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  • Apnimed upsizes IPO to $192 million to fund launch of oral sleep‑apnea drug
    Apnimed, a Massachusetts‑based biotech, announced an upsized initial public offering that now includes 12 million shares priced at $16 each, generating $192 million in gross proceeds. This amount e…
    Fierce Biotech · 7h agoDealPositive↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 15h agoEarningsNegative↗ source
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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 · 19h 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 · 20h agoEarningsNeutral↗ 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 · 23h agoDealNeutral↗ source
  • FDA advisory panel backs Replimune's melanoma therapy RP1, raising approval prospects
    Advisors to the U.S. Food and Drug Administration voted 10-3 in favor of Replimune's experimental melanoma treatment, RP1, despite lingering scientific concerns about the data presented. The panel…
    BioPharma Dive · 14h agoRegulatoryPositive↗ 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 · 19h agoRegulatoryNegative↗ 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 · 22h agoNegative↗ source
  • Bristol Myers pushes Cobenfy Alzheimer’s psychosis readout to early 2027 after enrollment delays
    Bristol Myers Squibb said the Phase 3 readout for its Cobenfy Alzheimer’s psychosis program will be postponed to early 2027. The company had previously expected data from the three Adept trials to…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • J&J invests $785M in Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson has agreed to pay $785 million up front to Sail Biomedicines, including a $465 million equity infusion and up to $140 million in milestone payments. The agreement also gives J&J a…
    Fierce Biotech · 1d agoDealPositive↗ 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 · 13h agoRegulatoryPositive↗ source
  • Replimune's melanoma virus therapy wins FDA advisory committee vote after two rejections
    Replimune's oncolytic virus RP1, also called vusolimogene oderparepvec and Tudriqev, has been rejected twice by the FDA. Today an advisory committee voted 10 to 3 that the candidate shows enough ef…
    Fierce Biotech · 17h agoRegulatoryPositive↗ 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 · 20h 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 · 23h agoNeutral↗ source
  • BMS CEO says firm not pressured to pursue acquisitions despite quiet M&A year
    BMS chief executive Chris Boerner told analysts on the second‑quarter earnings call that the company’s robust late‑stage pipeline means it does not feel any compulsion to chase deals. The firm has…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Labcorp reports Q2 sales of $3.73 billion, lifts full-year revenue outlook despite missing consensus
    Labcorp announced second‑quarter revenue of $3.73 billion, up from $3.53 billion a year earlier, driven by strong performance across its core businesses. The Diagnostics division grew 5.5% to $2.9…
    Fierce Biotech · 1d agoEarningsNeutral↗ source
  • Takeda drops its second celiac disease candidate, TAK-101, after unimpressive phase 2 results
    Takeda said it is halting development of TAK-101, its second candidate for celiac disease, after a phase 2 study failed to meet expectations. TAK-101 is a nanoparticle that carries gliadin, a glut…
    Fierce Biotech · 1d agoNegative readoutNegative↗ 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 · 1d agoLayoffsNegative↗ source
  • GSK signs up to $110 million AI data partnership with Relation
    GSK announced a research collaboration with AI-focused biotech Relation, valued at up to $110 million. Under the agreement Relation will produce large-scale datasets that capture how human cells r…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Sanofi’s new CEO vows deeper review of late-stage pipeline after series of trial failures
    Sanofi appointed Belén Garijo as chief executive in February with a clear mandate to tighten R&D governance and boost productivity. The board tasked her with bringing more rigor to the company’s st…
    Fierce Biotech · 1d agoNegative readoutNegative↗ 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 · 1d agoPositive readoutPositive↗ source
  • Boston Scientific lowers full-year revenue outlook as restructuring plan targets slowing growth
    Boston Scientific announced on July 29 that it is cutting its 2026 full-year organic revenue growth forecast to 5-6%, down from the prior 6.5-8% range. The revision follows a second consecutive qu…
    Fierce Biotech · 1d agoEarningsNegative↗ source
  • FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs
    The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee rates
    The FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products. The guidances cover peptide therapies u…
    raps · 1d agoRegulatoryNeutral↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 1d agoNegative↗ source