Relay’s zovegalisib hits in phase II vascular anomalies trial
Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response in patients with PIK3CA-driven vascular anomalies (VAs). The isoform-selective PI3Ka inhibitor is in late-stage clinical trials with various combinations for P13Ka-mutated, HR+/HER2- advanced breast cancer, with VAs representing a second indication for which Leerink Partners analyst Andrew Berens forecasts $2.8 billion in peak revenues.

Relay’s zovegalisib hits in phase II vascular anomalies trial
Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response in patients with PIK3CA-driven vascular anomalies (VAs). The isoform-selective PI3Ka inhibitor is in late-stage clinical trials with various combinations for P13Ka-mutated, HR+/HER2- advanced breast cancer, with VAs representing a second indication for which Leerink Partners analyst Andrew Berens forecasts $2.8 billion in peak revenues.
Artificial intelligence agents get ready to take on the scientific method
There are real world demonstrations of how autonomous artificial intelligence agents are poised to disrupt biomedical research, according to two papers published May 19 in Nature. Each describes an AI system that assists across the piece, from generating hypotheses to designing experiments, analyzing the data and refining hypotheses in the light of new data.
Create Medicines secures $122M for in vivo CARs
Create Medicines Inc. closed a $122 million series B financing round to support its pipeline of therapies that use mRNAs delivered via liquid nanoparticles to express chimeric antigen receptors (CARs) in T cells, NK cells and myeloid cells inside the body of patients. The Cambridge, Mass.-based company estimates the capital will last through 2028, providing the opportunity for multiple clinical readouts of its various products.
Vincentage’s oral GLP-1 meets phase III obesity endpoints
Vincentage Pharma Co. Ltd.’s once-daily oral small-molecule GLP-1 receptor agonist, VCT-220, met the primary endpoints in a pivotal phase III trial in overweight or obese patients in China. Based on the top-line data, the Chengdu, China-based company plans to submit an NDA for chronic weight management to China’s National Medical Products Administration.
Boston Scientific reports Seismiq IVL data from Fracture study
Boston Scientific Corp. reported positive results from the Fracture investigational device exemption trial which evaluated its Seismiq 4CE coronary intravascular lithotripsy (IVL) catheter in patients with severely calcified coronary artery disease. Late-breaking data presented at the EuroPCR conference in Paris showed that the pivotal study met its primary safety and effectiveness endpoints, with high rates of freedom from major adverse cardiac events at 30 days and strong procedural success.
Today's news in brief
BioWorld briefs for May 19, 2026.
Elixir Dynamx system sees lower event rates than drug-eluting stent
Elixir Medical Corp. reported four-year data from the Bioadaptor randomized controlled trial presented at the EuroPCR conference in Paris, which showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent, including reduction in cardiovascular death.
CDC vaccines panel to be ‘re-established’
It’s back to the drawing board for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP). After a year of Health and Human Services Secretary Robert Kennedy gutting the panel and restocking it mostly with people who share his views on vaccines, the CDC published a notice in the May 19 Federal Register saying it’s withdrawing the amended ACIP charter renewal issued April 6 and is instead “re-establishing” the committee.
Supreme Court upholds FCA’s ‘whistle while you work’
Eli Lilly and Co. lost its bid to have the U.S. Supreme Court strike down the whistleblower provisions in the False Claims Act (FCA) as unconstitutional.
SEC looks to reforms to Make IPOs Great Again
In a move aimed at incentivizing companies to go and stay public, the U.S. SEC proposed two rulemakings May 19 as a foundation to the agency’s Make IPOs Great Again agenda.

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Analysis and data insight

Med-tech M&A’s blockbuster streak continues with $19B April value
Deals and M&A
Med-tech M&A value through the first four months of 2026 reached $62.01 billion, the highest total for the period since 2022’s $73.58 billion and a dramatic step up from 2025’s $20.03 billion and 2024’s $5.74 billion over the same period.
Sen. Cassidy’s primary loss increases uncertainty
Medical technology
On the heels of the ouster of Marty Makary as the U.S. FDA commissioner and the serial leadership vacancies at the CDC and the FDA’s drugs and biologics centers, the government’s adherence to science took another blow May 16 when Sen. Bill Cassidy, R-La., lost the Louisiana primary, ending his bid...
Bundibugyo is harsh reminder of need for broad vaccine strategies
Science
On Sunday, May 17th, 2026, the World Health Organization classified the ongoing Bundibugyo ebolavirus outbreak in the Democratic Republic of Congo (DRC) as a public health emergency of international concern (PHEIC). The rapid escalation to PHEIC is due to several factors. Given the high number of...
Biopharma deal and M&A values soar in early 2026
Deals and M&A
Biopharma deal value through the first four months of 2026 reached $92.98 billion, outpacing every recent year and running well ahead of 2025’s strong $79.82 billion over the same period. January and February each cleared $30 billion, while March and April totaled $18.05 billion and $13.3 billion,...

Financings

Degron closes $40M series A to advance molecular glue degraders
Cancer
Degron Therapeutics Inc. closed a $40 million series A extension round that will see the company advance its molecular glue degraders targeting previously undruggable or insufficiently drugged proteins.

Medical technology

Medical devices evolving into intelligent, adaptive systems
Cardiovascular
The convergence of robotics, sensors and AI is reshaping how medical devices interact with patients, clinicians and healthcare systems. Across the field, from oncology to cardiology and women’s health, companies are integrating software, connectivity, data analytics and biological information into...

USPTO doubles down on inconsistencies in dual IPR-court action
Analysis and data insight
The U.S. Patent and Trademark Office (USPTO) is driving home its message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting “inconsistent positions” as a litigation strategy.
Life sciences ‘sweet’ opportunity in US-China talks
Analysis and data insight
Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings...

Newco news

Eyes are first prize for newco Link Biologics
Science
The classic origin story for a biotech startup is that of a scientist who nurtures his work out of a university and to commercial success. For Link Biologics Ltd. and its TSG6-based pipeline, the story is the other way around; it began with now-CEO Reuben Dawkins meeting University of Manchester...
Sonire starts US study of cancer HIFU after $18M series A
Clinical
Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
Pilatus PLT-012 takes immunometabolic approach to reprogram TME
Cancer
Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin...
Anaptysbio’s spinout First Tracks hits the slopes
Immune
Anaptysbio Inc. announced in September of 2025 that it planned to separate its drug development business from the royalties it receives on Jemperli (dostarlimab) from GSK plc and imsidolimab from Vanda Pharmaceuticals Inc. Just seven months later, on April 20, 2026, well ahead of its “year-end...
Tortugas launches with $106M for neurology, neuropsychiatric drugs
Financings
Tortugas Neuroscience Inc. came out of its shell to announce the raising of $106 million between its seed and series A financing rounds. “We like the symbolism of the sea turtle – long-lived, persistent, very determined,” Tortugas CEO Jeff Jonas said of the company’s name.

U.S.

Andes virus cases rise to 11; Hondius passengers in quarantine to June 21
Infection
The number of cases of hantavirus infection has risen from eight to 11, following the repatriation of passengers from the cruise ship MV Hondius, with World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus warning the danger is not over. “In fact, it has entered a new phase as...

Europe

MHRA sets out proposal to redefine gene therapies
Gene therapy
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on changes it is proposing to the legal definition of gene therapies, to reflect the advances in technology and manufacturing over the two decades since the current legislation was drawn up. The aim is to...

Scarlet raises $4M to take manufactured red blood cells into clinic
Financings
Scarlet Therapeutics Ltd. has demonstrated its manufactured red blood cells (RBCs) act in the same way as their natural counterparts in vivo, opening the way for the cells to be used as drug delivery vehicles and raising the possibility they could replace conventional blood transfusions. To build...
Hantavirus is ‘sentinel’ more than acute pandemic threat
Analysis and data insight
News of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press conference on Thursday, officials from the WHO did their best to calm the public’s fears that the MV Hondius, the ship currently heading...

Clinical

Budo judo moves aplenty for Climb in autoimmune
Analysis and data insight
Climb Bio Inc. outlined May 5 an enticing data spill ahead this year with Fc-enhanced monoclonal antibody budoprutug (budo) in autoimmune diseases. Mizuho analyst Joseph Catanzaro appreciated in his report Wellesley Hills, Mass.-based Climb’s...
Phase II Engene trouble: NMIBC detalimogene data throttle stock
Cancer
Hopes piqued last November for detalimogene voraplasmid in bladder cancer took a hit from the latest word from the study, as did shares of Engene Therapeutics Inc. (NASDAQ:ENGN), which closed May 7 at $1.72, down 80.6%, or $7.13.
Entrada sinks on mixed DMD data with ENTR-601-44
Musculoskeletal
A lower-than-expected increase in dystrophin over baseline in the first and lowest-dose cohort of a phase I/II study of ENTR-601-44 in Duchenne muscular dystrophy (DMD) caused shares of Entrada Therapeutics Inc. to plunge more than 57%, despite...
Abdakibart phase II graded, puts Avalo in HS upper class
Dermatologic
Avalo Therapeutics Inc. may have designed in lead asset abdakibart, a drug for hidradenitis suppurativa (HS) that offers a novel mechanism of action, wide dosing interval, and more-than-satisfying outcomes on the Hidradenitis Suppurativa Clinical...
MMI’s Symani system treats Alzheimer’s patient in IDE study
Medical technology
Medical Microinstruments Inc.’s (MMI) Symani surgical system was used to treat a patient with Alzheimer’s disease as part of a study evaluating robotic-enabled microsurgery for the condition. The procedure investigated whether restoring lymphatic...
Cytokinetics metrics satisfy in nHCM phase III
Cardiovascular
Thanks to a trial design that, according to Evercore ISI analyst Cory Kasimov, “played out exactly as drawn up,” Cytokinetics Inc. hit both of the phase III co-primary endpoints with aficamten in symptomatic non-obstructive hypertrophic...

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