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967 stories matching this filter · ← front page

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  • Novo Nordisk's late-stage anti-inflammatory heart drug fails Phase 3 trial
    Novo Nordisk announced that its experimental anti-inflammatory compound designed to target cardiovascular inflammation did not meet its primary endpoint in a Phase 3 trial. The study was intended…
    Endpoints · 5h agoNegative readoutNegative↗ source
  • Novo Nordisk’s IL-6 drug ziltivekimab misses Phase 3 cardiovascular endpoint, shares drop 9%
    Novo Nordisk announced that its IL-6 inhibitor ziltivekimab did not meet the primary goal in a late-stage Phase 3 trial aimed at lowering major cardiovascular events. The ZEUS study enrolled patie…
    BioSpace · 5h agoNegative readoutNegative↗ source
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fda recalls22
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Ophthalmology255
Infectious Disease253
Nephrology239
  • Alnylam cuts TTR franchise guidance, market cap loses $10.8B as shares tumble 28%
    Alnylam announced a reduction in its full-year revenue outlook for its transthyretin (TTR) franchise, trimming the midpoint by $200 million. The company now projects TTR therapy sales of $4.2 bill…
    BioSpace · 7h agoEarningsNegative↗ source
  • Capricor CEO hints at possible lawsuit after FDA panel rejects Duchenne cardiomyopathy therapy
    An FDA Cellular, Tissue, and Gene Therapies advisory committee voted 9-3 against recommending Capricor Therapeutics' cell therapy deramiocel for Duchenne muscular dystrophy cardiomyopathy. The pane…
    BioSpace · 2h agoRegulatoryNegative↗ source
  • Eli Lilly and Resilience commit $750 million to expand U.S. KwikPen device capacity for diabetes and obesity treatments
    Eli Lilly and contract development and manufacturing organization Resilience have announced a $750 million investment to boost U.S. production of the KwikPen device that delivers Lilly’s injectable…
    BioSpace · 4h agoDealPositive↗ source
  • Moderna sticks to 10% revenue growth goal despite Phase 3 norovirus vaccine miss
    Moderna said it will continue to aim for up to 10% revenue growth this year, even though its experimental norovirus vaccine did not achieve statistical significance in a Phase 3 interim analysis.…
    BioSpace · 5h agoNegative readoutNeutral↗ source
  • AbbVie says Skyrizi maintains strong sales momentum as competition rises
    AbbVie highlighted that its immunology drug Skyrizi continues to generate robust sales despite increasing competition in the market. The company noted that demand for the therapy remains solid and…
    Endpoints · 2h agoPositive↗ source
  • Pharma groups support revised 340B rebate pilot that permits limited rebate denials
    Health Resources and Services Administration (HRSA) announced details of a revised 340B rebate pilot. The new rules would let drug manufacturers refuse rebates on a limited set of drugs, a shift fr…
    Endpoints · 3h agoRegulatoryPositive↗ source
  • AbbVie shares slip 4% as Q2 immunology earnings beat falls short of lofty expectations
    AbbVie’s stock fell about 4% on Friday after the company reported second‑quarter results that modestly exceeded analyst forecasts, disappointing investors who had set very high expectations. The f…
    BioSpace · 5h agoEarningsNegative↗ source
  • Ratio Therapeutics secures $70M Series C for radiopharma trials as Vogenx eyes $67M IPO
    Ratio Therapeutics, a Boston-based biotech, announced a $70 million Series C financing to fund its radiopharmaceutical development program. The round was led by existing backers Duquesne Family Of…
    Endpoints · 5h agoDealPositive↗ source
  • UniQure prepares for FDA advisory committee on Huntington’s gene therapy amid rare-disease regulatory jitters
    UniQure said it is ready to present its Huntington's disease gene therapy, AMT-130, to an FDA advisory committee, as discussed in its Q2 earnings call. The company expects the FDA may schedule the…
    BioSpace · 8h agoRegulatoryNeutral↗ source
  • Karyopharm stock tumbles after Phase 3 Xpovio trial fails in endometrial cancer
    Karyopharm announced that its Phase 3 XPORT-EC-042 study of Xpovio in endometrial cancer did not meet its primary endpoint. The failure represents the company's second unsuccessful attempt to expa…
    Endpoints · 10h agoNegative readoutNegative↗ source
  • Latigo Biotherapeutics reports non-opioid drug cuts acute pain in Phase 2b trial
    Latigo Biotherapeutics announced that its experimental non-opioid analgesic demonstrated a reduction in acute pain in a Phase 2b clinical trial. The study results suggest the candidate may offer a…
    Endpoints · 13h agoPositive readoutPositive↗ source
  • Moderna delays norovirus vaccine readout, cites insufficient infections
    Moderna announced that its norovirus vaccine trial will not yield efficacy data this season because infection rates were lower than expected. The company said it will open an additional trial coho…
    Endpoints · 4h agoNegative readoutNeutral↗ source
  • Apnimed secures $192 million IPO to fund sleep-apnea drug program targeting 2027 launch
    Apnimed, a biotech focused on sleep apnea, announced it raised $192 million through an initial public offering. The capital will be used to advance its lead drug candidate, with plans to begin a l…
    Endpoints · 13h agoDealPositive↗ source
  • Ionis veteran scientist Frank Bennett to retire in 2027 as Recursion appoints its first AI chief
    Ionis announced that Frank Bennett, who joined the company as a founding scientist in 1989 and later became chief scientific officer, will retire in February 2027 after a 37-year career. Bennett’s…
    Endpoints · 9h agoNeutral↗ source
  • BMS beats Q2 forecasts and lifts 2026 outlook despite delays in Cobenfy and milvexian data
    BMS reported second‑quarter revenue of $12.97 billion, topping analysts' estimate of $11.73 billion, and earnings per share of $2.04, well above the $1.60 consensus. The strong results prompted the…
    BioSpace · 1d agoEarningsNeutral↗ source
  • AtaiBeckley secured co-development and royalty offers before $2.8 B Lilly acquisition
    AtaiBeckley, a psychedelic biotech, received co-development and royalty proposals prior to finalizing a $2.8 B acquisition by Eli Lilly. Details were disclosed in an SEC filing that outlined the s…
    Endpoints · 1d agoDealNeutral↗ source
  • Sanofi books over €1 billion impairment after ending eczema drug and halting two immunology programs
    Sanofi disclosed that it will record more than €1.03 billion in impairment charges for the second quarter. The bulk of the charge stems from the decision to terminate development of an eczema trea…
    Endpoints · 1d agoNegative↗ source
  • J&J strikes up to $925M deal with Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson announced a collaboration with Flagship Pioneering’s Sail Biomedicines to develop in vivo CAR‑T therapies for immune‑mediated diseases. The agreement provides up to $925 million i…
    BioSpace · 1d agoDealNeutral↗ source
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Analysts say Daiichi Sankyo’s ADC pipeline lags rivals as cash flow peaks, cutting expectations
    Jefferies analysts warned that Daiichi Sankyo's early‑stage antibody‑drug conjugate (ADC) pipeline is falling behind competitors, even as the company approaches a peak in cash flow from its existin…
    BioSpace · 1d agoNegative↗ source
  • Johnson & Johnson prepares $2.58 billion option to acquire Sail Biomedicines, expanding in-vivo CAR-T portfolio
    Johnson & Johnson announced a $2.58 billion option agreement to purchase Sail Biomedicines, a Flagship Pioneering‑backed biotech focused on in‑vivo CAR‑T therapies. The deal includes an upfront pa…
    Endpoints · 1d agoDealNeutral↗ source
  • FDA advisory panel backs Replimune’s melanoma immunotherapy combined with Opdivo
    The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10-3 to recommend Replimune’s RP1 immunotherapy, used together with Bristol Myers Squibb’s Opdivo, for patients with advanced…
    BioSpace · 22h agoRegulatoryPositive↗ source
  • Trump administration delays start of first pharma tariff wave originally set for July 31
    President Donald Trump's administration had scheduled the first set of pharmaceutical tariffs to begin on July 31, but the rollout has been postponed. A White House official said the implementation…
    Endpoints · 1d agoRegulatoryNeutral↗ source