US-based biopharmaceutical company PTC Therapeutics Inc (NASDAQ:PTCT) revealed on Wednesday that it has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for USD150m.
The PRV was granted by the US Food and Drug Administration (FDA) following approval of KEBILIDI (eladocagene exuparvovec-tneq) for the treatment of aromatic l-amino acid decarboxylase (AADC) deficiency, a rare genetic disorder. The sale of the PRV is subject to customary closing conditions.
The PRV program encourages the development of new drugs and biologics for rare pediatric diseases. A PRV can be redeemed to receive priority review of a subsequent marketing application for a different product, or it can be sold or transferred.
Johnson & Johnson submits New Drug Application for TAR-200 to treat bladder cancer
Phase I/II clinical trial of Ariceum Therapeutics' 225Ac-SSO110 gets US FDA approval
Adaptive Biotechnologies and NeoGenomics partner to expand MRD monitoring for blood cancer
BioArctic reports FDA acceptance of BLA for for subcutaneous maintenance dosing of Leqembi
Elicera Therapeutics receives ODD for ELC-100
ReciBioPharm secures grant to expand RNA manufacturing in LMICs
Johnson & Johnson agrees acquisition of Intra-Cellular Therapies Inc