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1,151 stories matching this filter · ← front page

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  • FDA finds Replimune's melanoma data package uninterpretable, foreshadows tough advisory committee review
    The FDA has deemed the single-arm mid-stage study submitted by Replimune for its oncolytic immunotherapy RP1 as not interpretable, raising concerns ahead of an upcoming advisory committee meeting.…
    BioSpace · 24d agoRegulatoryNegative↗ source
  • Apnimed targets up to $160 million IPO to fund sleep‑apnea drug AD109
    Apnimed, a sleep‑specialist biotech, announced plans for an initial public offering that could raise up to $160 million in gross proceeds. The company will sell 10 million shares at $14‑$16 each,…
    BioSpace · 24d agoDealPositive↗ source
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  • Pharma deals in China face heightened IP risk under U.S. BIOSECURE Act
    Pharma companies are increasing licensing activity in China, but experts say patent attorneys must now factor in the geopolitical implications of the BIOSECURE Act. The legislation seeks to compil…
    BioSpace · 24d agoRegulatoryNegative↗ source
  • Oak Hill Bio to merge with RA Capital SPAC as InnoCare’s TYK2 candidate reports positive Phase 3 results
    Oak Hill Bio, a biotech focused on Angelman syndrome, announced it will combine with RA Capital’s special purpose acquisition company, Research Alliance Corporation III. The transaction will give O…
    Endpoints · 24d agoDealPositive↗ source
  • FDA staff say Replimune's melanoma trial fails to demonstrate efficacy
    FDA staff reviewing Replimune's pivotal melanoma study concluded that the trial design did not provide sufficient evidence that the RP1 therapy works. The assessment was issued ahead of a schedule…
    Endpoints · 24d agoRegulatoryNegative↗ source
  • GSK launches $2.5 billion restructuring plan to fund late-stage pipeline and offset upcoming HIV drug patent loss
    GSK reported $2.4 billion in impairment charges for the second quarter and unveiled a three‑year restructuring designed to save roughly $2.5 billion. The company says the savings will be redirecte…
    BioSpace · 24d agoPositive↗ source
  • Alnylam shares tumble 30% even as biotech sector rallies
    Alnylam's stock fell about 30% on July 28, 2026, even though the broader biotech market is experiencing a resurgence. The market rebound follows years of a bearish environment, with increased merg…
    Endpoints · 24d agoNegative↗ source
  • Mirae secures $5.4 million to convert patient chatbot messages into clinical data
    Mirae, a health‑tech startup, announced it has closed a financing round that brought in $5.4 million. The capital will be used to develop its chatbot platform that encourages patients to describe…
    Endpoints · 24d agoDealPositive↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 24d agoPositive readoutPositive↗ source
  • Claris Bio secures $118 million to launch pivotal eye-drop trials next year
    Claris Bio announced a financing round that raised $118 million to move its investigational eye‑drop therapy forward. The capital will fund two pivotal Phase 3 studies slated to start next year, f…
    Endpoints · 24d agoDealPositive↗ source
  • GSK launches three-year cost-cutting plan as new CEO targets R&D efficiency
    GSK announced a three-year restructuring program designed to cut costs and sharpen focus on its advanced assets. The plan was presented by CEO Luke Miels, who has been in the role for just over si…
    Endpoints · 24d agoNeutral↗ source
  • Oak Hill Bio to go public via SPAC merger, securing $175 million for Angelman syndrome program
    Oak Hill Bio announced it will become a publicly traded company through a merger with the special purpose acquisition company Research Alliance Corporation III. The transaction will provide $75 mi…
    BioSpace · 24d agoDealPositive↗ source
  • Altimmune's GLP-1/glucagon shot reduces drinking in Phase 2 alcohol use disorder trial
    Altimmune announced results from its mid‑stage Phase 2 RECLAIM trial evaluating pemvidutide, a GLP‑1/glucagon dual agonist, in patients with moderate‑to‑severe alcohol use disorder. The trial comp…
    Endpoints · 24d agoPositive readoutPositive↗ source
  • FDA advisory panel debates allowing compounding pharmacies to produce seven peptides
    The FDA’s advisory committee spent two days reviewing whether compounding pharmacies should be permitted to manufacture a set of seven peptide products. The discussion involved both committee membe…
    Endpoints · 24d agoRegulatoryNeutral↗ source
  • Webinar Explores AI-Driven Intelligence Engine for Optimizing Antibody, ADC and Peptide Candidates
    Drug discovery teams are grappling with an ever‑growing volume of data, and converting that data into actionable insight remains a key hurdle. In a recent BioSpace webinar, Patsnap’s Ben Coverdale…
    BioSpace · 24d agoNeutral↗ source
  • OKYO Pharma CSO Raj Patil boosts stake to 20,030 shares
    OKYO Pharma, a clinical stage biotech focused on neuropathic corneal pain and anterior segment eye diseases, disclosed that its chief scientific officer, Raj Patil, PhD, bought additional shares.…
    globenewswire health · 24d agoDealNeutral↗ source
  • Danske Bank reports share sell-off by APMH Invest under ongoing buy-back program
    Danske Bank A/S disclosed recent transactions made by persons required to report under the EU Market Abuse Regulation. The notification dated 28 July 2026 notes that APMH Invest A/S has been conti…
    globenewswire health · 24d agoRegulatoryNeutral↗ source
  • DSV A/S manager files share transaction report
    DSV A/S disclosed a manager's transaction in its shares via Company Announcement No. 1172. The filing, typical for insider reporting, indicates that a senior executive or board member bought or so…
    globenewswire health · 24d agoRegulatoryNeutral↗ source
  • Danske Bank reports senior staff transactions on July 28, 2026
    Danske Bank A/S released a brief notice on July 28, 2026 indicating that transactions involving its senior employees have been disclosed. The announcement provides only the fact of the disclosure…
    globenewswire health · 24d agoNeutral↗ source
  • Otsuka receives FDA approval for Simtriyo, first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD
    Otsuka Pharmaceutical announced that the FDA has approved its daily pill centanafadine, branded as Simtriyo, for the treatment of attention-deficit hyperactivity disorder in patients six years and…
    BioSpace · 25d agoApprovalPositive↗ source
  • AstraZeneca reports mixed late-stage trial results: Claudin 18.2 ADC shows limited success while Ultomiris fails in rare disease
    AstraZeneca announced that two of its late-stage clinical programs have delivered disappointing outcomes. The company disclosed the data in a statement released on Monday. The trial of the Claudin…
    Endpoints · 25d agoNegative readoutNegative↗ source
  • Yarrow goes public while Otsuka receives FDA approval for new ADHD medication
    Yarrow Bioscience completed a merger that took the company public and will now trade under its own ticker. The firm is developing an anti-TSHR antibody aimed at treating Graves’ disease and the ass…
    Endpoints · 25d agoApprovalPositive↗ source
  • AstraZeneca says AI has yet to yield clinical candidates but could lower risk in late-stage trials
    AstraZeneca's chief executive Pascal Soriot told reporters that the company's AI‑driven efforts in drug design have not yet produced a candidate that has entered clinical testing. He added that th…
    Endpoints · 25d agoNeutral↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, adding anti‑CD122 antibody program
    Argenx announced a $2.2 billion cash transaction to purchase Forte Biosciences, a biotech focused on autoimmune therapies. The acquisition brings Forte's anti‑CD122 monoclonal antibody, which is c…
    Endpoints · 25d agoDealPositive↗ source
  • Virginia judge orders FDA to revisit Biden-era mifepristone restrictions
    A federal judge in Virginia has ruled that the FDA must reexamine certain restrictions on the abortion medication mifepristone that were put in place during the previous administration. The judge…
    Endpoints · 25d agoRegulatoryNeutral↗ source