Shares of Repros Therapeutics Inc. (RPRX) spiked more than 38 percent just after the opening bell on Friday, after the company reported it held a “constructive” meeting with the FDA regarding a potential Androxal NDA filing.
Repros said that based on the data compiled to date, the FDA did not identify any additional clinical studies that would be required for filing the NDA. Although no specific request was made, the FDA stated that as a result of the recent Advisory Committee Meeting, cardiovascular risk is of particular interest and that additional safety studies could be required in the future.
RPRX shares recently gained $3.39 to $9.83 on a traded volume of 5.6 million shares, in comparison to 1.23 million shares of average trading volume. In the past 52 weeks, shares of The Woodlands, Texas-based firm have traded between a low of $5.92 and a high of $22.57. Shares are down 34.89% year-over-year, and 47% year-to-date.
Repros Therapeutics has a total market capitalization of $225 million.
Tekmira Pharmaceuticals (TKMR) surged more than 5% on Friday to $16.56 after it reported 3Q revenue that topped expectations. The biopharmaceuticals firm posted revenue of $4.4 million in the period, beating Wall Street estimates of $2.7 million.
In the past 52 weeks, shares of this experimental Ebola treatment developer have traded between a low of $7.17 and a high of $31.48. Tekmira shares are up 110% year-over-year, and 104% year-to-date.
Intercept Pharmaceuticals, Inc. (ICPT) shares are down 76 points, or 45%, to about $171 in mid-day trading Friday. The nosedive came after the company reported weaker-than-expected earnings and researchers said [via Bloomberg] that Intercept’s much-anticipated experimental liver drug obeticholic acid, or OCA, “raised bad cholesterol and caused itching in some patients, spurring the need for more safety studies.” Intercept Pharmaceuticals said it may need to consider a lower dose.
On valuation measures, Intercept Pharmaceuticals is currently valued at $3.60B and has a median Wall Street price target of $499.50 with a high target of $693. Approximately 2.74M shares have already changed hands, compared to the stock’s average daily volume of 494.75K. In the past 52 weeks, shares of the New York-based biopharmaceutical company have traded between a low of $46.81 and a high of $497.00 with the 50-day MA and 200-day MA located at $235.93 and $251.72 levels, respectively. Additionally, shares of ICPT trade at a P/E ratio of 4.61 and have a Relative Strength Index (RSI) and MACD indicator of 26.34 and -18.97, respectively.
ICPT currently prints a one year return of about 394.55%, and a year-to-date return of around 261.72%.
AAC Holdings, Inc. (AAC) is currently changing hands at $25.39, up close to 9 percent. Not seeing any news to account for the move.
During today’s trading session, AAC gapped open sharply higher and climbed for the majority of the morning, reaching a new 52-week high of $26.50. Over the last 12 months, the stock has been trading between $17.60 and $26.50.
AAC is currently valued at $538M. While the company’s long-term EPS growth forecast is more than 20 percent, at 617, the price-to-earnings ratio remains very high. AAC Holdings has a median Wall Street price target of $27.50 with a high target of $28.00.
The name currently prints a year-to-date return of around 37%.
Shares of Regulus Therapeutics Inc. (RGLS) shot up more than 8% in mid-day trading, nearing $21.40 a share after closing at $19.66. Not seeing any news or rumors to account for the move.
Regulus Therapeutics Inc., currently valued at $928.59M, has a median Wall Street price target of $23.00 with a high target of $34.00. Approximately 652K shares have already changed hands, compared to the stock’s average daily volume of 1.16M.
In the past 52 weeks, shares of San Diego, California-based biopharmaceutical company have traded between a low of $5.40 and a high of $21.70 with the 50-day MA and 200-day MA located at $10.60 and $7.94 levels, respectively. Additionally, shares of RGLS have a Relative Strength Index (RSI) and MACD indicator of 81.61 and +2.54, respectively.
RGLS currently prints a one year return of about 187.85%, and a year-to-date return of around 166.04%.