Clinical Trials

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    Shares of psychedelics biotech nearly double on depression data

    The small, Ireland-based company GH Research said its inhaled version of mebufotenin — a molecular cousin to psilocybin — was fast and effective in a treatment-resistant depression trial.

    By • Feb. 3, 2025
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    Pfizer drug acquired in $11B buyout confirms benefit in colon cancer

    The results could sway U.S. regulators to convert Braftovi’s accelerated clearance in colorectal tumors into a full approval — boosting an oncology portfolio Pfizer is looking to for revenue growth.

    By • Feb. 3, 2025
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    Trendline

    Vaccine development

    Vaccine developers are turning from COVID-19 to invest more heavily in shots for RSV, influenza and pneumococcal disease.

    By BioPharma Dive staff
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    Rival radiopharma drug to Novartis’ Lutathera succeeds in trial, ITM says

    ITM's lutetium-containing therapy extended progression-free survival versus everolimus in patients with a specific kind of neuroendocrine tumor.

    By • Jan. 28, 2025
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    Akero says MASH drug reverses liver damage in study, doubling shares

    Results showing Akero’s efruxifermin improved fibrosis by more than what Wall Street expected lifted the stock of both it and rival MASH developer 89bio.

    By • Jan. 27, 2025
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    Muscle-building drug improves body composition in obesity trial, Veru says

    Shares in Veru fell by nearly half following the news, despite positive results in preserving lean muscle mass.

    By • Jan. 27, 2025
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    Novo shares climb on early data for dual-acting obesity drug

    An experimental drug called amycretin showed signs it could be more potent than Eli Lilly’s rival Zepbound, though analysts cautioned certain aspects of the study may have inflated its performance. 

    By • Jan. 24, 2025
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    IGM’s autoimmune pivot backfires as top drug disappoints in testing

    The biotech will stop developing two drugs and lay off much of its staff after its lead therapy wasn’t as potent in early testing as the company expected.

    By • Jan. 9, 2025
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    Bayer says menopause drug succeeds in breast cancer study

    The results suggest Bayer’s elinzanetant may help a broader group of women with vasomotor symptoms, which are associated with menopause as well as a common breast cancer therapy.

    By • Jan. 9, 2025
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    Metsera reveals data supporting long-acting obesity shot

    The startup, which has already raised more than half a billion dollars, released Phase 2 results that could position its drug as a future threat to weight loss medicines from Novo Nordisk and Eli Lilly. 

    By • Jan. 7, 2025
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    J&J says cancer drug combination showed survival benefit over Tagrisso

    Results from the Mariposa study found a regimen of Rybrevant and Lazcluze helped patients with a common form of advanced lung cancer live longer.

    By • Jan. 7, 2025
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    ALS drug development

    ALS drugs from Denali, Calico come up short, marking setback for Healey trial

    Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.

    By • Jan. 7, 2025
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    Neumora plummets on depression drug data

    The well-funded biotech lost most of its value after its drug flunked a late-stage trial. One analyst described the results as a “worst-case scenario for the program.”

    By • Jan. 2, 2025
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    Tracker

    10 clinical trials to watch in the first half of 2025

    Expected readouts in diabetes, cancer and depression headline a series of study results that could help the biotechnology sector regain its footing after a shaky year.

    By BioPharma Dive staff • Jan. 2, 2025
  • White flags bearing Novo Nordisk's logo are seen against a blue sky.
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    Novo’s next-gen obesity drug misses expectations in closely watched trial

    Novo shares lost nearly a fifth of their value after an experimental combination treatment called cagrisema fell short of the bar set by executives.  

    By • Updated Dec. 20, 2024
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    Roche sticks with Parkinson’s drug despite second study failure

    Even with another mid-stage setback, Roche believes there were enough positive signs to “merit further exploration” of the drug, which it’s been developing with Prothena for more than a decade.

    By • Dec. 19, 2024
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    Regeneron says study data support big bet on new blood thinners

    The company is planning a “broad Phase 3 program” for two anticoagulants after they outperformed marketed medicines in a pair of mid-stage trials. 

    By • Dec. 19, 2024
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    Vertex ‘ends the year in pain’ as latest non-opioid drug data disappoint

    Mixed results from a study focused on lower back pain left analysts wanting as well as confused about Vertex's plans to forge ahead in the indication.

    By • Dec. 19, 2024
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    Sanofi, Teva say study results show gut disease drug could be ‘best in class’

    Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals.

    By • Dec. 17, 2024
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    Maternal mortality trends are dire — and reversing them remain an uphill battle

    Rising maternal mortality, particularly among vulnerable groups, has roots in insufficient research involving pregnant women.

    By Michael Gibney • Dec. 17, 2024
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    Edgewise weighs fast approval path for muscular dystrophy drug

    The biotech company will meet with regulators to discuss Phase 2 biomarker data that sent its shares climbing by more than 20% Monday.

    By • Dec. 16, 2024
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    Merck calls quits on two immunotherapies for cancer

    The company is scrapping two drugs aimed at targets called TIGIT and LAG-3, both of which were in the middle of Phase 3 testing.

    By • Dec. 16, 2024
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    Keros shares collapse on ‘unanticipated’ setback for lung disease drug

    Safety concerns Keros observed in a Phase 2 trial triggered a stock selloff for what had been one of the sector’s most successful initial public offerings of the last four years, according to BioPharma Dive data.

    By Kristin Jensen • Dec. 12, 2024
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    With new data, Lilly sets pace for next wave of breast cancer drugs

    While other big pharmas have faltered, Lilly made headway in a Phase 3 trial that could provide a treatment option to replace fulvestrant.

    By • Updated Dec. 11, 2024
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    ASH/Todd Buchanan

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    ASH24: Leukemia drug sequencing, sickle cell questions and a new kind of CAR-T

    Data from Eli Lilly and AstraZeneca could help doctors decide treatment order in chronic lymphocytic leukemia. Elsewhere, answers remained elusive on Pfizer's abrupt withdrawal of Oxbryta.

    By • Dec. 10, 2024
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    NewAmsterdam drug shows ‘unexpected’ signs of protecting the heart in latest study

    The findings add to evidence that the company’s drug, obicetrapib, could change the narrative surrounding a once-abandoned class of heart medicines called CETP inhibitors.  

    By • Dec. 10, 2024