Merrimack Stock Up On Fast Track Status For Seribantumab

Merrimack Pharmaceuticals, Inc.’s shares (NASDAQ:MACK) were up 4.4% after the company announced that the FDA has granted Fast Track designation to seribantumab (MM-121) for the treatment of heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC), in patients whose disease has progressed following immunotherapy.

We note that the FDA grants Fast Track status to facilitate the development and expedite the review process for candidates that are being developed for the treatment of serious conditions with an unmet medical need.

Seribantumab, a fully human monoclonal antibody that targets ErbB3, is currently in a phase II study (SHERLOC), which is evaluating the candidate in combination with docetaxel or Alimta, compared to docetaxel or Alimta alone, in patients with heregulin-positive, locally advanced or metastatic NSCLC. The study is designed to support a Biologics License Application (BLA) in the U.S.

The primary endpoint of the study is overall survival, while the secondary endpoints include progression free survival, objective response rate, safety, and quality of life measures. Results from the study are expected in 2018.

According to the American Cancer Society, approximately 224,000 new cases of lung cancer (comprising both small cell lung cancer and NSCLC) are estimated to be diagnosed in 2016. Out of this, NSCLC is anticipated to comprise 83%. Moreover, the company estimates that approximately 101,000 NSCLC patients will have heregulin-positive tumors.

Merrimack currently carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector include GW Pharmaceuticals plc (NASDAQ:GWPH) , Innoviva, Inc. (NASDAQ:INVA) and United Therapeutics Corp. (NASDAQ:UTHR) . Each of these stocks sports a Zacks Rank #1 (Strong Buy).

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