12:00 AM
Feb 11, 2013
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

BTG plc (LSE:BTG) was off 7.4p to 327p last week after submitting an NDA to FDA for Varisolve to treat varicose veins. The product is polidocanol endovenous microfoam.

Hemispherx Biopharma Inc. (NYSE-M:HEB) lost $0.05 (18%) to $0.23 last week after FDA issued a complete response letter for Ampligen rintatolimod to treat chronic fatigue syndrome (CFS). The agency asked for at least one additional clinical trial, complete non-clinical studies and additional data analyses. Hemispherx said it will request a meeting with FDA before submitting a formal appeal.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) lost $7 to $165.88 last week after the European Commission approved Zaltrap aflibercept from partner Sanofi (Euronext:SAN; NYSE:SNY) in combination with FOLFIRI chemotherapy to treat metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Sanofi said it plans to launch this year.

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) was up $0.93 to $38.68 last week after announcing plans to submit an sNDA to FDA in March to add a thrice-weekly dose of Copaxone glatiramer to the multiple sclerosis drug's label. Teva already markets once-daily Copaxone to treat relapsing-remitting MS (RRMS) in the U.S.

Teva also said it plans to sell an injectables manufacturing plant in Irvine, Calif. The announcements came when the company reported 4Q12 earnings that missed the Street's estimates (see "EPS Watch," A17).

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) gained $0.56 to $46 last week after Germany's Federal Joint Committee (G-BA) said in a final assessment that cystic fibrosis drug Kalydeco ivacaftor provides a "significant" degree of additional benefit for patients older than 12 and a "marginal" degree of benefit for patients ages 6-11 years. Vertex will now negotiate a price (see B14).

Clinical milestones

Emergent BioSolutions Inc. (NYSE:EBS) was off $0.60 to $15.70...

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