Clovis soars as a new round of PhIII Rubraca data looks promising — but roci scandal bites again with $142M settlement

Shares of Clovis Oncology soared 50% Monday morning, after the biotech reported a solid slate of progression-free survival data for its PARP drug Rubraca (rucaparib) that will help it line up right alongside rivals in the field, possibly eliminating an advantage held by Tesaro for access to a wider group of ovarian cancer patients.

Soon after the data hit, though, Clovis revealed in an SEC filing that it had tentatively reached a deal to settle a class action lawsuit brought by shareholders after Clovis’ disastrous setback on rociletinib, rejected by the FDA after questions arose about the dodgy data that had been circulated about that cancer therapy ahead of the FDA’s decision. The biotech is setting aside $142 million in cash and stock to settle allegations that it actively misled investors on roci. And Clovis also disclosed that it is under investigation by the SEC as well as the Justice Department over the roci case.

Rubraca, though, looks better than ever.

Investigators reported that the drug hit all three primary endpoints for progression-free survival in tumor BRCA-mutant, HRD-positive and overall intent-to-treat populations. It also hit a key secondary endpoint for an independent review of those results.

If it all holds up at the FDA, the data should pave the way to broader use of the drug, Clovis’ only marketed therapy. And it may well end up eating into Tesaro’s market share, a point that helped drive down its shares by 8% this morning.

Clovis says that it will file a supplemental application “within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy.”

by John Carroll — on June 19, 2017

Source: https://endpts.com/

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