12:00 AM
 | 
Nov 12, 2012
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Corcept Therapeutics Inc. (NASDAQ:CORT) fell $0.30 (16%) to $1.60 on Wednesday after FDA's Endocrinologic and Metabolic Drugs Advisory committee voted 10-0 that efficacy and safety data for pasireotide from competitor Novartis AG (NYSE:NVS; SIX:NOVN) support approval to treat Cushing's disease. The PDUFA date is not disclosed. Corcept markets Korlym mifepristone, the only drug approved in the U.S. to treat Cushing's syndrome.

Last week, the biotech's shares lost $0.64 (33%) to $1.31.

ImmunoGen Inc. (NASDAQ:IMGN) was up $0.24 to $11.25 last week after FDA accepted and granted Priority Review to a BLA from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit for trastuzumab emtansine (T-DM1) to treat HER2-positive, unresectable locally advanced or metastatic breast cancer in patients who have received prior treatment with Herceptin trastuzumab and a taxane-based chemotherapy. The PDUFA date is Feb. 26. The compound uses ImmunoGen's TAP antibody-conjugate technology.

Vectura Group plc (LSE:VEC) was off 7.50p to 79.50p last week, while Sosei Group Corp. (Tokyo:4565) lost ¥2800 to ¥220,000 after partner Novartis AG (NYSE:NVS; SIX:NOVN) submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for QVA149 to treat chronic obstructive pulmonary disease (COPD).

Zogenix Inc. (NASDAQ:ZGNX) was up $0.23 (10%) to $2.48 on Thursday after FDA's Anesthetic and Analgesic Drug Products Advisory Committee announced it will meet on Dec. 7 to discuss an NDA for Zohydro ER hydrocodone bitartrate to treat chronic pain. The product has a March 1 PDUFA date.

For the week, Zogenix was up $0.19 to $2.57.

Clinical milestones

Amgen Inc. (NASDAQ:AMGN) was off $1.28 to $85.17 last week. The company reported hypercholesterolemia compound AMG 145 met the primary endpoints of reducing LDL-C from baseline to week 12 vs. placebo in four Phase II trials (see "Piecing Together PCSK9," A10).

BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) fell $0.99 (40%) to $1.46 on Thursday after discontinuing the Phase III BCX1812-301 trial of peramivir to treat patients hospitalized for serious influenza infection. The discontinuation was based on a pre-planned interim...

Read the full 1668 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >