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Stock Market & Financial Investment News

News Breaks
August 1, 2013
13:15 EDTBCRXBioCryst gets FDA approval to initiate BCX 4161 trials
BioCryst disclosed in a regulatory filing that on July 31, the company was notified by the United States Food and Drug Administration that the clinical hold placed on its hereditary angioedema drug BCX 4161 has been removed. The FDA notified BioCryst that the complete response submitted by BioCryst to address the clinical hold satisfactorily addressed the FDAs concerns. This notification by the FDA provides BioCryst the ability to initiate BCX 4161 clinical trials in the United States and/or include U.S. clinical sites in its BCX 4161 clinical trials.
News For BCRX From The Last 14 Days
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February 8, 2016
16:23 EDTBCRXOn 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.
14:06 EDTBCRXBioCryst downgraded to Hold from Buy at Needham
12:05 EDTBCRXOn 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.
11:08 EDTBCRXBioCryst downgraded to Neutral after avoralstat trial faiure at Piper Jaffray
As previously reported, Piper Jaffray analyst Charles Duncan downgraded BioCryst to Neutral from Overweight after avoralstat failed to meet its primary endpoint in a Phase 2 trial. The results were not entirely unexpected given prior management signals, Duncan told investors in a research note, but added that there is now limited visibility on the development plan for an oral kallikrein inhibitor in the next 6-12 months. The analyst cut his price target on BioCryst to $5 from $15.
11:02 EDTBCRXBioCryst downgraded to Neutral from Overweight at Piper Jaffray
10:06 EDTBCRXHigh option volume stocks
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09:55 EDTBCRXBioCryst plummets after hereditary angioedema drug disappoints in study
Shares of BioCryst Pharmaceuticals (BCRX) are plunging in morning trading after the biotechnology company reported disappointing clinical trial results for its potential hereditary angioedema treatment. WHAT'S NEW: Biocryst this morning announced results from its OPuS-2 trial evaluating avoralstat in treatment of patients with hereditary angioedema, or HAE. BioCryst said either a 500 mg or 300 mg dose of the drug was administered three times daily to patients suffering HAE attacks, but said those patients did not have a lower rate of edema, or swelling, than patients given a placebo. The primary goals of the study were to characterize the efficacy of avoralstat in reducing the frequency of angioedema attacks and to evaluate the safety and tolerability of 12 weeks of avoralstat treatment. The primary efficacy endpoint of the study was angioedema attack frequency, with secondary endpoints including quality of life, attack duration and attack severity. EXECUTIVE COMMENTARY: President and Chief Executive Officer Jon Stonehouse said that the OPuS-2 trial was a "well-designed and executed trial that gave us a clear answer; this dosage form of avoralstat is not a viable formulation to move forward." Stonehouse also commented that "While we are disappointed in the study results, we learned that meaningfully better exposure is needed for avoralstat to succeed. We expect results from a relative bioavailability study testing a novel solid dosage form of avoralstat by mid-year -- the primary goals of this study are to achieve much higher exposures and twice daily dosing." He said that the company's other opportunity to achieve higher exposure of an oral kallikrein inhibitor is with BCX7353 and the company expects results from the BCX7353 APeX-1 dose ranging study in HAE patients by year end. PRICE ACTION: In morning trading, BioCryst dove 66% to $2.10.
09:17 EDTBCRXOn The Fly: Pre-market Movers
HIGHER: Apollo Education (APOL), up 26.6% after announcing that it will be acquired for $9.50 per share... Sprouts Farmers Market (SFM), up 5% after being added to S&P 400... GoPro (GPRO), up 3.4% after signing a licensing agreement with Microsoft (MSFT). LOWER: BioCryst Pharmaceuticals (BCRX), down 60.9% after reporting OpuS-2 clinical trial results... CTI BioPharma (CTIC), down 55.4% after the FDA placed a partial clinical hold on pacritinib studies... Tableau (DATA), down 5.5% after being downgraded to Equal Weight at Morgan Stanley... HSBC (HSBC), down 3.6% after being downgraded to Underweight from Equal Weight at Morgan Stanley... Chesapeake Energy (CHK), down 21% after Hedgeye analyst Kevin Kaiser said in an interview with Barron's that Chesapeake could go to zero... Twitter (TWTR), down 2.9% after backlash over its new algorithmic timeline.
06:09 EDTBCRXBioCryst to host conference call
Conference call to discuss the OPuS-2 trial results and other aspects of BioCryst's HAE development program will be held on February 8 at 8am. Webcast Link
06:07 EDTBCRXBioCryst reports OpuS-2 clinical trial results
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