Proteon Therapeutics ($PRTO) announced receiving the Breakthrough Therapy (BTD) status from the FDA for its lead product candidate vonapanitase for increasing arteriovenous fistula secondary patency. The status provides for more intensive guidance from the FDA on development. It also offers more senior agency personnel and a rolling review of the New Drug Application.
Synthetic Biologics ($SYN) announced receiving a Breakthrough therapy for its co-lead product candidate SYN-004 (ribaxamase) for preventing Clostridium difficile (C. diff) infection. Breakthrough Therapy status provides for more intensive FDA guidance on the best development path, the involvement of more senior agency personnel and a rolling review of the New Drug Application.