The big news today is that Proteon Therapeutics Inc (NASDAQ:PRTO) has received Breakthrough Designation from the FDA for Vonapanitase, an investigational drug that may prolong the patency and reduce the failure of hemodialysis vascular access in patients with CKD.

In reaction, Proteon shares jumped nearly 25% to $1.70, as of this writing.

CEO Timothy Noyes commented, “We believe the decision by the FDA to grant vonapanitase a Breakthrough Therapy designation speaks to the clinical importance of fistula survival and use for hemodialysis to patients with chronic kidney disease. Our productive ongoing dialogue with the FDA has helped to create a clear path forward for vonapanitase, and we look forward to continuing to work closely with the FDA to expedite our development efforts for this important program.”

Maxim analyst Jason McCarthy also commented, “Breakthrough designation does represent elements of validation. PATENCY-2 is now more than halfway enrolled. This combined with data from PATENCY-1 suggests regulators see value and recognize the medical need. It also suggests to us that regulators are comfortable with the amended protocol for the PATENCY-2 trial which should increase the probability of success.”

McCarthy rates PRTO shares a Buy, with a price target of $6.00, which implies an upside of 362% from current levels. On the other hand, Oppenheimer’s Jay Olson reiterates a Hold rating on the stock, without listing a price target.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Jay Olson have a yearly average loss of 12.2% and a return of 4.4% respectively. McCarthy has a success rate of 36% and is ranked #4492 out of 4563 analysts, while Olson has a success rate of 46% and is ranked #1721.

Proteon Therapeutics, Inc. engages in the research and development of biopharmaceutical products. It produces and commercializes vonapanitase for the treatment of renal and vascular disease. The company was founded by F. Nicholas Franano and William P. Whitaker in 2001 and is headquartered in Waltham, MA.