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Stock Market & Financial Investment News

News Breaks
June 23, 2014
07:52 EDTISIS, CLDN, ARWR, SRPT, INO, BMRN, ALNY, SGMO, IDRA, BLUE, AGTCPiper 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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February 9, 2016
16:07 EDTSGMOSangamo reports Q4 EPS (20c), consensus (21c)
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16:03 EDTARWRArrowhead reports Q1 EPS (32c), consensus (41c)
Reports Q1 revenue $43,750, consensus $130,000. Reports cash and equivalents $62.17M.
12:32 EDTSRPTOptions with decreasing implied volatility
Options with decreasing implied volatility: VHC APOL SRPT GRUB BWLD DECK UBNT GMCR
07:40 EDTSRPTSarepta PDUFA delay positive, says Oppenheimer
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February 8, 2016
16:23 EDTSRPTOn The Fly: Top stock stories for Monday
Stocks began the session deep in negative territory thanks in part to lower oil prices, poor banking data out of China, and selling in Europe. The market saw little in the way of buying for most of the day, with all ten of the S&P sectors in negative territory. Oil prices struggled to stay above $30 per barrel, while "safe haven" gold moved above $1,200 an ounce, its highest price since June. Once oil settled, stocks saw a late rally and cut into their losses, but the averages still ended the day deep in the red even following the comeback. ECONOMIC EVENTS: In the U.S., the labor market conditions index came in at 0.4 for January, below expectations for a reading of 2.0. In Asia, markets in mainland China, Hong Kong, Taiwan and Korea were all closed for the New Year holiday. Data was still released in China that showed the country's foreign currency reserves fell to their lowest level since May 2012, dropping about $99B in January, though that was better than analyst forecasts and ahead of some recent whispers. COMPANY NEWS: Chesapeake Energy (CHK) tumbled 33.2% to $2.05 after media reports indicated that the natural gas producer has hired restructuring lawyers from Kirkland & Ellis. The company later remarked that the law firm has been retained as an adviser, though Chesapeake noted it has "no plans" to pursue bankruptcy, which helped the stock recover some of its early losses... Meanwhile, another player in the oil space with ties to Chesapeake, Energy Transfer Equity (ETE), declined 41.3% to $4.10 after the company disclosed it was making a change to the Chief Financial Officer of its general partner. Williams Company (WMB), which has agreed to merge with Energy Transfer, also slid nearly 35%... Yelp (YELP) ended Monday down 11% at $16.11 after the earlier than expected release of its quarterly earnings report, which the company blamed on the news distribution service that issued the press release before the results were due. Yelp's earnings and revenue came in above expectations, though the company also disclosed that its finance chief Rob Krolik would be stepping down. MAJOR MOVERS: Among the notable gainers was Apollo Education (APOL), which rallied 24% to $8.62 after agreeing to be acquired for $9.50 per share by a group of investors led by private equity firm Apollo Global (APO), with the news also sending its for-profit education competitor DeVry (DV) up 5.5%. Also higher was GoPro (GPRO), which gained 10.3% to $10.99 after Microsoft (MSFT) announced a new collaborative patent licensing agreement with the beaten down action camera maker. In addition, Outerwall (OUTR), owner of the Redbox and Coinstar kiosk brands, rose 11% to $30.01 after Bloomberg reported that at least three buyout firms have sought to take it private in the past two years, with activist investor Engaged Capital later in the day confirming a 14% stake in the company. Among the noteworthy losers was Sarepta (SRPT), which declined 12.1% to $10.74 after the FDA delayed a decision on the company's closely-watched Duchenne muscular dystrophy treatment eteplirsen. Also lower was BioCryst (BCRX), which plunged 71% to $1.77 after a clinical trial of its hereditary angioedema drug failed to meet its primary endpoint. Meanwhile, Twitter (TWTR) fell 5.3% to $14.89 following reports over the weekend that it is rethinking its news feed, potentially ordering posts based on popularity rather than chronological date. INDEXES: The Dow fell 177.92, or 1.1%, to 16,027.05, the Nasdaq lost 79.39, or 1.82%, to 4,283.75, and the S&P 500 declined 26.61, or 1.42%, to 1,853.44.
16:05 EDTAGTCApplied Genetic reports Q2 EPS 17c, may not compare to consensus (19c)
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12:05 EDTSRPTOn The Fly: Top stock stories at midday
Stocks on Wall Street began the session deep in negative territory and proceeded to move lower throughout the session, amid a renewed selloff in oil prices and fears that bankruptcies related to the prolonged slump will begin to pick up pace. The move lower is not restricted to the energy sector and has been broad-based, as each of the major equity indexes was lower by about 2% or more. ECONOMIC EVENTS: In the U.S., the labor market conditions index came in at 0.4 for January, below expectations for a reading of 2.0. In Asia, markets in mainland China, Hong Kong, Taiwan and Korea were all closed for the New Year holiday. Data was still released in China that showed the country's foreign currency reserves fell to their lowest level since May 2012, dropping about $99B in January, though that was better than analysts forecast and ahead of some recent whispers. COMPANY NEWS: Chesapeake Energy (CHK) tumbled over 50%, dropping as low as $1.50 per share, after media reports indicated that the natural gas producer has hired restructuring lawyers from Kirkland & Ellis. Subsequently, the stock was halted pending news and the company confirmed that Kirkland & Ellis continues to advise the company as it seeks to further strengthen its balance sheet. However, Chesapeake noted that it currently has "no plans to pursue bankruptcy," and its shares recovered some of their earlier losses upon being reopened for trading. The stock was down a bit over 25% near noon... Meanwhile, another player in the oil space with ties to Chesapeake, Energy Transfer Equity (ETE), declined 30% after the company disclosed, via a regulatory filing after Friday's close, that it was making a change to the Chief Financial Officer of its general partner. According to the company, the departure of CFO Jamie Welch from the post was not caused by any disagreements between him and the MLP over accounting issues or financial matters. Williams Company (WMB), with has agreed to merge with Energy Transfer, also slid 25%. MAJOR MOVERS: Among the notable gainers was Apollo Education (APOL), which rallied 25% after it agreed to be acquired by a group led by private equity company Apollo Global (APO) for $9.50 per share. Also higher was GoPro (GPRO), which gained 9% after Microsoft (MSFT) announced a new collaborative patent licensing agreement with the beaten down action camera maker. Among the noteworthy losers was Sarepta (SRPT), which fell 12% after the FDA delayed a decision on the company's Duchenne muscular dystrophy treatment eteplirsen. Also lower was BioCryst (BCRX), which plunged 67% after a clinical trial of its hereditary angioedema drug failed to meet its primary endpoint. In addition, DexCom (DXCM) was 17% lower after it was downgraded to Neutral from Outperform at Baird. INDEXES: Near midday, the Dow was down 317.14, or 1.96%, to 15,887.83, the Nasdaq was down 101.02, or 2.32%, to 4,262.12, and the S&P 500 was down 36.43, or 1.94%, to 1,843.62.
10:17 EDTSRPT, BMRNSarepta approval seen as 'long shot' as FDA pushes back decision
Shares of drugmaker Sarepta Therapeutics (SRPT) took a dive in morning trading after the company said the U.S. Food and Drug Administration delayed a decision on eteplirsen for the treatment of Duchenne muscular dystrophy. WHAT'S NEW: Sarepta announced that the FDA has pushed out the the Prescription Drug User Fee Act, or PDUFA, date for eteplirsen for the treatment of Duchenne muscular dystrophy to May 26. The previous PDUFA date for the eteplirsen new drug application, or NDA, was originally set for late February. FDA POSTPONEMENT: The FDA notified Sarepta that it's submission of 4-year clinical data, including additional six minute walk test and loss of ambulation data compared to historical control, was designated as a "major amendment" to the NDA and that the PDUFA goal date was extended to allow for a full review of the submission. The FDA previously granted eteplirsen Priority Review status, as well as Rare Pediatric Disease Designation, Orphan Drug Designation and Fast Track Status to eteplirsen. WHAT'S NOTABLE: In late January, the FDA postponed a meeting of its advisory committee to review the Sarepta drug due to an inclement weather forecast for Washington D.C. LONG SHOT: Piper Jaffray analyst Edward Tenthoff told investors in a note that the FDA's PDUFA date postponement for eteplirsen is "not surprising" following the delay of the January 22 AdCom due to weather. Tenthoff also noted that a new AdCom has yet to be scheduled. The analyst continues to see eteplirsen accelerated approval by the new PDUFA date as a "long shot." He believes that the panel discussion will be a "plea from the community" to approve something for DMD and that members will not be asked to vote on drug approval. Tenthoff has a Neutral rating and $15 price target on Sarepta. OTHERS TO WATCH: Other companies developing treatments for Duchenne muscular dystrophy include BioMarin (BMRN) and PTC Therapeutics (PTCT). PRICE ACTION: Sarepta is down 9.5% in morning trading to $11.06.
09:22 EDTSRPTSarepta accelerated approval by new PDUFA a 'long shot,' says Piper
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08:32 EDTSRPTSarepta receives notification of PDUFA extension for eteplirsen to May 26
Sarepta Therapeutics announced that the U.S. FDA will require additional time to complete its review of the New Drug Applicationfor eteplirsen, for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping. In a notice received from the FDA, the Prescription Drug User Fee Act date for eteplirsen has been extended to May 26, 2016. The rescheduled date for the Peripheral and Central Nervous System Advisory Committee meeting has not yet been determined. The FDA notified Sarepta that its January 8, 2016 submission of 4-year clinical effectiveness data, which included additional six minute walk test and loss of ambulation data compared to a historical control, has been designated as a major amendment to the NDA. The FDA stated that the PDUFA goal date has been extended by three months to allow for a full review of the submission. As described in the Sarepta Advisory Committee Briefing Document Addendum, the principal basis for establishing the effectiveness of eteplirsen is a comparison of patients in Study 201/202 to a historical control group. The FDA has previously granted eteplirsen Priority Review status, which is designated for drugs that provide a treatment where no adequate therapy exists. The FDA also granted Rare Pediatric Disease Designation to eteplirsen, as well Orphan Drug Designation and Fast Track Status.
07:25 EDTINOBiotech Industry Organization to hold a conference
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07:06 EDTSGMOSangamo announces FDA clearance of IND application for SB-318
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February 3, 2016
10:00 EDTBLUEOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Capella Education (CPLA) initiated with an Outperform at Credit Suisse... DeVry (DV) initiated with an Outperform at Credit Suisse... Gilead (GILD) initiated with a Buy at Standpoint Research... Grand Canyon (LOPE) initiated with a Neutral at Credit Suisse... Hannon Armstrong (HASI) initiated with an Equal Weight at Morgan Stanley... Houghton Mifflin (HMHC) initiated with an Outperform at Credit Suisse... Mediaset (MDIUY) initiated with a Buy at Jefferies... Palo Alto (PANW) initiated with a Buy at Maxim... Splunk (SPLK) initiated with a Buy at Maxim... Strayer (STRA) initiated with a Neutral at Credit Suisse... Tableau (DATA) initiated with a Sell at Maxim... Tesla (TSLA) initiated with a Sell at Berenberg... WisdomTree (WETF) initiated with an Outperform at Northland... bluebird bio (BLUE) initiated with an Outperform at Leerink.
08:02 EDTBLUEbluebird bio initiated with an Outperform at Leerink
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February 2, 2016
14:52 EDTINOZika virus acquired through sexual transmission reported in Dallas
Dallas County Health and Human Services announced it has received confirmation from the Centers for Disease Control and Prevention of the first Zika virus case acquired through sexual transmission in Dallas County in 2016. The patient was infected with the virus after having sexual contact with an ill individual who returned from a country where Zika virus is present, DCHHS reported. Publicly traded companies working on combating Zika include Inovio (INO), Cerus (CERS), NewLink (NLNK) and Intrexon (XON).
12:56 EDTINOMizuho downplays near-term Zika revenue potential for NewLink, Intrexon
The Zika virus and its link to microcephaly and fetal brain damage have exploded into public view and lead to several drugmakers announcing plans to fight the disease, but Mizuho analyst Eric Criscuolo downplayed the potential for Zika to truly move the needle for companies in the space in the near-term. PERIPHERAL OPPORTUNITIES: NewLink (NLNK) announced plans to develop treatment options for the Zika virus as the disease was declared a global health emergency by the World Health Organization this week. While the company "could" secure funding and partnerships for the project, Criscuolo does not view NewLink's Zika plans as core to its investment story, encouraging investors to instead evaluate the company on the basis of its HyperAcute and IDO programs. Meanwhile, Intrexon's (XON) efforts in mosquito population control have also gained attention amid the rise of Zika, whose primary transmission vector is the mosquito. Though even a small slice of global mosquito spending would represent "significant" revenue for Intrexon, Criscuolo cautions that the company's program is still in early stages, with attempts at a wider rollout likely encountering political, biological, financial and public opinion hurdles. Separately, the analyst said he wouldn't be surprised to see OraSure (OSUR) also attempt to develop a Zika test given the company's response to Ebola last year, though as with NewLink, Criscuolo believes any such effort would be peripheral to OraSure's primary businesses. OTHERS TO WATCH: Other publicly traded companies involved in combating Zika include Inovio (INO) and Cerus (CERS). PRICE ACTION: Shares of NewLink are up roughly 5% to $25.63. Meanwhile, Intrexon has slipped 5.5% on Tuesday afternoon but is still up 15% over the last five trading days. Among others with links to Zika, OraSure is up fractionally, Inovio has fallen 7% and Cerus has dipped 1.4% this afternoon.
08:36 EDTBMRN, SGMO, ALNYPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
13:42 EDTINOWHO declares Zika virus to be global emergency, Reuters reports
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08:03 EDTALNYAlnylam completes enrollment in APOLLO Phase 3 study with Patisiran
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05:57 EDTINOInovio volatility elevated, developing vaccine for Zika virus infection
Inovio February call option implied volatility is at 108, March is at 100; compared to its 52-week range of 49 to 115, suggesting large price movement as the company develops a DNA-based vaccine for preventing and treating the Zika virus infection.
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