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  • Beeline Medicines reports promising Phase 2 results for lupus using repurposed Bristol Myers drug
    Beeline Medicines announced that its Phase 2 trial in systemic lupus erythematosus produced encouraging results. The study tested three different doses of a compound originally discovered by Brist…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • VectorY Therapeutics raises $83.5M Series A to develop brain-targeted antibody gene therapy
    VectorY Therapeutics announced it has closed a Series A financing round, adding €74.5 million ($83.5 million) to its capital. The funds will be used to advance its lead gene-therapy candidate VTx-…
    Endpoints · 1d agoDealNeutral↗ source
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  • Flagship-backed Valo Health merges with Montai Therapeutics to boost AI-driven drug pipeline
    Valo Health and Montai Therapeutics announced they will combine under the Valo brand, creating a larger AI-focused biotech aimed at accelerating early-stage drug discovery. Valo, launched in 2020…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Dual targeting of GPCRs and mutated Gαq/11 shows promise for uveal melanoma
    Researchers at Thomas Jefferson University reported a new strategy to disrupt signaling in uveal melanoma, a rare eye cancer. The study found that simultaneously inhibiting the G protein-coupled r…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Neurosterix raises $105 million Series B to advance schizophrenia candidate
    Neurosterix announced it has closed a $105 million Series B financing round. The capital will be used to develop its lead drug candidate for schizophrenia, which targets a pathway also addressed by…
    Endpoints · 1d agoDealPositive↗ source
  • Merck KGaA receives FDA approval for Abbisko-licensed joint tumor therapy
    Merck KGaA announced that the U.S. Food and Drug Administration has granted approval to a drug it licensed from Chinese biotech Abbisko. The approval covers treatment of rare non-cancerous tumors t…
    Endpoints · 1d agoApprovalPositive↗ source
  • Capricor cuts 10% of staff as it readies FDA decision on DMD cell therapy, NextCure trims workforce ahead of merger
    Capricor Therapeutics announced that it has reduced its workforce by about 10% during the third quarter, bringing its employee count down from 231 full‑time staff. The company said it had $198.5 mi…
    Fierce Biotech · 2d agoLayoffsNeutral↗ source
  • Amgen builds Sjögren’s case with detailed phase 3 data ahead of Novartis showdown
    Amgen has shared more data from a phase 3 Sjögren’s disease trial that dazzled analysts, digging into the details that could shape its showdown with Novartis.
    Fierce Biotech · 2d agoDealNeutral↗ source
  • FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapies
    The U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors. The g…
    raps · 2d agoRegulatoryNeutral↗ source
  • UK science minister urges life-science firms to boost domestic investment as government raises medicine spending
    At a Financial Times Global Pharma and Biotech Summit, the UK science minister highlighted the need for greater domestic investment in life-science companies. The call follows a recent increase in…
    Endpoints · 1d agoPositive↗ source
  • Hims & Hers pivots to branded GLP-1 drugs after striking deal with Eli Lilly
    Hims & Hers, which previously emphasized personalized care through compounded products, is changing its business model. The company is now focusing on established brand-name GLP-1 treatments rathe…
    Endpoints · 1d agoDealPositive↗ source
  • Beam Therapeutics reports year-long reduction in sickle cell crises in phase 1/2 risto-cel study
    Beam Therapeutics disclosed data from its phase 1/2 trial of risto-cel, a base-edited autologous cell therapy targeting the BCL11A gene in sickle cell disease. The trial enrolled 31 adults and ado…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Bayer's asundexian receives FDA approval for stroke prevention
    Bayer announced that the U.S. Food and Drug Administration has approved its oral anticoagulant asundexian for stroke prevention. The drug is indicated to lower the risk of subsequent stroke in pati…
    Endpoints · 3d agoApprovalPositive↗ source
  • Oura to buy AI virtual care firm Counsel Health for $625 million, expanding in-app health services
    Oura, known for its smart ring and health tracking, announced it will acquire Counsel Health, an AI-driven virtual primary-care provider, for $625 million in cash. The acquisition is slated to clo…
    Fierce Biotech · 2d agoDealPositive↗ source
  • AstraZeneca acquires Omniose to boost bacterial vaccine capabilities
    AstraZeneca has completed the purchase of Omniose, a specialist in vaccine bioconjugation, making the company a wholly owned subsidiary of its infectious disease division. The two firms began coll…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Mirum's hepatitis D antibody brelovitug meets primary endpoint in phase 3 trial
    Mirum Pharmaceuticals announced that its experimental antiviral monoclonal antibody brelovitug achieved the primary efficacy goal in a phase 3 study for hepatitis D. The trial results continue a s…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Mirum readies FDA filing after positive Phase 3 results for hepatitis D therapy
    Mirum Pharmaceuticals announced that its hepatitis D candidate has met its primary goals in the second of two pivotal studies. The company said the data support moving the product toward regulatory…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • Beam Therapeutics' base-edited sickle cell therapy shows success in Phase 1/2 trial
    Beam Therapeutics announced on Tuesday that its base-edited gene therapy for sickle cell disease met its primary endpoints in a Phase 1/2 study. The trial demonstrated that a single administration…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • PepGen reports positive Phase 2 data for PGN-EDODM1 in myotonic dystrophy
    PepGen disclosed that its experimental oligonucleotide therapy PGN-EDODM1 showed encouraging early signals in a Phase 2 cohort of patients with myotonic dystrophy type 1 (DM1). The company said the…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • Start Center for Cancer Research launches Italy’s first early-phase oncology trial site with IFO
    Start Center for Cancer Research has opened its first early-phase cancer clinical trial site in Italy, partnering with the public research hospital group Istituti Fisioterapici Ospitalieri (IFO).…
    Fierce Biotech · 2d agoDealPositive↗ source
  • PepGen's Phase 2 DM1 Data Show 46% Average Splicing Correction, Shares Jump 163%
    PepGen reported results from the 10 mg/kg multiple‑ascending‑dose cohort of its ongoing Phase 2 Freedom2‑DM1 trial, testing PGN‑EDODM1, an oligonucleotide designed to correct the molecular defect i…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • London startup Oyster Therapeutics raises $60M to develop oral tau degraders for Alzheimer’s
    Oyster Therapeutics, a London‑based biotech, announced it has closed a $60 million Series A‑2 financing round. The round was led by 4BIO Capital, a life‑science venture capital firm, with addition…
    Endpoints · 3d agoDealPositive↗ source
  • Intersurgical pulls 22mm smoothbore breathing tubes after FDA warns of detaching connectors
    The FDA Center for Devices and Radiological Health issued an early alert about a potentially high‑risk issue with certain Intersurgical breathing devices. Intersurgical has sent a letter to custom…
    fda medwatch · 3d agoRegulatoryNegative↗ source
  • FDA issues early alert as Arrow International recalls guidewires with spring wire guide components
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk issue with certain Arrow International guidewire products that contain spring wire guide c…
    fda medwatch · 3d agoRegulatoryNeutral↗ source
  • Deerfield Management teams with AWS to boost AI-driven life-science ventures
    Deerfield Management announced a collaboration with Amazon Web Services aimed at accelerating AI-native healthcare and life-science companies in its portfolio. The agreement links AWS's generative…
    Fierce Biotech · 3d agoDealPositive↗ source