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July 8, 2014
07:31 EDTANAC, SGMO, XLRN, MDCO, INSY, GERN, EGRX, DSCO, ARGS, THLDPiper Jaffray to hold a symposium
Catalyst Symposium to be held in Boston on July 8.
Check below for free stories on ANAC;ARGS;DSCO;EGRX;GERN;INSY;MDCO;XLRN;SGMO;THLD the last two weeks.
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August 14, 2014
10:05 EDTXLRNOn The Fly: Analyst Initiation Summary
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05:36 EDTXLRNAcceleron initiated with an Outperform at FBR Capital
Target $47.
August 13, 2014
16:13 EDTARGSArgos Therapeutics reports Q2 EPS (61c), consensus (60c)
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August 12, 2014
10:49 EDTEGRXEagle Pharmaceuticals price target raised to $30 from $22 at Cantor
Cantor said Ryanodex, which Eagle Pharmaceuticals has priced significantly above the firm's initial expectations, is planned to launch at the end of this month and should help offset some of the losses associated with argatroban. The firm raised its price target on Eagle to $30 from $22 and reiterates its Buy rating on the shares.
09:21 EDTINSYOn The Fly: Pre-market Movers
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08:34 EDTGERNGeron says imetelstat remains on full clinical hold
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07:48 EDTINSYInsys Therapeutics submits NDA for new formula of Dronabinol Oral Solution
Insys Therapeutics announced it has submitted a New Drug Application to the FDA for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol, or THC. Upon completion of the Phase III trial: Insys' Dronabinol Oral Solution demonstrated bioequivalence by using 4.25 mg of oral solution versus 5 mg of Marinol, suggesting patients may achieve similar clinical benefits with a lower dose of THC. All patients who took the oral solution achieved detectable plasma levels at 15 minutes, while less than 25% of Marinol patients achieved detectable plasma levels over the same duration. It took four hours for all Marinol subjects to achieve detectable plasma levels. The dronabinol oral solution compared to the Marinol arm also showed less intra patient variability by over 60 percent when measuring total patient exposure to THC. Insys conducts cannabinoid research and production in the United States at its advanced pharmaceutical-grade manufacturing facility, which is approved by the DEA and inspected by the FDA. The company is expanding its production capabilities to include an additional facility to meet anticipated demand once the FDA approves its pipeline products.
07:01 EDTXLRNAcceleron reports Q2 EPS (52c), consensus (45c)
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06:56 EDTINSYInsys Therapeutics on track to submit NDA for Dronabinol Oral Solution during Q3
The company is also on track to submit at least four IND applications with the FDA in the second half of 2014. Michael L. Babich, president and CEO, stated, "We remain on track to submit the NDA for our proprietary Dronabinol Oral Solution, in Q3. Assuming FDA approval, we believe our formulation will provide cancer and AIDS patients with several advantages over the currently available gelatin capsules and a GMP alternative to medical marijuana. Currently, the market for generic Marinol is estimated at $150M and our product would be the only branded one competing in this market. With 70% of generic dronabinol prescriptions written by approximately 8,000 healthcare providers, and prescriptions growing organically at a rate of four percent annually, the approval of this novel formulation would create an opportunity to satisfy a growing unmet medical need. Once launched, we believe we have the potential to capture a significant share in a manner similar with what we've been able to achieve with Subsys."
06:53 EDTINSYInsys Therapeutics reports Q2 adjusted EPS 58c, consensus 30c
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August 11, 2014
18:29 EDTGERNOn The Fly: After Hours Movers
UP AFTER EARNINGS: DealerTrack (TRAK), up 11.3%... DTS Inc. (DSTI), up 12.8%... Globalstar (GSAT), up 1.6%... Halozyme Therapeutics (HALO), up 2.4%. ALSO HIGHER: Intercept Pharmaceuticals (ICPT), up 57.7% after announcing that 46% of OCA group met FLINT endpoint as well as reporting second quarter results... Cempra (CEMP), up 5.8% following Intercept Pharmaceuticals' FLINT announcement... Scotts Miracle-Gro (SMG), up 3.6% after board approves a $500M share repurchase authorization and announces a $2.00 per share special dividend. DOWN AFTER EARNINGS: Galena Biopharma (GALE), down 13.4%... Nuance Communications (NUAN), down 9.7%... Millennial Media (MM), down 7.1%... MasTec (MTZ), down 3.6%... Turtle Beach (HEAR), down 3.5%... magicJack (CALL), down 5.8%... Geron (GERN), down 2.4%. ALSO LOWER: Sprouts Farmers Market (SFM), down 3.7% after filing to sell 15M shares of common stock for holders.
16:31 EDTGERNGeron reports Q2 EPS (6c), consensus (6c)
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15:27 EDTANAC, SGMOWedbush to hold a conference
Life Sciences Management Conference to be held in New York on August 12-13.
07:33 EDTEGRXEagle Pharmaceuticals reports Q2 EPS (21c), consensus (37c)
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August 7, 2014
17:56 EDTMDCOThe Medicines Co. could have 25% upside, Barron's says
FDA approval of The Medicines Co. skin infection drug Orbactiv should give shares a boost and although the stock is not cheap, it is cheap enough to buy, Barron's argues in its Barron's Take column. The company's pipeline should bolster its earnings, the paper adds. Reference Link
16:13 EDTANACAnacor reports Q2 EPS (58c), consensus (63c)
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08:12 EDTMDCOThe Medicines Co. to host conference call
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05:11 EDTMDCOThe Medicines Co. Orbactiv approved by FDA
The Medicines Company announced that the FDA has approved Orbactiv for injection for the treatment of adults with acute bacterial skin and skin structure infections, or ABSSSI, caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus. Orbactiv is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration. Once fully infused over three hours, the Orbactiv treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.

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