Intensity Therapeutics, Inc. (INTS) issued a business update on its phase 3 sarcoma clinical program. In the fourth quarter, the company submitted a new IND to the FDA which included the phase 3 protocol for a superiority trial of the lead product INT230-6 used as monotherapy compared to the standard of care drugs in 2nd and 3rd line treatment for certain soft tissue sarcoma subtypes. The FDA provided a "Study May Proceed" letter for phase 3. The company is working with contracted vendors to initiate the phase 3 trial in the first half of 2024.
Also, during the fourth quarter, the company was granted a meeting that was held with the FDA to review the INT230-6 chemical manufacturing and controls or CMC for INT230-6. The company and FDA agreed upon a plan for the CMC set of activities for the active pharmaceutical ingredients and the drug product, INT230-6, necessary for the NDA.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.