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Stock Market & Financial Investment News

News Breaks
April 25, 2014
06:04 EDTSRPT, AGNStocks with implied volatility below IV index mean; AGN MNKD
Stocks with implied volatility below IV index mean; Allergan (AGN) 29, MannKind (MNKD) 75 according to iVolatility.
News For AGN;SRPT From The Last 14 Days
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August 31, 2015
08:04 EDTAGNAllergan completes Nuarex acquisition
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07:39 EDTAGNCiti calls Allergan a 'stock to own,' keeps $360 target
Citi analyst Liav Abraham calls Allergan a "stock to own" given its "attractive" organic growth profile, pipeline potential and ability to do more acquisitions. He reiterates a Buy rating on the stock with a $360 price target.
August 28, 2015
09:50 EDTAGNAllergan plans for generic version of Endo's Fortesta blocked, Bloomberg reports
A judge upheld Endo's (ENDP) patents on Fortesta expiring in 2018 and blocked Allergan's (AGN) bid to launch a generic version of the testosterone gel, according to Bloomberg.
August 27, 2015
12:57 EDTSRPTFDA will approve Sarepta and BioMarin DMD drugs, Feuerstein says
TheStreet's biotech reporter Adam Feuerstein predicts that the FDA will approve both Biomarin's (BMRN) drisapersen and Sarepta's (SRPT) eteplirsen, which are both drugs to treat Duchenne muscular dystrophy, adding that the agency has been "essentially approving every drug that comes before it" and that it "can't and won't" say no to two drugs meant to improve the lives of kids with a fatal disease. Feuerstein noted he doesn't think the drugs are equivalent and he's still in the "eteplirsen is better than drisapersen" camp. Reference Link
August 26, 2015
13:38 EDTSRPTSarepta rises after FDA accepts muscular dystrophy drug application
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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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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.
08:14 EDTAGNAllergan multiple is low, says Leerink
Leerink predicts that Allergan's 2016 EPS will come in at $17-$18. The firm thinks the company has "durable revenue streams," and a "deep pipeline with several potential blockbuster candidates." Leerink adds that the company "has significant capacity for M&A." It keeps a $388 price target and Outperform rating on the shares.
August 24, 2015
13:54 EDTSRPTFly 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.
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.
08:37 EDTAGNAllergan recalls certain lots of REFRESH, FML, Blephamide treatments
Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH Lacri-Lube 3.5g and 7g for dry eye, REFRESH P.M. 3.5g for dry eye, FML 0.1%, and Blephamide 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product.
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
08:32 EDTSRPTSarepta says FDA grants rare pediatric disease designation for Eteplirsen
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August 20, 2015
11:49 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: SRPT ACHN VIAV ZG RAD DIS ORCL SPY XLF OEX
08:16 EDTAGNAllergan's Botox resubmission for lower limb spasticiy accepted by FDA
Allergan 's resubmission of its Supplemental Biologics License Application for Botox for the treatment of adults with lower limb spasticity in adults has been accepted by the FDA. A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act date is expected to be in 1Q16. The resubmission provides additional data from a double-blind, placebo controlled study involving 468 patients with lower limb spasticity. The FDA also approved an increase to the maximum Botox cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
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