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Stock Market & Financial Investment News

News Breaks
February 27, 2013
13:53 EDTGSK, SRPTSarepta higher after report of hospitalizations related to GSK drug
Shares of Sarepta Therapeutics (SRPT) are up $2.86, or 9.85%, to $31.89 and the strength is being attributed to a report by TheStreet.com that said patients were hospitalized after being treated with GlaxoSmithKline's (GSK) experimental drug for Duchenne muscular dystrophy. The report adds that Sarepta is scheduled to meet with the FDA this quarter to discuss a possible accelerated approval filing of its own Duchenne muscular dystrophy treatment, eteplirsen.
News For SRPT;GSK From The Last 14 Days
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February 11, 2016
09:36 EDTGSKActive equity options trading on open
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February 10, 2016
10:35 EDTSRPTOptions with decreasing implied volatility
Options with decreasing implied volatility: VHC APOL SRPT GRUB BWLD DECK HBI NUAN YY PNRA ABC
February 9, 2016
12:32 EDTSRPTOptions with decreasing implied volatility
Options with decreasing implied volatility: VHC APOL SRPT GRUB BWLD DECK UBNT GMCR
08:40 EDTGSKVBI Vaccines announces research collaboration with GlaxoSmithKline
VBI Vaccines (VBIV) has entered into a research collaboration with GlaxoSmithKline Biologicals SA (GSK) to evaluate VBI's LPV Platform. VBI's LPV Platform is a proprietary formulation and process that enables the development of vaccines and biologics with improved stability and preserved potency. Under the terms of the research collaboration, GSK has the option to negotiate an exclusive license to VBI's LPV Platform for use in a defined field. Further terms of the collaboration were not disclosed.
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.
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 EDTSRPTSarepta 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.
08:10 EDTGSKOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
07:03 EDTGSKBiogen joins Centre for Therapeutic Target Validation
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06:28 EDTGSKPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 4, 2016
07:23 EDTGSKGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 3, 2016
07:23 EDTGSKGlaxoSmithKline confirms 2015 ordinary dividend of 80p, special dividend of 20p
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07:23 EDTGSKGlaxoSmithKline sees double digits CER FY16 core EPS percentage growth
If FX rates held at January average levels estimated impact of +5% on 2016 Sterling core EPS growth.
07:21 EDTGSKGlaxoSmithKline reports Q4 EPS (7.3p) vs. 21.5p last year
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February 2, 2016
08:17 EDTGSKAdaptimmune, GSK expand strategic immunotherapy collaboration
Adaptimmune Therapeutics (ADAP) and GlaxoSmithKline (GSK) announced that the companies have expanded the terms of their strategic collaboration agreement to accelerate Adaptimmune's lead clinical cancer program, an affinity enhanced T-cell immunotherapy targeting NY-ESO-1, toward pivotal trials in synovial sarcoma. Adaptimmune and GSK announced a strategic collaboration and licensing agreement in June 2014 for up to five programs, including the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1 program through clinical proof of concept and, on exercise, will assume full responsibility for the program.
07:42 EDTGSKPressure mounts on big pharma names to shrink, sharpen focus, FT says
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06:32 EDTGSKGSK, J&J back Index Ventures' $1B biotech business spinoff, Reuters says
GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ) will back a new spinoff from Index Ventures, which is spinning off its biotech portfolio into a new $1B entity, Reuters reports. The New Medicxi Ventures business will be helmed by the existing life sciences team from Index and will include all the current biotech portfolio firms, the report says. Medicxi raises $229M for a new fund in Europe with GSK and J&J each putting in 25%, Reuters reports. Reference Link
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