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March 12, 2014
07:10 EDTNLNKNewLink Genetics weakness creates buying opportunity, says Cantor
Cantor reports that NewLink's stock has been pressured since the announcement of the continuation of the IMPRESS trial of its pancreatic cancer drug to the next review point. The firm expected this to occur but notes that the timing of the continuation has raised concerns about survival rates and the possibility that the control arm is performing better than expected. Cantor thinks it's too early to be concerned about these issues, and raised its price target on the shares to $34 from $30 while keeping a Buy rating on the stock.
News For NLNK From The Last 14 Days
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October 1, 2015
07:23 EDTNLNKNewLink Genetics awarded $18M contract option from BARDA
NewLink Genetics Corporation (NLNK) announced today that the Biomedical Advanced Research and Development Authority, or BARDA, of the United States Department of Health and Human Services, or HHS, has exercised an $18M option on NewLink Genetics' existing contract to support the scale-up of the manufacturing process relating to its investigational rVSV-ZEBOV GP vaccine candidate. BARDA made an initial $30M contract award to NewLink in late 2014 and is now providing additional funding to continue development of the Ebola vaccine candidate. Merck (MRK) has the license for research, development, manufacturing and commercialization of the rVSV-ZEBOV GP vaccine.
07:23 EDTNLNKNewLink Genetics awarded $18M contract option from BARDA
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September 29, 2015
08:39 EDTNLNKOracle Health Sciences adds 93 biopharma customers
Oracle (ORCL) Health Sciences announced that 93 emerging biopharma organizations worldwide have become new customers in the past year, adopting Oracle Health Sciences solutions to succeed in this rapidly evolving market and deliver drugs to patients faster. Organizations, including Accera and NewLink (NLNK), selected Oracle Health Sciences solutions to manage their end-to-end clinical trial processes, boost clinical development productivity, facilitate compliance, and build scalable, affordable platforms for growth.
September 28, 2015
16:19 EDTNLNKOn 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.
September 27, 2015
17:02 EDTNLNKNewLink Genetics reports early Phase 1a data on GDC-0919
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15:55 EDTNLNKNewLink Genetics presents early Phase 1b data on indoximod
NewLink Genetics presented early-stage clinical data from a Phase 1b study of indoximod, its wholly owned indoleamine 2,3 dioxygenase pathway inhibitor, in combination with ipilimumab for the treatment of patients with unresectable stage 3 or 4 melanoma. The data reported are from a safety study of nine patients to determine the safety of indoximod and to establish the dose for a Phase 2 study in combination with ipilimumab. "Combination therapy with indoximod and ipilimumab showed encouraging clinical activity in some patients," said the company. Of the seven patients evaluable for a response, one patient had a complete response and one patient had a partial response by RECIST criteria. Five patients in the study had progressive disease, and two patients are still awaiting follow up. The combination was well-tolerated and did not demonstrate any regimen-limiting immune-based toxicities, abnormalities in liver function tests or other toxicities that have been reported with this class of drugs. The Phase 2 study, currently enrolling 38 patients, will utilize a revised study design with standard of care immune checkpoint inhibition -- consisting of four cycles of concomitant ipilimumab, repeat cycles of nivolumab or repeat cycles of pembrolizumab -- being given in combination with indoximod. The Phase 2 dose for indoximod has been established at 1,200mg twice daily.

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