Merrimack (MACK) Onivyde Labeling Appears as Expected, Says Mizuho Securities

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Merrimack Pharmaceuticals (MACK) Weakness Creates Buying Opportunity, Mizuho Securities Says

October 23, 2015 6:51 AM EDT

Weakness in Merrimack Pharmaceuticals (NASDAQ: MACK) following FDA approval of ONIVYDE presents a buying opportunity, according to Eric Criscuolo of Mizuho Securities. The firm reiterated an Outperform rating and price target of $16.

Criscuolo commented, "We think the 13% decline following news of ONIVYDE approval... More

Merrimack Pharma (MACK) to Resume Trading at 1:40 PM EDT

October 22, 2015 1:32 PM EDT

Merrimack Pharma (NASDAQ: MACK) to Resume Trading at 1:40 PM EDT

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FDA Approves Merrimack Pharma's (MACK) ONIVYDE

October 22, 2015 11:32 AM EDT

(Updated - October 22, 2015 11:35 AM EDT)

The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

According to the National Cancer Institute, there will be 48,960 new cases of pancreatic cancer diagnosed in the U.S. in 2015, and nearly the same number of deaths caused by the disease (40,560). Pancreatic cancer can be difficult to diagnose early and treatment options are limited, especially when the disease has spread to other parts of the body (metastatic... More

Merrimack Pharma (MACK) Halted, News Pending

October 22, 2015 11:23 AM EDT

Merrimack Pharma (NASDAQ: MACK) Halted, News Pending

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PharmaEngine Announces Taiwan FDA Approval of ONIVYDE to Treat Metastatic Pancreatic Cancer (MACK)

October 22, 2015 9:08 AM EDT

PharmaEngine, Inc. (TWO: 4162) announced that the Taiwan Food and Drug Administration (TFDA) has approved ONIVYDETM (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. ONIVYDE is not indicated for use as a single agent. The TFDA is the first regulatory authority in the world granting the approval of ONIVYDE.

"We are very grateful that the TFDA granted the regulatory approval in such a rapid pace, especially the accelerated efforts made by the Center of Drug Evaluation (CDE) and the... More