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News Breaks
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.
News For ANAC;ARGS;DSCO;EGRX;GERN;INSY;MDCO;XLRN;SGMO;THLD From The Last 14 Days
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October 16, 2014
15:22 EDTGERNGeron volatility increases to 134
Geron overall option implied volatility of 134 is above its 26-week average of 106 according to Track Data, suggesting large price movement.
09:02 EDTINSYInsys Therapeutics weakness creates buying opportunity, says JMP Securities
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October 15, 2014
18:26 EDTINSYOn The Fly: After Hours Movers
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16:34 EDTINSYInsys Therapeutics receives DEA approval to produce pharmaceutical Cannabidiol
Insys Therapeutics announced that its FDA inspected and Drug Enforcement Agency approved facility in Round Rock, Texas, has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol. The company has also been granted a quota to produce 15kg of CBD in 2014 and expects a larger quota in 2015 for its continued clinical studies. Insys believes these quantities are sufficient to pursue its CBD development program as currently planned. Insys held a pre-IND meeting with the FDA in September 2014 regarding its development program for CBD in pediatric patients suffering from Dravet Syndrome and Lennox-Gastaut Syndrome, two rare forms of pediatric epilepsy. Insys projects to file an IND in December 2014 for these indications. Babich also noted that Insys has compared its pharmaceutical CBD, which is synthetically produced, with plant-derived CBD obtained from the National Institute on Drug Abuse (NIDA), and found both materials contain an identical chemical structure. "We are pleased that testing in our laboratories has confirmed our long-standing belief that our pharmaceutical CBD is the chemical structure of plant-derived CBD and we believe our purity levels will provide consistent material in the clinical programs," Babich concluded.
16:31 EDTINSYInsys Therapeutics provides update on Dronabinol Oral Solution NDA
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10:57 EDTXLRNAcceleron to host educational webcast
Educational webcast on Beta-thalassemia will be held on October 17 at 12:30 pm. Webcast Link
10:52 EDTXLRNAcceleron management to meet with FBR Capital
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07:36 EDTDSCODiscovery Labs to collaborate with Battelle For Aerosurf program
Discovery Laboratories has entered into a strategic collaboration with Battelle, an independent research and development organization with 35 years of specific expertise in aerosol science. The parties intend to further develop Discovery Labs' proprietary capillary aerosol generator - or CAG - for use in the planned Aerosurf phase 3 clinical program and, if approved, initial commercialization. The CAG is currently being used in neonatal intensive care units for the company's Aerosurf phase 2 clinical program for the treatment of respiratory distress syndrome in premature infants. Battelle and Discovery Labs generally will share equally in the agreed costs of the device development for the Aerosurf RDS program. In consideration for its investment and expertise, Battelle will receive warrants and future royalties on AEROSURF sales and license sales revenues.
October 14, 2014
07:33 EDTXLRNAcceleron initiates ACE-083 Phase 1 clinical trial
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October 13, 2014
07:25 EDTMDCOEuropean Association of Cardiothoracic Surgery to hold annual meeting
28th EACTS Annual Meeting is being held in Milan, Italy on October 11-15.
October 10, 2014
07:14 EDTMDCOThe Medicines Co's Q3 Angiomax estimate lowered at Credit Suisse
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October 9, 2014
19:02 EDTTHLDThreshold Pharmaceuticals licenses rights to development program for Hypoxin
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16:57 EDTMDCOThe Medicines Co. announces journal publication of SOLO II phase 3 trial
The Medicines Company announced the publication of the results from the SOLO II phase 3 clinical trial of ORBACTIV, or oritavancin, for injection in the journal Clinical Infectious Diseases. ORBACTIV, is the first and only single dose intravenous antibiotic approved by FDA for the treatment of adults with Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, caused or suspected to be caused by susceptible isolates of designated Gram-positive pathogens. The publication reported that a single, once only, 1200 mg intravenous dose of ORBACTIVTM was non-inferior to twice-daily intravenous dosing of vancomycin given for 7 to 10 days in patients with ABSSSI caused or suspected to be caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. A single 1200 mg IV dose of ORBACTIV results in efficacy in ABSSSIs that is comparable and statistically non-inferior to vancomycin administered intravenously for 7-10 days. ORBACTIV had a safety profile comparable to vancomycin when monitored for up to 60 days following a single dose, with similar intensity, onset and duration of AEs.
October 8, 2014
16:02 EDTANACAnacor files $70M of convertible senior notes due 2021
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October 7, 2014
07:24 EDTSGMOAlliance for Regenerative Medicine
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