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June 23, 2014
07:52 EDTARWR, SRPT, INO, BMRN, ALNY, SGMO, IDRA, BLUE, AGTC, ISIS, CLDNPiper Jaffray to hold a symposium
GenomeRX Symposium to be held in New York on June 23.
News For AGTC;ALNY;ARWR;BLUE;BMRN;CLDN;IDRA;INO;ISIS;SGMO;SRPT From The Last 14 Days
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August 26, 2015
10:00 EDTSRPTOn The Fly: Analyst Upgrade Summary
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09:19 EDTSRPTSarepta upgraded at RBC Capital on expectations for eteplirsen approval
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09:09 EDTSRPTSarepta upgraded to Outperform from Sector Perform at RBC Capital
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09:02 EDTSRPTSarepta should be bought on any weakness, says Roth Capital
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07:09 EDTARWR, ALNY, IDRAVertex, Novavax among select biotechs to buy on weakness, says Piper Jaffray
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August 25, 2015
18:47 EDTSRPTOn The Fly: After Hours Movers
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17:19 EDTSRPTFDA files NDA for Sarepta's eteplirsen
Sarepta Therapeutics announced that the FDA has filed the New Drug Application, or NDA, for eteplirsen for the treatment of Duchenne muscular dystrophy, or DMD, amenable to exon 51 skipping. Approximately 13% of people with Duchenne muscular dystrophy are estimated to have a mutation addressable by Eteplirsen/exon 51 skipping. The FDA has completed its filing review and has determined that our application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act action date for a decision on the application is February 26. The FDA has granted eteplirsen Priority Review status, which is designated to drugs that offer benefit over existing therapies, or provide a treatment where no adequate therapy exists.
August 24, 2015
13:54 EDTSRPT, BMRNFly Watch: Sarepta upgraded ahead of FDA deadline on DMD drug
The 60-day FDA review period for Sarepta's (SRPT) rolling NDA submission for its Duchenne muscular dystrophy drug eteplirsen ends tomorrow, Tuesday, August 25. Piper Jaffray is among research firms taking a bullish stance on the stock ahead of tomorrow's deadline. BACKGROUND: Eteplirsen is an "exon skipping" treatment that attempts to bypass genetic mutations to allow improved functioning of the affected gene. On August 21, Sarepta announced that the FDA granted a rare pediatric disease designation for eteplirsen, in addition to its previous orphan designation and fast track status. Piper Jaffray's Edward Tenthoff noted today that the drug could see a February 2016 PDUFA date, potentially yielding "blockbuster sales" for the company. Importantly, BioMarin's (BMRN) drisapersen is slightly ahead of eteplirsen's approval process with a December 27 PDUFA date, posing a potential competitive risk for Sarepta. PDUFA dates are FDA deadlines for approving new drugs, normally coming within 6 or 10 months of an NDA acceptance depending on the drug's priority status. ANALYST TAKE: Tenthoff stated in note to investors this morning that he expects the Food and Drug Administration to accept the New Drug Application for Sarepta's eteplirsen at the end of its 60-day review period tomorrow. Additionally, Tenthoff sees a joint advisory committee for eteplirsen and the similar drisapersen from BioMarin on November 23-24. On May 19, Sarepta said it held pre-NDA meetings with the FDA, and Piper Jaffray said it believes the company has now met all of the agency's information requests. The analyst upgraded Sarepta to Overweight from Neutral and hiked his price target to $48 from $28 and now values eteplirsen at $1.3B, up from $919M previously. PRICE ACTION: Shares of Sarepta Therapeutics are up roughly 1% in intraday trading to $34.21. The stock jumped about 60% on May 20 after the company announced its mid-year NDA plans for eteplirsen. BioMarin shares, meanwhile, are down 2% to $123.59 this afternoon.
11:43 EDTALNYThe Medicines Co. and Alnylam Pharmaceuticals hold a joint conference call
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09:45 EDTSRPTOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Bank of America (BAC) upgraded to Outperform from Market Perform at Keefe Bruyette... Bristol-Myers (BMY) upgraded to Neutral from Underweight at Piper Jaffray... Chevron (CVX) upgraded to Neutral from Underperform at BofA/Merrill... Abercrombie & Fitch (ANF) upgraded to Overweight from Neutral... Nike (NKE) upgraded to Outperform from Market Perform at Telsey Advisory... DreamWorks (DWA) upgraded to Buy from Neutral at B. Riley... Caesarstone (CSTE) upgraded to Overweight from Equal Weight at Barclays... TransAlta (TAC) upgraded to Outperform from Market Perform at BMO Capital... Sarepta (SRPT) upgraded to Overweight from Neutral at Piper Jaffray... AutoZone (AZO) upgraded to Buy from Neutral at BofA/Merrill... Royal Dutch Shell (RDS.A) upgraded to Buy from Hold at Jefferies... Allscripts (MDRX) upgraded to Buy from Hold at Argus... China Unicom (CHU) upgraded to Buy from Hold at Jefferies... Ross Stores (ROST) upgraded to Buy from Neutral at Buckingham.
07:02 EDTBMRNMedivation to acquire worldwide rights to Talazoparib from BioMarin
Medivation (MDVN) and BioMarin Pharmaceutical (BMRN) have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib, a highly-potent, orally-available poly ADP ribose polymerase inhibitor currently in a Phase 3 study for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer. Under the agreement, Medivation will be responsible for all research, development, regulatory and commercialization activities for all indications on a global basis. Under the terms of the agreement, Medivation will pay BioMarin $410 million upfront, up to an additional $160 million upon the achievement of regulatory and sales-based milestones and mid-single digit royalties for talazoparib. At the closing of the transaction, Medivation will assume all financial obligations associated with the development and commercialization of talazoparib. The closing of the transaction is conditioned on the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is anticipated to close in 2015.
06:50 EDTSRPTSarepta upgraded to Overweight from Neutral at Piper Jaffray
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August 21, 2015
10:36 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: PTCT UVXY VIX VXX SVXXY SRPT TZA UPRO VNR SPXU
09:38 EDTBMRNUBS global healthcare analysts hold an analyst/industry conference call
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08:32 EDTSRPTSarepta says FDA grants rare pediatric disease designation for Eteplirsen
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06:23 EDTBMRNUBS sees 'meaningful' upside to BioMarin on positive Hemophilia data
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August 20, 2015
16:24 EDTAGTCBiogen reports 8.1% passive stake in Applied Genetic
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11:49 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: SRPT ACHN VIAV ZG RAD DIS ORCL SPY XLF OEX
08:34 EDTBLUEJPMorgan views bluebird bio selloff as 'highly compelling opportunity'
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07:31 EDTALNYAlnylam Pharmaceuticals to hold a roundtable
Final Roundtable in a series of online "RNAi Roundtables" entitled, "Patisiran & Revusiran for Treatment of Transthyretin (TTR)-Mediated Amyloidosis", consisting of presentations by Alnylam scientists, clinical collaborators and patient advocates review recent progress in many of the company's development-stage pipeline programs will be held on August 20 at 9 am. Webcast Link
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