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March 10, 2014
Emerging Biotech Conference 2014 is being held in Snowbird, Utah on March 10-12.
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October 1, 2015
07:01 EDTALNYGenzyme opts into ALN-AT3 Hemophilia Program
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September 30, 2015
07:11 EDTEPZM, ALNYLeerink to hold a roundtable
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September 29, 2015
12:33 EDTVRTXOn The Fly: Top stock stories at midday
Stocks on Wall Street were slightly higher at midday as the market seeks to break its losing streak, helped by an improvement in consumer confidence that came despite the recent market volatility. ECONOMIC EVENTS: In the U.S., consumer confidence unexpectedly rose in September. Analysts expected the consumer confidence reading to pull back to 96.8 from the prior 101.5 figure, but it actually strengthened to 103.0. The S&P/Case-Shiller 20-city composite home price index was up a seasonally adjusted 0.2% month over month in July, versus the consensus forecast for a rise of 0.1%. Stocks sold off in much of Asia last night, with China's Shanghai composite index sliding 2% while Japan's Nikkei dropped 4%, erasing year-to-date gains in the process. COMPANY NEWS: Shares of Yahoo (YHOO) advanced 3% after its board authorized the company to continue to pursue its spin-off of Aabaco Holdings, a newly formed independent registered investment company that will hold all of Yahoo's remaining holdings in Alibaba Group (BABA). MAJOR MOVERS: Among the notable gainers was Radius Health (RDUS), which rose nearly 10% after Ben Harrington of the Betaville blog stated during an appearance on Tip TV that he has heard that "something will be happening" in terms of M&A involving the company over the "next few weeks." Also higher were several recently beaten down biotech stocks that were seeing some bounceback, including Vertex Pharmaceuticals (VRTX), which gained 5%, and Biogen (BIIB), which advanced 4%. Notably, both of them, along with Amgen (AMGN), were mentioned in a note to investors by Cowen analyst Ken Cacciatore as "hypothetical" targets for Allergan (AGN). Among the noteworthy losers was OvaScience (OVAS), which dropped 38% after saying it now longer expects to meet its 2015 goal of 1,000 Augment cycles. Esperion (ESPR) also fell 38% after the company warned that the FDA could require it to undertake new studies before its ETC-1002 is approved. INDEXES: Near midday, the Dow was up 7.27, or 0.05%, to 16,009.16, the Nasdaq was up 7.38, or 0.16%, to 4,551.35, and the S&P 500 was up 4.56, or 0.24%, to 1,886.33.
08:57 EDTVRTXCowen lists Vertex, Biogen and Amgen as hypothetical Allergan targets
Cowen analyst Ken Cacciatore noted that the price agreed for Allergan's (AGN) generic divestiture to Teva (TEVA) is fixed and that the cash value from this deal has not depreciated in any way while the corresponding valuations of potential targets have corrected, increasing the potential value creation available for Allergan as it decides how to deploy its capital. To illustrate the value creation that Allergan's capital deployment could generate, Cacciatore estimates the type of accretion potential that might be seen if the company were to buy Vertex with an acquisition price of $36.5B, if it were to acquire Biogen (BIIB) at a price of $91B or if it were to purchase Amgen (AMGN) with an acquisition price of $140B. Although the market correction has lowered Allergan's stock, the decline could be viewed as a near-term positive, given that a key component of its strategy and business model is to seek to aggressively deploy its capital, Cacciatore argues in a note to investors. The analyst keeps an Outperform rating and $400 price target on Allergan shares.
September 28, 2015
16:19 EDTEPZMOn The Fly: Top stock stories for Monday
Stocks on Wall Street were sharply lower as investors continue to worry about the health of China's economy and continue to flee the biotech sector. The iShares NASDAQ Biotechnology Index (IBB) was down 6.33% today and is down about 18.5% since September 21, when Democratic presidential candidate Hillary Clinton pledged to take action against the high prices of specialty drugs. Adding to the tentative mood among investors was noted investor Carl Icahn's preview for a presentation that will be made available on his site tomorrow, entitled "Danger Ahead." The preview includes several cautious comments that the billionaire has publicly made recently regarding his concerns about the high-yield bond market and the stock market. ECONOMIC EVENTS: In the U.S., personal income grew 0.3% in August, versus expectations for it to rise 0.4%. Personal spending rose 0.4% last month, versus expectations for growth of 0.3%. The pending home sales index fell 1.4% in August, missing expectations for it to have risen 0.4%. The Dallas Fed manufacturing outlook survey for September had a reading of -9.5, versus expectations for a reading of -10.0. In China, industrial profits plunged 8.8% in August, adding to the recent string of weak data from the Asian giant. COMPANY NEWS: Apple (AAPL) reported that it set a record by selling more than 13M new iPhone 6s and iPhone 6s Plus models in the first three days after launch of the devices. However, shares of the tech giant slid about 2% to $112.44 following the announcement... Alcoa (AA) shares advanced 52c, or 5.73%, to $9.59 after the company announced that its board has approved a plan to separate into two independent, publicly-traded companies - an Upstream company that will operate under the Alcoa name and a new "Value-Add company" that will provide high-performance, multi-material products whose name will be announced at a later date... Biotech stocks continued recent declines, with Valeant (VRX) dropping 16.6% after a group of Democratic congressmen urged additional scrutiny of the company's "price hike" business model, while Epizyme (EPZM) and NewLink (NLNK) fell a respective 27% and 21% after presenting data at the 2015 European Cancer Congress... Shares of both Energy Transfer Equity (ETE) and Williams (WMB) fell after they announced a combination deal valued at approximately $37.7B, including the assumption of debt and other liabilities. Under the terms of their deal, an affiliate of ETE will acquire Williams at an implied current price of $43.50 per Williams share, the companies said. In late June, Energy Transfer Equity made a proposal to merge with Williams in an all-equity transaction valued at that time at $53.1B, including the assumption of debt and other liabilities. Under that prior merger proposal, ETE would have acquired all of the outstanding common stock of Williams at an implied price of $64 per Williams share, which represented a 32.4% premium to Williams' common share closing price as of June 19. Energy Transfer Equity shares closed down $2.95, or 12.69%, to $20.29 after announcing today's revised deal, while Williams dropped $5.03, or 12.09%, to close at $36.57. MAJOR MOVERS: Among the notable gainers was Republic Airways (RJET), which surged $2.38, or 81.8%, to $5.29 after announcing that the company and Teamsters Local 357 have reached a consensual tentative agreement on the terms of a new three-year contract for the 2,100 Republic pilots represented by the International Brotherhood of Teamsters. Also higher was Media General (MEG), which gained $2.49, or 22.3%, to $13.64 after Nexstar (NXST) proposed a cash-and-stock deal to acquire the company for $14.50 per share, which Media General said it would "carefully review." Additionally, Sanchez Energy (SN) rose 4.5% to $5.57 after agreeing to sell certain Eagle Ford Shale midstream assets to Sanchez Production Partners (SPP) for $345M. Among the noteworthy losers was Huntsman (HUN), which plunged $3.99, or 28.7%, to $9.92 after warning that headwinds would impact its third quarter earnings. Also lower were shares of Depomed (DEPO) and Horizon Pharma (HZNP), falling a respective 22% and 21%, after Depomed continued its criticism of Horizon's hostile takeover bid for the company. INDEXES: The Dow fell 312.78, or 1.92%, to 16,001.89, the Nasdaq lost 142.53, or 3.04%, to 4,543.97, and the S&P 500 dropped 49.57, or 2.57%, to 1,881.77.
14:49 EDTALNYAlnylam granted summary judgment by U.S. district court in patent dispute
Alnylam Pharmaceuticals announced that Chief Judge Patti Saris of the U.S. District Court for the District of Massachusetts granted Alnylam's summary judgment motion in an inventorship dispute, holding that Professor Brenda Bass, Distinguished Professor at the University of Utah, is not a co-inventor of certain patents, termed the Tuschl II patents, jointly owned by co-defendants the Max Planck Society, UMass, Massachusetts Institute of Technology, and the Whitehead Institute for Biomedical Research, and exclusively licensed to Alnylam. In 2011 Utah sued Alnylam, Max Planck, UMass, MIT, and Whitehead alleging that Dr. Bass was either the sole or a co-inventor of the Tuschl II patents, seeking correction of inventorship as well as unspecified monetary damages. In 2015 Utah dropped their sole inventorship claim. The Court found that there was no collaboration between Dr. Bass and Dr. Tuschl, which is a pre-requisite for co-inventorship, and also granted the defendants' motion for summary judgment on Utah's state law claims. While Utah can appeal this ruling, Alnylam remains firm in its belief that the inventorship of the Tuschl II patents as stated in the issued patents is correct, the company said.
11:14 EDTALNYAlnylam OLE data has positive read through to Phase 3 trial, says Piper Jaffray
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10:00 EDTVRTXOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: ANI Pharmaceuticals (ANIP) upgraded on valuation at Roth Capital... AbbVie (ABBV) upgraded to Neutral from Sell at Citi... Astec (ASTE) upgraded to Accumulate from Neutral at Global Hunter... Atmel (ATML) upgraded to Strong Buy from Outperform at Raymond James... BAE Systems (BAESY) upgraded to Outperform from Market Perform at Bernstein... BG Group (BRGYY) upgraded on valuation at BMO Capital... Boston Scientific (BSX) upgraded to Buy from Hold at Needham... C.H. Robinson (CHRW) upgraded to Buy from Hold at BB&T... Citi (C) upgraded to Buy from Hold at Jefferies... Diamond Offshore (DO) upgraded to Hold from Sell at Deutsche Bank... Endologix (ELGX) upgraded to Buy from Neutral at BTIG... Infosys (INFY) upgraded to Hold from Sell at Societe Generale... J.C. Penney (JCP) upgraded on confidence in CEO, initiatives at Sterne Agee CRT... Knowles (KN) upgraded to Market Perform from Underperform at FBR Capital... Lexicon (LXRX) upgraded to Hold from Sell at Gabelli... MTN Group (MTNOY) upgraded to Buy from Hold at Deutsche Bank... Natera (NTRA) upgraded to Outperform from Neutral at Wedbush... Omnicell (OMCL) upgraded to Buy from Neutral at Sidoti... RBC Bearings (ROLL) upgraded to Buy from Accumulate at Global Hunter... Raptor Pharmaceuticals (RPTP) upgraded to Perform from Underperform at Oppenheimer... Regal Entertainment (RGC) upgraded to Buy from Neutral at B. Riley... Repsol (REPYY) upgraded on valuation at BMO Capital... Star Bulk Carriers (SBLK) upgraded to Buy from Hold at Deutsche Bank... Stoneridge (SRI) upgraded to Buy from Hold at BB&T... Transocean (RIG) upgraded to Hold from Sell at Deutsche Bank... Vertex (VRTX) upgraded to Buy from Hold at Argus... Wabash (WNC) upgraded to Buy from Accumulate at Global Hunter.
08:05 EDTALNYAlnylam reports new results from ongoing Phase 2 OLE study of patisiran
Alnylam Pharmaceuticals and collaborators announced new results from the company's ongoing Phase 2 open-label extension study of patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR-mediated amyloidosis patients with familial amyloidotic polyneuropathy. In collaboration with investigators at The Scripps Research Institute and Misfolding Diagnostics, Inc., patisiran administration was shown to reduce pathogenic, misfolded TTR monomers and oligomers in FAP patients in the Phase 2 OLE study. Specifically, patisiran administration resulted in a rapid and sustained reduction of approximately 90% in serum non-native conformations of TTR. Since NNTTR is pathogenic in ATTR amyloidosis, these results provide direct mechanistic evidence supporting the therapeutic hypothesis that TTR knockdown has the potential to result in clinical benefit. In addition, Alnylam presented complete 12-month data from all 27 patients initially enrolled in the patisiran OLE study, showing a mean 3.1-point decrease in the modified Neuropathy Impairment Score at 12 months as well as sustained mean maximum reductions in total serum TTR of 91% for over 18 months. Moreover, patisiran administration was found to be generally well tolerated out to 21 months of treatment. Alnylam's ongoing Phase 2 OLE study is an open-label, multi-center trial designed to evaluate the long-term safety and tolerability of patisiran administration in FAP patients that were previously enrolled in a Phase 2 study. Patisiran is being administered once every 3 weeks at a dose of 0.3 mg/kg by intravenous infusion. The study is measuring a number of clinical endpoints every six months, including mNIS+7 which is an evaluation of muscle weakness, sensory and autonomic function, and nerve conductance, where neuropathy progression leads to an increased score over time. The change in the mNIS+7 measurement from baseline to 18 months is the primary endpoint in the company's ongoing Phase 3 APOLLO trial of patisiran in FAP patients.
07:38 EDTVRTXVertex upgraded to Buy from Hold at Argus
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07:04 EDTEPZMEpizyme data positive, says RBC Capital
After new data on Epizymne's solid tumor treatment tazemetostat,was presented, RBC Capital thinks the data is significantly positive. The firm says that, "the Phase I results clearly demonstrate clinical activity for tazemetostat in a heavily pre-treated patient population with poor prognosis." It keeps an Outperform rating on the shares.
06:07 EDTEPZMEpizyme to host conference call
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September 27, 2015
15:13 EDTEPZMEpizyme reports Phase 1 tazemetostat results, expands trial plans
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September 25, 2015
18:49 EDTEXELExelixis up 16% after Phase 3 trial of cabozantinib met primary endpoint
In after-hours trading, shares are up 16% to $6.86.
18:16 EDTEXELExelixis says Phase 3 trial of cabozantinib met primary endpoint
Exelixis announced positive results from METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with renal cell carcinoma who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis disclosed that the trial met its primary endpoint, demonstrating a statistically significant increase in progression-free survival for patients in the cabozantinib arm. Principal investigator Toni K. Choueiri, M.D. will present detailed data from the late-breaking METEOR abstract on Saturday, September 26, during the Presidential Session I at the European Cancer Congress 2015, which is being held September 25-29 in Vienna. The METEOR data and an accompanying editorial were also published today in The New England Journal of Medicine.
16:17 EDTVRTXOn The Fly: Top stock stories for Friday
Stocks opened with sharp gains the day after Fed Chair Janet Yellen gave some clarity to the market by suggesting the Fed will most likely raise interest rates by the end of the year. During afternoon trading, the news flow slowed and the volume lightened on the buy side, leaving the sellers with the upper hand. The Nasdaq was the first index to move into negative territory, led by broad weakness in biotech stocks, while the Dow was helped to stay in the green by a big post-earnings move higher in Nike (NKE). The averages limped into the close, leaving the market with an interesting set-up to begin next week. Outside of stock news, it was certainly a headline packed day, as Speaker of the House John Boehner announced that he will resign at the end of October, Chinese President Xi Jinping continued his U.S. visit and Pope Francis addressed the United Nations while spending a second day in New York City. ECONOMIC EVENTS: In the U.S., the third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... Federal Reserve Chair Janet Yellen said during a speech at UMass Amherst last night that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago. Of note, the Fed chair paused multiple times toward the end of her speech and received medical attention afterward, but returned to her regular schedule later in the evening, with the bank explaining that Yellen was dehydrated after a long day but was otherwise fine. COMPANY NEWS: Nike jumped $10.23, or 8.9%, to $125.02 after Thursday night's report of better than expected earnings and futures orders prompted numerous price target hikes at Street research firms. Additionally, Sterne Agee upgraded Nike to Buy from Neutral, saying it thinks the company is benefiting from its "global grass roots engagement with its customers," which enables it to meet its customers' needs and determine to what extent it can raise prices. The firm, which thinks that the company is continuing to gain share, has a $150 price target on the athletic gear giant... Biotech stocks, which were already having a bad week, ended the week on a down note, as the iShares NASDAQ Biotechnology Index (IBB) fell 4.9%, giving it a weekly decline of about 13%. Among the biggest large-cap losers in the space were Vertex (VRTX), which fell 7%, Regeneron (REGN), which dropped 6% and Celgene (CELG), which slid 4.8%. MAJOR MOVERS: Among the notable gainers was Jabil Circuit (JBL), which advanced $2.38, or 12.2%, to $21.88 after it reported higher than expected earnings and gave guidance for its November quarter that was significantly above expectations. Also higher was Cirrus Logic (CRUS), which gained $3.90, or 14.4%, to $31.03 after tear downs of Apple's (AAPL) iPhone 6S and 6S Plus led analysts to conclude that the chipmaker appears poised to obtain more revenue from the new devices than from the previous generation of the market-leading smartphone. Among the noteworthy losers was Finish Line (FINL), which fell $4.86, or 19.6%, to $19.91 after reporting second quarter revenue that missed expectations and saying it expects adjusted earnings this fiscal year to increase in a low single to mid single digits percentage from last year. Also lower following its earnings report was smartphone and software maker BlackBerry (BBRY), which slid 7.68% to $6.49 after the company posted a second quarter loss that was steeper than analysts expected. BlackBerry also confirmed press reports that it plans to launch a new phone that uses Google's (GOOG) Android operating system instead of its own proprietary BB10 OS. Shares of Aratana Therapeutics (PETX), which dropped $6.81, or 38.97%, to $10.68 after the company said that, based on "mixed clinical and scientific results," it does not believe that canine lymphoma products AT-004 and AT-005 in their current, first-generation forms will capture the desired lymphoma market opportunity. INDEXES: The Dow rose 113.35, or 0.7%, to 16,314.67, the Nasdaq fell 47.98, or 1.01%, to 4,686.50, and the S&P 500 added/slipped 0.90, or 0.05%, to 1,931.34.
12:47 EDTEXELExelixis management to meet with William Blair
Meetings to be held in Europe on September 29-30 hosted by William Blair.
07:42 EDTEXELExelixis: CHMP adopts positive opinion for cobimetinib, vemurafenib combination
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07:22 EDTEXELEuropean Society for Medical Oncology to hold a conference
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07:18 EDTVRTXVertex receives CHMP positive opinions for Orkambi, Kalydeco in EU
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