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96 stories matching this filter · ← front page

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  • Pediatric rare cancer research draws steady investment despite biotech market volatility
    The article notes that pediatric rare cancers continue to attract investment because they address the greatest unmet medical needs and allow clear measurement of patient impact. Even as the biotec…
    BioSpace · 8h agoPositive↗ source
  • Amylyx reports promising GLP-1 blocker results while Summit faces survival setbacks and Definium shows anxiety therapy benefit
    Amylyx said its investigational GLP-1 blocker avexitide cut the combined rate of level 2 and level 3 hypoglycemic events by about 55% in patients with post‑bariatric hypoglycemia, beating analyst e…
    BioSpace · 1d agoNeutral↗ source
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CLINUVEL to cut up to 20% of staff and move headquarters to New York
CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
BioSpace · 22h agoLayoffsNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial after safety concerns
    Regeneron announced termination of a Phase 1/2 study of its investigational anti-inflammatory antibody REGN7041, which was being evaluated for non-infectious uveitis. The company said the decision…
    BioSpace · 2d agoNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial over unfavorable risk-benefit profile
    Regeneron has stopped a Phase 1/2 study of its anti‑inflammatory antibody REGN7041 in non‑infectious uveitis, citing an unfavorable benefit‑risk assessment. The antibody targets CD3 on immune cell…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Summit Therapeutics and Akeso celebrate third China approval for ivonescimab as new data show waning survival benefit
    Summit Therapeutics and its partner Akeso received a third approval in China for ivonescimab, a PD-1/VEGF bispecific antibody, for first-line treatment of advanced squamous non-small cell lung canc…
    BioSpace · 2d agoRegulatoryNegative↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca announced it is stopping a Phase 3 study of its bispecific antibody volrustomig in metastatic non-small cell lung cancer after an interim analysis showed the drug is unlikely to meet it…
    BioSpace · 3d agoNegative readoutNegative↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca said it is ending its Phase 3 eVOLVE-Lung02 trial that evaluated the bispecific antibody volrustomig combined with chemotherapy as a first-line option for metastatic non-small cell lung…
    BioSpace · 3d agoNegative readoutNegative↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Taiho and Cullinan’s zipalertinib shows progression‑free survival benefit in Phase 3 NSCLC trial
    Taiho Pharmaceutical and Cullinan Therapeutics reported that their EGFR inhibitor zipalertinib, combined with chemotherapy, significantly extended progression‑free survival for patients with advanc…
    BioSpace · 6d agoPositive readoutPositive↗ source
  • Avalyn Pharma CEO shares personal moment as company prepares for Nasdaq IPO
    Avalyn Pharma and Generate Biomedicines executives talked about the long hours and challenges of preparing their companies for an initial public offering. Avalyn CEO Lyn Baranowski highlighted a m…
    BioSpace · 7d agoPositive↗ source
  • Seven deaths linked to Neurocrine’s Prader-Willi drug Vykat raise safety concerns
    Clinicians have warned that seven patients who received Neurocrine Biosciences' recently approved Prader-Willi syndrome therapy Vykat have died, prompting a new safety alert for the patient communi…
    BioSpace · 7d agoRegulatoryNegative↗ source
  • Sentynl inks up to $475M licensing deal to commercialize Mereo’s alvelestat for rare lung disease
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, signed an agreement to obtain exclusive U.S. rights to market alvelestat, Mereo BioPharma’s investigational therapy for alpha-1 antitrypsin…
    BioSpace · 8d agoDealPositive↗ source
  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 9d agoNegative readoutNegative↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 10d agoDealNeutral↗ source
  • Moderna's mRNA flu vaccine mFLUVISA receives FDA approval after earlier filing refusal
    The U.S. Food and Drug Administration initially issued a refusal-to-file letter to Moderna's flu vaccine in February, but a few days later reversed that decision and accepted a revised submission f…
    BioSpace · 14d agoApprovalPositive↗ source
  • Sanofi pauses Phase 2 bronchiectasis study of SAR445399 amid new CEO’s portfolio review
    Sanofi has halted a Phase 2 trial of its investigational antibody SAR445399 in non‑cystic fibrosis bronchiectasis. The pause was attributed to strategic business reasons linked to an internal portf…
    BioSpace · 13d agoRegulatoryNeutral↗ source
  • AstraZeneca and BMS deny merger talks, Reuters says no deal
    Reuters reported that rumors of a merger between AstraZeneca and Bristol Myers Squibb have been dismissed. A senior source close to the matter told Reuters there is no deal and no discussions betw…
    BioSpace · 14d agoDealNeutral↗ source
  • Five BioSpace NextGen companies debut on US markets in 2026, four actively hiring
    BioSpace NextGen honorees accounted for about one third of the 14 U.S. biotech companies that went public in 2026. The five companies together raised roughly $1.5 billion in IPO proceeds, includin…
    BioSpace · 15d agoPositive↗ source
  • Pathos AI signs two cancer deals, including $2 bn contract with China's Alphamab and partnership with AstraZeneca
    Pathos AI announced two new collaborations to expand its oncology pipeline, one with AstraZeneca and another with a subsidiary of China's Alphamab Oncology. The deal with Jiangsu Alphamab Biopharm…
    BioSpace · 16d agoDealPositive↗ source
  • Merck’s anti‑TL1A antibody tulisokibart fails Phase 2b in systemic sclerosis lung disease but succeeds in hidradenitis suppurativa
    Merck reported mixed Phase 2b results for its anti‑TL1A monoclonal antibody tulisokibart, acquired in the 2023 Prometheus Biosciences purchase. In patients with systemic sclerosis‑associated inter…
    BioSpace · 15d agoNegative readoutNeutral↗ source
  • As portfolio erodes, BMS stands to gain a lot from rumored AstraZeneca merger
    While both drugmakers face looming patent cliffs, analysts say joining forces could help Bristol Myers Squibb replenish its eroding portfolio—while the strategic case for AstraZeneca seems to be mo…
    BioSpace · 15d agoDealNeutral↗ source
  • Analysts deem AstraZeneca-BMS merger unlikely despite market buzz
    Analysts say that talks between AstraZeneca and Bristol Myers Squibb are unlikely to result in a merger because the two companies have overlapping product lines that would attract heavy antitrust s…
    BioSpace · 17d agoDealNeutral↗ source
  • BioNTech appoints Sobi CEO Guido Oelkers as new chief, founders to launch separate mRNA biotech
    BioNTech announced that Guido Oelkers, current chief executive of Swedish Orphan Biovitrum (Sobi), will assume the role of CEO in early 2027. The move follows the earlier decision of co‑founders U…
    BioSpace · 16d agoNeutral↗ source
  • Analysts say Daiichi Sankyo’s ADC pipeline lags rivals as cash flow peaks, cutting expectations
    Jefferies analysts warned that Daiichi Sankyo's early‑stage antibody‑drug conjugate (ADC) pipeline is falling behind competitors, even as the company approaches a peak in cash flow from its existin…
    BioSpace · 20d agoNegative↗ source