FDA Greenlights Bladder Cancer Drug, RPRX Up 30% After-hours, Mega Leap For MGNX

(RTTNews) - ImmunoGen Inc.'s (IMGN) phase I cohort evaluating Mirvetuximab soravtansine as single-agent therapy for platinum-resistant, folate receptor alpha-positive ovarian cancer has confirmed objective response rate of 44% and median progression-free survival of 6.7 months.

Based upon the findings in phase I cohort, the company is planning to meet with the FDA early in 3Q2016 and initiate phase III testing in 4Q2016.

IMGN closed Wednesday's trading at $5.50, down 0.54%. In after hours, the stock was up 2.73% to $5.65.

Shares of MacroGenics Inc. (MGNX) rose more than 16% on Wednesday after the company licensed its preclinical product candidate MGD015 to Janssen Biotech Inc.

MGD015 is designed to redirect T cells to eliminate cells which overexpress an undisclosed antigen in various hematological malignancies and solid tumors.

The IND-enabling activities as well as future clinical development of MGD015 will be taken care of by Janssen. MacroGenics will receive a $75 million upfront license fee and is also entitled to receive up to an additional $665 million in clinical, regulatory and commercialization milestone payments, if all goes well.

If commercialized, MacroGenics would be eligible to receive double-digit royalties on any global net sales and has the option to co-promote MGD015 with Janssen in the U.S.

MGNX closed Wednesday's trading at $21.06, up 16.74%.

Roche Group's (RHHBY.OB) cancer immunotherapy Atezolizumab, under brand name Tecentriq, has been granted accelerated approval by the FDA to treat the most common type of bladder cancer, called urothelial carcinoma. The approval comes nearly 4 months ahead of schedule.

Tecentriq is the first FDA-approved PD-L1 inhibitor to treat this type of cancer.

Urothelial carcinoma is the most common type of bladder cancer and occurs in the urinary tract system, involving the bladder and related organs. The National Cancer Institute estimates 76,960 new cases of bladder cancer and 16,390 deaths from the disease in 2016.

The drug is expected to be launched in the U.S. within one to two weeks, and is reportedly said to cost about $12,500 a month.

The company's VENTANA PD-L1 (SP142) Assay has also been approved by the FDA as a complementary diagnostic to provide PD-L1 status on patients who are considering treatment with Tecentriq. This test is the first to evaluate patient PD-L1 status using immune cell staining and scoring within the tumor microenvironment, providing clinicians with information that may guide immunotherapy decision, the company noted.

RHHBY.OB closed Wednesday's trading at $31.05, unchanged from the previous day's close.

Shares of Repros Therapeutics Inc. (RPRX) were up over 30% in extended trading on Wednesday, following positive results from a phase 2b study of oral Proellex in women with severe menstrual bleeding due to uterine fibroids.

Excessive menstrual bleeding is a key symptom of uterine fibroids.

According to the study results, 79% of Proellex-treated subjects became amenorrheic (cessation of menses) with no evidence of a dose effect.

After the first 18 week treatment period, the women were withdrawn from drug to allow for menses. The women in the study are currently being treated with the second course of treatment for another 18 weeks. The results of the second course of treatment should be reported within the next 5 months, the company noted.

RPRX closed Wednesday's trading at $2.15, down 3.15%. In after hours, the stock was up over 30% to $2.80.

TRACON Pharmaceuticals (TCON) has initiated dosing in a phase 1b/2 clinical trial evaluating TRC105 in combination with approved drug Nexavar to treat patients with hepatocellular carcinoma.

The trial is designed to enroll about 39 patients at multiple centers in the United States and top-line data is anticipated in 2017.

TCON closed Wednesday's trading at $6.69, up 0.22%.

XBiotech Inc.'s (XBIT) Marketing Authorization Application for Xilonix in colorectal cancer is under accelerated review by the European Medicines Agency, with the results expected in the third quarter of this year.

Enrollment is on track for a separate pivotal Phase III trial of Xilonix in advanced colorectal cancer that is part of the FDA's Fast Track program, the company said.

XBIT closed Wednesday's trading 6.91% higher at $15.01.