Medtronic turned investors on with earnings results, other stocks moved on regulatory news, but overall biotech stocks had little to be thankful for on a second glum day this holiday-shortened week.
rose post-earnings after analysts suggested shares had found the bottom and the worst may be over the for the medical device maker, which earlier this fall recalled its Fidelis leads and hastily ramped-up supply of its Quattro lead to meet the subsequent demand. Earnings fell 2% in the fiscal second quarter in light of the Fidelis recall, but investors saw a negative impact that was less severe than expected and shifted focus to Medtronic's completed Kyphon acquisition among other things. Shares climbed $3.47, or 7.7%, to $48.72.
Following a meeting with the Food and Drug Administration and the principal investigator at the National Cancer Institute,
said Tuesday that the agency has allowed it to resume enrollment in phase III and phase II clinical trials of the Delcath System. The system is designed to deliver chemotherapeutic agent Melophan to the liver for cancer patients who have liver tumors that cannot be removed.
On Oct. 23, the company put enrollment on hold in response to an FDA inquiry into serious gastrointestinal adverse events in four patients, two of whom died, in trials prior to a protocol amendment. Shares rose 69 cents, or 47.6%, to $2.14.
( BVF) said Tuesday that the FDA classified as Class 2 the response the company submitted on Oct. 23 for its salt formulation of buproprion, meaning it will take the agency six months to review. The goal date for the FDA to make a decision is April 23. CEO David Squires said he was surprised and disappointed with the agency's decision to classify Biovail's response at Class 2. BMO Capital Markets downgraded the company to underperform from market perform and lowered its price target to $16 from $20.25. Shares fell $1.91, or 11.6%, to $14.54.
BMO Capital also changed its rating for
( PHRM) following Monday's buyout news. The company raised its rating for Celgene to outperform from market perform and increased its price target to $76 from $66. And it lowered its rating for Pharmion to market perform from outperform.
Pharmion was trading down 76 cents, or 1.2%, at $64.38 on Tuesday while Celgene was down 45 cents, or 0.7%, at $64.45.
On the clinical side,
said it began dosing in a 797-patient phase II trial to evaluate the efficacy of its ARRY-797 for treating pain in dental patients undergoing third-molar extraction. Shares were trading up 22 cents, or 2%, at $11. The stock is a component of the Nasdaq biotechnology index, which was down 2.95, or 0.3%, at 832.71.