Akeso, Summit drug extends survival in closely watched lung cancer trial

Though ivonescimab reduced the risk of death by one-third compared to chemotherapy in a China-based study, the total survival benefit of four months stirred debate and pressured company shares.

By Jonathan Gardner • Updated June 1, 2026

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.

By Jacob Bell • May 29, 2026

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases or in reprogramming cells inside the body.

By BioPharma Dive staff

Allogene CEO to step down; Agios drug fails key test

David Chang will leave his post after an eight-year run at the cell therapy maker. Elsewhere, a next-generation blood disease drug stumbled and an acquisition yielded an FDA approval for AbbVie.

By Ben Fidler • May 29, 2026

GSK, Ionis unveil data for hepatitis B drug touted as ‘functional cure’

The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.

By Jonathan Gardner • May 28, 2026

Verge, following trial failure, rebrands its AI drug discovery ambitions

Formerly known as Verge Genomics, the new Verge Labs will help pharma and biotech partners match potential brain drugs to patients who best benefit from them.

By Gwendolyn Wu • May 27, 2026

Cardio drugmaker Kardigan plans to go public

Founded by former MyoKardia executives, the startup has in mid- to late-stage testing three medicines licensed from the likes of Sanofi, Ionis and Bristol Myers Squibb.

By Jacob Bell • May 27, 2026

Kailera’s three-pronged obesity shot shows promise in early trial

As Lilly completes the pivotal program for its “triple-G” drug, Phase 1 data from Kailera partner Hengrui suggest their offering might spur greater weight loss.

By Jonathan Gardner • May 27, 2026

Apogee eczema drugs gets Blackstone backing, heads to Phase 3

The company made the announcement after a new round of research results bolstered the case for the experimental medicine, which may ultimately compete against Dupixent and Ebglyss.

By Kristin Jensen • May 27, 2026

Astellas eyes more cost cuts; FDA panel to debate Moderna vaccine

The Japanese pharma is aiming for $1.3 billion in yearly savings between now and 2030. Elsewhere, Datroway gained a new clearance in breast cancer and the FDA approved a drug for hepatitis D.

By Ben Fidler • May 26, 2026

SR One’s Simeon George on how China is rewriting biotech’s venture playbook

The veteran investor says that the trove of ready-made prospects is making the global biotech ecosystem “more competitive” and steering dollars away from “half-baked ideas.”

By Gwendolyn Wu • May 26, 2026

Parkinson’s drug from Biogen, Denali comes up short

High-level results have led the companies to scrap a mid-stage trial, though Denali plans to continue independently running a separate experiment focused on a certain subset of Parkinson’s patients.

By Jacob Bell • Updated May 22, 2026

RA Capital banks $75M for a biotech SPAC

Research Alliance III follows a few months after Cormorant Asset Management priced a $150 million IPO for its own blank-check entity.

By Gwendolyn Wu • May 21, 2026

BioMarin notches win in study that could expand use of top-selling medicine

The success came two days after a Phase 3 setback for another experimental drug and helps improve the position of Voxzogo amid increased competition.

By Kristin Jensen • May 21, 2026

After raising $800M, Parabilis seeks an IPO to pursue ‘undruggable’ targets

Parabilis is teeing up the latest high-profile stock issuance in a year when biotech IPOs are averaging more than $286 million in total proceeds.

By Jonathan Gardner • May 20, 2026

Oorja, run by Acceleron veterans, launches to make new fibrosis drugs

The biotechnology startup emerged from stealth with a peptide drug it claims to have the potential to reverse lung scarring in people with idiopathic pulmonary fibrosis.

By Gwendolyn Wu • May 20, 2026

Immunovant’s potential autoimmune ‘blockbuster’; Wave’s RNA editing update

Immunovant shares climbed on results an analyst deemed “compelling” in tough-to-treat arthritis. Elsewhere, Wave’s pioneering rare disease program advanced and Takeda lost an antitrust suit.

By BioPharma Dive staff • May 20, 2026

BioMarin drug acquired in buyout misses goal in rare disease study

Tested in a condition known as ENPP1 deficiency, the treatment failed a trial goal that’s important to regulators, spurring doubts about its approval prospects. 

By Delilah Alvarado • May 19, 2026

A migraine drugmaker heads to the public markets through reverse merger

Mentari Therapeutics, a spinout from the prolific hub-and-spoke biotech Paragon, is developing two medications it hopes can treat migraines that aren’t well controlled by existing drugs.

By Jacob Bell • May 19, 2026

Relay drug shows early promise against rare blood vessel diseases

While early, the findings suggest the therapy could be superior to Novartis’ Vijoice at treating “vascular anomalies,” a cluster of chronic conditions with few available treatments.

By Ben Fidler • May 19, 2026

Høeg fired in latest FDA shakeup; 20 people die after taking Amgen drug

The agency has once again shuffled the leadership for two top drug review offices. Elsewhere, Parabilis partnered with Regeneron and an obesity pill is headed toward an approval in China.

By BioPharma Dive staff • May 18, 2026

Regeneron immunotherapy combo comes up short in melanoma trial

A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in market value.

By Ben Fidler • May 18, 2026

FDA hold puts Aardvark Prader-Willi drug in limbo

The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.

By Jonathan Gardner • May 15, 2026

Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers

Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted immune drug.

By BioPharma Dive staff • May 15, 2026

Create Medicines raises $122M to bolster in vivo CAR-T therapies

The fresh funds will support the biotech's pipeline of RNA-based CAR-T cell therapies for cancer and autoimmune conditions.

By Delilah Alvarado • May 14, 2026

Assertio accepts new buyout bid; AI biotech Isomorphic banks $2B

Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a first-of-its-kind approval application and AC Immune is swapping CEOs.

By BioPharma Dive staff • May 13, 2026