Apogee Therapeutics Inc. rolled out favorable phase II results and entered a deal with funds managed by Blackstone Life Sciences for up to $1.3 billion in nondilutive total capital in order to move forward with zumilokibart (zumi), for which the Boston-based firm disclosed the clinical findings. Specifically, Apogee made public 16-week numbers from part B of the Apex trial with zumi, described as a potential best-in-class anti-IL-13 antibody, in patients with moderate to severe atopic dermatitis (AD). Apogee CEO Michael Henderson said the data suggest that zumi could become the “front-line drug of choice” in AD. Shares (NASDAQ:APGE) were trading at $37.90, up $1.15.

BMS-Hengrui deal strikes panic in Washington

On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd, Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025. As previously reported by BioWorld, Shanghai-based Hengrui and Princeton, N.J.-based BMS inked a deal worth up to potentially $15.2 billion to advance 13 early development programs in the fields of oncology, hematology, and immunology. “I write to draw your attention to a dangerous surge of American capital and know-how into the People’s Republic of China (PRC) biotechnology sector and urge you to cover biotechnology as a prohibited technology as soon as possible,” Moolenaar wrote, pointing to “fierce” competition between the U.S. and the PRC in the biotechnology space.

D&D’s zabopegdutide shows upbeat top-line phase II MASH data

D&D Pharmatech Inc. announced May 27 positive top-line tissue biopsy results of zabopegdutide (DD-01) from a 48-week phase II study of metabolic dysfunction-associated steatohepatitis (MASH), pushing company shares up 30% on the day. The secondary endpoint (liver biopsy) findings add to D&D’s initial upbeat top-line readout in June last year, when it announced that DD-01 met the phase II study’s primary endpoint after 12 weeks of treatment. Results from the planned 12-week assessment of safety and efficacy of DD-01 showed 75.8% of treated patients achieved at least a 30% reduction in liver fat (compared to 11.8% with placebo). The latest secondary endpoint analysis showed that zabopegdutide hit major U.S. FDA-relevant histology endpoints for MASH, including fibrosis improvement and MASH resolution. Zabopegdutide is a dual glucagon-like peptide-1 and glucagon receptor agonist in development by D&D and Gaithersburg, Md.-based subsidiary, Neuraly Inc.

Initial data hint that US MFN pricing is hitting access in Europe

There are initial signs that President Donald Trump’s most-favored nation (MFN) policy may be further delaying access to new drugs in Europe, as companies hold off commercializing in these countries to avoid lower European prices being referenced in the U.S. Approvals data for the past 18 months suggest a decline in the number of FDA-approved drugs that subsequently are approved by the EMA. There has been a particularly steep drop since October 2025, according to a new approvals tracker published by the European Federation of Pharmaceutical Industries and Associations (EFPIA). If the trend persists, China will soon surpass the EU for approving and launching FDA-approved drugs, according to EFPIA.

Will Ovid’s golden age of KCC2 metamorph CNS?

The “deep dive” April 8 by Ovid Therapeutics Inc. into potassium-chloride co-transporter 2 (KCC2) research included company officials and independent experts in the space, where a handful of drug developers are known to be working. New York-based Ovid owns a portfolio of potential first-in-class direct activators of KCC2, and the firm detailed pharmacodynamic results along with the translational and clinical development strategy. In the hopper are OV-350 (an intravenous tool program and KCC2 direct activator) and OV-4071 (an oral KCC2 direct activator). A neuron-specific membrane protein that acts as the primary chloride extruder in mature neurons, KCC2 – encoded by the SLC12A5 gene – keeps steadily low intracellular chloride concentrations, key for inhibitory GABAergic signaling in the central nervous system (CNS). Out-of-whack KCC2 leads to neuronal hyperexcitability, a factor in epilepsy, pain, and developmental disorders.

Insulet initiates voluntary correction on Omnipod devices

Insulet Corp. has initiated a voluntary medical device correction affecting insulin pump pods in its Omnipod product lines after discovering a manufacturing issue that could lead to the leaking of insulin and the under-delivery of doses in some patients. The company said that some pods from specific lots may have a small tear in the cannula. It is the second time in as many months that the company has had to make a correction related to cannula tears, leaving many analysts disappointed, worried about the risk of more scrutiny, and describing the development as unwelcome.

Ongoing coverage of the Ebola outbreak

Stay up to date as BioWorld reports on the latest developments of the Ebola virus public health emergency.

Also in the news

28bio, Abivax, Adcedno, Aim Medical, Autobahn, Biocytogen, Biohaven, Biomunex, Bionano, Bioprotect, Biostem, Breezebio, Cartesian, Cgbio, Co-Diagnostics, Corbus, Cornerstone, Cosara, Decoy, Delphia, Depuy, Dexcom, Dyne, Editas, Eli Lilly, Gain, Genprex, Gilead, Gordion, H. Lundbeck, Hanchorbio, Hologic, Human Life Foundation Models, Human Longevity, Insilico, Jiangxi Kvvit, Kane, Kura, LIB, Merck, Merz, Metriopharm, Microbot, Mindmaze, Minmaxmedical, Nanobiotix, Nervgen, Olympus, Oncopeptides, Outlook, Pfizer, Pharming, Rani, Renovorx, Saga, Salus, Siemens, Spectral, Sun, Tangramed, Toby, Verastem, Vialase, Virax