Edgewise heads to phase III with solid EDG-7500 data in HCM
Demonstrating better tolerability and safety in comparison with standard of care, Edgewise Therapeutics Inc.’s EDG-7500 is moving toward a phase III trial for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), the most common form of genetic heart disease. Boulder, Colo.-based Edgewise reported top-line phase II results from part D of the Cirrus-HCM trial, showing meaningful responses in terms of hemodynamics, biomarkers and patient-reported measures.

Edgewise heads to phase III with solid EDG-7500 data in HCM
Demonstrating better tolerability and safety in comparison with standard of care, Edgewise Therapeutics Inc.’s EDG-7500 is moving toward a phase III trial for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), the most common form of genetic heart disease. Boulder, Colo.-based Edgewise reported top-line phase II results from part D of the Cirrus-HCM trial, showing meaningful responses in terms of hemodynamics, biomarkers and patient-reported measures.
Another shot: Moderna flu vaccine re-upped in adcom
Moderna Inc. will soon find out if the tumult-ridden U.S. FDA’s switcheroo in mid-February will stick regarding mRNA-1010, a prospective new seasonal influenza vaccine. The Vaccines and Related Biological Products Advisory Committee on June 17 takes up the matter of the shot, which trails a curious history.
2025 annual report reflects the changing role of EMA
The EMA’s 2025 annual report highlights the pressure it is under to streamline and simplify assessment processes, and the expanded – and explicit – role the agency now has in boosting the competitive position of the EU in the development and manufacturing of drugs.
Today's news in brief
BioWorld briefs for June 16, 2026.
HLTH Europe panel on AI liability in healthcare: Who is responsible?
Liability remains one of the biggest barriers to the adoption of AI in healthcare. As more tools get developed for use in clinical settings, a key question persists: Who is ultimately at fault when something goes wrong – the hospital, the clinician or the developer? That uncertainty is making clinicians hesitant to adopt new technologies, delegates heard at the HLTH Europe conference in Amsterdam on June 16.
Dimerix out-licenses DMX-200 to Everest in AU$481M deal
Dimerix Ltd. has signed an exclusive licensing deal with Everest Medicines Ltd. to commercialize its phase III kidney disease candidate DMX-200 in a transaction worth up to AU$481 million (US$340 million), plus sales royalties.
For clonal hematopoiesis, epigenetics can be in driver’s seat
Clonal hematopoiesis (CH), where few blood stem cells produce a significant fraction of mature blood cells that are genetically identical, is partly an inevitable feature of aging. Certainly, it is near universal in those older than 60. CH is not itself a disease, but 1%-2% of CH cases progress to acute myeloid leukemia, and it raises the risk of some other types of cancer as well. A total of eight genes are responsible for 95% of CH cases, George Vassiliou told the audience in Saturday’s plenary session at the 2026 Annual Congress of the European Hematology Association (EHA 2026).

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Analysis and data insight

China partnerships drive biopharma’s biggest deal month since 2023
Deals and M&A
Biopharma deal value through the first five months of 2026 reached $135.36 billion, outpacing every prior year and topping 2025’s previous high of $103.92 billion. May was the year’s biggest month so far at $41.78 billion in transactions, making it one of the strongest individual months on record,...
EY report: Biopharma is balancing record growth and mounting pressures
Deals and M&A
The biotech industry delivered another year of strong headline performance in 2025, yet beneath the surface, a growing divide between the industry’s haves and have-nots is reshaping every dimension of how companies raise money, build pipelines and navigate an increasingly volatile policy...
Med-tech IPO window holds with $1.51B raised through May in 2026
Financings
Total med-tech financing through the first five months of 2026 reached $11.01 billion, falling between 2024’s $12.76 billion and 2023’s $8.95 billion over the same period, and trailing 2025’s $14.83 billion.
Competitive approach better than restricting deals with China?
Regulatory
The recent introduction of the bipartisan Biotech Investment National Security Act in the U.S. House has industry and venture capitalists urging lawmakers to take a breath, step back, and consider a less invasive approach than restricting U.S. biopharma deals with Chinese innovators.

Financings

Ethyreal launches to treat the underlying cause of Graves’, TED
Conferences
Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone receptor, at the Endocrine Society’s 2026 annual meeting on June 15.

Medical technology

Children overlooked as pediatric innovation struggles for funding
Conferences
Even though children make up a quarter of the population, healthcare technologies are not often designed with them in mind. Investment in pediatric innovation remains limited with investors often viewing returns in the space as less predictable. Nevertheless, a number of companies are looking to...

Dermasensor receives CE mark for skin cancer detection device
Regulatory
Dermasensor Inc. received CE mark approval for its handheld skin cancer detection device using spectroscopy and AI to test suspicious skin lesions for cancer in real time at the point of care. The device is designed to help qualified healthcare professionals decide whether suspicious skin lesions...
Pumps, patches and fixes at the ADA
Conferences
Dexcom Inc. and Insulet Corp. reported new clinical trial data on their diabetes technologies at the 2026 Scientific Sessions of the American Diabetes Association in New Orleans, offering insights that could aid in clinical adoption. Abbott Laboratories, meanwhile, highlighted the risks of diabetic...

Newco news

Skape Bio unlocks GPCR targets with de novo-designed miniproteins
Science
Modulating G protein-coupled receptors (GPCRs) is one of the major challenges in biomedicine. These are flexible proteins with small, deep binding pockets. The scientific community has explored small molecules, antibodies and nanobodies to develop ligands. Skape Bio Inc. is betting on creating...
Newco news: Oorja energizes with $30M for IPF
Respiratory
Oorja Bio Inc., named after the phonetic spelling of “energy” in Sanskrit, secured $30 million from founding investor Westlake Biopartners in a series A financing round to advance its in-licensing approach to develop drugs for idiopathic pulmonary fibrosis (IPF) and other fibrotic and...
Curacle, Memento ink $1B deal for ocular TIE2/VEGF bispecific
Deals and M&A
Curacle Co. Ltd. inked a potential $1.07 billion deal with U.S.-based “newco” Memento Medicines on May 10, granting the latter exclusive global rights to develop and commercialize preclinical TIE2/VEGF-directed bispecific antibody MT-103 for retinal disorders.
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.

U.S.

Elixiron’s enrupatinib shows upbeat interim phase II AD results
Clinical
Elixiron Immunotherapeutics Inc. announced positive interim open-label phase II Alzheimer’s disease (AD) study findings of enrupatinib, an oral brain-penetrant colony-stimulating factor 1 receptor inhibitor, with plans to move the asset into a biomarker-based and placebo-controlled study.

Europe

Industry calls for greater competitiveness incentives in EU Biotech Act
The industry is in support of the EU Biotech Act but says it needs to go further to restore Europe’s competitive position in biopharma. Instead of incremental adjustments, there should be wide-ranging change to create a system that supports the full lifecycle of drug development, from academic...

Sanofi phase III CIDP quit dents Dianthus; C1 mismatch?
Clinical
Investors in Dianthus Therapeutics Inc. apparently chose to ignore subtleties in the difference between efforts with that firm’s claseprubart vs. those by competitor Sanofi SA, which said that the phase III Mobilize study testing riliprubart in chronic inflammatory demyelinating polyneuropathy...
UK Biobank seeks to recall downloads after health data breach
Asia-Pacific
After a major breach of trust when its data were advertised for sale in China, the UK Biobank will now attempt to recall data previously downloaded by legitimate researchers and seek assurances information has been deleted from local servers.

Clinical

Longbio’s LP-003 meets phase III allergy endpoints
Immune
After raising HK$1.255 billion (US$160 million) in its IPO on the Hong Kong Stock Exchange earlier this month, Longbio Pharma Co. Ltd.’s lead candidate, LP-003, met the primary endpoint of total nasal symptom scores during peak pollen season in...
Oricell brings first pivotal-stage CAR T in liver cancer
Cancer
Oricell Therapeutics Holdings Ltd.’s glypican-3 (GPC3)-targeted autologous CAR T therapy, Ori-C101, is heading into a confirmatory registration phase II trial in patients with GPC3-positive advanced hepatocellular carcinoma, positioning it as the...
Takeda’s zasocitinib bests Sotyktu in phase III psoriasis trial
Dermatologic
Takeda Pharmaceutical Co. Ltd.’s oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb Co.’s first-in-class Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout of moderate to...
GLP-1s and more weigh in at ADA
Conferences
GLP-1 receptor agonists remained center stage at the 2026 Scientific Sessions of the American Diabetes Association with Boehringer Ingelheim GmbH and Astrazeneca plc, joining the leaders, Eli Lilly and Co. and Novo Nordisk A/S, in presenting data...
Clinical footwork pays off in Tango’s PDAC combo phase I/II
Conferences
Tango Therapeutics Inc. will be sitting down with the U.S. FDA soon to discuss pivotal work ahead based on what Cantor analyst Eric Schmidt called “amazing” data from the phase I/II study of vopimetostat, a PRMT5 inhibitor, paired with Revolution...
ASCO 2026: Chinese biopharma arrives at ASCO with pivotal wins
Analysis and data insight
If the 2026 American Society of Clinical Oncology (ASCO) annual meeting in Chicago from May 30 to June 3 demonstrated anything about the evolution of China’s biotechnology sector, it was that the industry’s center of gravity is shifting. While...

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