TGTX Poised For GENUINE Reaction, AMAG Ahead Of Schedule, Watch Out For AEZS

(RTTNews) - TG Therapeutics Inc. (TGTX) is all set to host a conference call on October 13, 2016 at 8:30am ET to provide an update on the ongoing phase III trial of TG-1101, dubbed GENUINE.

The GENUINE trial is evaluating TG-1101 in combination with *Imbruvica in previously treated Chronic Lymphocytic Leukemia patients with high-risk cytogenetic features. Imbruvica is an approved drug for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström's macroglobulinemia, and is co-marketed by Pharmacyclics and Janssen.

The trial, which is being conducted under a Special Protocol Assessment with the FDA, was initiated in January 2015, and is designed to enroll approximately 330 patients, with the first 200 patients evaluated for overall response rate, and all patients followed for progression-free.

TGTX closed Wednesday's trading at $8.25, down 7.20%. In after-hours, the stock fell 20% to $6.60.

AMAG Pharmaceuticals Inc.'s (AMAG) phase III label expansion trial of Feraheme for the treatment of iron deficiency anemia has surpassed approximately two-thirds of the total target enrollment of 2,000 patients. The company now expects the filing of supplemental new drug application to occur in mid-2017.

Feraheme was approved by the FDA in June 2009 as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

The company has been seeking to broaden the use of Feraheme beyond the current chronic kidney disease indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment or in whom oral iron was contraindicated.

The supplemental new drug application for Feraheme for broader IDA indication was turned down by the FDA in January 2014, with the company being asked to generate additional clinical trial data.

In other news, the company announced that the definitive pharmacokinetic study and the comparative pain study for the Makena subcutaneous auto-injector program (Makena SQ) have been initiated with the first patient dosed.

Makena injection was approved by the FDA in February 2011 to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

In the second quarter of 2016, Makena sales were up 23% to $78.4 million while Feraheme sales were up 18% to $24.3 million compared to the year-ago quarter.

AMAG closed Wednesday's trading at $23.19, down 0.43%.

Shares of Aeterna Zentaris Inc. (AEZS) (AEZ.TO) rose more than 9% on Wednesday, following an exclusive license agreement with Specialised Therapeutics Asia Pte Ltd. for its lead investigational anti-cancer compound, Zoptrex.

Under the agreement terms, Specialised Therapeutics Asia has been granted the right to commercialize Zoptrex in Australia and New Zealand.

A phase III trial of Zoptrex in endometrial cancer is underway, and is expected to be completed this year. If all goes well as planned, Aeterna expects to submit a new drug application for Zoptrex to the FDA in the first half of 2017.

AEZS closed Wednesday's trading at $3.80, up 9.51%.

Shares of ProMetic Life Sciences Inc. (PLI.TO) jumped over 10% on Wednesday, following encouraging early efficacy results from its ongoing phase II clinical trial of PBI-4050 in patients with Alström syndrome.

Alström syndrome is a rare disorder that can lead to serious or life-threatening medical problems involving the liver, kidneys, bladder, and lungs.

Based on the review of safety data, the Drug Safety Monitoring Board has recommended that patient enrolment should continue in the Alström syndrome phase II trial.

According to the initial results, the first five patients who completed 12 weeks of treatment with PBI-4050 had a significant reduction of liver fibrosis, as measured by transient elastography (FibroScan).

PLI.TO closed Wednesday's trading 10.45% higher at $3.17.