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February 11, 2013
09:29 EDTRPRXRepros updates Adroxal study, requests end of Proellex Phase 2 study
Repros Therapeutics provided an update for both of its core clinical programs. As part of the FDA requirement for total number of subjects to be exposed for six months, the company is conducting a 500 subject open label study. To date, the company has enrolled 499 subjects and expects the study to be fully enrolled this week. The company has sent a "request for guidance" letter to the FDA. The key points were the identification of a single high enrolling site with a population whose baseline characteristics appear different from the other sites; the company has proposed enrolling an additional 40 subjects into each of the two pivotal studies to allow for subset analysis while retaining the power of the original protocols; the company proposed moving two sites from the enrolling study ZA-302 to the closed for enrollment study ZA-301. When the company receives guidance from FDA, it will update the financial community. The company has requested an end of Phase 2 meeting for its vaginal Proellex program for the treatment of uterine fibroids. The request was for a meeting before the end of April.
News For RPRX From The Last 14 Days
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September 26, 2014
16:56 EDTRPRXIntegrated Core Strategies reports 5.2% passive stake in Repros Therapeutics
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10:18 EDTRPRXOptions with decreasing implied volatility
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10:09 EDTRPRXHigh option volume stocks
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09:03 EDTRPRXOn The Fly: Pre-market Movers
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07:06 EDTRPRXRepros Therapeutics schedules Type B pre-NDA meeting with FDA
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06:45 EDTRPRXRepros Therapeutics granted Type B Pre-NDA meeting with FDA
Repros Therapeutics reported it has been granted a Type B Pre-NDA meeting with the FDA in the first half of November. In this meeting the company will seek guidance on its planned New Drug Application for Androxal for the treatment of secondary hypogonadism with preservation of testicular function. Repros believes that the NDA for AndroxalŽ will be filed around the end of 2014.
05:20 EDTRPRXRepros reports Androxal met primary efficacy endpoints
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September 25, 2014
10:33 EDTRPRXOptions with decreasing implied volatility
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September 24, 2014
11:04 EDTRPRXOptions with decreasing implied volatility
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September 22, 2014
13:57 EDTRPRXRepros Therapeutics volatility increases on wide price movement
Repros Therapeutics overall option implied volatility of 128 is above its 26-week average of 89 according to Track Data, suggesting large price movement.
09:18 EDTRPRXRepros Therapeutics provides update on Androxal
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September 18, 2014
13:38 EDTRPRXRepros needed unique Androxal label even before ADCOM panel, says Ladenburg
Ladenburg said that given the FDA advisory committee's 20 to 1 vote that it believes the FDA will likely revise testosterone replacement therapy labels to restrict their use in hypogonadal patients with clear etiology. However, Ladenburg added that Repros was always going to have to establish a unique label for Androxal and the firm believes that the company's ongoing and completed trials will provide sufficient data for filing and approval by the FDA in secondary hypogonadism. The firm maintains its Buy rating and $35 price target on Repros.
12:45 EDTRPRXOn The Fly: Midday Wrap
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11:15 EDTRPRXRepros sinks after panel backs tests for testosterone therapies
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10:52 EDTRPRXOptions with increasing implied volatility
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07:19 EDTRPRXRepros Therapeutics sell-off overdone, says Brean Capital
Brean Capital said the selling in Repros Therapeutics is overdone after an FDA panel voted overwhelmingly in support for a more restrictive label that limits the use of TRT drugs to only patients with classic hypogonadism. The firm feels since Androxal has not been targeting age-related hypogonadism it does not deserve to be negatively impacted by yesterday's ruling. Brean Capital maintains its Buy rating on Repros Therapeutics and $41 price target on the shares.
07:00 EDTRPRXRepros Therapeutics price target lowered to $13 from $24 at Piper Jaffray
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06:10 EDTRPRXFDA panel votes 20-1 to study changes to testosterone therapies
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