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  • Bristol Myers shows modest revenue rise, Biogen beats forecasts, Regeneron outlook remains uncertain
    BioPharma Dive highlighted the latest quarterly earnings from three major biotech firms, noting how investors are interpreting the results. Bristol Myers Squibb reported $11.5 billion in revenue f…
    BioPharma Dive · 5mo agoEarningsNeutral↗ source
  • FDA approves Arvinas' PROTAC drug Veppanu for specific metastatic breast cancer
    U.S. regulators have granted approval for Veppanu, a protein-degrading therapy developed by biotech firm Arvinas, to treat a defined group of patients with metastatic, estrogen-receptor-positive, H…
    BioPharma Dive · 5mo agoApprovalPositive↗ source
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  • Summit Therapeutics' ivonescimab misses interim goal, shares tumble 27% as trial setback raises doubts
    Summit Therapeutics reported that its experimental immunotherapy ivonescimab failed to achieve statistical significance at an interim analysis of the late-stage HARMONi-3 trial in frontline non‑sma…
    BioPharma Dive · 5mo agoNegative readoutNegative↗ source
  • Summit Therapeutics shares tumble 20% after interim Phase 3 miss for ivonescimab
    Summit Therapeutics saw its shares fall about 20% after the market close on Thursday. The decline came after an interim analysis of a Phase 3 trial for its cancer candidate ivonescimab failed to m…
    Endpoints · 5mo agoNegative readoutNegative↗ source
  • Two biotech firms raise $556 million in combined IPOs
    Seaport Therapeutics and Hemab Therapeutics launched initial public offerings on Thursday, together bringing in $556.4 million to fund further development of their drug pipelines. Hemab Therapeuti…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • FDA greenlights Pfizer/Arvinas breast cancer therapy vepdegestrant despite modest trial results
    The U.S. Food and Drug Administration announced approval of vepdegestrant, a therapy developed by Pfizer and Arvinas, for a specific subtype of breast cancer. The decision comes even though the cl…
    Endpoints · 5mo agoApprovalNeutral↗ source
  • Moderna reports Q1 revenue surge driven by international COVID vaccine sales despite larger net loss
    Moderna posted first‑quarter revenue of $389 million, more than triple the same period a year earlier, primarily from overseas COVID‑19 vaccine sales. The company recorded a net loss of $1.3 billi…
    BioPharma Dive · 5mo agoEarningsNeutral↗ source
  • FDA drops Casey Means as surgeon general nominee, naming Fox News radiologist Nicole Saphier instead
    FDA withdrew the nomination of Casey Means for surgeon general and appointed Nicole Saphier, a radiologist and Fox News commentator. The switch underscores the administration’s limited sway in the…
    STAT · 5mo agoRegulatoryNegative↗ source
  • FDA finds low levels of PFAS in most U.S. baby formulas, says supply remains largely safe
    The FDA recently tested 312 infant formula samples from 16 brands and released its findings. The agency detected five types of PFAS, with PFOS appearing in about half of the samples, but 95% of th…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • BMS's Krazati fails confirmatory colorectal cancer trial, jeopardizing its accelerated approval
    Bristol Myers Squibb said its drug Krazati did not meet the primary endpoint in a confirmatory study for second‑line colorectal cancer. The trial was required to verify the benefit that earned the…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • Merck remains optimistic on Terns leukemia drug despite new data
    Merck said Thursday that it still sees a compelling outlook for Terns' leukemia drug even after updated study data suggested it may be less differentiated. The updated data came from a trial of TE…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • J. Craig Venter, pioneering genomics scientist, dies at 79 after cancer treatment
    J. Craig Venter, a leading figure in genomics, passed away at age 79. The cause was complications from a cancer treatment. Venter’s work helped turn genetics from a craft into an industrial inform…
    STAT · 6mo agoPositive↗ source
  • FDA oncology panel votes against AstraZeneca's camizestrant trial, citing lack of meaningful benefit
    The FDA's oncology advisory committee convened for the first time in about nine months and evaluated AstraZeneca's late-stage trial of its oral selective estrogen receptor degrader, camizestrant.…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • NIH grant success rates hit historic low, pushing researchers to seek alternative funding
    NIH grant success rates have fallen to historic lows, with only about 13% of applications receiving funding in the most recent fiscal year. Researchers are responding by dedicating more time to wr…
    STAT · 6mo agoNegative↗ source
  • Avalyn Pharma raises $300M in IPO to fund inhalable lung-fibrosis drugs
    Avalyn Pharma completed a $300 million initial public offering, pricing 16.7 million shares at $18 each and exceeding its original $200 million target. The proceeds will be used to develop inhalab…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Trump nominates radiologist Nicole Saphier as third surgeon general candidate, emphasizes vaccine schedule questions
    The White House announced Dr. Nicole Saphier as its third nominee for surgeon general, replacing the previously considered candidate whose medical license had lapsed. Saphier is a board‑certified…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • STAT podcast highlights investor buzz around hair loss drugs, AI in trials, and Servier's M&A ambitions
    The latest episode of STAT’s “The Readout LOUD” podcast explored why investors are increasingly focused on treatments for hair loss, noting recent trial data that has generated notable market inter…
    STAT · 6mo agoNeutral↗ source
  • Akeso‑Summit’s ivonescimab lands a prime ASCO plenary slot despite unclear survival data
    The upcoming American Society of Clinical Oncology meeting will feature a plenary presentation from Akeso and Summit Therapeutics on their lung‑cancer candidate ivodescimab. Industry observers note…
    STAT · 6mo agoNeutral↗ source
  • Hinge receives FDA clearance for new migraine device
    Hinge announced that its migraine treatment device has received clearance from the U.S. Food and Drug Administration. The clearance allows the company to market the device in the United States and…
    STAT · 6mo agoApprovalPositive↗ source
  • Trump withdraws Casey Means as surgeon general nominee, names radiologist Nicole Saphier
    The Trump administration has withdrawn its nomination of Casey Means to serve as the next surgeon general. Means had been backed by the Make America Healthy Again movement, which sees the decision…
    STAT · 6mo agoNegative↗ source
  • FDA pilots real-time clinical trials as Amgen, AstraZeneca join proof-of-concept studies; AbbVie eyes KRAS biotech Kestrel
    The U.S. Food and Drug Administration announced a pilot program for "real-time" clinical trials, designed to cut the lag between data collection and regulatory review. AstraZeneca and Amgen have l…
    BioPharma Dive · 6mo agoRegulatoryNeutral↗ source
  • Chiesi to acquire KalVista for $1.9 billion, adding hereditary angioedema pill to rare-disease portfolio
    Italian pharmaceutical group Chiesi announced it will purchase KalVista Therapeutics for $1.9 billion. The transaction values KalVista at $27 per share, a 40 percent premium to its last closing pri…
    STAT · 6mo agoDealPositive↗ source
  • FDA schedules first oncology advisory panel in nine months, will review AstraZeneca candidates
    The FDA announced it will hold an oncology advisory committee meeting roughly nine months from now. The meeting will focus on evaluating a pair of investigational drugs from AstraZeneca, though de…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • Report shows modest health equity gains but experts warn they may not last
    A new Commonwealth Fund report covering 2022 to 2024 highlights several state-level actions that narrowed health disparities. Two states broadened Medicaid eligibility, many expanded postpartum cov…
    STAT · 6mo agoNegative↗ source
  • FDA urges Amgen to withdraw Tavneos after alleging data manipulation by former developer
    The FDA has sent a formal letter to Amgen recommending that the company pull its drug Tavneos from the market. The agency says new information shows the original approval filings from ChemoCentryx…
    BioPharma Dive · 6mo agoRegulatoryNegative↗ source