Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) announced that indoximod, its investigational drug candidate, was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of heregulin positive non-small cell lung cancer.
“This is an important regulatory step forward for the clinical development of MM-121 in non-small cell lung cancer and we are pleased to have access to additional support from the FDA in this indication,” said Sergio Santillana, M.D., MSc, Chief Medical Officer. “Merrimack is dedicated to designing and developing novel precision therapeutics that shape treatment strategies for patients, and our randomized Phase 2 clinical trial of MM-121 in heregulin positive non-small cell lung cancer is well underway. We look forward to expanding the development of MM-121 to a biomarker-selected population of breast cancer patients later this year.”
The FDA’s orphan drug designation is granted to drugs and biologics intended to treat rare diseases or conditions with a prevalence of fewer than 200,000 people in the U.S. This designation includes eligibility for a seven-year period of marketing exclusivity for MM-121 upon approval, as well as other development assistance and financial incentives.
MM-121 is currently being evaluated in the SHERLOC study, a global randomized Phase 2 study that will assess progression-free survival of MM-121 in combination with docetaxel versus docetaxel alone. The study is enrolling patients with heregulin positive non-small cell adenocarcinoma of the lung who have progressed after a platinum-containing regimen and may have received anti PD-1 or anti-PD-L1 therapy. Top-line data for the SHERLOC study are expected in the second half of 2018.
In addition, Merrimack will be evaluating MM-121 in the SHERBOC trial, a global randomized Phase 2, double-blind, placebo-controlled clinical study of MM-121 added to standard of care in patients with heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer. The first patient is expected to be dosed in the SHERBOC study by the end of 2017.
Shares of Merrimack are currently trading at $11.61, up $0.18 or 1.57%. MACK has a 1-year high of $67.90 and a 1-year low of $11.22. The stock’s 50-day moving average is $13.80 and its 200-day moving average is $5.21.
On the ratings front, Baird analyst Brian Skorney reiterated a Hold rating on MACK, with a price target of $15, in a report issued on October 13. The current price target represents a potential upside of 31% from where the stock is currently trading. According to TipRanks.com, Skorney has a yearly average return of 7.6%, a 56% success rate, and is ranked #629 out of 4701 analysts.
Merrimack engages in discovering, developing and preparing to commercialize innovative medicines consisting of novel therapeutics paired with diagnostics for the treatment of cancer. Its offers first commercial product, Onivyde, which is a novel encapsulation of the marketed chemotherapy drug irinotecan in liposomal formulation.