Clovis Oncology Analyst Turns Bearish Ahead Of PDUFA Date For Rubraca

Despite optimistic expectations concerning label expansion for Clovis Oncology Inc’s CLVS 3.1% Rubraca to include prostate cancer, an analyst at BofA Securities is turning bearish on the stock.

The Clovis Analyst

Tazeen Ahmad downgraded Clovis shares from Neutral to Underperform but maintained a $6 price target.

The Clovis Thesis

The recent run in Clovis shares indicates a high likelihood of the FDA approving Rubraca in second line BRCA+ metastatic castration-resistance prostate cancer, or mCRPC, by the May 15 PDUFA date, Ahmad said in a Thursday note. (See the analyst’s track record here.)
AstraZeneca plc’s AZN 2.22% competing PARP inhibitor — Lynparza — is also being reviewed for a potentially broader HRR+ label in second-line mCRPC, the analyst said.
Assuming a 15% peak penetration in the U.S. BRCA+ market, BofA estimates peak non-risk-adjusted worldwide sales of $150 million for Rubraca in mCRPC.
Ahmad said he would also wait and see whether the COVID-19 pandemic will impact Clovis’ early launch trajectory.
Once on therapy, Rubraca’s oral dosing could prove helpful, the analyst said.
A broader label for AstraZeneca to include ATM mutations could be perceived as favorable, especially among community-based doctors at the onset, he said.
BofA models risk-adjusted peak sales of $579 million for Rubraca in 2028 across all indications.
“Upside risks are a faster-than-expected ramp from prostate indication on top of its ongoing ovarian launch as well as value from CLVS’ pipeline.”
https://www.benzinga.com/analyst-ratings/analyst-color/20/04/15775246/clovis-oncology-analyst-turns-bearish-ahead-of-pdufa-date-for-rubraca