Today, a brief rundown of news involving Inhibrx Biosciences and the Food and Drug Administration, as well as updates from Fractyl Health, Capricor Therapeutics and Argenx that you may have missed.
Inhibrx Biosciences delivered mid-stage study results suggesting its experimental drug might boost the effects of cancer immunotherapy. Inhibrx said Monday a combination of its treatment INBRX-106 and Merck & Co.'s Keytruda was associated with a 44% response rate in a Phase 2 trial in a kind of head and neck cancer, compared to 21.4% for those who received Keytruda alone. Three "complete" responses were observed in those who got INBRX-106, versus none in the control group. The findings indicate stimulating a T cell receptor called OX40, as INBRX-106 does, may be the "first add-on mechanism" that might "clearly differentiated from Keytruda," wrote Stifel analyst Dara Azar. Reuters in April reported that Merck and others were exploring a possible buyout of Inhibrx. The company's market value has since swelled to nearly $2 billion.
The Food and Drug Administration has issued its seventh clearance under the "national priority" voucher program meant to accelerate drug reviews. The approval issued Friday was granted to a cancer drug called Bizengri from privately held biotechnology company Partner Therapeutics. Bizengri was initially approved in 2024 for some lung and pancreatic cancers that harbor a certain alteration to a gene called NRG1. The new approval broadens use to include NRG1 fusion-positive cholangiocarcinoma, an ultra-rare and aggressive cancer that forms in the bile ducts. The FDA's voucher program cuts drug evaluations to as little as one to two months. But the initiative has drawn criticism for its potential to be used as a tool to curry political favor.
Fractyl Health has begun human testing of a gene therapy for Type 2 diabetes. Regulators in the Netherlands accepted an application by Fractyl to start the study, which will evaluate an experimental treatment called RJVA-001 that spurs pancreatic cells to produce the GLP-1 hormone in response to meals. The trial will enroll adults whose disease isn't controlled despite treatment with multiple glucose-lowering drugs, including GLP-1 medicines. Fractyl expects to dose the first patient and report preliminary data in the second half of 2026.
Capricor Therapeutics has sued partner Nippon Shinyaku in a New Jersey Chancery Court over an alleged "fundamental pricing flaw" in the companies' collaboration for a Duchenne muscular dystrophy cell therapy. Capricor handed Nippon Shinyaku U.S. rights to the therapy, deramiocel, in 2022. But Capricor alleged in its complaint that the terms of the existing deal will prevent patients covered by Medicare, Medicaid or private insurance from accessing the treatment and that NS Pharma has refused to compromise or otherwise work to fix the agreement. The FDA is currently reviewing deramiocel as a treatment for heart-related complications of Duchenne. A decision is expected by Aug. 22.
The FDA has also expanded use of Argenx's fast-selling autoimmune disease therapy Vyvgart. Argenx said late Friday that the agency has broadened the existing clearance of Vyvgart in generalized myasthenia gravis to include all adults living with the disease, regardless of the types of errant antibodies driving their condition. The new clearance makes Vyvgart the only therapy available for all forms of the disease and widens its total addressable market by 18%, wrote William Blair analyst Myles Minter. Vyvgart generated more than $4 billion in sales in 2025.
