Kyverna Therapeutics Inc. made public a positive primary analysis from its registrational trial, KYSA-8, of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome (SPS). The phase II data rolled out in a late-breaking oral presentation at the American Academy of Neurology annual meeting in Chicago. In the study, a single dose of miv-cel delivered rapid, statistically significant, and clinically meaningful improvements across all primary and secondary endpoints in SPS at 16 weeks, with the majority of patients regaining function, and all quitting chronic immunotherapies. Such outcomes have not previously been seen in the condition, classed as an extremely rare autoimmune neurological disorder that causes progressive muscle stiffness and painful spasms. Miv-cel proved well-tolerated, too. Potentially the first CAR T therapy for an autoimmune condition, the drug in December showed what Leerink analyst Thomas Smith called “remarkable clinical benefit” in the top-line results from KYSA-8, including a 46% median improvement in the timed 25-foot walk test primary endpoint at week 16. Shares of Emeryville, Calif.-based Kyverna (NASDAQ:KVTX) were trading at $9.48, down 23 cents.

Revolution hype continues with first-line PDAC data at AACR

Positive readouts continue for Revolution Medicines Inc., with updated phase I/II data yielding impressive findings for daraxonrasib, its oral RAS(ON) multi-selective inhibitor, in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). Findings, presented at the American Association for Cancer Research meeting, came from two studies, one testing the drug as a monotherapy and one in combination with chemotherapy. The combination study, in particular, exceeded historical standard-of-care benchmarks, noted Evercore ISI analysts, and both trial updates bode well for the phase III RASolute 303 study, which recently began enrolling previously untreated PDAC patients, irrespective of tumor RAS genotype, and will test daraxonrasib as both a monotherapy and in combination with chemotherapy.

Netrin-1 inhibitor blocks chemo resistance in pancreatic cancer

Netris Pharma SA has delivered positive phase Ib data showing its first-in-class netrin-1 inhibitor NP-137 alleviates resistance to chemotherapy in pancreatic cancer. This could represent an important advance in treating these tumors, which are notoriously resistant to chemotherapy. Resistance frequently develops via the epithelial to mesenchymal transition (EMT), which enables pancreatic cancer cells to become more invasive and promotes metastasis. Netrin-1 plays a central role in EMT, leading to the remodeling of the tumor microenvironment into a dense, fibrous structure, which alongside supporting tumor growth, restricts the blood supply and prevents systemically-administered drugs from reaching cancer cells.

CMS to bridge coverage for obesity drugs as BALANCE teeters

When the U.S. CMS didn’t get any takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced last night that it will instead provide that coverage by extending its temporary bridge demonstration model through the end of 2027. Originally, the bridge was meant to provide Medicare coverage for obesity drugs, for the first time ever, from July until January when the BALANCE model was to kick in. The big difference between the two models is who's picking up the tab.

Akeso sets durability bar as immuno-oncology 2.0 race heats up

Akeso Pharmaceuticals Inc. has raised the bar for next-generation immuno-oncology, reporting more than 23 months median overall survival in pancreatic cancer with its PD-1/CTLA-4 bispecific antibody cadonilimab, as emerging competitors begin to post earlier signals across solid tumors at the American Association for Cancer Research annual meeting in San Diego April 17 to 22. The data, from the phase II Compassion-26 study in pancreatic ductal adenocarcinoma, highlight a shift underway in immuno-oncology. While companies such as Shanghai Junshi Biosciences Co. Ltd. are reporting high early response rates with bispecific combinations, Akeso’s results emphasize the importance of durability and long-term survival in defining clinical value.

Boston Sci’s CEO ‘disappointed’ as company cuts 2026 guidance

Boston Scientific Corp.'s CEO, Mike Mahoney, said that the year is turning out to be “more challenging” than the company anticipated, prompting a cut to its organic sales growth guidance to 6.5% to 8%, from 10% to 11%. The company also lowered its adjusted earnings per share guidance to $3.34 to $3.41, from $3.43 to $3.49 previously. Analysts welcomed the lower guidance seeing it as somewhat of a relief and an opportunity to reset on the back of the company’s share price, which has fallen sharply over the last year.

AI opens the way to systematic risk assessment of zoonotic potential of viruses

Researchers in the U.K. have developed an AI-driven method of identifying viruses in wild animals with the potential to spillover into humans. The technique makes it possible to use the genome sequences of the spike proteins by which viruses enter host cells to assess the potential to infect humans without having to isolate an individual virus and tests its infectivity in the lab. That will open the way to carry out a systematic risk assessment of which of the 40,000 viruses that infect mammals could spillover into humans. “What we really want to be able to do, is to identify viruses that are in mammals that can also have the ability to infect humans as well, to get a step ahead in terms of pandemic preparedness for zoonotic events,” said Dalan Bailey, leader of the viral glycoprotein group at the Pirbright Institute, a national center specializing in research and surveillance of animal viruses with zoonotic potential.

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