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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.
News For ANAC;ARGS;DSCO;EGRX;GERN;INSY;MDCO;XLRN;SGMO;THLD From The Last 14 Days
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July 21, 2014
16:35 EDTARGSArgos Therapeutics presents results from trial of AGS-004
Argos Therapeutics announced that the company has presented data from its research involving AGS-004, the company's investigational fully personalized immunotherapy for HIV, at the International AIDS Society Towards a Cure Symposium that was held at the Victoria University City Convention Centre in Melbourne, Australia. Results were presented by Dr. Irina Tcherepanova, Argos' director of molecular biology, in a poster titled "Impact of RNA loaded Dendritic cell immunotherapy on HIV sequence Evolution in Chronic HIV Subjects Undergoing ATI," on Saturday, July 19, from 4:35 – 6:00 PM. Previously, Argos reported results of a Phase 2a clinical trial designed to assess the impact of AGS-004 during a 12-week ART analytical treatment interruption in chronic HIV-1-infected subjects. In this follow-up sub-study, results presented revealed how viral protein sequences evolve in response to AGS-004-induced immune pressure, and that viral load control was associated with low viral sequence divergence. "To our knowledge this is the first report associating HIV antigen sequence divergence in response to autologous therapeutic immunization with durability of VL control. These results further illustrate the potential for AGS-004 and we are looking forward to additional research milestones later this year," said Charles Nicolette, Argos' chief scientific officer and VP of research and development. This is the first analysis aimed at understanding the effects of AGS-004-induced immune pressure in HIV subjects on viral evolution and diversity. AGS-004 is being further evaluated in a double-blind placebo-controlled phase 2b clinical trial and the company plans to announce initial results from this trial in the coming months.
12:32 EDTANACAnacor price target raised to $35 from $29 at Wedbush
07:03 EDTANACAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacor’s drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacor’s contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
July 18, 2014
10:48 EDTINSYHigh option volume stocks
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July 10, 2014
14:28 EDTXLRNT. Rowe Price reports 10.4% passive stake in Acceleron
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July 9, 2014
09:05 EDTINSYInsys Therapeutics management to meet with Oppenheimer
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07:10 EDTTHLDThreshold Pharmaceuticals initiates dosing with TBorD in Phase 1/2 trial
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July 8, 2014
08:32 EDTANACAnacor announces FDA NDA approval for KERYDIN
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07:31 EDTXLRN, THLD, SGMO, MDCO, INSY, ANAC, GERN, EGRX, DSCO, ARGSPiper Jaffray to hold a symposium
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07:03 EDTINSYInsys Therapeutics completes human abuse study for Dronabinol Oral Solution
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07:03 EDTEGRXEagle Pharmaceuticals receives orphan drug designation for bendamustine HCl
Eagle Pharmaceuticals (EGRX) announced that the FDA has granted orphan drug designation to bendamustine hydrochloride, a ready-to-dilute concentrate solution for injection that will be administered by infusion over 10 minutes after dilution in 50mL of sodium chloride or a saline / dextrose mixture, for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin’s lymphoma. Pursuant to the orphan drug designation, Eagle is eligible to receive tax incentives and Prescription Drug User Fee Act fee savings, and believes it may receive seven years of marketing exclusivity. The currently marketed bendamustine HCI product, Treanda, which is manufactured by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries (TEVA), is a lyophilized powder requiring reconstitution and dilution in 500mL of saline or a sodium chloride / dextrose mixture before administration over 30 minutes for CLL and 60 minutes for NHL.
05:32 EDTTHLDThreshold Pharmaceuticals assumed with a Buy at Brean Capital
Target $15.

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