At least nine PDUFAs on FDA February docket

FDA’s February docket includes at least five candidates for new products and four indication extensions.

First up on the eighth is clemidsogene lanpravovec (RGX-121) to treat Mucopolysaccharidosis Type II (MPS II), though things do not look promising after FDA placed a clinical hold on the gene therapy last week. RegenxBio Inc. (NASDAQ:RGNX) said FDA placed a hold on both RGX-121 and MPS I therapy RGX-111 after a patient in the RGX-111 trial developed a CNS tumor.  While delivering different genes both use the same AAV vector, which may have integrated into the genome and driven the tumor. RegenxBio is still investigating a conclusive cause, and has not issued an update since Jan. 28, when it said it had yet to receive the FDA hold letter...