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Stock Market & Financial Investment News

News Breaks
August 11, 2014
04:55 EDTSTAA, STAA, STAA, VTL, VTL, VTL, ANAC, ANAC, ANAC, PTCT, PTCT, PTCT, SGMO, SGMO, SGMO, RNA, RNA, RNA, BLUE, BLUE, BLUE, BIND, BIND, BIND, FCSC, FCSC, FCSC, CRDC, CRDC, CRDC, DRTX, DRTX, DRTXWedbush to hold a conference
Life Sciences Management Conference to be held in New York on August 12-13.
News For DRTX;CRDC;FCSC;BIND;BLUE;RNA;SGMO;PTCT;ANAC;VTL;STAA From The Last 14 Days
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October 31, 2014
10:00 EDTSTAAOn The Fly: Analyst Downgrade Summary
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09:10 EDTSTAAOn The Fly: Pre-market Movers
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06:09 EDTSTAASTAAR Surgical downgraded to Hold from Buy at Canaccord
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05:42 EDTSTAASTAAR Surgical downgraded to Market Perform from Outperform at William Blair
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October 30, 2014
16:14 EDTSTAASTAAR Surgical reports Q3 adjusted EPS 0c, consensus 2c
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October 27, 2014
16:36 EDTRNAOn The Fly: Closing Wrap
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12:30 EDTRNASarepta dives after FDA requests additional data on DMD drug
Shares of drug maker Sarepta (SRPT) are plunging after the FDA said the company would have to submit more data on its Duchenne muscular dystrophy, or DMD, drug before the agency would consider approving the treatment. WHAT'S NEW: The FDA informed Sarepta that it would have to submit additional data on its DMD drug, eteplirsen, before filling an application for FDA approval of the drug, Sarepta reported this morning. The FDA wants several additional data points, including four more weeks of data on 12 patients taking eteplirsen and three month data on 12-24 additional patients. The agency also requested MRI data on patients from a recent study conducted by an independent academic group. After reviewing the agency's requests, Sarepta said it expected to file a new application for approval of eteplirsen in the middle of next year. ANALYST REACTION: In a note to investors earlier today, Piper Jaffray analyst Edward Tenthoff wrote that the FDA is concerned about quality control issues involving the company's staining and analysis of dystrohpin, a protein that boosts muscle strength. DMD is triggered by errors in the gene that governs dystrohpin, and Sarepta has used dystrophin production levels as a primary endpoint for the evaluation of eteplirsen. The earliest that the drug could be approved by the FDA is 2016, wrote the analyst, who slashed his price target on the shares to $21 from $37. The FDA was not convinced of Sarepta's contention that dystrophin was an appropriate way to measure eteplirsen's effectiveness, Roth Capital contended. The firm does not expect Sarepta's drug to be approved until the first quarter of 2016 at the earliest. Roth says that its Buy rating and $34 price target on the name are under review. WHAT'S NOTABLE: Shares of Prosensa (RNA), which has also developed a DMD treatment, are climbing. Prosensa is due to file for FDA approval of its drug by the end of the year. According to Roth Capital, Prosensa has not relied on dystrophin levels to prove the effectiveness of its treatment. PRICE ACTION: In early afternoon trading, Sarepta tumbled 35% to $15.39, while Prosensa climbed 6% to $12.73.
12:27 EDTRNAOn The Fly: Midday Wrap
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09:14 EDTRNAOn The Fly: Pre-market Movers
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09:02 EDTRNAProsensa may benefit most from Sarepta news, says Roth Capital
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08:50 EDTRNAProsensa up 16% after FDA requires additional data from Sarepta
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08:05 EDTPTCTPTC Therapeutics announces positive data from Translarna study
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October 23, 2014
09:12 EDTCRDCCardica shareholder Broadfin seeks election of three directors to the Board
Cardica shareholder Broadfin Capital, beneficial owner of approximately 17.3% of the shares of Cardica, filed preliminary proxy materials with the SEC to seek the election of its three independent candidates to Cardica's Board of Directors at the upcoming Annual Shareholder Meeting on December 11. In the proxy materials, Broadfin states that "the strategic, operational and financial failures of the current Board and management of Cardica" are resulting in "the continued material destruction of shareholder value." "The Board's recent reactive addition of two new directors does not go far enough in building the strong, diverse, experienced and independent group of directors that are best positioned to lead our company."
October 22, 2014
17:33 EDTCRDCCardica issues statement regarding Broadfin board nominations
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16:12 EDTSGMOSangamo backs FY14 revenue view $45M-$50M, consensus $47.57M
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16:06 EDTSGMOSangamo reports Q3 EPS (11c), consensus (14c)
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October 21, 2014
07:06 EDTBLUEFierce Biotech to hold a breakfast meeting
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October 20, 2014
07:16 EDTSTAAAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
06:50 EDTRNAProsensa upgraded to Overweight from Underweight at JPMorgan
JPMorgan upgraded Prosensa two notches to Overweight citing a favorable risk/reward around the potential approval of Drisapersen for Duchenne muscular dystrophy. The firm believes regulatory risk for the drug has been significantly reduced in both the U.S. and Europe. JPMorgan raised its price target for shares to $18 from $4.40.

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