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  • Telix to acquire German radioisotope maker ITM in deal valued up to $2.35 billion
    Telix Pharmaceuticals announced it will purchase ITM Isotope Technologies Munich SE, a German producer of medical radioisotopes, for an upfront payment of $1.65 billion. The transaction could rise…
    Endpoints · 1mo agoDealNeutral↗ source
  • ADARx aims for $318 million IPO as TRexBio and Retension also file
    ADARx Pharmaceuticals, a siRNA biotech currently in Phase 3 trials, announced plans to raise roughly $318 million through an initial public offering. The company is joining other biotech firms suc…
    Endpoints · 1mo agoDealNeutral↗ source
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  • TRex Bio and Retension Pharma announce plans for IPOs, outlining biotech pipeline funding
    Biotech companies Retension Pharmaceuticals and TRex Bio have filed with the SEC indicating they intend to go public this year, adding to the current wave of biotech IPOs. TRex Bio said it will us…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Regulators call for unified AI guidelines in drug development at RAPS Convergence 2026
    Regulators and industry experts gathered at RAPS Convergence 2026 in Charlotte, NC to discuss the growing role of artificial intelligence in drug development. The panel highlighted that differing…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA staff flag no major concerns for Grail's multi-cancer test ahead of advisory committee
    FDA staff have completed a review of Grail's multi-cancer early detection test and reported no major concerns. The assessment comes as the test approaches a scheduled advisory committee meeting, w…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Novo outlines diversification strategy with new pipeline assets and bolt-on deals
    Novo Pharmaceuticals' chief executive Maziar Mike Doustdar used the company's recent capital-markets day in London to lay out a diversification plan. He said the rebranded firm will focus on expand…
    Endpoints · 1mo agoDealPositive↗ source
  • Cue Biopharma's chronic hives drug clears Phase 2 trial, first immunology data after cancer pivot
    Cue Biopharma announced that its candidate for chronic spontaneous urticaria successfully completed a Phase 2 trial in China. The trial marks the company's first clinical data since it shifted its…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Cue Biopharma's CUE-221 meets primary endpoint in phase 2 CSU trial, eyes phase 2b/3
    Cue Biopharma reported that its chronic spontaneous urticaria (CSU) candidate CUE-221 achieved the primary endpoint in a midstage study conducted in China. The trial enrolled 145 patients who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • FDA to replace animal testing terms with broader nonclinical language in regulations
    The U.S. Food and Drug Administration announced it will revise its regulations to replace references to animal testing with broader terms such as "nonclinical tests" and "nonclinical studies". The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Iambic Therapeutics launches next-gen Enchant AI model and inks R&D partnership with AbbVie
    Iambic Therapeutics, a San Diego‑based biotech founded in 2019, announced the release of the next generation of its Enchant artificial‑intelligence model. The updated model is intended to enhance…
    Endpoints · 1mo agoDealPositive↗ source
  • Singapore’s Health Sciences Authority expands regulatory partnerships across Africa, Asia and Europe
    Singapore’s Health Sciences Authority (HSA) announced that it is broadening its regulatory reliance and cooperation framework. The agency is establishing new alliances with regulatory bodies in se…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Beacon Therapeutics reports positive pivotal trial results for X-linked retinitis pigmentosa gene therapy
    Beacon Therapeutics said its gene therapy for X-linked retinitis pigmentosa (XLRP) met the primary endpoint in a phase 2/3 Vista study. The trial enrolled 85 male patients and compared two dose lev…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Novartis faces another setback while Novo drops Nordisk partnership
    The latest edition of Endpoints Weekly notes that Novartis experienced another failure, though the newsletter does not provide details about the product or trial. It also reports that Novo Nordisk…
    Endpoints · 1mo agoNegative↗ source
  • FDA clears Aptitude’s latest Metrix molecular dx to test for COVID
    The FDA granted Aptitude its first 510(k) clearance for the next-generation Metrix COVID diagnostic that features three-times greater sensitivity with 30% faster results that its original emergency…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • FDA approves Eli Lilly's oral SERD Inluriyo combo for second-line metastatic breast cancer
    The FDA has given approval to a new combination therapy from Eli Lilly that includes its oral selective estrogen receptor degrader, Inluriyo, for patients with metastatic breast cancer who have pro…
    Endpoints · 1mo agoApprovalPositive↗ source
  • EU regulator backs Novo's hemophilia A preventive therapy and recommends seven additional drugs
    The European Medicines Agency's human medicines committee issued a positive opinion on Novo's preventive treatment for hemophilia A, indicating it meets the agency's standards for further developme…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Novo Nordisk acquires three early-stage obesity programs from Kallyope
    Novo Nordisk announced the purchase of three early-stage obesity drug programs from New York‑based biotech Kallyope, expanding its metabolic pipeline. The acquired assets are not GLP‑1 incretins.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Electra Therapeutics raises $350 million in Nasdaq IPO to fund commercial expansion
    Electra Therapeutics announced that it priced its initial public offering on the Nasdaq at $350 million, becoming the 21st biotech to go public in 2026. The Bay Area‑based company said the capital…
    Endpoints · 1mo agoDealPositive↗ source
  • All 50 states, DC, and Puerto Rico join new Medicaid most-favored-nation drug pricing model, Trump says
    President Donald Trump announced that every U.S. state, the District of Columbia and Puerto Rico will take part in a new Medicaid drug‑pricing framework. The model requires pharmaceutical manufact…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA reports decline in initial drug rejections, refutes claims of rising denials
    The U.S. Food and Drug Administration announced that the number of drugs turned down after an initial review has fallen, contrary to recent speculation. The agency said the notion that it is incre…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • China unveils new five-year plan to boost biotech and pharma and compete globally
    China's government released its latest five-year plan aimed at expanding the country's biotech and pharmaceutical sectors. The document outlines a strategy to strengthen research, development and m…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Alkermes reports promising Phase 1b results for orexin agonist ALKS 7290 in ADHD
    Alkermes presented data from a Phase 1b study that evaluated its orexin-based compound ALKS 7290 in adults with attention-deficit/hyperactivity disorder. The trial enrolled 50 participants who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • AI's early, uneven impact on clinical trials sparks surprise
    The pharmaceutical industry is beginning to see artificial intelligence applied to clinical trial processes, though adoption is occurring in fits and starts. Early uses of AI are emerging in areas…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Medtronic secures FDA clearance for LigaSure vessel sealer on Hugo robotic platform
    Medtronic announced that the U.S. Food and Drug Administration has cleared its LigaSure RAS Maryland jaw vessel sealer-divider for use with the company's Hugo robotic-assisted surgery system. The…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Xenon pauses enrollment in phase 3 depression trials after reports of psychosis and other neuropsychiatric events
    Xenon Pharmaceuticals announced it has voluntarily stopped enrolling new patients in its two phase 3 studies of azetukalner for major depressive disorder and bipolar depression. The decision follo…
    Fierce Biotech · 1mo agoNegative↗ source