12:00 AM
Mar 26, 2012
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) lost $1.10 to $14 last week after announcing EMA accepted for review an MAA for lomitapide to treat homozygous familial hypercholesterolemia (HoFH).

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) gained $0.31 to $15.72 last week even though FDA's Oncologic Drugs Advisory Committee voted 13-1 that Taltorvic ridaforolimus from partner Merck & Co. Inc. (NYSE:MRK) did not demonstrate a favorable benefit-risk profile as a maintenance therapy for metastatic soft tissue or bone sarcoma patients with stable disease following chemotherapy. The PDUFA date is June 5 (see "Defining Meaningful," A12).

Gilead Sciences Inc. (NASDAQ:GILD) gained $0.22 to $46.85 on Friday after FDA's Antiviral Drugs Advisory announced it will meet on May 11 to discuss an NDA for the fixed-dose Quad regimen to treat HIV-1 infection in adults. The PDUFA date is Aug. 27. The stock was up $0.12 on the week.

NeurogesX Inc. (NASDAQ:NGSX) was off $0.05 to $0.57 last week after EMA said partner Astellas Pharma Inc. (Tokyo:4503) withdrew an application for a label extension for Qutenza capsaicin patch to treat peripheral neuropathic pain in adults, except when pain is caused by diabetes. According to the agency, Astellas said EMA's CHMP indicated the data provided was not sufficient to demonstrate a positive benefit-risk balance.

Qutenza is...

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