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4 Big Biotech Losers Heading Into The New Year

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4 Big Biotech Losers Heading Into The New Year

Here is a look at some of the largest declining biotech names during the final week of 2016.

Anthera

Anthera Pharmaceuticals Inc (NASDAQ: ANTH) focuses on the development of products to treat serious diseases associated with inflammation, including enzyme replacement therapies and autoimmune diseases.

Anthera's stock is down more than 60 percent for the week after the company announced results from a Phase 3 trial which evaluated its therapy called Sollpura for the treatment of patients suffering from exocrine pancreatic insufficiency due to cystic fibrosis.

The study narrowly missed the primary endpoint for change in the Coefficient of Fat Absorption (CFA) non-inferiority margin and demonstrated non-inferiority in the per protocol CFA analysis.

Anthera plans on initiating a new study to demonstrate efficacy of Sollpura by addressing the scientific findings from the study and anticipates to file a Biologics License Applications (BLA) from the U.S. Food and Drug Administration in the first quarter of 2018.

Seattle Genetics

Seattle Genetics, Inc. (NASDAQ: SGEN) focuses on developing therapies for the treatment of cancer.

The stock has lost nearly 15 percent this week after the company surprised investors with an announcement that it received a notice from the FDA that a clinical hold or partial clinical hold has been placed on the company's therapy called vadastuximab talirine (SGN-CD33A).

Vadastuximab talirine is currently undergoing several early stage trials and the hold is initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment.

The company said it's working with the FDA to identify appropriate protocol amendments (if needed) for patient safety and to enable continuation of the trials.

Cempra

Cempra Inc (NASDAQ: CEMP) focuses on developing differentiated antibiotics for the acute care and community settings to meet medical needs in the treatment of bacterial infectious diseases.

Shares lost more than 60 percent this week after the company said it has received a Complete Response Letter (CRL) from the FDA related to its new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

According to the letter, the FDA can't approve the company's drug application at this time and requires additional clinical safety information and the satisfactory resolution of manufacturing facility inspection deficiencies are required before the NDAs be approved.

Innocoll

Innocoll Holdings PLC (NASDAQ: INNL) is a biopharmaceutical and medical device company that manufacturers and sells collagen-based products.

Shares were trading lower by more than 60 percent Friday after the company confirmed it has received a Refusal to File letter from the FDA in relation to its therapy called XARACOLL.

XARACOLL is the company's product candidate for the treatment of postsurgical pain. The FDA said in its preliminary review that Innocoll's initial application for approval wasn't sufficiently complete for a substantive review.

The FDA said XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information. Accordingly, the company hopes to work with the FDA over the coming weeks to address the open issues and create a path forward for the successful re-filing of its application.

Posted-In: Biopharmaceutical Stocks biotechnology stocksBiotech News FDA Movers Trading Ideas General Best of Benzinga

 

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