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CLVS

Clovis

$29.16

-0.205 (-0.70%)

08:07
10/02/18
10/02
08:07
10/02/18
08:07

Clovis receives Breakthrough Therapy Designation for Rubraca

Clovis Oncology announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation for Rubraca as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor-directed therapy and taxane-based chemotherapy. Breakthrough Therapy designation is granted by the FDA to investigational agents intended to treat a serious or life-threatening disease or condition and whose preliminary clinical evidence may demonstrate substantial improvement on at least one clinically significant endpoint over available therapy. The FDA previously granted Breakthrough Therapy designation to Rubraca for the monotherapy treatment of certain advanced ovarian cancer patients and then in December 2016 approved Rubraca for the treatment of certain adult patients with deleterious BRCA mutation associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. The FDA subsequently approved Rubraca in a second indication, the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, in April 2018. This most recent Breakthrough Therapy designation was granted to Rubraca based on initial efficacy and safety results from TRITON2, the Phase 2 study of Rubraca in men with advanced prostate cancer with BRCA 1/2 mutations and deleterious mutations of other homologous recombination repair genes, in the metastatic castration-resistant setting.

CLVS Clovis
$29.16

-0.205 (-0.70%)

09/24/18
LEER
09/24/18
INITIATION
Target $30
LEER
Market Perform
Clovis initiated with a Market Perform at Leerink
Leerink analyst Andrew Berens started Clovis Oncology with a Market Perform rating and $30 price target.
09/21/18
JPMS
09/21/18
NO CHANGE
Target $71
JPMS
Overweight
Clovis price target lowered to $71 from $87 at JPMorgan
JPMorgan analyst Cory Kasimov lowered his price target for Clovis Oncology to $71 after "reigning in" his ovarian expectations but keeps an Overweight rating on the shares. With the European Society of Medical Oncology meeting coming up in October, Kasimov is previewing the first look at data from Clovis's Triton-2 study in prostate cancer. The analyst is "quite confident" that the company's PARP inhibitor rucaparib should produce response rates that are well above chemotherapy and anti-androgens, at least in third line BRCA positive patients. He views the Triton-2 update as an important event for Clovis and believes "promising results could represent a step towards restoring more favorable sentiment." A response rate of at least 30% is the lower bar for share appreciation, Kasimov tells investors in a research note. He keeps an Overweight rating on Clovis.
09/17/18
GUGG
09/17/18
INITIATION
Target $75
GUGG
Buy
Clovis initiated with a Buy at Guggenheim
Target $75.
09/17/18
PIPR
09/17/18
NO CHANGE
Target $35
PIPR
Neutral
Piper sees Astra's Lynparza as 'much cleaner' than Tesaro's Zejula
Piper Jaffray analyst Christopher Raymond reiterates a Neutral rating and $35 price target on Tesaro (TSRO) after analyzing a year's worth of adverse event reporting as captured by FDA's Adverse Event Reporting System database, which he obtained through a Freedom of Information Act request. The analyst, while cautioning that the database "likely contains inaccuracies and is far from perfect," is "struck by how much cleaner" AstraZeneca's (AZN) Lynparza appears versus Tesaro's Zejula and Clovis Oncology's (CLVS) Rubraca. Further, Raymond is also surprised that Zejula's adverse events rates do not appear to have decreased in any meaningful way year-over-year, despite Tesaro's active down-dosing efforts. Since the analyst thinks PARPi differentiation remains largely around safety, he lowered his Zejula estimates in 2019 and beyond. Lynparza is likely to maintain the upper hand, Raymond tells investors in a research note.

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