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News Breaks
February 1, 2013
13:25 EDTBMRN, BMRN, BMRN, CLVS, CLVS, CLVS, TSRO, TSRO, TSROLeerink's biotech analysts hold an analyst/industry conference call
Biotech Analysts Kozul, Liang and Schwartz provide a review of development programs for novel oral PARPs (Poly(ADP-ribose) polymerase); Biomarin's BMN-673, Clovis Oncology's Rucaparin and Tesaro's Niraparib on an Analyst/Industry conference call to be held on February 4 at 2 pm.
News For BMRN;CLVS;TSRO From The Last 14 Days
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February 12, 2016
08:59 EDTCLVSClovis says FDA schedules rociletinib NDA for discussion by ODAC on April 12
Clovis Oncology said that the U.S. FDA has scheduled the New Drug Application for rociletinib for discussion by the Oncologic Drugs Advisory Committee, or ODAC, on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA. "We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer."
February 8, 2016
10:17 EDTBMRNSarepta approval seen as 'long shot' as FDA pushes back decision
Shares of drugmaker Sarepta Therapeutics (SRPT) took a dive in morning trading after the company said the U.S. Food and Drug Administration delayed a decision on eteplirsen for the treatment of Duchenne muscular dystrophy. WHAT'S NEW: Sarepta announced that the FDA has pushed out the the Prescription Drug User Fee Act, or PDUFA, date for eteplirsen for the treatment of Duchenne muscular dystrophy to May 26. The previous PDUFA date for the eteplirsen new drug application, or NDA, was originally set for late February. FDA POSTPONEMENT: The FDA notified Sarepta that it's submission of 4-year clinical data, including additional six minute walk test and loss of ambulation data compared to historical control, was designated as a "major amendment" to the NDA and that the PDUFA goal date was extended to allow for a full review of the submission. The FDA previously granted eteplirsen Priority Review status, as well as Rare Pediatric Disease Designation, Orphan Drug Designation and Fast Track Status to eteplirsen. WHAT'S NOTABLE: In late January, the FDA postponed a meeting of its advisory committee to review the Sarepta drug due to an inclement weather forecast for Washington D.C. LONG SHOT: Piper Jaffray analyst Edward Tenthoff told investors in a note that the FDA's PDUFA date postponement for eteplirsen is "not surprising" following the delay of the January 22 AdCom due to weather. Tenthoff also noted that a new AdCom has yet to be scheduled. The analyst continues to see eteplirsen accelerated approval by the new PDUFA date as a "long shot." He believes that the panel discussion will be a "plea from the community" to approve something for DMD and that members will not be asked to vote on drug approval. Tenthoff has a Neutral rating and $15 price target on Sarepta. OTHERS TO WATCH: Other companies developing treatments for Duchenne muscular dystrophy include BioMarin (BMRN) and PTC Therapeutics (PTCT). PRICE ACTION: Sarepta is down 9.5% in morning trading to $11.06.
February 5, 2016
10:02 EDTTSROOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 21st Century Fox (FOXA) initiated with an Outperform at Telsey Advisory... AbbVie (ABBV) initiated with an Outperform at William Blair... CBS (CBS) initiated with an Outperform at Telsey Advisory... Criteo (CRTO) initiated with an Outperform at Boenning & Scattergood... LHC Group (LHCG) initiated with a Buy at Jefferies... Marriott Vacations (VAC) initiated with an Outperform at Credit Suisse... Prestige Brands (PBH) initiated with an Overweight at Piper Jaffray... Rubicon Project (RUBI) initiated with an Outperform at Boenning & Scattergood... TESARO (TSRO) initiated with a Buy at Lake Street... Time Warner (TWX) initiated with an Outperform at Telsey Advisory... TubeMogul (TUBE) initiated with a Neutral at Boenning & Scattergood... Viacom (VIAB) initiated with an Outperform at Telsey Advisory... Wyndham (WYN) initiated with a Neutral at Credit Suisse.
08:36 EDTTSROTESARO initiated with a Buy at Lake Street
Lake Street analyst Carl Byrnes started TESARO with a Buy rating and $61 price target. The risk/reward is "highly compelling" at current valuation levels, Byrnes tells investors in a research note.
February 2, 2016
08:36 EDTBMRNPiper Jaffray biopharma analyst holds an analyst/industry conference call
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