Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

Regulatory milestones

AB Science S.A. (Euronext:AB) fell €2.95 (21%) to €11.36 on Friday after EMA's CHMP recommended against approval of Masiviera masitinib for first-line treatment of non-resectable locally advanced or metastatic pancreatic cancer in combination with gemcitabine.

According to CHMP, masitinib was not effective in the overall group of pancreatic cancer patients. The committee also was concerned about masitinib's toxicity and with impurities and the quality of potential commercial batches of the compound.

AB Science, which plans to appeal, was down €3.98 (26%) on the week.

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) was down $0.56 to $21.01 last week after FDA issued a complete response letter for an sNDA seeking to expand the label of anemia drug Feraheme ferumoxytol to include all adults with iron deficiency anemia who have failed or could not tolerate oral iron treatment. Feraheme is approved to treat iron deficiency anemia in adults with chronic kidney disease (CKD).

According to AMAG, FDA said the company "has not provided sufficient information" for Feraheme for the broader indication. AMAG said FDA suggested the company "generate additional clinical trial data" and said it hopes to start another trial this year (see "Analyst Picks," A20).

Amarin Corp. plc (NASDAQ:AMRN) fell $0.54 (24%) to $1.73 on Tuesday after FDA's Division of Metabolism and Endocrinology Products said it "does not plan to re-instate" an SPA for the company's Phase

Read the full 2191 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury


Article Purchase

This article may not be distributed to non-subscribers