SALT LAKE CITY, May 13, 2022 –PolarityTE, Inc. (Nasdaq: PTE) today announced that the U.S. Food and Drug Administration (FDA) granted a Regenerative Medicine Advanced Therapy (RMAT) designation to SkinTE under the Company’s open IND. [Read more…]
To date, 64 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 187 requests and issued 70, which means that a handful are not yet public knowledge.
Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
Thus far, AlloVir is the only company to receive three RMATs, while 5 companies (Abeona Therapeutics, Athersys, CARsgen Therapeutics, Rocket Pharmaceuticals, and CRISPR Therapeutics) have received two RMAT designations from the U.S. FDA.
A diagnosis of chronic obstructive pulmonary disease (COPD) can be alarming, but thanks to stem cell treatments for COPD, the situation may not be dire. Once a patient develops COPD, it means that he or she has developed complications to existing breathing problems. The chronic disease happens when inflammation in the lung interferes with airflow.
Not being able to breathe properly and having frequent chest tightness can be distressing, especially when it is caused by a chronic disease, rather than a temporary illness like bronchitis. Thankfully, new options for treatment emerge every day. Among these options are stem cell treatments for COPD. [Read more…]
HONG KONG, April 29, 2022 — Global Cord Blood Corporation (NYSE: CO, “GCBC” or the “Company”), China’s leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, announced today that the Company will acquire 100% of Cellenkos, Inc (“CLNK”) and the rights to develop and commercialize all of its existing and future products worldwide except those related to CLNK’s existing collaboration with Incyte Corporation (Nasdaq: INCY, “Incyte”). [Read more…]