Clovis Oncology Inc (NASDAQ:CLVS) announced yesterday afternoon that the New Drug Applications (NDA) for its anti-cancer agent rucaparib was accepted for filing and granted Priority Review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017. CLVS also announced the efficacy data from the submission.
Despite the FDA acceptance, Piper Jaffray analyst Steven Breazzano reiterates a Neutral rating on shares of CLVS with a $14.00 price target, which represents a 39% decrease from where the stock is currently trading. Breazzano keeps his eyes on the biotech firm’s future, particularly toward the full data at ESMO in platinum sensitive vs. refractory/resistant patients to have a better sense of the pipeline drug’s profile.
Breazzano believes that in targeting somatic and germline BRCA mutations in patients who have received two or more lines of chemotherapy, the firm strategically targets a broader label than rival Astrazeneca’s ovarian cancer drug Lynparza, currently designed for a similar pool of patients, but who have received three or more lines of chemotherapy. From the analyst’s perspective, “Given CLVS’ second to market position, the broader indication may help facilitate market adoption.”
The analyst concludes, “Overall, given the several imperfect comparisons across line of therapy and platinum sensitivity, CLVS’ data appears to compare at least in line, given the Lynparza datapoints of 46% ORR in platinum sensitive >3 lines, and 47% ORR in patients <3 lines (not clear platinum status) and 30% in platinum refractory, though we await full ruca data at ESMO as well as TSRO’s QUADRA study to better assess the rapidly evolving PARP landscape.”
According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, three-star analyst Steven Breazzano is ranked #1,513 out of 4,123 analysts. Breazzano has a 100% success rate and realizes 10.1% in his annual returns.
TipRanks analytics demonstrate CLVS as a Buy. Based on 6 analysts polled in the last 3 months, 2 rate a Buy on CLVS, while 4 maintain a Hold. The consensus price target stands at $19.83, marking an almost 14% downside from where the shares last closed.