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  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Phase III trial shows tebentafusp doubles five-year survival in untreated metastatic uveal melanoma
    A Phase III study of tebentafusp in patients with previously untreated metastatic uveal melanoma reported that five-year overall survival was roughly twice that of the control group. The trial als…
    onclive · 6mo agoPositive readoutPositive↗ source
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  • Biogen advances tau-targeting Alzheimer drug to Phase 3 despite mixed Phase 2 data
    Biogen reported results from a Phase 2 trial of its tau-targeting Alzheimer’s candidate diranersen (BIIB080). The study measured tau levels in cerebrospinal fluid and brain tissue of patients with…
    STAT · 6mo agoPositive readoutPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 6mo agoApprovalPositive↗ source
  • AVB-001 Cell Therapy Demonstrates Safety and Immune Activation in Platinum-Resistant Ovarian Cancer
    AVB-001, an encapsulated interleukin-2 cell therapy, was evaluated in patients with platinum-resistant high-grade serous ovarian carcinoma. The study reported that the treatment was well tolerated.…
    onclive · 6mo agoPositive readoutPositive↗ source
  • FDA commissioner Marty Makary exits, acting head Kyle Diamantas named as podcast discusses impact and Senate health race
    The Readout Loud podcast episode focused on health politics, featuring a discussion of FDA commissioner Marty Makary's departure. Hosts examined why Makary is leaving, which of his policies might…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Encoded Therapeutics gene therapy cuts seizures 76% in Dravet syndrome children
    Encoded Therapeutics presented data at the ASGCT26 meeting showing its gene therapy achieved a 76% reduction in seizures among children with Dravet syndrome. The result was observed in three patie…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Rintatolimod added to pembrolizumab and cisplatin yields 50% response rate in recurrent ovarian cancer
    A clinical study evaluated the combination of rintatolimod, pembrolizumab and cisplatin in patients with recurrent ovarian cancer. The regimen produced an objective response rate of 50%, indicatin…
    onclive · 6mo agoPositive readoutPositive↗ source
  • Stage IV Breast Cancer Cases Rise Over Past Decade, Dana-Farber Study Shows
    A recent analysis by Dana-Farber Cancer Institute examined breast cancer diagnoses over the past ten years. The researchers found that the number of patients diagnosed with stage IV disease has ri…
    onclive · 6mo agoNeutral↗ source
  • Degron Therapeutics raises $40M in Series A extension, total $95M, as Cabaletta releases early CAR‑T data
    Degron Therapeutics, a US‑China biotech focused on molecular‑glue degrader technology, announced an additional $40 million in Series A extension funding, bringing its total capital raised to $95 mi…
    Endpoints · 6mo agoDealNeutral↗ source
  • Biogen reports mixed results in mid‑stage trial of tau‑targeting Alzheimer’s therapy
    Biogen disclosed data from a Phase 2 study of its experimental Alzheimer’s drug that targets the tau protein. The trial showed a combination of positive and negative signals, with some measures ind…
    STAT · 6mo agoNegative readoutNeutral↗ source
  • Experts anticipate Daraxonrasib and new GI cancer therapies at ASCO 2026
    Ahead of the 2026 ASCO Annual Meeting, leading oncologists and researchers focusing on gastrointestinal cancers highlighted the topics they expect to dominate the conference. Central among the buz…
    onclive · 6mo agoNeutral↗ source
  • Triplet immunotherapy improves survival in HER2‑positive gastric cancer, suggesting broader immune activation
    New data from a study of HER2‑positive gastric cancer patients evaluated a triplet immunotherapy regimen. The analysis compared the combination against standard approaches and focused on overall su…
    onclive · 6mo agoPositive readoutPositive↗ source
  • Zenidatamab regimens show survival benefit in HER2-positive gastric cancer, but PD-L1 test variability raises treatment questions
    The HERIZON‑GEA‑01 study reports that zenidatamab‑based treatment schedules lead to a notable improvement in overall survival for patients with HER2‑positive gastric cancer. These efficacy finding…
    onclive · 6mo agoPositive readoutPositive↗ source
  • Biogen's anti-tau Alzheimer drug BIIB080 fails primary endpoint in Phase 2, but shows slower decline
    Biogen reported results of its Phase 2 trial of BIIB080, a tau-targeting therapy for Alzheimer’s disease. The study’s primary endpoint was not met, meaning the drug did not achieve the pre-specifi…
    Endpoints · 6mo agoNegative readoutNeutral↗ source
  • Regenxbio reports positive Duchenne gene therapy trial results, targets FDA approval by 2027
    Regenxbio announced that its gene therapy for Duchenne muscular dystrophy achieved the required endpoints in a pivotal clinical trial. The data met the study's predefined criteria, which the compa…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • CREATE Medicines raises $122 million to advance CAR-T candidates into human trials
    CREATE Medicines, formerly Myeloid Therapeutics, announced a $122 million financing round. The funding came from Newpath Partners, ARCH Venture Partners, Hatteras Venture Partners and other invest…
    STAT · 6mo agoDealPositive↗ source
  • Acting FDA Commissioner Kyle Diamantas Seen as Drama-Free Stabilizer for Biotech
    Kyle Diamantas has been named the acting commissioner of the Food and Drug Administration, stepping into the role after Marty Makary’s resignation. He previously led the FDA’s food safety division,…
    STAT · 6mo agoRegulatoryPositive↗ source
  • Dr. Jones reports GLP-1 agonists may outperform aspirin in colorectal cancer prevention and tolerability
    Dr. Colton Jones presented findings from a retrospective analysis that compared GLP-1 receptor agonists with aspirin for primary prevention of colorectal cancer. The analysis indicated that patien…
    onclive · 6mo agoPositive readoutPositive↗ source
  • FDA searches for new commissioner as Marty Makary departs, Trump administration outlines priorities
    Marty Makary is leaving his role at the FDA, as reported in STAT’s D.C. Diagnosis newsletter. The Trump administration has released a lengthy wish list for the next FDA commissioner, indicating th…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • MacroGenics sells manufacturing operations to Bora for $122.5M; West Pharma reports cybersecurity breach
    MacroGenics announced it is selling its clinical and commercial drug substance manufacturing portfolio to CDMO Bora. The deal includes an upfront payment of $122.5 million. The transaction transfe…
    Endpoints · 6mo agoDealNeutral↗ source
  • STAT launches investigative series on alcohol epidemic killing 178,000 Americans annually
    STAT has begun a new investigative series that examines the United States’ ongoing alcohol crisis, which the outlet says results in roughly 178,000 deaths each year. The reporting team traveled na…
    STAT · 6mo agoNegative↗ source
  • STAT+: CDC plans to transfer monkeys to nonprofit’s sanctuary as it seeks to reduce animal testing
    The CDC intends to transfer more than 160 macaques to Born Free USA, a nonprofit that runs a large primate sanctuary in Texas, as the agency seeks to phase out…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 6mo agoRegulatoryNeutral↗ source
  • Major digital health firms stay out of Medicare's chronic care ACCESS pilot
    The latest STAT Health Tech newsletter reports that the biggest players in digital health are not participating in Medicare's ACCESS pilot, a program designed to test chronic-care solutions for Med…
    STAT · 6mo agoNeutral↗ source