle charges they made misleading statements about the Phase 2 studies. They allegedly told investors that the drug had significant therapeutic benefits when it did not. The company then continued studying the treatment. Cassava said Tuesday that it started preclinical studies of simufilam for epilepsy in people with tuberous sclerosis complex. Its stock $SAVA was down about 21% on Tuesday morning. — Lei Lei Wu Alumis inks deal in Japan: The California immunology biotech will get $40 million in upfront and near-term payments from Kaken Pharmaceutical as part of a licensing deal for rights to its oral TYK2 inhibitor in Japan. The Tokyo-based drugmaker also promised about $140 million in biobucks as part of the licensing deal for Alumis’ ESK-001 in dermatology indications. Alumis shares $ALMS were up about 22% on Tuesday morning. It is currently working on a merger with Acelyrin . — Kyle LaHucik Relmada Therapeutics’ bladder cancer deal: The Florida biotech will pay $3.5 million upfront and issue 3 million, or 10%, of its shares to Trigone Pharma for worldwide rights to an experimental bladder cancer drug. Called NDV-01, the drug is a sustained-release and intravesical formulation of gemcitabine and docetaxel. Relmada will take over development and other work for NDV-01 once an ongoing Phase 2 wraps up. Relmada gets rights to all regions except India, Israel and South Africa. Trigone could receive another $200 million in milestone payments and 3% royalties on net sales. The move comes a few months after Relmada’s depression drug failed another Phase 3 trial. — Kyle LaHucik Mural Oncology to stop a Phase 3 study in ovarian cancer: The biotech said an interim survival analysis showed that its IL-2 drug, called nemvaleukin alfa, plus Merck’s Keytruda was unlikely to succeed versus chemotherapy. Mural’s stock $MURA fell 60% on Tuesday morning. — Lei Lei Wu