BIOTECHNOLOGY

“The submission of the BLA marks a pivotal step for Capricor Therapeutics and those impacted by DMD. This BLA is the culmination of a body of work that has been focused on bringing this potentially transformational therapy to those patients in need,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “We believe that the strength of this application is that deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. We look forward to working with the FDA throughout the review process to support this potential approval.”

“Our longstanding commitment to operational resilience has positioned us to navigate these challenges effectively,” said Dr. Ko Chung Lin, CEO of PharmaEssentia. “We recognize that dependable medication supply is essential, and we are working closely with our partners around the world to ensure the continuity of these important therapies. We have made substantial investment to ensure that all of our supply chain elements are strong, of the highest quality, and reliable.”

After reviewing YolTech Therapeutics submission, the FDA determined that the therapy is not only appropriate for primary hyperoxaluria type 1 (PH1), but also applicable to the broader category of primary hyperoxaluria (PH). As a result, the designations were granted for PH, reflecting the expanded scope of the therapy’s potential impact. These dual designations underscore the transformative potential of YOLT-203 to address this rare and life-threatening genetic disorder.

Eisai and Biogen Japan will continue to contribute to the advancement of Alzheimer’s disease treatment through ongoing collaboration with academia.

Phase 1/2 data showed a median overall survival (“mOS”) of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone notes Intensity Therapeutics.

SenoVax has previously been demonstrated to reduce lung cancer growth1, which was the subject of the Company’s IND #307452. It has also been shown to accelerate recovery of blood cell production after chemotherapy notes Immorta Bio.