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February 5, 2014
08:34 EDTSRPTSarepta announces Eteplirsen demonstrates stability through Phase IIb study
Sarepta Therapeutics announced new pulmonary function data through Week 120 from Study 202, a Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy. Results through more than two years of treatment showed stable pulmonary function in the Intent-to-Treat study population. These data are consistent with previously reported 120-week clinical data showing a general stabilization of walking ability in eteplirsen-treated patients evaluable on the 6-minute walk test. Results through Week 120 for other exploratory efficacy endpoints, including timed function tests and the North Star Ambulatory Assessment have shown declines compared to baseline. These endpoints are less well characterized in DMD patients than the 6MWT and pulmonary function tests and have more inter- and intra-patient variability, although they may be predictors of decline at various stages of this disease. All patients evaluable on measures of ambulation are still able to perform these tests with the exception of one patient who is no longer able to perform the Gowers’ maneuver. Eteplirsen was well tolerated through week 120 and there were no reported clinically significant treatment-related adverse events and no treatment-related serious adverse events. In addition, there were no hospitalizations or discontinuations.
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April 21, 2014
17:14 EDTSRPTSarepta rally should continue, Barron's says
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16:40 EDTSRPTOn The Fly: Closing Wrap
Stocks on Wall Street were higher for the fifth straight session. Volume remained light on this Monday following Easter, as a number of international markets remained closed. The averages spent time on both sides of the flat-line early in the trading day before settling into a narrow range in positive territory for most of the second half of the session. ECONOMIC EVENTS: In the U.S., the Chicago Fed national activity index fell to 0.20 in March, matching the consensus forecast. The Conference Board's index of leading indicators rose 0.8% in March, beating the consensus forecast for an increase of 0.7%. COMPANY NEWS: Ford (F) is preparing to announce that its Chief Operating Officer, Mike Fields, will take the CEO role at the company following the retirement of current CEO Alan Mulally later this year, according to a report from Bloomberg. Shares of Ford were little changed for the session following the report, losing 2c, or 0.13%, to close at $15.98... U.S.-listed shares of British pharmaceutical company AstraZeneca (AZN) gained $5.61, or 8.84%, to $69.10 after the U.K.'s Sunday Times said Pfizer (PFE) has takeover interest in the company. Analysts had mixed opinions on the report, with Citigroup saying a bid looks "highly probable," while analysts at Bernstein think such a deal would conflict with Pfizer's strategy of getting smaller. Shares of Pfizer rose 61c, or 2.02%, to $30.86 following the report... MAJOR MOVERS: Among the notable gainers was Sarepta Therapeutics (SRPT), up $9.58, or 39.26%, to $33.98 after announcing plans to submit a New Drug Application to the FDA by the end of this year for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy. Also higher was Advanced Micro Devices (AMD), which rose 43c, or 11.65%, to $4.12 after the semiconductor manufacturer reported earnings and revenue that topped expectations after the close on Thursday. Among the noteworthy losers was MoneyGram (MGI), down $2.01, or 13.57%, to $12.80 in its second straight losing session after Wal-Mart (WMT) announced that it was launching its own money transfer service. MoneyGram's slide today comes after the stock dropped by more than 18% on Thursday following Wal-Mart's announcement. Also lower was lululemon (LULU), down $2.64, or 5.11%, to $49.07 after analysts at Sterne Agee said the company's investor day presentation, held on Thursday, did not include a substantive plan to grow same-store sales. INDEXES: The Dow was up 40.71, or 0.25%, to 16,449.25, the Nasdaq was up 26.03, or 0.64%, to 4,121.55, and the S&P 500 was up 7.04, or 0.38%, to 1,871.89.
15:39 EDTSRPTLeerink's biotech analyst holds an analyst/industry conference call
Biotech Analyst Schwartz, along with a Key Opinion Leader, discuss Sarepta's announcement that the Company will file a New Drug Application for Eteplirsen before the end of 2014 and Prosensa's drugs in development for Duchenne Muscular Dystrophy on an Analyst/Industry conference call to be held on April 22 at 12:45 pm.
13:01 EDTSRPTSarepta upgraded to Buy from Hold at Canaccord
Price target is $63.
12:47 EDTSRPTOn The Fly: Midday Wrap
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12:35 EDTSRPTSarepta surges after plans for Muscular Dystrophy drug filing
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12:00 EDTSRPTSarepta rises 48.2%
Sarepta is up 48.2%, or $11.76, to $36.16
10:56 EDTSRPTSarepta price target raised to $37 from $19 at Piper Jaffray
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10:53 EDTSRPTSarepta upgraded to Outperform from Market Perform at JMP Securities
Price target is $54.
10:49 EDTSRPTOptions with decreasing implied volatility: SRPT NSR INFY CMG GOOG
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10:45 EDTSRPTLeerink still cautious on FDA approving eteplirsen with existing data
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10:01 EDTSRPTOn The Fly: Analyst Upgrade Summary
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10:00 EDTSRPTSarepta rises 51.4%
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09:21 EDTSRPTOn The Fly: Pre-Market Movers
HIGHER: Sarepta (SRPT), up 54% after announcing plans to to submit NDA for Eteplirsen by year end 2014. Shares of Prosnesa (RNA), another drugmaker working on a competing DMD drug, are up more than 12%... AstraZeneca (AZN), up 6% after the Sunday Times says that Pfizer (PFE) is considering a takeover bid for the company. Pfizer is up 1.2% following the report... Newmont Mining (NEM), up 8% after WSJ says the company and Barrick Gold (ABX) could resume merger talks as soon as today... Cbeyond (CBEY), up 39% after agreeing to be acquired for about $323M by Birch Communications... Momenta Pharma (MNTA), up 10.5% after the Supreme Court rejected Teva's (TEVA) bid to delay generic Copaxone... Nu Skin (NUS), up 5% after saying its China division will resume corporate-hosted business meetings... Micron (MU), up 4% after price target raised at Drexel Hamilton... DOWN AFTER EARNINGS: Acacia Research (ACTG), down 6%... athenahealth (ATHN), down 5.6%.
09:19 EDTSRPTSarepta upgraded to Outperform from Market Perform at William Blair
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09:00 EDTSRPTSarepta rises 54.6%
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08:27 EDTSRPTSarepta volatility expected to move, plans to submit NDA for Eteplirsen by year
Sarepta implied volatility is expected to move on plans to submit NDA for Eteplirsen by year end 2014. Overall option implied volatility of 145 is above its 26-week average of 104 according to Track Data, suggesting large price movement.
07:13 EDTSRPTSarepta to host conference call
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07:04 EDTSRPTSarepta plans to submit NDA for Eteplirsen by year end 2014
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April 19, 2014
20:24 EDTSRPTSarepta shares could double, Barron's says
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