Orca Bio to seek approval of T cell transplant after positive trial data

Results showed Orca’s treatment, a purified mix of donor-derived T cells and stem cells, was safer than standard transplant in treating certain blood cancers.

By Ned Pagliarulo • March 17, 2025

Arvinas gets positive breast cancer data, but finds differentiation a hard sell

Trial results show vepdegestrant, a protein-degrading drug Arvinas is developing with Pfizer, improved on fulvestrant in a subgroup of breast cancer patients, but not the overall study population.

By Ned Pagliarulo • March 11, 2025

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Novo’s Wegovy successor disappoints in second large trial

A study in people with obesity and diabetes again found CagriSema helps people lose weight, but not by enough to clearly surpass Eli Lilly’s Zepbound.

By Jonathan Gardner • March 10, 2025

Mineralys shares climb on study data for blood pressure drug

Findings from a pair of studies in tough-to-treat hypertension establish Mineralys’ drug as a “derisked, almost-commercial stage cardiometabolic asset,” wrote one analyst firm following the company.

By Ben Fidler • March 10, 2025

J&J scraps depression testing for potential blockbuster drug

Analysts say the decision is a “big blow” to a once-promising class of brain therapies that include’s J&J’s aticaprant and a drug from Neumora.

By Jacob Bell • March 7, 2025

Tris to ask for approval of dual-acting pain drug

Positive data from a pair of acute pain studies convinced the company that its drug, which works differently than existing medications, has a good shot at reaching market.

By Jacob Bell • March 6, 2025

Blocking PD-1 and VEGF: The bispecific cancer drugs that could best Keytruda

Striking study results last year indicated a new type of medicine may improve on Merck’s immunotherapy, spurring a wave of research practically overnight.

By Ben Fidler • March 4, 2025

Protagonist says Takeda-partnered drug succeeds in rare blood cancer

Takeda paid Protagonist $300 million one year ago to license rights to rusfertide, which the companies are developing to treat polycythemia vera.

By Ned Pagliarulo • March 3, 2025

Summit partners with Pfizer to study bispecific, ADC combinations

The partners will test Summit’s ivonescimab alongside Pfizer’s antibody-drug conjugates in hopes of finding “potentially landscape-changing combinations.”

By Jonathan Gardner • Feb. 24, 2025

Sanofi, Teva add to case for new bowel disease drug

Detailed results presented at a medical congress help reinforce analyst expectations the drug, called duvakitug, will be competitive with other Crohn’s, colitis medicines in testing.

By Ned Pagliarulo • Feb. 24, 2025

Partnering for success in early phase clinical development

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

Feb. 24, 2025

Solid says early data suggest ‘differentiated’ Duchenne gene therapy

The company raised $200 million after early findings hinted its therapy could be more potent than others like it, including Sarepta Therapeutics’ Elevidys.

By Ben Fidler • Feb. 18, 2025

Sanofi to take $250M charge on study failure for E. coli vaccine

The French drugmaker said the vaccine it agreed to develop with Johnson & Johnson a year ago was “not sufficiently effective.”

By Kristin Jensen • Feb. 13, 2025

New study offers hints of GLP-1 drugs’ potential in curbing alcohol cravings

A small semaglutide trial suggests the medicine's suppression of appetite may extend to alcohol, but larger tests are needed to establish a conclusive benefit.

By Jonathan Gardner • Feb. 12, 2025

Pliant shares collapse as company halts fibrosis drug study

In what one analyst called a “unique situation,” the company stopped dosing patients on the recommendation of trial monitors, but doesn’t yet know what led to their decision.

By Ben Fidler • Feb. 10, 2025

Novo outlines new late-stage study of obesity drug CagriSema

CagriSema, which underperformed expectations in its first Phase 3 test, will be studied at different doses and for longer duration in the new trial.

By Jonathan Gardner • Feb. 5, 2025

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 Jacob Bell • Feb. 3, 2025

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 Jonathan Gardner • Feb. 3, 2025

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 Ned Pagliarulo • Jan. 28, 2025

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 Ned Pagliarulo • Jan. 27, 2025

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 Jonathan Gardner • Jan. 27, 2025

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 Jonathan Gardner • Jan. 24, 2025

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 Ben Fidler • Jan. 9, 2025

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 Delilah Alvarado • Jan. 9, 2025

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 Jonathan Gardner • Jan. 7, 2025