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March 25, 2014
06:57 EDTSLXP, BCRX, QCOR, KERX, AUXL, CBST, IRWD, ACRXBiotech weakness a buying opportunity, says Mizuho
Mizuho said the recent weakness in biotech will prove transient and has created buying opportunities in AcelRx (ACRX), Auxilium (AUXL), BioCryst (BCRX), Ironwood (IRWD), Keryx (KERX), Salix (SLXP), Cubist (CBST), and Questcor (QCOR).
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October 9, 2015
20:11 EDTACRXAcelRx management to meet with Roth Capital
Meeting to be held in San Francisco on October 15 hosted by Roth Capital.
09:59 EDTBCRXOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Alamo Group (ALG) downgraded to Underperform from Buy at BofA/Merrill... Allison Transmission (ALSN) downgraded to Neutral from Overweight at JPMorgan... Ashland (ASH) downgraded to Buy from Conviction Buy at Goldman... BioCryst (BCRX) downgraded to Neutral from Buy at BofA/Merrill... BioMed Realty (BMR) downgraded to Market Perform from Outperform at Raymond James... Eagle Materials (EXP) downgraded to Neutral on less visibility at Longbow... Eaton (ETN) downgraded to Neutral from Overweight at JPMorgan... Ecolab (ECL) downgraded to Neutral from Overweight at JPMorgan... FireEye (FEYE) downgraded to Neutral from Buy at Dougherty... Franklin Resources (BEN) downgraded to Hold from Buy at Deutsche Bank... Gap (GPS) downgraded to Neutral from Buy at MKM Partners... Global Payments (GPN) downgraded to Hold from Buy at Jefferies... Honda (HMC) downgraded to Hold from Buy at Jefferies... PACCAR (PCAR) downgraded to Neutral from Overweight at JPMorgan... Precision Drilling (PDS) downgraded to Sector Perform from Outperform at Scotia... Solera (SLH) downgraded to Neutral from Buy at Goldman... Tesla (TSLA) downgraded to Underweight from Equal Weight at Barclays... Toyota (TM) downgraded to Hold from Buy at Jefferies... Weir Group (WEIGY) downgraded to Underperform from Sector Perform at RBC Capital... Zumiez (ZUMZ) downgraded to Hold from Buy at Stifel... ePlus (PLUS) downgraded to Neutral from Buy at Sidoti.
06:50 EDTBCRXBioCryst downgraded to Neutral from Buy at BofA/Merrill
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October 8, 2015
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12:20 EDTBCRXOn The Fly: Top stock stories at midday
Stocks on Wall Street were mixed at midday, with the Dow a bit higher, the S&P little changed and the Nasdaq lagging. The averages began the session uniformly in negative territory, but began to pare their losses almost immediately, then spent the rest of the morning teetering near the flat line. The tepid action is not surprising as investors await the release of the minutes from last month's FOMC rate setting meeting. ECONOMIC EVENTS: In the U.S., initial jobless claims dropped to 263,000 in the week ended October 3, versus expectations for 273,00 first-time claims. Investor attention is clearly focused on this afternoon's release of the FOMC minutes for the September 16-17 policy meeting, given the Fed's surprise decision to delay liftoff at that time. The minutes are scheduled to be released at 2 pm EDT. In Asia, markets were mixed, with Japan, Hong Kong, Taiwan and India all seeing some profit taking following days of strong gains, though mainland China re-opened for the first time since last Wednesday following the Golden Week holiday and saw a catch-up rally that pushed the Shanghai composite up about 3%. COMPANY NEWS: EMC (EMC) rose over 5.5% in early trading amid conflicting reports regarding M&A talks between the IT services and software company and Dell, which is privately owned by founder Michael Dell and private-equity partner Silver Lake. Last night, The Wall Street Journal reported that Dell and Silver Lake are in "advanced talks" to buy EMC, noting that one source indicated the deal being discussed calls for the buyers to spin off EMC's VMware (VMW) unit. Then, Re/code's Arik Hesseldahl reported that EMC has approached Dell in recent weeks about selling its VNX data storage business to the private technology company, but contended that acquiring a unit would make more logical and financial sense for Dell than buying all of EMC. However, CNBC's David Faber subsequently said, in keeping with the Journal, that Dell is in talks to acquire all of EMC for "above $27 per share," adding that a deal could be announced as soon as a week from now. Several analysts weighing in on the potential for a deal expressed doubt that a takeover of EMC by Dell is likely, but agreed that some alternate deal may make sense, adding that a potential Dell-EMC tie-up would be negative for HP Enterprise (HPQ)... Shares of eBay (EBAY) were among the worst performing on the S&P 500, sliding almost 8% near noon. The weakness in the online marketplace operator followed a report from e-commerce solutions and data provider ChannelAdvisor (ECOM), which estimated that eBay's same-store sales growth decelerated to 1.1% in September from August's 3.4% rate. In the same blog post, ChannelAdvisor reported that Amazon's (AMZN) same-store sales grew 19.2% in September, noting that was a decrease compared to August's 24.7% SSS growth rate. MAJOR MOVERS: Among the notable gainers was Tronox (TROX), which jumped 18.5% after Bloomberg reported that Apollo Global (APO) was mulling a takeover of Chemours (CC) as a potential first step in then consolidating titanium-dioxide makers. Shares of Chemours gained 7.5% following the report. Also higher were Polycom (PLCM) and Mitel (MITL), which gained 15% and 17%, respectively, after Elliott Management disclosed stakes in both companies and urged the two to consider a combination. Among the noteworthy losers was BioCryst (BCRX), which dropped 21% after the company said it completed patient enrollment in its clinical trial of orally-administered avoralstat in patients with hereditary angioedema, noting that without a deferral an NDA filing would occur in 2018. That NDA timing estimate was further out than prior comments from the company. Also lower was GoPro (GPRO), which fell 5.7% after Cleveland Research downgraded the stock to Neutral from Buy and lowered estimates below consensus to reflect deterioration in action camera shipments. INDEXES: Near midday, the Dow was up 25.75, or 0.15%, to 16,938.04, the Nasdaq was down 30.53, or 0.64%, to 4,760.62, and the S&P 500 was barely changed at 1,995.32.
10:56 EDTBCRXBioCryst weakess overdone, says JPMorgan
10:08 EDTBCRXHigh option volume stocks
High option volume stocks: BCRX RHI NBIX ZBH FMC JAKK GWW DPZ MXIM ROK
07:02 EDTACRXAcelRx provides update on Zalviso
AcelRx provided a regulatory update on Zalviso intended for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The company has received formal minutes of the telephonic meeting held in early September 2015, with the Division of Anesthesia, Analgesia, and Addiction Products of the FDA. As reflected in the minutes, the Division restated at the meeting a request for clinical data to complement other data AcelRx has developed to assess the overall performance of the Zalviso device. The company is planning to submit a protocol to the Division for a clinical study in post-operative patients designed to evaluate the effectiveness of changes made to enhance product performance. AcelRx expects to be ready to initiate the study in the first quarter of 2016, and likely will await comments on the protocol from the Division. The company will be prepared to work with the FDA to facilitate the timely study initiation.
06:08 EDTBCRXBioCryst's candidate for hereditary angioedema meets all Phase 1 objectives
BioCryst's randomized, placebo-controlled, Phase 1 clinical trial of orally-administered BCX7353 in healthy volunteers met all of its objectives. The safety, tolerability, drug exposure and on-target plasma kallikrein inhibition results support advancing the development program into a Phase 2 study in hereditary angioedema patients. Oral BCX7353 was generally safe and well tolerated at all doses. No dose-limiting toxicity was identified. Daily dosing with BCX7353 strongly inhibited plasma kallikrein at all four dose levels. A Phase 2, four week dose ranging trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BCX7353 as a preventative treatment to reduce the frequency of attacks in HAE patients is expected to begin by late 2015 or early 2016.
06:05 EDTBCRXBioCryst completes patient enrollment in OPus-2 trial of Avoralstat
BioCryst has completed enrollment in OPuS-2, a blinded, randomized, placebo-controlled clinical trial of orally-administered avoralstat in patients with hereditary angioedema. The trial designed to evaluate the efficacy and safety of two doses of avoralstat, 300 mg and 500 mg, administered three-times daily compared with placebo. The primary efficacy endpoint for the trial is the mean angioedema attack rate, which will be reported for each avoralstat dose group compared to placebo. BioCryst expects to report OPuS-2 results in early 2016. The results of this trial will be provided for regulatory discussions required for completion of avoralstat registration. The company plans to initiate a rat carcinogenicity study in early 2016. Without a deferral, NDA filing would occur in 2018.
06:03 EDTBCRXBioCryst to host conference call
Conference call to discuss the results of the BCX7353 Phase 1 trial and other aspects of BioCryst's HAE development program will be held on October 8 at 8:30 am. Webcast Link
October 6, 2015
07:01 EDTACRXAcelRx announces initiation of clinical study of ARX-04 in ER patients
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October 5, 2015
09:08 EDTACRXAcelRx price target raised to $10.50 from $8.50 at Roth Capital
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06:28 EDTKERXKeryx upgraded to Equal Weight from Underweight at Morgan Stanley
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October 1, 2015
06:09 EDTACRXAcelRx to host analyst and investor day
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