AZN's Falcon Hits Goal, FDA Approves MS Drug, CANF Awaits Data In June

(RTTNews) - ZINBRYTA, jointly developed by Biogen Inc. (BIIB) and AbbVie (ABBV), has been granted FDA approval for relapsing forms of multiple sclerosis.

According to Biogen, ZINBRYTA is the first once-monthly, self-administered treatment in multiple sclerosis, and it demonstrated superior efficacy over a widely used interferon. Clinical data showed that the drug significantly reduced relapses and brain lesions for up to three years compared to its own AVONEX intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring, added the company.

ZINBRYTA will sport a boxed warning for the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders.

BIIB closed Friday's trading at $282.79, up 0.28%.

Shares of Atossa Genetics Inc. (ATOS) rose more than 11% on Friday, following a $10 million stock purchase agreement with Aspire Capital Fund, LLC.

Under terms of the agreement, after the SEC declares the registration statement related to the transaction effective, Aspire has committed to purchase up to $10 million of Atossa's common stock over 30 months, based on prevailing market prices over a period preceding each sale.

ASPR closed Friday's trading at $0.31, up 11.55%.

AstraZeneca plc's (AZN) phase III trial of Fulvestrant for the treatment of locally-advanced or metastatic breast cancer, in postmenopausal women who have not had prior hormonal treatment for hormone receptor positive breast cancer met its primary endpoint of extended progression-free-survival.

The trial, dubbed FALCON, compared Fulvestrant 500mg to Anastrozole 1mg. Fulvestrant 500mg demonstrated superiority compared with Anastrozole 1mg.

Fulvestrant has been approved in the US since 2002 and in Europe since 2004 as a monotherapy for the treatment of postmenopausal women with hormone receptor-positive advanced or metastatic breast cancer (HR+ MBC) whose cancer has progressed following antioestrogen therapy.

In March of this year, the FDA expanded the use of Fulvestrant to include use in combination with Ibrance for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed following endocrine therapy.

AZN closed Friday's trading at $29.88, down 0.23%.

Can-Fite BioPharma Ltd. (CANF) expects to report data from a phase II trial of CF101, conducted by its subsidiary OphthaliX, in the treatment of glaucoma and related syndromes of ocular hypertension next month.

The company plans to file a phase III trial protocol for CF101 in the treatment of psoriasis with the EMA in the first half of 2016 and commence the study by the end of 2016.

A global phase II trial of CF102 in liver cancer in the U.S., Europe, and Israel is underway, and completion of enrollment with approximately 78 patients is expected in the second half of 2016.

The company is preparing to file its phase II protocol for CF102 in the treatment of non-alcoholic steatohepatitis (NASH), with institutional review boards (IRBs) in the second quarter of 2016.

CANF closed Friday's trading at $2.79, up 0.72%.

Intercept Pharmaceuticals Inc.'s (ICPT) Ocaliva was granted accelerated approval by the FDA on Friday for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis.

Ocaliva is indicated for use in combination with ursodeoxycholic (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

Ocaliva is expected to be available in the U.S. within 7-10 days and will be distributed through a specialty pharmacy network. The drug is expected to achieve blockbuster sales approaching $3 billion by 2020, according to reports.

ICPT closed Friday's trading at $141.77, up 2.93%.

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion on Merck's (MRK) investigational, once-daily, fixed-dose combination tablet ZEPATIER for the treatment of chronic hepatitis C virus in adult patients.

The CHMP positive opinion will be reviewed by the European Commission. Merck anticipates that the European Commission decision will be made in mid-2016.

If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization to ZEPATIER with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.

ZEPATIER received approval in the U.S. and Canada in January 2016.

MRK closed Friday's trading at $56.48, up 0.16%.