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June 23, 2014
ROTH Healthcare Corporate Access Day to be held in London, England on June 23-24.
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May 29, 2015
10:01 EDTPRTAOn The Fly: Analyst Initiation Summary
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05:48 EDTPRTAProthena initiated with a Buy at UBS
Target $58.
May 27, 2015
09:15 EDTLGNDLigand management to meet with Craig Hallum
Meeting to be held in Kansas City on May 28 hosted by Craig Hallum.
07:07 EDTGALEGalena announces publication of two abstracts at ASCO
Galena Biopharma announced two abstract publications at the American Society of Clinical Oncology, or ASCO, 2015 Annual Meeting. "The two abstracts published by ASCO provide meaningful advancements for both of our cancer immunotherapy programs, NeuVax and GALE-301," said Mark Schwartz, Ph.D., president and CEO. "The use of Leica's Bond Oracle HER2 IHC system ensures we have enrolled the specified HER2 1+/2+ patients for our Phase 3 NeuVax™ PRESENT trial and moves us further down the path of providing targeted, personalized medicine for these women. Meanwhile, the published preliminary data from our GALE-301 program is quite promising as it shows significant reduction of recurrences with our vaccine. We expect to present more mature data at a scientific conference this Fall, and we are currently evaluating the next steps to potentially advance GALE-301 into a randomized late-stage trial to prevent recurrence in ovarian and endometrial cancers."
May 26, 2015
09:23 EDTIPCIOn The Fly: Pre-market Movers
UP AFTER EARNINGS: AutoZone (AZO), up marginally after reporting third quarter results. ALSO HIGHER: Geeknet (GKNT), up 119.7% after being acquired by Hot Topic for $17.50 per share... IntelliPharmaCeutics (IPCI), up 16.8% after being granted fast track designation for Rexista Oxycodone by FDA... McDermott (MDR), up 9.2% after favorable mention in Barron's and after being awarded a project for 12 jackets offshore Saudi Arabia... Time Warner Cable (TWC), up 5.2% following announcement of merger with Charter (CHTR)... Charter is up fractionally. DOWN AFTER EARNINGS: Sky-mobi (MOBI), down 7.9%. ALSO LOWER: Etsy (ETSY), down 5.7% following a Wall Street Journal report that (AMZN) is targeting Etsy with an artisan goods marketplace... First Solar (FSLR), down 4.1% after being downgraded to Underperform from Sector Perform at RBC Capital... AstraZeneca (AZN), down 1.9% after Amgen (AMGN) ends participation in co-development and commercialization of brodalumab... Amgen is down 1.5%.
08:06 EDTIPCIIntellipharmaceutics granted fast track designation for Rexista Oxycodone by FDA
Intellipharmaceutics International announced that the FDA has reviewed the Company's request for Fast Track designation for its abuse deterrent Rexista Oxycodone XR extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System and has concluded that it meets the criteria for Fast Track designation. Rexista Oxycodone XR is intended for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
07:55 EDTPTCTPTC Therapeutics should be owned after recent weakness, says Oppenheimer
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05:15 EDTIPCIIntellipharmaceutics agrees to acquire operating property in Toronto for C$4.7M
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May 21, 2015
18:49 EDTPTCTOn The Fly: After Hours Movers
UP AFTER EARNINGS: Hewlett-Packard (HPQ), up 1%. ALSO HIGHER: Autobytel (ABTL), up 14.1% after acquiring Dealix Corporation and Autotegrity from CDK Global (CDK) for $25M and raising fiscal 2015 guidance... StemCells (STEM), up 2.5% after being initiated with a Buy at Cantor... PTC Therapeutics (PTCT), up 2.3% after a Benefit Assessment by Germany's Federal Joint Committee indicated that Translarna provided a benefit for ambulatory patients... CBOE Holdings (CBOE), up 1.6% after raising share repurchase authorization by $100M... Cypress Semiconductor (CY), up 1.2% after being initiated with a Buy at Mizuho. DOWN AFTER EARNINGS: Aeropostale (ARO), down 18.5%... Brocade (BRCD), down 2.1%... Marvell Technology (MRVL), down 2.9% after reporting quarterly results and departure of CFO. ALSO LOWER: Otonomy (OTIC), down 17.7% following report of Phase 2b topline data for OTO-104... Viggle (VGGL), down 18.8% after filing to sell common stock... CEL-SCI (CVM),down 2.7% after announcing a proposed offering of common stock and warrants.
16:06 EDTPTCTPTC says assessment showed Translarna provided benefit for ambulatory patients
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11:47 EDTIPCIIntellipharmaceutics path for Rexista significantly shorter, says Brean Capital
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08:14 EDTIPCIIntellipharmaceutics intends to accelerate Rexista Oxycodone XR program
Intellipharmaceutics announced that the FDA provided the company with notification regarding its Investigational New Drug Application, or IND, submission for Rexista Oxycodone XR extended release tablets. The notification from the FDA stated that the Company will not be required to conduct Phase III studies if bioequivalence to Oxycontin is demonstrated. The company had earlier announced, on March 30, that it had submitted an IND to the FDA for Rexista Oxycodone XR in anticipation of the commencement of Phase III clinical trials. At the same time the Company had also announced that topline data results of three definitive Phase I pharmacokinetic clinical trials all met the bioequivalence criteria when compared to the existing branded drug Oxycontin. The company believes, in light of these prior results, that it will not be required to conduct Phase III studies, although no assurance to that effect can be given. The company believes the FDA notification is significant as it provides a basis for an accelerated development plan for its Rexista Oxycodone XR product candidate, without the need for more costly and time-consuming Phase III studies. The company intends to file a New Drug Application, or NDA, for Rexista Oxycodone XR extended release tablets with the FDA within the next 6 to 12 months, although no assurance to this effect can be given. Further, there can be no assurance that the FDA will ultimately approve the NDA for sale of Rexista Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.
May 18, 2015
07:22 EDTPRTAUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 18 at 8 am; not all company presentations may be webcasted. Webcast Link
07:05 EDTBLRXBioLineRx reports Q1 EPS (1c), one estimate (6c)
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