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  • Argenx to acquire peptide specialist Unnatural Products in deal worth up to $1.15 billion
    Argenx announced it will purchase Unnatural Products, a peptide discovery biotech, in a transaction that could total up to $1.15 billion. The deal provides $550 million upfront, with additional co…
    BioSpace · 3h agoDealPositive↗ source
  • Novartis' Phase 3 HORIZON trial shows pelacarsen lowers Lp(a) but fails to cut cardiovascular events
    Novartis and Ionis reported that the Phase 3 HORIZON trial of the antisense drug pelacarsen did not improve major adverse cardiovascular events despite markedly lowering lipoprotein(a) levels. The…
    BioSpace · 3h agoNegative readoutNegative↗ source
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  • Vir Biotechnology reports 44% undetectable hepatitis delta virus in Phase 3 trial, eyes mid-2027 filing
    Vir Biotechnology announced results from its Phase 3 Eclipse 1 trial of a monthly subcutaneous combination of siRNA therapy elebsiran and monoclonal antibody tobevibart for chronic hepatitis delta.…
    BioSpace · 1h agoPositive readoutPositive↗ source
  • Argenx to acquire Unnatural Products' macrocyclic peptide platform for $550 million upfront
    Argenx announced that it will acquire the California-based protein specialist Unnatural Products, paying $550 million upfront for its macrocyclic peptide platform. The deal could rise to more than…
    BioPharma Dive · 2h agoDealPositive↗ source
  • AbbVie and BMS each secure FDA approval, but impact of their neuro‑drug acquisitions remains uncertain
    AbbVie and Bristol Myers Squibb have both received FDA clearance for new Parkinson's treatments, prompting a fresh look at the large neuro‑focused deals they completed last year. AbbVie bought Cere…
    BioSpace · 13h agoDealNeutral↗ source
  • FDA launches Rare Disease Framework to embed patient input early in drug development
    FDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…
    BioSpace · 14h agoRegulatoryPositive↗ source
  • Delix Therapeutics secures $100 million Series C to advance psychedelic pipeline
    Delix Therapeutics announced it has closed a $100 million Series C financing round. The capital will be used to accelerate development of its pipeline of psychedelic and neuroplastogen candidates…
    Endpoints · 3h agoDealPositive↗ source
  • Boehringer Ingelheim to seek approval for obesity injection survodutide after trial shows no added cardiovascular risk
    Boehringer Ingelheim announced it will file for regulatory approval of its investigational GLP-1 based obesity injection, survodutide, in the coming year. The move follows a phase 3 trial that dem…
    Endpoints · 3h agoApprovalNeutral↗ source
  • Compass Pathways to file FDA approval for psilocybin depression therapy within weeks
    Compass Pathways announced it will complete its FDA filing for the psilocybin‑based depression treatment COMP360 in the next two weeks. The company expects the rolling submission to enable a drug…
    BioSpace · 3h agoRegulatoryNeutral↗ source
  • J&J/Protagonist’s oral Icotyde shows Phase 3 benefit in psoriatic arthritis but trails AbbVie’s Skyrizi
    A Phase 3 study of Johnson & Johnson and Protagonist Therapeutics’ oral IL‑23 receptor antagonist Icotyde met its primary endpoint, demonstrating improvement in psoriatic arthritis symptoms. In th…
    BioSpace · 3h agoPositive readoutNeutral↗ source
  • Eli Lilly to pursue FDA approval for obesity drug in obstructive sleep apnea after positive Phase 3 trial
    Eli Lilly announced that it will seek regulatory approval for its obesity medication as a treatment for obstructive sleep apnea, following a successful Phase 3 study. The trial showed positive res…
    Endpoints · 4h agoPositive readoutPositive↗ source
  • Novo’s IL-6 inhibitor ziltivekimab may target milder cardio-renal patients after Phase 3 miss
    At the American Heart Association meeting, investigators discussed new data on Novo Nordisk’s IL-6 inhibitor ziltivekimab, suggesting it could be studied in patients with less severe cardiovascular…
    BioSpace · 4h agoNegative readoutNeutral↗ source
  • Marea Therapeutics' triglyceride drug lowers levels without raising blood sugar in high-risk patients
    Marea Therapeutics reported new data on its investigational lipid‑lowering medicine, showing it can further reduce triglyceride levels in patients with dangerously high blood concentrations. The s…
    Endpoints · 5h agoPositive readoutPositive↗ source
  • Argenx to acquire macrocycle biotech Unnatural Products in up to $1.15 billion deal
    Argenx announced Monday it will acquire Unnatural Products, a biotech focused on macrocycle therapeutics that began as a garage startup. The transaction is structured as an up-to-$1.15 billion dea…
    Endpoints · 7h agoDealNeutral↗ source
  • Phase II success does not guarantee easy Phase III launch, says Thermo Fisher
    Positive Phase II data often signals the start of Phase III planning, but the transition involves far more than simply adding patients and sites. When a trial expands into new countries, differenc…
    BioPharma Dive · 9h agoNeutral↗ source
  • State incentives can shape site decisions for commercial-stage life sciences firms
    The article advises commercial-stage life-science companies to consider state and local incentives early in expansion planning to improve site selection and preserve capital. Incentives most relev…
    BioPharma Dive · 9h agoNeutral↗ source
  • Heron sells assets to CorMedix for $145M upfront, Faeth shares plunge
    Heron Therapeutics announced it has sold a portfolio of assets to CorMedix for an upfront cash payment of $145 million. The transaction gives CorMedix additional product candidates and expands its…
    Endpoints · 2h agoDealNeutral↗ source
  • Zura Bio’s Phase 2 trial of tibulizumab fails, shares plunge
    Zura Bio announced that its experimental drug tibulizumab did not meet efficacy endpoints in a Phase 2 study of a painful skin disorder. The company said that both dose levels performed no better t…
    Endpoints · 5h agoNegative readoutNegative↗ source
  • Gene therapy sponsors urged to address six GMP manufacturing considerations early
    SK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…
    BioSpace · 14h agoNeutral↗ source
  • Early technical expertise key to tackling complex life-science construction projects
    Life‑science construction projects often present problems that lack obvious solutions, such as retrofitting existing buildings, using unconventional materials, or fitting large process equipment in…
    BioPharma Dive · 9h agoPositive↗ source
  • Biotech controversies cloud Vivek Ramaswamy’s Ohio governor campaign
    Vivek Ramaswamy, a former biotech entrepreneur, was defeated in Ohio’s governor race, a loss that coincided with heightened scrutiny of his industry background. Six biotech leaders publicly asked…
    BioPharma Dive · 3h agoNegative↗ source
  • 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 · 4h agoLayoffsNegative↗ source
  • US government removes WuXi AppTec from Chinese military list
    The Pentagon removed WuXi AppTec from its list of Chinese military companies, but the Shanghai-headquartered service provider still risks being redesignated. The US deputy secretary of defense has…
    Endpoints · 11m ago↗ source
  • Third Rock enters $2B partnership with AI-focused Chinese biotech
    Third Rock Ventures is betting up to $2.16 billion on a little-known Chinese biotech’s AI platform. Funnel Biosciences describes itself as an AI-driven biologics company. Under a research collabora…
    Endpoints · 11m ago↗ source
  • FDA orders class-wide GLP-1 label update to include potential risk for rare eye disease
    Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update.
    BioSpace · 18m ago↗ source