12:00 AM
Jul 22, 2013
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Biogen Idec Inc. (NASDAQ:BIIB) was up $7.15 to $230.27 on Friday after FDA accepted a BLA and EMA accepted an MAA for Plegridy peginterferon beta-1a (BIIB017) to treat relapsing forms of multiple sclerosis (MS). The company submitted the BLA in May. The PDUFA date is not disclosed. Biogen Idec gained $3.93 on the week.

Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) was up $0.30 (12%) to $2.75 last week after FDA accepted for review a resubmitted NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH). The PDUFA date is Jan. 3, 2014.

Curis Inc. (NASDAQ:CRIS) slipped $0.07 to $3.75 last week after the European Commission conditionally approved an MAA from partner Roche (SIX:ROG; OTCQX:RHHBY) for Erivedge vismodegib to treat adults with symptomatic metastatic or locally advanced basal cell carcinoma (BCC) for whom surgery or radiotherapy are considered inappropriate. The approval triggers a $6 million milestone payment to Curis from Roche's Genentech Inc. unit. FDA granted full approval to Erivedge to treat advanced BCC in January 2012.

Clinical milestones

Celgene Corp. (NASDAQ:CELG) gained $1.33 to $135.89 last week despite discontinuing the open-label Phase III ORIGIN (CLL-008) trial of Revlimid lenalidomide in elderly patients with previously untreated B cell chronic lymphocytic leukemia (CLL) due to an imbalance in treatment arm deaths. There were 34 deaths among 210 patients in the Revlimid arm compared with 18 deaths among 211 patients in the chlorambucil arm. FDA placed the trial on clinical hold on July 12 (see B15).

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