ARTICLE | Finance

Regulatory milestones

Highlights of weekly biotech stock moves

November 8, 2010 8:00 AM UTC

Adventrx Pharmaceuticals Inc. (NYSE-A:ANX) lost $0.03 to $2.07 last week after resubmitting an NDA to FDA for Exelbine vinorelbine injectable emulsion to treat non-small cell lung cancer (NSCLC). The company said the submission included 12 months of site-specific stability data for the anti-mitotic chemotherapeutic agent, which the company said fulfills a request from FDA (see B9).

Biodel Inc. (NASDAQ:BIOD) fell $1.50 (41%) to $2.13 on Monday after FDA issued a complete response letter and requested two new clinical trials for diabetes candidate Linjeta (formerly VIAject). The agency asked the company to conduct a new trial in each of Linjeta's proposed indications - Type I and II diabetes. Biodel was down $1.75 (48%) to $1.88 for the week (see B9)...