Reunion’s psychedelic drug headed to late-stage testing

The drug, which functions similar to psilocybin, scored positive enough results in a mid-stage study that Reunion is now setting up a larger experiment to hopefully secure approval in postpartum depression.

By Jacob Bell • Aug. 18, 2025

Vor says drug licensed from RemeGen succeeded in Sjögren’s study

While Vor provided no details on the results, the company is now evaluating a global trial of the drug in the chronic immune condition.

By Ned Pagliarulo • Aug. 13, 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

Pfizer looks to expand ADC use after positive bladder cancer data

Padcev, an antibody-drug conjugate which Pfizer acquired via its $43 billion Seagen deal, could help people who don’t qualify for chemotherapy.

By Jonathan Gardner • Aug. 12, 2025

IO Biotech sees path forward for skin cancer vaccine despite study setback

A regimen involving the company’s shot failed a Phase 3 trial “by a hair,” an executive said, leading the company to believe it still could win U.S. approval.

By Jonathan Gardner • Aug. 11, 2025

Novartis drug acquired in Morphosys deal succeeds against tough-to-treat autoimmune disease

The drug, ianalumab, met its objectives in two Phase 3 studies in Sjögren’s syndrome, boosting the outlook of a multibillion-dollar deal that hadn’t yet paid dividends.

By Ben Fidler • Aug. 11, 2025

Lilly shares fall as obesity pill misses expectations in key trial

While orforglipron succeeded in a Phase 3 trial, its weight loss effects were more modest than investors and analysts anticipated, leading to a selloff in shares that erased about $100 billion in market value. 

By Jonathan Gardner • Aug. 7, 2025

Vertex plan to build on pain drug breakthrough hits hurdles

The drugmaker shed billions of dollars in value after it told investors that widening Journavx’s approval to chronic pain would take more testing. A successor medicine, meanwhile, fell short in Phase 2.

By Ned Pagliarulo • Aug. 5, 2025

A brain biotech slumps even with ‘best case’ seizure data

Positive results from a mid-stage study apparently weren’t enough to raise investor confidence in Praxis Precision Medicines and its experimental drug for epilepsy.

By Jacob Bell • Aug. 4, 2025

Lilly’s Mounjaro protects heart health in large diabetic study

The fast-selling GLP-1 drug matched Lilly's older medicine Trulicity in a closely watched cardiovascular outcomes trial, while showing greater weight loss and blood sugar control.

By Ned Pagliarulo • July 31, 2025

Celcuity shares triple on late-stage results for breast cancer therapy

Trial data showed the drug dramatically reduced cancer progression risk in certain patients, supporting Celcuity’s plans to soon file for approval.

By Delilah Alvarado • July 28, 2025

Atai backs away from schizophrenia drug after trial failure

The company plans to direct resources away from a drug developed by subsidiary Recognify Life Sciences and toward Atai’s wholly owned, psychedelics-focused pipeline.

By Jacob Bell • July 28, 2025

Alkermes narcolepsy drug headed for late-stage testing

Part of a class of therapies that boost “orexin” proteins, the drug just scored positive results in a Phase 2 trial. Analysts have guessed it could ultimately generate billions in sales.

By Jacob Bell • July 21, 2025

AstraZeneca rare disease drug fails key trial tests

Anselamimab, which AstraZeneca acquired via Caelum Biosciences, missed its primary goal in two late-stage trials, but appeared to have some benefit in a subgroup of patients.

By Gwendolyn Wu • July 16, 2025

Hengrui, Kailera say dual-acting obesity shot succeeds in China study

The results position Hengrui to seek approval of the Zepbound-like drug in China, and Kailera, a well-funded startup, to begin global late-stage testing.

By Ben Fidler • July 15, 2025

AstraZeneca blood pressure drug succeeds in late-stage trial

Baxdrostat, which AstraZeneca acquired in a 2023 buyout of CinCor Pharma, could become a new treatment for people whose hypertension is either uncontrolled by or resistant to existing medicines.

By Ned Pagliarulo • July 14, 2025

Takeda to seek approval of new kind of narcolepsy drug after study data

Positive late-stage study results position the company to file for clearance of what could be the first narcolepsy drug that targets orexin proteins. 

By Ben Fidler • July 14, 2025

From data to decisions: How pharma can move faster without sacrificing trust

Pharma's speed advantage depends on trust. Is your data foundation strong enough?

By Pankit Bhalodia, Partner at West Monroe Life Sciences • July 14, 2025

Apogee touts positive data for atopic dermatitis drug

The antibody treatment could compete with Sanofi’s Dupixent and Eli Lilly’s Ebgylss, while offering the potential for less frequent dosing.

By Delilah Alvarado • July 7, 2025

Study results boost Cogent’s case for rare disease drug

One analyst described Cogent’s data as a “home run scenario” for bezuclastinib, which the company is positioning as a competitor to Blueprint Medicines’ Ayvakit.

By Gwendolyn Wu • July 7, 2025

[Podcast] Trial Trailblazers: Behind clinical breakthroughs

Explore how innovative clinical trials are transforming treatments for children with rare diseases in this compelling podcast.

By BioPharma Dive's studioID • July 7, 2025

Organon drug for endometriosis falls short in mid-stage study

Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

By Kristin Jensen • July 2, 2025

Atai and Beckley, set to merge, reveal study success for psychedelic drug

Positive study results in Phase 2 lead to a green light for the companies’ combination and plans to move their nasal spray into pivotal testing.

By Kristin Jensen • July 1, 2025

Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment

The success of Vertex's opioid alternative Journavx could aid a group of biotechs that aim to take a similar path with NaV1.8 and NaV1.7 inhibitors.

By Jacob Bell • July 1, 2025

Moderna flu shot outperforms marketed vaccines in large late-stage trial

The mRNA drug developer said it will begin discussing approval with the FDA, which has adopted stricter vaccine review standards.

By Jonathan Gardner • June 30, 2025

New Amgen obesity drug data disappoint Wall Street

Full Phase 2 study results showed side effects that led people to stop treatment with MariTide, as well as weight loss effects that weren’t as strong as previously reported.

By Jonathan Gardner • June 24, 2025