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  • Johnson & Johnson secures option to acquire in-vivo CAR-T developer Sail Biomedicines for up to $2.6 billion
    Johnson & Johnson announced a strategic partnership with Sail Biomedicines, a Flagship Pioneering‑backed startup, that includes an upfront cash payment and an equity investment. The initial paymen…
    BioPharma Dive · 5h agoDealPositive↗ 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 · 6h agoEarningsNeutral↗ source
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  • 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 · 9h agoDealNeutral↗ source
  • FTC Sues Hims & Hers for Alleged Illegal Sharing of Patient Data and Deceptive Billing
    The Federal Trade Commission has filed a lawsuit against Hims & Hers, a California‑based telehealth company, accusing it of violating privacy laws. The complaint says the firm used tracking pixels…
    BioPharma Dive · 5h agoRegulatoryNegative↗ source
  • Regeneron defends M&A stance as cash hoard reaches $18 billion amid trial setbacks
    Analysts on Regeneron's second‑quarter earnings call questioned the company's lack of merger and acquisition activity, pointing to an $18 billion cash reserve and recent clinical trial setbacks. C…
    BioSpace · 6h agoEarningsNeutral↗ source
  • Sanofi CEO pledges deeper review of late-stage pipeline before Phase 3 moves
    Sanofi's new chief executive, Belén Garijo, announced that the company will examine its late-stage pipeline more closely. The goal is to ensure that data from Phase 2 (or Phase 1b, depending on th…
    BioSpace · 9h agoNeutral↗ source
  • Biopharma layoffs in 2026 often marred by impersonal and poorly timed communications
    Over 50 biopharma companies have announced workforce cuts or plan to do so in 2026. According to a BioSpace survey, the manner in which these layoffs are communicated can leave a lasting negative i…
    BioSpace · 14h agoLayoffsNegative↗ source
  • Biogen’s early Phase 2 data supports tau-targeting Alzheimer’s approach
    Biogen has released early Phase 2 results for its experimental Alzheimer’s therapy diranersen, indicating that reducing tau protein levels may lead to cognitive benefits. The findings add to a lon…
    BioSpace · 17h agoPositive readoutPositive↗ source
  • Arvinas CEO outlines strategy to rebuild pipeline after lead asset departure
    In a recent episode of the Denatured podcast, Arvinas President and CEO Randy Teel discussed how the company is shifting focus to an early‑stage pipeline after its lead asset was out‑licensed or di…
    BioSpace · 10h agoPositive↗ source
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 14h agoDealPositive↗ source
  • Alnylam plunges as earnings deliver ‘one-two punch’
    The RNA-focused biotech shed 30% of its market value — or close to $12 billion — amid growing investor concerns about its main drug business.
    BioPharma Dive · 1h ago↗ source
  • Daiichi’s pipeline falls behind rivals as cash flow nears peak: analysts
    With Enhertu and Datroway hitting their peak revenue and rivals flowing into the antibody-drug conjugate space, Jefferies cuts expectations for Daiichi Sankyo.
    BioSpace · 8h ago↗ source
  • Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
    Argon Medical is correcting affected convenience kits by removing included Spectra Medical Devices Lidocaine Ampules.
    fda medwatch · 17h ago↗ source
  • FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocel
    During an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…
    BioSpace · 22h agoApprovalNegative↗ source
  • Caldera and Vidya secure $478M via reverse mergers to go public
    Caldera Therapeutics, a U.S. bispecific antibody biotech, announced a reverse merger with Nasdaq-listed Synlogic to become a public company. The deal includes a $278 million private placement from…
    BioSpace · 1d agoDealPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • Novo Nordisk faces shareholder fraud lawsuit over undisclosed dosing changes in CagriSema Phase 3 trial
    New Jersey federal judge Robert Kirsch ruled that shareholders can pursue claims that Novo Nordisk misled investors about its Phase 3 study of the weight‑loss drug CagriSema. The plaintiffs allege…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • FDA briefing hints tough road for Capricor and Replimune ahead of advisory committee meetings
    The FDA released briefing documents for upcoming advisory committee meetings concerning Capricor Therapeutics' Duchenne muscular dystrophy cell therapy and Replimune's advanced melanoma candidate.…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1d agoNegative readoutNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launches
    Kyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…
    BioSpace · 1d agoDealPositive↗ source
  • Incyte drops early-stage JAK2 inhibitor to prioritize next-generation pipeline
    Incyte announced it is terminating development of its early-stage oral JAK2 inhibitor, INCB160058, after a Phase 1 study in myeloproliferative neoplasms. The company said the decision reflects the…
    BioSpace · 1d agoNegative↗ source
  • 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 · 1d agoNegative readoutNeutral↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 1d agoDealNeutral↗ source