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  • Intercept’s next-generation FXR agonist INT-787 fails Phase 2 trial in alcohol-associated hepatitis
    Intercept Pharmaceuticals reported that its experimental FXR agonist INT-787 did not demonstrate efficacy in a Phase 2 study of patients with severe alcohol-associated hepatitis. The trial results…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • Study links specific dietary fats to pancreatic cancer risk, highlighting oleic acid as promoter and omega-3s as protective
    Researchers at Yale Cancer Center examined how different types of dietary fat affect pancreatic cancer development in a mouse model. Rather than focusing on total fat intake, the study compared twe…
    onclive · 6mo agoNeutral↗ source
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  • Experts stress seamless coordination for relapsed multiple myeloma patients across academic and community clinics
    In a recent opinion segment, Dr. Ajay K. Nooka convened a discussion with Dr. Noopur S. Raje and Dr. Surbhi Sidana about how to best coordinate care for patients with relapsed and refractory multip…
    onclive · 6mo agoNeutral↗ source
  • Patient with EGFR-mutated NSCLC develops brain metastases after first-line EGFR inhibitor and chemotherapy
    Dr. Sands presented a case of a patient with metastatic non-small cell lung cancer that carries an EGFR mutation. The patient was treated with a first-line regimen that combined an EGFR tyrosine k…
    onclive · 6mo agoNeutral↗ source
  • Celcuity reports positive Phase 3 results for gedatolisib in PIK3CA-mutant breast cancer
    On May 4, 2026 Celcuity announced that its experimental drug gedatolisib achieved success in two treatment regimens for patients whose tumors carry PIK3CA mutations, according to data from its ongo…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Latus Bio raises $97 million to advance gene therapies for Huntington’s and Batten disease
    Latus Bio announced closing a $97 million Series A round, including a $43 million extension to a prior $54 million raise. Funding was led by 8VC and included eight other investors such as DCVC Bio…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • UCB to buy Candid Therapeutics for up to $2.2 billion, targeting bispecific antibodies for autoimmune disease
    UCB announced a deal to acquire Candid Therapeutics, a startup focused on bispecific antibody drugs, for an upfront payment of $2 billion with up to $200 million in future milestones. The transacti…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • UCB commits $2 billion to Candid's T cell engager program for autoimmune diseases
    UCB, a long standing European pharmaceutical company, announced a $2 billion investment in Candid, a biotech focused on T cell engager therapies aimed at autoimmune conditions. The deal reflects U…
    Endpoints · 6mo agoDealPositive↗ source
  • Celcuity reports positive Phase 3 data for gedatolisib, bolstering broader approval prospects
    Celcuity announced new data from an ongoing Phase 3 trial of its experimental breast cancer drug gedatolisib. The data showed that two- and three-drug combinations that included gedatolisib delaye…
    BioPharma Dive · 6mo agoPositive readoutPositive↗ source
  • Supreme Court reverses stay, allowing mail ordering of abortion pill mifepristone
    The U.S. Supreme Court issued a decision on Monday that restores the ability to order the abortion medication mifepristone by mail. This action overturns a stay that had been placed by a federal ap…
    Endpoints · 6mo agoRegulatoryPositive↗ source
  • Swiss biotech Windward Bio raises $165 million to launch Phase 3 asthma trial for China-derived drug
    Swiss biotech Windward Bio announced it has secured $165 million in financing. The capital will be used to move one of its two experimental medicines, originally discovered in China, into a Phase…
    Endpoints · 6mo agoDealPositive↗ source
  • AI drug repurposing in oncology hampered by fragmented data, curated knowledge needed
    AI tools are being used to look for new cancer indications for existing biologics, but the article notes that fragmented and disparate data sets limit even the most advanced models. Repurposing pr…
    BioPharma Dive · 6mo agoNeutral↗ source
  • Vertex halts mRNA cystic fibrosis program citing tolerability concerns
    Vertex Pharmaceuticals announced it is ending development of its mRNA-based cystic fibrosis therapy after encountering tolerability problems that echo challenges seen elsewhere in the field. The B…
    Endpoints · 6mo agoNegative↗ source
  • FDA narrows search for new CBER chief to three or four finalists
    The FDA announced that its search for a new head of the Center for Biologics Evaluation and Research (CBER) has been narrowed. According to a source familiar with the process, the agency is now fo…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • Biotech sees rise of lean startups backed by large funding and Chinese assets
    A new wave of biotech companies is emerging that prioritises lean organizational structures over extensive early‑stage research programs. These firms are being launched with modest employee counts…
    Endpoints · 6mo agoNeutral↗ source
  • Bristol Myers faces pivotal year as Q1 earnings season begins
    The weekly Endpoints newsletter for the last week of April highlighted that several pharmaceutical companies released their first-quarter earnings. Among them, Bristol Myers was singled out as bei…
    Endpoints · 6mo agoEarningsNeutral↗ source
  • Bristol Myers shows modest revenue rise, Biogen beats forecasts, Regeneron outlook remains uncertain
    BioPharma Dive highlighted the latest quarterly earnings from three major biotech firms, noting how investors are interpreting the results. Bristol Myers Squibb reported $11.5 billion in revenue f…
    BioPharma Dive · 6mo agoEarningsNeutral↗ source
  • FDA approves Arvinas' PROTAC drug Veppanu for specific metastatic breast cancer
    U.S. regulators have granted approval for Veppanu, a protein-degrading therapy developed by biotech firm Arvinas, to treat a defined group of patients with metastatic, estrogen-receptor-positive, H…
    BioPharma Dive · 6mo agoApprovalPositive↗ source
  • Summit Therapeutics' ivonescimab misses interim goal, shares tumble 27% as trial setback raises doubts
    Summit Therapeutics reported that its experimental immunotherapy ivonescimab failed to achieve statistical significance at an interim analysis of the late-stage HARMONi-3 trial in frontline non‑sma…
    BioPharma Dive · 6mo agoNegative readoutNegative↗ source
  • FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation
    The U.S. Food and Drug Administration has granted approval to Axsome Therapeutics’ oral medication Auvelity for the treatment of agitation in patients with Alzheimer’s disease. Axsome noted that a…
    Endpoints · 6mo agoApprovalPositive↗ source
  • Summit Therapeutics shares tumble 20% after interim Phase 3 miss for ivonescimab
    Summit Therapeutics saw its shares fall about 20% after the market close on Thursday. The decline came after an interim analysis of a Phase 3 trial for its cancer candidate ivonescimab failed to m…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • Two biotech firms raise $556 million in combined IPOs
    Seaport Therapeutics and Hemab Therapeutics launched initial public offerings on Thursday, together bringing in $556.4 million to fund further development of their drug pipelines. Hemab Therapeuti…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Moderna discusses post-marketing data with FDA to expand Covid-19 vaccine label
    Moderna announced it is working with US regulators to supply post-marketing data on its Covid-19 vaccines. The effort aims to address the FDA's decision last year to narrow the vaccine label, limi…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • FDA greenlights Pfizer/Arvinas breast cancer therapy vepdegestrant despite modest trial results
    The U.S. Food and Drug Administration announced approval of vepdegestrant, a therapy developed by Pfizer and Arvinas, for a specific subtype of breast cancer. The decision comes even though the cl…
    Endpoints · 6mo agoApprovalNeutral↗ source
  • Amgen initiates three late-stage trials of obesity shot MariTide, including a switch-patient study
    Amgen announced the start of three new Phase 3 trials for its long-acting obesity injection, MariTide. One of the studies will enroll participants who are transitioning away from the GLP-1 therapi…
    Endpoints · 6mo agoCRLPositive↗ source