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  • Capricor boosts manufacturing capacity as FDA decision on DMD cell therapy looms
    Capricor Therapeutics, a biotech developing a cell therapy for Duchenne muscular dystrophy, is preparing for an FDA decision expected by late November. The company’s third-quarter operating expens…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Flagship Pioneering combines Valo Health and Montai Therapeutics into a single company
    Flagship Pioneering announced that two of its portfolio companies, Valo Health and Montai Therapeutics, are merging to form a new entity. The combined firm will consolidate resources and expertise…
    Endpoints · 1d agoDealNeutral↗ source
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  • PepGen stock surges as DM1 oligonucleotide PGN-EDODM1 shows record splicing correction in Phase 2
    PepGen reported that its experimental oligonucleotide PGN-EDODM1 achieved a mean splicing correction of 46.5% at week 13 in a Phase 2 trial for myotonic dystrophy type 1 (DM1). This performance exc…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • 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
  • US biotech faces growth slowdown as China’s coordinated investment threatens industry
    During a BioSpace webinar, industry experts warned that uncertainty in U.S. policy is slowing biotech growth while China accelerates its life-science sector with deliberate investment. Strand Ther…
    BioSpace · 1d agoRegulatoryNegative↗ 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
  • FDA issues warning letters to two Chinese API makers for refusing record requests
    The U.S. Food and Drug Administration sent warning letters to Chongqing Qiancan Technology and Tianjin Healthcare Medical Technology after both companies declined to provide records the agency requ…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • Capricor trims 10% of workforce as FDA decision on Duchenne cell therapy approaches
    Capricor Therapeutics announced it is cutting about 10% of its staff ahead of an upcoming FDA decision on its Duchenne muscular dystrophy cell therapy, deramiocel. The biotech said it had 231 full…
    BioSpace · 1d agoLayoffsNegative↗ 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
  • 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 · 1d 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
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 1d agoNeutral↗ 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
  • Bayer's Sunharbo becomes first FDA-approved factor XIa inhibitor blood thinner
    Bayer's oral anticoagulant Sunharbo, known as asundexian, has received FDA approval, making it the first factor XIa inhibitor cleared for use in the United States. The drug is intended to lower th…
    BioSpace · 2d agoApprovalPositive↗ source
  • Beam Therapeutics' base-edited risto-cel shows 12-month pain-crisis freedom in sickle cell trial, paving way for FDA filing
    Beam Therapeutics reported that its base-edited cell therapy, risto-cel, achieved at least 12 consecutive months without severe vaso-occlusive crises in patients with sickle cell disease during a m…
    BioSpace · 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 · 2d agoApprovalPositive↗ source
  • FDA's new rare-disease framework faces first test with Capricor's Duchenne therapy decision
    The FDA announced a new "fit-for-purpose" rare disease framework that aims to evaluate therapies based on patient need and realistically attainable evidence. The first real test of the approach wi…
    BioSpace · 2d agoRegulatoryNeutral↗ 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
  • Coherus trims workforce by 30% as Gyre Therapeutics also cuts staff after acquisition
    Coherus Oncology announced a 30% reduction in its workforce as part of a reorganization that narrows its pipeline. The cuts follow a decision to deprioritize a combination therapy across multiple…
    BioSpace · 2d agoLayoffsNegative↗ 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
  • 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 · 2d agoDealPositive↗ source
  • Acting FDA commissioner reports strong public interest in new expedited IND pilot
    Acting FDA Commissioner Kyle Diamantas told attendees at the Friends of Cancer Research annual meeting that the agency’s newly launched Expedited IND pilot has attracted considerable public attenti…
    raps · 2d agoRegulatoryPositive↗ source
  • Democrats demand unredacted drug pricing agreements from pharma firms after midterm victories
    Congressional Democrats have intensified scrutiny of pharmaceutical pricing agreements made under the previous administration. On Monday they sent letters to every drug maker that entered a most f…
    Endpoints · 2d agoRegulatoryNeutral↗ source