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  • Epkinly shows 51% lower risk of progression in frontline DLBCL trial, boosting hopes for expanded approval
    New Phase 3 data from the Epkinly and R-CHOP combination in diffuse large B cell lymphoma showed a 51% reduction in the risk of disease progression or death compared with standard therapy. The stud…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • ArriVent BioPharma's Phase 3 lung cancer trial misses primary endpoint, shares tumble
    ArriVent BioPharma reported that its investigational EGFR tyrosine kinase inhibitor firmonertinib did not achieve a statistically significant improvement in progression-free survival in the Phase 3…
    BioSpace · 14d agoNegative readoutNegative↗ source
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  • Cadrenal Therapeutics launches strategic review to explore sale or partnership for its late-stage cardiology pipeline
    Cadrenal Therapeutics, a heart-focused biotech, announced a strategic review of its late-stage cardiology pipeline, seeking to offload assets or the entire company. The board is evaluating options…
    Fierce Biotech · 15d agoDealNegative↗ source
  • Caribou Biosciences to halt R&D and cut staff as financing for allogeneic CAR-T dries up
    Caribou Biosciences, co‑founded by Nobel laureate Jennifer Doudna, announced it will stop all clinical‑stage work and lay off staff because of a financing freeze in the allogeneic CAR‑T market. Th…
    BioSpace · 15d agoLayoffsNegative↗ source
  • Matchpoint Therapeutics raises $150M Series B to advance oral covalent therapies for autoimmune disease
    Matchpoint Therapeutics announced a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures, Digitalis Ventures, Invus, BB…
    Fierce Biotech · 15d agoDealPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 15d agoRegulatoryNeutral↗ source
  • Biotech VC Forbion raises record €2.3 bn ($2.6 bn) to back 30 high-potential life-science companies
    Forbion announced a record fundraising of €2.3 bn ($2.6 bn) across two new funds, bringing its assets under management to about €7.5 bn ($8.4 bn). The capital will be allocated through the Forbion…
    BioSpace · 15d agoDealPositive↗ source
  • ARPA-H launches Surpass program to speed and broaden clinical trials
    The U.S. Department of Health and Human Services announced a new initiative called Surpass, aimed at removing obstacles that slow clinical development and changing how trials are designed and run.…
    Fierce Biotech · 15d agoPositive↗ source
  • Bayer invests $2.2 billion in Ohio to build pharma manufacturing plant
    Bayer announced a $2.2 billion investment to construct a new pharmaceutical manufacturing complex in New Albany, Ohio. The plant will produce drug substances and finished products for oncology, ca…
    BioSpace · 15d agoDealNeutral↗ source
  • TCGX raises $600 million to fund Asian biotech startups
    Investment firm TCGX announced a new $600 million Asia Life Sciences Fund I aimed at supporting biotech companies across the region. The fund will operate separately but in close coordination with…
    Fierce Biotech · 15d agoDealPositive↗ source
  • Atsena reports early efficacy signals for gene therapy ATSN-201 in X-linked retinoschisis trial
    Atsena Therapeutics presented data from the early parts of its Lighthouse gene therapy trial for X-linked retinoschisis (XLRS) at the American Academy of Ophthalmology meeting. The trial administe…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Venture capital continues to flow into biopharma in Q3 2026, favoring later-stage and AI-driven companies
    Venture capital funding into biopharma topped $16 billion in the first half of 2026 and kept rising in the third quarter, according to industry sources. Investors remain selective, directing money…
    BioSpace · 15d agoDealNeutral↗ source
  • Stryker appoints Spencer Stiles as CEO, Kevin Lobo to become Executive Chair
    Stryker announced a leadership change, naming Spencer Stiles as the new chief executive officer. Stiles, who has been president and COO, will also join the board. Kevin Lobo, who has led the compa…
    Fierce Biotech · 15d agoNeutral↗ source
  • Executive candidates need full truth, not a sales pitch, to address company challenges
    The article argues that candidates for senior roles must be given an honest picture of the company's problems rather than a polished sales narrative. It notes that during executive searches, infor…
    BioSpace · 15d agoNeutral↗ source
  • iRegene Therapeutics’s NouvSight001 Cleared for Clinical Trials in the U.S. and China for Retinitis Pigmentosa
    Following its Parkinson’s disease program, iRegene advances another off-the-shelf cell therapy into clinical development in the U.S. and China.
    Fierce Biotech · 15d agoNeutral↗ source
  • Epkinly shows 51% PFS boost in frontline DLBCL, may become new standard of care
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a substantial gain in progression‑free survival when added to the standard R‑CHOP regimen in newly diagnosed diffuse large…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • MimiVax’s cancer vaccine fails phase 2 glioblastoma study, but CEO still sees data as ‘inspiring’
    MimiVax has reports a phase 2b miss in newly diagnosed glioblastoma patients, but remains positive about a significant survival benefit in a subset of patients 65 years and under.
    Fierce Biotech · 15d agoNegative readoutNegative↗ source
  • Forbion raises record €2.3 billion to back 30 European biotech firms
    Forbion Capital Partners announced it has closed two new funds, the Growth Opportunities Fund IV and Ventures Fund VIII, together raising €2.3 billion, a record for the European life‑sciences ventu…
    Fierce Biotech · 16d agoDealPositive↗ source
  • TRex Bio targets $111M IPO as Retension and Lycia also prepare public listings
    TRex Bio, backed by Eli Lilly, filed with the SEC to raise about $111.3 million by offering 8.3 million shares priced between $14 and $16. If the midpoint price is achieved, the company expects net…
    Fierce Biotech · 16d agoDealNeutral↗ source
  • UK regulator to shift from one-off checks to continuous monitoring of AI medical devices
    The UK’s Medicines and Healthcare products Regulatory Agency announced a new policy that will require continuous monitoring of AI‑driven medical devices, replacing the current one‑time review model…
    Fierce Biotech · 16d agoRegulatoryPositive↗ source
  • Caribou Biosciences halts pipeline and announces major workforce cut
    Caribou Biosciences, a Bay Area biotech that develops off-the-shelf CAR-T cell therapies, said it will stop all clinical development and begin a substantial workforce reduction. The company, which…
    Fierce Biotech · 15d agoLayoffsNegative↗ source
  • Compliance worries keep AI adoption in drug manufacturing low, survey finds
    A new survey of more than 400 research and manufacturing professionals shows that over 90% of drugmakers have not committed to expanding AI use in regulated drug production. While AI is widely em…
    BioSpace · 16d agoRegulatoryNegative↗ source
  • ArriVent’s phase 3 EGFR inhibitor trial misses primary endpoint, shares plunge 57%
    ArriVent BioPharma reported results from its phase 3 Furvent trial, which evaluated firmonertinib, a brain-penetrant EGFR inhibitor, in patients with exon 20 insertion-mutated non-small cell lung c…
    Fierce Biotech · 16d agoNegative readoutNegative↗ source
  • Kairos pushes prostate cancer drug ENV-105 into earlier treatment line after promising mid-phase data
    Kairos Pharma announced a change to its phase 2 trial of ENV-105, a prostate cancer candidate, moving it to an earlier line of therapy. The modified protocol will enroll patients whose PSA rises a…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • Abbott receives FDA clearance for CardioMEMS HF System updates enabling home pressure monitoring via smartphone app
    Abbott announced that the U.S. Food and Drug Administration has cleared updated software for its CardioMEMS HF System. The changes add a patient facing component through the CardioGuide HF mobile a…
    Fierce Biotech · 16d agoApprovalPositive↗ source