02.10.2014 08:58:03

ARDX Surges On Study Data, HBIO Opens Wallet, ZGNX On Watch, PTLA Creates Buzz

(RTTNews) - Shares of Ardelyx Inc. (ARDX) surged over 33% on Wednesday, following positive results from a phase IIb clinical trial evaluating the company's experimental drug for constipation-predominant irritable bowel syndrome - Tenapanor.

According to the company, there was an increase in the complete spontaneous bowel movement (CSBM) responder rate for Tenapanor-treated patients compared to patients receiving placebo in the phase IIb trial.

Ardelyx licensed Tenapanor to AstraZeneca plc (AZN) in October 2012. In addition to IBS-C, Ardelyx and AstraZeneca are evaluating Tenapanor for the treatment of hyperphosphatemia in patients with end-stage renal disease and for its effect on markers of kidney disease and fluid status in patients with chronic kidney disease.

ARDX closed Wednesday's trading at $19, up 33.71%.

Enanta Pharmaceuticals Inc. (ENTA) has regained full rights of EDP-239, a phase I drug candidate for hepatitis C virus, from Novartis AG (NVS) since HCV research would no longer be a strategic focus for the latter.

Enanta and Novartis entered into their strategic collaboration to advance EDP-239 in February 2012.

ENTA closed Wednesday's trading at $40.29, up 1.82%.

Shares of Esperion Therapeutics Inc. (ESPR) were up more than 33% to $32.52 in extended trading on Wednesday after the company announced positive top-line results from a phase IIb study of its cholesterol drug ETC-1002-008.

In the phase 2b study, which evaluated the efficacy and safety of ETC-1002 monotherapy against Ezetimibe monotherapy (Merck's Zetia) in patients with hypercholesterolemia, with or without statin intolerance, ETC-1002 was associated with significantly greater LDL-cholesterol lowering from baseline.

Harvard Bioscience Inc. (HBIO) has acquired two privately held life science companies - Multi Channel Systems MCS GmbH and Triangle BioSystems Inc for a total of approximately $11 million in cash.

Both companies are key developers of equipment in the field of electrophysiology, and their acquisitions substantially bolster Harvard Bioscience's leadership within the electrophysiology market.

Harvard Bioscience expects the acquisitions to be accretive to 2015 earnings and add $7.5 million to $8.5 million in revenue next year.

HBIO closed Wednesday's trading 2.93% higher at $4.21.

IGI Laboratories Inc. (IG) has acquired two previously marketed ophthalmic drug products, in addition to the right to acquire three additional previously marketed injectable drug products from affiliates of Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO).

The company expects to have the acquired products in the market under its IGI label by the end of 2015.

IG closed Wednesday's trading at $8.81, down 5.47%.

Immunovaccine Inc.'s (IMV.V) lead cancer vaccine candidate DPX-Survivac is all set to advance into phase II clinical study in diffuse large B cell lymphoma later this year. The efficacy phase II trial will enroll up to 24 patients, with the first patient expected to be dosed by early 2015.

IMV.V closed Wednesday's trading at C$0.88, unchanged from the previous day's close.

Portola Pharmaceuticals' (PTLA) first phase III study of its investigational drug andexanet alfa met the primary endpoint of immediately and significantly reversing the anticoagulation activity of Bristol-Myers Squibb Co. (BMY) and Pfizer Inc.'s (PFE) direct Factor Xa inhibitor Eliquis.

The company expects to report additional data this year and next with other Factor Xa inhibitors, including Rivaroxaban, Edoxaban, Betrixaban and Enoxaparin. Portola anticipates filing a Biologics License Application with the FDA for Accelerated Approval at the end of 2015.

PTLA closed Wednesday's trading at $29.32, up 15.98%.

Zogenix Inc. (ZGNX) has submitted to the FDA a supplemental New Drug Application for a modified formulation of its opioid pain medication Zohydro ER. The new formulation contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection and nasal insufflation.

The company anticipates a target action date on the supplement during the first quarter of 2015.

Zohydro ER, the company's currently marketed acetaminophen-free, pure hydrocodone product was approved by FDA last October. The approval has drawn criticism from experts who are of the view that Zohydro ER can be crushed, chewed or mixed with alcohol to provide a kick as it lacks abuse-deterrent features.

If the new formulation of Zohydro ER is approved, the company expects a transition from the currently marketed product to this new formulation in the second quarter of 2015.

ZGNX closed Wednesday's trading 1.74% higher at $1.17.

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Aktien in diesem Artikel

Ardelyx Inc 5,01 1,25% Ardelyx Inc
Enanta Pharmaceuticals Inc 5,75 -3,36% Enanta Pharmaceuticals Inc
Harvard Bioscience Inc. 1,93 -6,31% Harvard Bioscience Inc.