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Stock Market & Financial Investment News

News Breaks
February 10, 2014
04:55 EDTALKS, ALKS, RGDO, RGDO, LXRX, LXRX, ZIOP, ZIOP, RNA, RNA, AUXL, AUXL, XON, XON, SIGA, SIGA, GALE, GALE, MSTX, MSTXBiotech Industry Organization to hold a conference
16h Annual BIO CEO & Investor Conference is being held in New York on February 10-11.
News For ALKS;GALE;SIGA;XON;AUXL;RNA;ZIOP;LXRX;RGDO;MSTX From The Last 14 Days
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October 29, 2014
07:13 EDTALKSAlkermes reports Q3 AMPYRA, FAMPYRA revenues $16.5M
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07:11 EDTALKSAlkermes says entering Q4 with 'strong momentum'
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07:09 EDTALKSAlkermes sees FY14 free cash flow $20M
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07:05 EDTALKSAlkermes sees FY14 EPS 19c-32c consensus 27c
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07:04 EDTALKSAlkermes reports Q3 EPS 3c, 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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12:14 EDTZIOPZiopharm management to meet with Maxim
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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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October 23, 2014
06:51 EDTALKSAlkermes concerns removed with FDA acceptance, says Citigroup
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October 22, 2014
14:08 EDTGALEGalena files to sell 2M shares of common stock for holders
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07:02 EDTALKSAlkermes aripiprazole lauroxil NDA accepted for filing by FDA
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05:17 EDTLXRXIpsen, Lexicon enter into ex-North America/Japan licensing agreement
Ipsen (IPSEY) and Lexicon Pharmaceuticals (LXRX) announced that they have entered into an exclusive licensing agreement for Ipsen to commercialize telotristat etiprate outside of North America and Japan, with a focus on the treatment of carcinoid syndrome. Lexicon retains sole rights to commercialize telotristat etiprate in the United States, Canada and Japan. Lexicon is conducting Phase 3 clinical trials of telotristat etiprate for carcinoid syndrome, a serious condition caused by symptomatic neuroendocrine tumors, which produce large amounts of serotonin. Carcinoid syndrome is characterized by severe diarrhea, flushing and, in some cases, heart valve damage. Telotristat etiprate is an oral, small-molecule inhibitor of tryptophan hydroxylase, or TPH, that reduces peripheral serotonin production without affecting brain serotonin levels. Telotristat etiprate has received fast track status and orphan drug designation from the FDA, and has received orphan drug designation from the European Medicines Agency. Under the financial terms of the agreement, Lexicon is eligible to receive up to $145M, comprising $23M upfront payment and additional payments contingent upon achievement of clinical, regulatory and commercial milestones. In addition, Lexicon is also eligible to receive royalties on net sales of telotristat etiprate in the licensed territory.
October 21, 2014
08:13 EDTAUXLBioSpecifics announces FDA approval of sBLA for XIAFLEX
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07:54 EDTALKSLeerink a buyer of Alkermes, ImmunoGen, Incyte
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October 20, 2014
17:33 EDTAUXLAuxilium announces XIAFLEX approved for treatment of up to two DC joints
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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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