Shares of Repros Therapeutics Inc (NASDAQ:RPRX) ended Friday session in red amid volatile trading. The shares closed down -0.12 points or -6.09% at $1.85 with 738,952.00 shares getting traded. Post opening the session at $1.95, the shares hit an intraday low of $1.84 and an intraday high of $1.99 and the price vacillated in this range throughout the day. The company has a market cap of $42.25 million and the numbers of outstanding shares have been calculated to be 24.32 million shares.
Repros Therapeutics Inc (RPRX) on May 18, 2016 reported that oral administration of Proellex® at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.
Normal blood loss in a menstrual cycle is approximately 35 mL. Woman experiencing blood loss of >80 mL are considered to suffer from menorrhagia or excessive menstrual bleeding. In this Phase 2b study, 12, 17 and 14 women with confirmed uterine fibroids were enrolled in the 6mg, 12mg and Placebo arms, respectively. One subject dosed at 6mg and one Placebo-treated subject were discontinued as they did not meet entry criteria, and thus were not eligible for efficacy analysis. At baseline, the mean amount of blood lost for one menstrual cycle was 177 mL, 251 mL and 260 mL for each arm, respectively. The blood loss ranged from a low of 82 mL to a high of 769 mL. Blood loss was determined by collecting all sanitary products used from an individual and then an alkaline hematin assay was performed to estimate the actual amount of blood collected in the pads.
When a sufficient concentration of Proellex® is achieved in circulation, amenorrhea (cessation of menses) is achieved. At the end of the first course of treatment (18 weeks LOCF), 79% of Proellex®-treated subjects became amenorrheic with no evidence of a dose effect. Two (17%) subjects treated with Placebo had amenorrhea at the end of course 1. The p-value for this comparison is 0.0004. Treatment effect was rapid with 78% of Proellex®-treated subjects became amenorrheic in the first 6 weeks of treatment. Bleeding diaries consistently report a statistically significant difference in the number of days of bleeding and bleeding intensity between those treated with Proellex® and Placebo.
Bleeding was also evaluated by PBAC (Pictorial Blood Assessment Chart). Subjects tallied sanitary product usage and stain size as guided by the chart. Proellex®-treated subjects reported a median 100% reduction (mean 95% reduction) in PBAC scores while Placebo-treated subjects reported a median 62% reduction, further supporting the treatment effect associated with bleeding (p=0.0001).
Shares of Sequenom, Inc. (NASDAQ:SQNM) ended Friday session in green amid volatile trading. The shares closed up +0.01 points or 0.98% at $1.03 with 734,321.00 shares getting traded. Post opening the session at $1.03, the shares hit an intraday low of $1.01 and an intraday high of $1.08 and the price vacillated in this range throughout the day. The company has a market cap of $124.00 million and the numbers of outstanding shares have been calculated to be 119.22 million shares.
Sequenom, Inc. (SQNM) on May 4, 2016 reported total revenues of $27.6 million, total accessioned units of 46,400, and a net loss of $13.4 million, or $0.11 per basic and diluted share, for the first quarter of 2016.
First Quarter 2016 Results
First quarter 2016 revenues of $27.6 million declined 27% from $37.8 million in the first quarter of 2015. Revenues and unit volumes in the first quarter of 2016 were lower than the first quarter of 2015, primarily reflecting the conversion of certain laboratory customers to licensee status under the Pooled Patents Agreement, and a smaller amount available to collect during the first quarter of 2016 for testing services performed in prior periods. This latter factor reflects the improvement in the timeliness of Sequenom Laboratories collections as a result of additional payor contracts. These changes resulted in approximately $10 million in net revenue reduction for the first quarter of 2016 compared to the first quarter of 2015.
Total patient samples accessioned decreased by 12% to 46,400 patient samples during the first quarter of 2016, compared to the prior year’s first quarter. Approximately 41,200 of those patient samples accessioned were for NIPT, including the MaterniT® 21 PLUS, VisibiliT™ and MaterniT® GENOME laboratory-developed tests, which is a 9% decrease in testing volume compared to the first quarter of 2015. The decrease in tests accessioned was driven by the conversions of laboratory customers to licensee status, as described above, partially offset by the increase in tests accessioned for patients in the average-risk pregnancy market.
The total volume of tests from Sequenom’s core business increased by 7% over the first quarter of 2015, largely as a result of Sequenom Laboratories’ entry into the average-risk pregnancy market. In this press release, “core business” refers to Sequenom’s revenue and unit volume excluding the effect of the conversion of certain laboratory customers to licensee status in 2015. Notably, the volume of NIPT tests in Sequenom’s core business, which includes average-risk pregnancies, increased by 14% for the first quarter of 2016 over the first quarter of 2015.
“During the quarter, we executed on a number of key initiatives designed to return Sequenom to sustainable growth, resulting in quarter over quarter growth in our unit volume,” said Dirk van den Boom, Ph.D., President and CEO of Sequenom. “Overall, we made meaningful progress toward achieving our goal of becoming financially self-sustaining while solidifying our position as a leader in reproductive health.”