by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
15/8/2025
May 2025 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
Stocks tumbled as sweeping tax and spending bill could dramatically increase federal deficit
US court has ruled that President Trump overstepped his authority when imposing his tariffs. But an appeals court later suspended the earlier judgment. Stocks also tumbled as investors kept close tabs on a sweeping tax and spending bill that could dramatically increase the federal deficit.
Antibody-Drug Conjugates
Merck withdrawn BLA for patritumab dx in NSCLC based on Phase 3 modest PFS benefit
RemeGen announced that disitamab vedotin, a novel HER2-targeted ADC, has been granted approval by the Center for Drug Evaluation (CDE) of China’s NMPA for its third indication of HER2-positive advanced breast cancer with liver metastasis previously treated with trastuzumab or its biosimilar and taxanes.
Interleukin-15 and Interleukin-2
ImmunityBio requested urgent meeting with FDA to address change in Agency’s guidance
ImmunityBio announced that it received a Refusal to File (RTF) letter from the FDA for the sBLA for use of Anktiva plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease.
Cell Therapies
Autolus announced positive CHMP opinion for obe-cel for adults with R/R B-ALL
Autolus announced that the EMA’s CHMP has recommended European Commission approval of obe-cel for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Other Innovative Treatment Areas
Merus’ petosemtamab with Keytruda interim data demonstrated robust efficacy in HNSCC
Merus announced interim clinical data as of a February 27, 2025 data cutoff from the ongoing Phase 2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab.
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