FDA Nod For AGN, ZYME Strikes A Deal With Janssen Biotech, TCON Abuzz

(RTTNews) - Today's Daily Dose brings you news about expanded FDA approval for Allergan's schizophrenia drug; post-hoc analysis of Lilly's EMPA-REG OUTCOME trial; Court ruling against MediWound; extension of FDA's decision deadline by 3 months on Theratechnologies' biologics license application, TRACON's phase I data and Zymeworks' deal with Janssen Biotech.

Read on...

Allergan plc's (AGN) supplemental New Drug Application for Vraylar for the maintenance treatment of adults with schizophrenia has been approved by the FDA.

Vraylar, an oral, once daily atypical antipsychotic was approved by the FDA in September 2015 for the treatment of schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder.

Without maintenance treatment, 60-70% of schizophrenia patients relapse within one year. The goal of clinicians is to minimize relapses, and the approval of VRAYLAR for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options, noted Dr. Herbert Meltzer, Professor of Psychiatry and Behavioral Sciences at Northwestern Feinberg School of Medicine.

In the first nine months of this year, Vraylar generated net revenue of $200.1 million.

AGN closed Monday's trading at $174.41, up 1.28%.

Eli Lilly & Co.'s (LLY) diabetes drug Jardiance significantly reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease, reveals a post-hoc analysis of the landmark EMPA-REG OUTCOME trial.

According to the analysis, Jardiance reduced the risk of cardiovascular death by 43 percent; death from any cause was reduced by 38 percent and hospitalization for heart failure was reduced by 44 percent.

Jardiance was approved by the FDA in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and in December 2016 to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Jardiance generated revenue of $304.3 million in the first nine months of 2017 for Lilly compared to $125.8 million in the year-ago period.

LLY closed Monday's trading at $82.86, down 0.52%.

MediWound Ltd. (MDWD) has been ordered by Tel Aviv District Court to purchase shares of three shareholders of PolyHeal Ltd. for approximately $1.5 million.

The ruling is related to a 2010 agreement, which MediWound entered into with Teva Pharmaceutical Industries Ltd. (TEVA) and PolyHeal to collaborate in the development, manufacturing and commercialization of PolyHeal's wound product.

MediWound might consider an appeal of the ruling.

MDWD closed Monday's trading at $4.30, down 6.01%.

OncoSec Medical Inc. (ONCS) has entered into a Warrant Exercise Agreement with certain holders of outstanding warrants to purchase up to an aggregate of 5.51 million shares of the Company's common stock for $1.69 each.

All of the warrants were exercised on Monday, and the Company received gross proceeds of approximately $9.3 million.

ONCS closed Monday's trading at $2.35, up 3.98%.

The FDA decision on Theratechnologies Inc.'s (TH.TO) Biologics License Application for Ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 has been extended by 3 months to April 3, 2018.

In June of this year, Ibalizumab was given priority review with a target action date of January 3, 2018.

With Theratechnologies' partner, TaiMed Biologics Inc., submitting additional documentation related to the manufacturing section of the BLA for Ibalizumab as recently as October 25, 2017, the FDA has pushed back the review date by 3 months in order to facilitate a full review of the submission.

If approved, Ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing, according to the Company.

TH.TO closed Monday's trading at C$7.33, down 2.27%.

Shares of TRACON Pharmaceuticals Inc. (TCON) were up more than 17% in after-hours trading on Monday, on news that positive results from a Phase 1 clinical trial of TRC102 and approved chemotherapy drug Fludara in patients with advanced hematologic malignancies were published in the journal Oncotarget.

The phase 1 trial enrolled a total of 20 patients, of whom 10 had chronic lymphocytic leukemia, 3 had follicular lymphoma, 3 had diffuse large B cell lymphoma, 2 had plasma cell myeloma, 1 had mantle cell lymphoma and 1 had anaplastic large cell lymphoma.

The combination of TRC102 and Fludara produced an overall response rate of 24%, with no dose limiting toxicity, noted the Company.

TCON closed Monday's trading at $2.80, unchanged from the previous day's close. In after-hours, the stock was up 17.86% to $3.30.

Shares of Zymeworks Inc. (ZYME) rose nearly 25% on Monday, following a licensing agreement with Johnson & Johnson's (JNJ) subsidiary Janssen Biotech Inc. to develop and commercialize six next generation bispecific antibody therapeutics.

Zymeworks stands to get an upfront payment of $50 million and up to $282 million in development and up to $1.12 billion in commercial milestone payments and tiered royalties on potential sales.

Janssen also has the option to develop two additional bispecific programs under the agreement subject to a future option payment.

ZYME closed Monday's trading at $8.57, up 24.75%.