12:00 AM
Mar 17, 2014
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) was off $0.16 to $15.11 last week after submitting an MAA to EMA for Zerenex ferric citrate to treat hyperphosphatemia in dialysis dependent and non-dialysis dependent patients with chronic kidney disease (CKD).

The product is under FDA review for CKD in dialysis patients, with a June 7 PDUFA date. In January, Japan approved the product as Riona.

Mallinckrodt plc (NYSE:MNK) was up $1.88 to $70.01 last week after FDA approved an NDA for Xartemis XR oxycodone/acetaminophen to manage acute pain severe enough to require the use of an opioid analgesic and when alternative treatment options are ineffective, not tolerated or would otherwise be inadequate.

Xartemis XR uses AcuForm gastric retentive formulation technology from Depomed Inc. (NASDAQ:DEPO), which will receive a $10 million milestone payment from Mallinckrodt. Depomed added $0.95 to $14.65 on the week.

Regado Biosciences Inc. (NASDAQ:RGDO) gained $3.12 (38%) to $11.30 on Monday after FDA granted Fast Track designation to the biotech's REG1 Anticoagulation System as anticoagulant therapy in patients with coronary artery disease during percutaneous coronary interventions (PCI). REG1 is in the Phase III REGULATE-PCI trial for the indication.

Regado was up $2.93 (36%) to $11.11 on the week.

TaiGen Biopharmaceuticals Holdings Ltd. (GreTai:4157) was up NT$0.80 to NT$63 on Friday after the Taiwan Food and Drug Administration approved an NDA for oral Taigexyn nemonoxacin to treat community-acquired bacterial pneumonia (CABP). The company has exclusive, worldwide rights to nemonoxacin from Actavis plc (NYSE:ACT).

TaiGen was up NT$2.50 on the week.

Veloxis Pharmaceuticals A/S (CSE:VELO) was up DKK0.05 to DKK0.95 last week after FDA accepted for review an NDA for Envarsus tacrolimus to prevent organ rejection in kidney transplant patients. The PDUFA date is Oct. 30. The product is also under review in Europe.

Clinical milestones

Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) gained as much as $0.42 (13%) on Friday before closing up $0.13 to $3.30 after presenting additional data from the Phase II 007 trial of ACH-3102 in combination with sovaprevir to treat chronic HCV genotype 1 infection. Sovaprevir led to a sustained virologic response (SVR) 12 weeks after the end of treatment in 100% of patients with HCV genotype 1b infection.

ACH-3102 is a pan-genotypic, second-generation HCV NS5A protein inhibitor. Achillion plans to start a Phase II trial mid-year to evaluate ACH-3102 in combination with its ACH-2684 in patients with HCV genotype 1b infection.

Sovaprevir has been on a partial clinical hold since last year. Achillion said it plans to...

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