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News Breaks
March 12, 2014
07:02 EDTATRSAntares Pharma receives second milestone payment from LEO Pharma
Antares Pharma announced the receipt of a second milestone payment of $5M from LEO Pharma. The milestone payment was received in connection with the launch of OTREXUP and the achievement of a specific percentage of patient lives covered by managed care organizations. To date, Antares has received $10M in milestone payments from LEO Pharma. On November 14, 2013, the company announced an exclusive license and promotion agreement with LEO Pharma for detailing OTREXUP to dermatologists for symptomatic control of severe recalcitrant psoriasis in adults. Under the terms of the agreement, Antares may receive up to a total of $20M in milestone payments. LEO Pharma will be responsible for all promotion and marketing costs in dermatology. Antares Pharma will record all product revenue associated with future dermatology prescriptions and pay LEO Pharma a percentage of OTREXUP net sales generated in dermatology.
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January 26, 2015
07:02 EDTATRSAntares says FDA issues complete response letter for Sumatriptan Injection ANDA
Antares Pharma announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the Abbreviated New Drug Application for Sumatriptan Injection USP for the acute treatment of migraine. The complete response letter from the FDA provided revisions to labelling and cited minor deficiencies. If approved, Sumatriptan Injection USP would represent the Company’s first ANDA approval and second device approved from the VIBEX auto injector platform. As previously disclosed, Teva Pharmaceutical Industries, Ltd. would distribute the product and share the profits equally with Antares Pharma. Eamonn P. Hobbs, President and CEO, stated, “We are pleased with the feedback received from the FDA in the complete response letter. The FDA has outlined the steps necessary to support approval of the ANDA, and we plan to work closely with the Agency on a response.”
06:16 EDTATRSAntares Pharma announces complete response letter for Sumatriptan ANDA
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January 16, 2015
10:20 EDTATRSAntares Pharma management to meet with JMP Securities
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January 13, 2015
09:07 EDTATRSOn The Fly: Pre-market Movers
HIGHER: Apple (AAPL), up 1.4% after Credit Suisse upgraded Apple to Outperform and raised its iPhone volume estimates again... Best Buy (BBY), up 2.8% after being upgraded to Buy from Neutral at Goldman... SunPower (SPWR), up 2.6% after being upgraded to Outperform at Credit Suisse... Alcoa (AA), up 2% after Q4 results beat expectations. RISING AFTER GUIDANCE: Pharmacyclics (PCYC), up 17.5%... CTI BioPharma (CTIC), up 8.3%... Emulex (ELX), up 15.5%... ARIAD (ARIA), up 2.6%. LOWER: ChannelAdvisor (ECOM), down 42% following preliminary fourth quarter revenue guidance and after receiving multiple analyst downgrades... Antares Pharma (ATRS), down 7.7% after the FDA recommended that the company create a larger safety database for its clinical development program for QuickShot Testosterone.
07:08 EDTATRSAntares Pharma receives written recommendations from FDA on QuickShot
Antares Pharma announced that it has received written recommendations from the FDA related to its clinical development program for QuickShot Testosterone, or QS T. The recommendations received were in response to various clinical, Chemistry, Manufacturing and Controls and user study submissions made by the company through November 2014. The company believes that it has already factored many of the recommendations cited in the advice letter into the protocol of the ongoing phase 3 study and into the protocols for planned human use studies as a result of guidance provided by FDA at the May 2014 Type C meeting. Based on a single reported occurrence of hives in the company’s phase 2 study, which the FDA characterized as an apparent allergic reaction, as well as the known safety experience with other parenteral testosterone products, the FDA is recommending that the company create a larger safety database, including approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year. The company does not believe that the adverse event of hives reported in the phase 2 study was related to study drug. Based on the number of subjects in previous studies and in the current phase 3 study, the company anticipates that it may need approximately 70 additional subjects exposed to QS T for six months. The company is assessing the FDA’s comments in the advice letter and their impact on the timing of the filing of a New Drug Application for QS T with the FDA. The timing, cost and design of the study to obtain the additional 70 subjects and data required will be determined based on further discussion with the FDA. The company continues to expect to release top-line pharmacokinetic data from the current phase 3 study in the second quarter of 2015.

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