Stifel upgraded ChemoCentryx (NASDAQ:CCXI) to “buy” from “hold” and raised its price target to $31 from $26, citing a more favorable risk/reward for avacopan heading into a new PDUFA date. The stock closed at $14.05 on July 6.
ChemoCentryx is a biopharmaceutical company focused on development and commercialization of new medications targeted at inflammatory disorders, autoimmune diseases and cancer.
“We now see a higher likelihood of approval as reflected in our new probability-of-success of 70%, up from 55%, but leave our launch projections unchanged: 2021 estimated for the U.S. and 2022 estimated for the EU,” writes analyst Dae Gon Ha, Ph.D.
ChemoCentryx voluntarily amended its NDA for avacopan, filing additional data and analyses to address key issues raised during an FDA advisory committee meeting. As a result, theFDA extended avacopan’s PDUFA date to Oct. 7 from July 7.
“Our caveat is that an amendment does not equate to guaranteed approval, but we think the FDA’s receptivity towards additional data/analyses in light of the unmet need and a standard of care in need of innovation resurfaces the question on FDA’s ‘flexibility’ when reviewing drug applications,” Dr. Ha said.
In addition, “if history is any guide PDUFA extensions may portend a more positively inclined outcome by the FDA,” he added.
Avacopan is indicated for the treatment of anti-neutrophil cytoplasmic autoantibody-associated vasculitis.
