Wed, Apr. 15, 4:11 PM
- The FDA has assigned a PDUFA goal date of November 30 for the completion of its review of the New Drug Application (NDA) for Repros Therapeutics' (NASDAQ:RPRX) enclomiphene citrate (formerly Androxal) for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. The review will include an advisory committee meeting.
- Previously: Repros up 21% premarket on Androxal NDA filing (April 2)
Thu, Apr. 2, 9:13 AM
Thu, Apr. 2, 8:20 AM
- Thinly-traded micro cap Repros Therapeutics (NASDAQ:RPRX) is up 21% premarket on average volume in response to its announcement after the close yesterday that the FDA accepted its New Drug Application (NDA) for Androxal (enclomiphene citrate) for review.
- Previously: FDA accepts Repros' NDA for enclomiphene citrate (April 1)
Wed, Apr. 1, 4:11 PM
- The FDA accepts for review the New Drug Application (NDA) for Repros Therapeutics' (NASDAQ:RPRX) Androxal (enclomiphene citrate) for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Androxal is designed to treat the underlying cause of secondary hypogonadism, insufficient stimulation of the testes by the pituitary gland.
Mon, Mar. 16, 9:22 AM
Wed, Mar. 4, 8:23 AM
- Based on the findings of an independent advisory panel, the FDA issues a formal announcement that restricts testosterone drug makers from promoting their products for age-related low testosterone, an ever-increasing target of prescriptions. The number of men being prescribed testosterone jumped over 75% between 2009 and 2013.
- The agency asks (not really a request) manufacturers to change their labeling to clarify that their products are only approved for men with specific medical conditions and that taking the drugs could increase their risk of heart attacks and strokes.
- The agency also requests that manufacturers of approved products, including skin patches, solutions, intramuscular injections and topical gels, conduct studies to determine if their treatments increase cardiovascular risk.
- Last year, the FDA mandated that testosterone product makers update their labeling to include a warning about the risk of blood clots.
- Related tickers: (NYSE:ABBV) (NASDAQ:ENDP) (NYSE:LLY) (NASDAQ:ATRS) (NASDAQ:RPRX) (NASDAQ:LPCN) (NYSE:TEVA) (NASDAQ:AUXL)
Mon, Feb. 2, 9:43 AM
- Repros Therapeutics (RPRX +2.4%) submits its New Drug Application (NDA) to the FDA for Androxal (single isomer of clomiphene citrate) for the treatment of secondary hypogonadism in overweight men who want to restore normal testicular function.
- A PDUFA date will be identified after the agency formally accepts the application.
- Previously: Repros moving forward with Androxal NDA (Dec. 29, 2014)
Dec. 30, 2014, 8:58 AM
- Repros Therapeutics (NASDAQ:RPRX) is up 6% premarket on light volume. After yesterday's close, the company announced the initiation of two Proellex clinical trials and progress on its Androxal NDA.
- Previously: Repros initiates trials assessing Proellex in uterine fibroids (Dec. 29)
- Previously: Repros moving forward with Androxal NDA (Dec. 29)
Dec. 29, 2014, 5:03 PM
- Repros Therapeutics (NASDAQ:RPRX) commences two Phase 2b studies evaluating the safety and efficacy of Proellex for the treatment of women with uterine fibroids that experience heavy vaginal bleeding due to the fibroids. The two trials have the same efficacy endpoint but use different routes of administration, oral and vaginal.
- The studies are powered to achieve their efficacy endpoints with only 15 subjects per treatment arm.
- After the patients have experienced menses following the first course of treatment, the company plans to request a Type C (pre-NDA) meeting with the FDA. It hopes to accomplish the meeting by late 2015.
Dec. 29, 2014, 4:40 PM
- Repros Therapeutics (NASDAQ:RPRX) submits a complete response to the FDA's guidance concerning the documentation for its New Drug Application (NDA) for Androxal (clomiphene citrate). The company believes that all questions have been addressed and expects its contract research organization (CRO) to file the NDA in Q1.
- The company has engaged a European regulatory consultant to assist with converting the Androxal NDA to a suitable Marketing Authorization Application (MAA) for clearance in Europe. It expects to file the MAA by Q1 2016.
- Previously: Repros jumps after FDA meeting on Androxal NDA (Nov. 7)
- Previously: Repros gets roughed up after FDA downgrades meeting (Oct. 17)
Dec. 29, 2014, 9:26 AM
- The U.S. District Court for the Southern District of Texas rules that Repros Therapeutics (NASDAQ:RPRX) is the rightful owner of two Androxal (clomiphene citrate) patents, No. 7,759,360 and No. 7,737,185.
- New York-based urologist Dr. Harry Fisch claimed that he was co-inventor. Judge Vanessa Gilmore disagreed, referring to his claims of co-inventorship "strained to the point of absurdity."
- The court grants both of the company's motions for summary judgement and denies Dr. Fisch's motion for same.
Dec. 26, 2014, 10:50 AM
- The judge presiding over Dr. Harry Fisch's patent suit against Repros (NASDAQ:RPRX) has granted a summary judgment in Repros' favor, thereby ending the dispute.
- Fisch, an NYC urologist, had accused Repros CEO Joe Podolski of stealing the idea behind its Androxal testosterone drug during a face-to-face meeting.
Nov. 10, 2014, 9:11 AM
Nov. 7, 2014, 12:52 PM
Nov. 7, 2014, 10:20 AM
- Nano cap Repros Therapeutics (RPRX +39.2%) is up in early trading on above average volume in response to the company's report on its meeting with the FDA regarding its planned NDA submission for Androxal (isomer of clomiphene citrate).
- The agency did identify any additional clinical trials that would needed for the NDA filing, but did state that additional safety studies would be required in the future (post approval - Phase 4). The company believes it has the information and data it needs for the filing and does not expect to meet with the FDA again prior to making the submission.
- Today's up move provides a respite for longs. Shares have been in a down trend for over a year since the high of $29.79 in late September 2013. Prices bottomed at $5.92 on October 21 after investors sold heavily in response the the FDA downgrading the meeting to Type C guidance.
- Previously: Repros gets roughed up after FDA downgrades meeting
Nov. 7, 2014, 9:14 AM
- Gainers: MITK +29%. RMTI +27%. RPRX +24%. SHLD +22%. CNET +15%. NETE +11%. PGNX +10%. ZNGA +9%. APT +9%. KING +9%. KING +9%. KGC +8%. TKMR +7%. AGIO +7%. BEBE +5%.
- Losers: SLXP -35%. MDRX -20%. CTIC -19%. ICPT -19%. UBNT -17%. ANF -13%. ANET -11%. ORBC -10%. AVNR -7%. FSLR -7%. PLNR -6%. NDLS -6%. RIG -5%. DVA -5%. NADL -5%.
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