Repros Therapeutics Inc. reported top-line results from two phase II studies on its lead pipeline candidate, Proellex, when delivered orally and vaginally for the treatment of uterine fibroids.
The company’s shares were up 3.87% on the news.
The studies enrolled women with confirmed fibroids by MRI at baseline, who were experiencing more than 80 mL of blood loss during menses. The primary endpoint of induction of amenorrhea was met as Proellex, when delivered by either route in doses of 6 or 12 mg, significantly reduced excessive menstrual bleeding – the key symptom of uterine fibroids.
Amenorrhea, cessation of menses, occurs when a sufficiently high plasma concentration of Proellex is achieved. Patients received 18 weeks of treatment, following which they were withdrawn from medication to allow for menses. The second 18-week course of treatment was started after menses occurred.
At the end of the second course of treatment, 92.9% of patients receiving Proellex orally achieved cessation of menses while only 50% of the vaginally treated subjects achieved the same.
As the drug was generally well tolerated, the company plans to initiate a meeting with the FDA to discuss phase III development of the oral dosage form by the end of this year.
Proellex is also being evaluated in phase II trials for the treatment of endometriosis. In September, the company reported positive data from the first course of treatment from the ongoing phase II study on Proellex (oral administration) for the treatment of premenopausal women with confirmed symptomatic endometriosis. Repros plans to have a discussion with the FDA for phase III studies on Proellex for the treatment of women struggling with painful menstruation.
Repros currently has a Zacks Rank #3 (Hold).
REPROS THERAPEU Price
Stocks to Consider
Some better-ranked stocks in the healthcare sector include Incyte Corporation (INCY - Free Report) , Anika Therapeutics (ANIK - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the three stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Incyte’s earnings estimates increased from 20 cents to 62 cents for 2016 and from $1.42 to $1.66 for 2017 over the last 60 days. The company has posted a positive average beat of 431.43% over the last four quarters.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company has posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 16.8% year to date.
Exelixis’ loss estimates narrowed from 71 cents to 51 cents for 2016 and from a loss of 16 cents to earnings of 4 cents for 2017 over the last 60 days. The company has posted a positive surprise thrice in the four trailing quarters with an average beat of 38.52%. Its share price has skyrocketed over 150% year to date.
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