Shares in Clovis Oncology ($CLVS) jumped yesterday on the news that the FDA will forgo its usual external panel review for its PARP drug rucaparib in what some investors are seeing as a good sign for a possible approval early next year.
The biotech, which has seen its fair share of troubles over the past year and not always seen eye-to-eye with the U.S. regulator, ended up 15% yesterday with a market cap of more than $1 billion, after saying in a brief SEC update that the FDA “is not currently planning to hold an advisory committee meeting to discuss the company’s New Drug Application for rucaparib.”
Clovis already has the coveted FDA “breakthrough” and “priority review” tags, which speeds up its assessment of the drug, and a set PDUFA date of Feb. 23, 2017.
The FDA is reviewing rucaparib in advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA and somatic BRCA mutations.
The drug, which was licensed from Pfizer ($PFE), works as a PARP inhibitor, a reasonably new class of cancer med currently led by AstraZeneca’s marketed ovarian cancer med ($AZN) Lynparza (olaparib). Other biotechs, including Tesaro ($TSRO) and Medivation ($MDVN)--soon to be a part of Pfizer--are also in the later stages of testing for their PARP candidates.
Just last month, in what investors also took as a positive sign, Clovis said it was to defer its milestone to payments to Pfizer for 18 months as it looks to save cash ahead of a potential 2017 launch. This saw its shares also jump on the news. Yesterday’s bounce was one of the biggest it has seen all year.
But the biotech has had a tough time of it up until now, being forced back in May to ax around one-third of its workforce and drop work on its other experimental cancer med, rociletinib, after it appeared that the FDA was set to reject it.
Its shares took a battering, although not by as much as they did back in November when the FDA first questioned the rociletinib data. This time last year its shares were over $100 but slumped to just $30 in November, dropping as low as $12 in May. Yesterday it finished at just over $28 a share.
Some investors still remain cautious over Clovis and the difficulties it has faced with the U.S. regulator. The biotech was down by more than 5% at midday today.