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1,838 stories matching this filter · ← front page

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  • Matchpoint Therapeutics raises $150 million Series B to move oral T-cell modulator MPT-062 toward clinical trials
    Matchpoint Therapeutics announced the closing of a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures and several exi…
    BioSpace · 1mo agoDealPositive↗ source
  • ARM playbook proposes data reuse to slash gene-editing R&D costs and broaden rare-disease therapies
    The Alliance for Regenerative Medicine released a new playbook that outlines how developers of gene‑editing therapies can reuse existing data to lower research and development expenses. The guidanc…
    BioSpace · 1mo agoRegulatoryPositive↗ source
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  • Venture debt becomes central financing option for late-stage European biotech
    BioSpace’s Denatured podcast recently featured Jennifer McMahon of Seroba and Joey Mason of Claret Capital discussing the growing role of venture debt in European biotech. The guests explained tha…
    BioSpace · 1mo agoPositive↗ source
  • Iambic Therapeutics targets $135M IPO to fund clinical trials of HER2 and KIF18A cancer drugs
    Iambic Therapeutics, a San Diego AI‑driven biotech, filed to raise $135 million in net proceeds through an initial public offering. The company plans to sell 9.4 million shares at $15 to $17 each,…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Ono Pharmaceutical pays $80 million for Asian rights to Biohaven IgG degrader trio, including phase-3 Graves disease candidate
    Japan's Ono Pharmaceutical has agreed to pay $80 million upfront for the rights to three Biohaven IgG degrader programs in Japan, South Korea, Taiwan and ASEAN markets. The agreement also includes…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Zealand's amylin analog shows strong weight loss but weak blood-sugar control in phase 2 trial
    Zealand Pharma, in partnership with Roche, released topline results from its mid‑phase Zupreme‑2 study of petrelintide, an amylin‑based candidate aimed at patients with overweight or obesity and ty…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Argenx’s FB102 meets primary endpoint in phase 2 celiac trial, paving way for pivotal study
    Argenx reported that its experimental antibody FB102 achieved a statistically significant improvement in villus height‑to‑crypt depth (Vh:Cd) compared with placebo in a phase 2 study of adults with…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • FDA unveils transparency roadmap with plans for public NDA/BLA disclosures and inspection report publishing
    The FDA published a transparency roadmap that outlines its FY 2026 achievements and sets out priorities for FY 2027. One key priority is a proposal to require public disclosure of new drug applica…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Rare disease biotech firms expand teams as FDA approvals boost pipelines
    Several biotech companies focused on rare diseases are actively hiring, offering opportunities for professionals interested in this niche therapeutic area. The article highlights four firms that ar…
    BioSpace · 1mo agoPositive↗ source
  • Q3 biopharma layoffs drop 90% year-over-year, affecting about 1,800 workers
    Biopharma companies reduced their layoff activity in the third quarter, with the number of employees affected falling about 90% compared with the same period last year. According to BioSpace data,…
    BioSpace · 1mo agoLayoffsNeutral↗ source
  • EU Commission urges EMA to fast-track Biotech Act preparations
    The European Commission has issued a statement urging the European Medicines Agency to accelerate work on the upcoming Biotech Act, which aims to streamline regulation of advanced therapies. The C…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Vir Biotechnology appoints David Liu as chief medical officer to steer hepatitis D phase 3 and cancer programs
    Vir Biotechnology announced the appointment of David Liu, M.D., Ph.D., as its new chief medical officer. Liu comes from a recent stint as CMO at Nuvation Bio and has held senior roles at AstraZene…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Eli Lilly’s trillion-dollar market cap mirrors Dodgers’ big-spending dominance
    The piece draws a parallel between Eli Lilly and the Los Angeles Dodgers, noting that both organizations dominate their fields by spending heavily. Lilly recently became the first pharmaceutical co…
    BioSpace · 1mo agoPositive↗ source
  • Merck barred from making subcutaneous Keytruda in 8 European countries
    With the patent court siding with Halozyme, Merck faces restrictions on a product that won approval in Europe last year.
    BioSpace · 1mo ago↗ source
  • Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight Europea...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1mo ago↗ source
  • Cerevance's solengepras cuts OFF time in phase 3 Parkinson's trial
    Cerevance reported that its oral non‑dopaminergic therapy, solengepras, produced meaningful improvements in both motor and non‑motor symptoms in a phase 3 Parkinson's disease study, rescuing the ca…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Cerevance's solengepras cuts Parkinson off-time by 0.6 hours in Phase 3, advancing toward FDA review
    Cerevance, a spinout from Takeda, reported that a high 150‑mg dose of its Parkinson's drug solengepras reduced daily "off time" by an average of 0.61 hours compared with placebo in the Phase 3 ARIS…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • 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 · 1mo 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 · 1mo agoNegative readoutNegative↗ source
  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoPositive↗ source