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  • Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
    The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
    BioSpace · 8h agoNegative readoutNeutral↗ 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 · 1h 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 · 1h agoLayoffsNegative↗ source
  • Incyte cuts early-stage cancer drug to focus on next-gen programs
    Investors are focused on Incyte’s late-stage programs as the biotech braces for the 2028 patent cliff of its leading product Jakafi.
    BioSpace · 35m ago↗ source
  • Novo ordered to face CagriSema fraud claims from shareholders: New Jersey court
    Shareholders allege that Novo Nordisk withheld information about crucial protocol changes in a Phase 3 study of the weight loss drug CagriSema, which led investors to buy company shares “at artific…
    BioSpace · 53m ago↗ source
  • Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
    The FDA published briefing documents ahead of advisory committee meetings for therapies from Capricor Therapeutics and Replimune indicate an uphill battle for the biotechs; GSK and AstraZeneca outl…
    BioSpace · 2h ago↗ source
  • FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
    The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
    BioSpace · 1d agoApprovalPositive↗ source
  • GSK shares rise as $2.5B cost-cutting plan unveiled
    As GSK records $2.4 billion in impairment charges for the second quarter, the U.K. pharma has announced a sweeping restructure designed to save about the same amount of money over the next few years.
    BioSpace · 23h agoLayoffsNegative↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 1d agoDealNeutral↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 1d agoRegulatoryNeutral↗ source
  • Webinar: Building the Intelligence Engine for Drug Discovery R&D Teams
    Drug discovery teams have more data than ever, but turning that data into actionable insight remains a major challenge. In this candid conversation, Patsnap’s Ben Coverdale is joined by Mark Davies…
    BioSpace · 16h agoRegulatoryNeutral↗ source
  • Altimmune rises as GLP-1/glucagon drug curbs heavy drinking in mid-stage study
    Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among oth…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch
    If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Oak Hill takes SPAC track to Nasdaq with Roche asset in tow
    Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 1d agoRegulatoryNeutral↗ source
  • Otsuka’s ADHD approval opens up new drug class with $615M opportunity
    Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
    BioSpace · 2d agoApprovalPositive↗ source
  • UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy
    In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.
    BioSpace · 1d agoPositive readoutPositive↗ source
  • Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom
    Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors. In‑vivo CAR‑T aims to genera…
    BioSpace · 2d agoNeutral↗ source
  • Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval
    Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.…
    BioSpace · 2d agoPositive readoutPositive↗ source
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 2d agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 2d agoRegulatoryNeutral↗ source
  • AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure
    AstraZeneca remains "very much on track" to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said durin…
    BioSpace · 2d agoDealNeutral↗ source
  • Argenx deepens immuno expertise with $2.2B Forte Biosciences buy
    The star of the takeover is Forte Biosciences' investigational antibody therapy, FB102, which has shown early potential in vitiligo and celiac disease.
    BioSpace · 2d agoDealNeutral↗ source