Meanwhile, the FDA on Tuesday
issued an alert
, warning that
Byetta for type II diabetes may be linked with cases of acute pancreatitis.
The FDA said Amylin has agreed to include information about acute pancreatitis in the precautions section of the product label. The San Diego-based company has a collaboration agreement with
(LLY - Get Report)
(ALKS - Get Report)
to develop a sustained release version of Byetta for type II diabetes.
Amlyin shares fell $2.45, or 5.1%, to $45.41; Eli Lilly was down 79 cents, or 1.4%, to $57.15; and Alkermes fell 73 cents, or 4.2%, to $16.74.
On the clinical front,
said that it will refile for a clinical trial for secondary hypogonadism (testosterone deficiency) treatment Androxal as it has met with the FDA to determine study goals. Repros said it agreed that trial endpoints associated with male sexuality weren't appropriate. Shares rose $1.96, or 18.2%, to $12.69.
fell $1.18, or 9.9%, to $10.79, after reporting that a midstage study on proteinuria associated with diabetic kidney disease failed. The study missed its primary endpoint of decreasing proteinuria, the presence of excess protein in the urine, which is an indicator of renal disease. The company said it will provide an update on its plans once it's done analyzing the data.
, which develops technology to repair tissue cells, said it plans to raise about $13.5 million in a registered direct offering of 11.8 million units to a group of institutional investors. The price of the offering is $1.14 per unit -- each unit consists of one share of the company's common stock and a warrant to buy 0.5 shares of Aastrom stock at $1.59 per share, a 25% premium to the stock's closing price on Oct. 15. It expects the offering to close soon. Shares dropped 17 cents, or 13.4%, to $1.10.