Key Developments: Zalicus Inc (ZLCS.O)

ZLCS.O on Consolidated Issue listed on NASDAQ Capital Market

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16 Apr 2014
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Latest Key Developments (Source: Significant Developments)

Zalicus and Epirus announce merger agreement
7:00am EDT 

Zalicus Inc and Epirus Biopharmaceuticals Inc:Agreement under which Epirus will merge with wholly-owned subsidiary of Zalicus in an all-stock transaction.Zalicus will be re-named Epirus Biopharmaceuticals Inc, and will operate under leadership of the Epirus.  Full Article

Zalicus Inc Reports Results From Phase 2 Clinical Trials Of Z160 In Chronic Neuropathic Pain
Monday, 11 Nov 2013 08:30am EST 

Zalicus Inc announced top-line results from two Phase 2 clinical studies of Z160 in chronic pain indications. Z160 did not meet the primary endpoint in either of the Phase 2 clinical studies in patients with lumbosacral radiculopathy (LSR) and post-herpetic neuralgia (PHN). Z160 was shown to be generally safe and well-tolerated with no drug-related serious adverse events. Based on these results, Zalicus is discontinuing the Z160 program and plans to focus efforts on Z944, oral T-type calcium channel modulator in development for the treatment of pain.  Full Article

Zalicus Inc Announces Positive Results of Z944 Phase 1b Clinical Study in Pain
Friday, 1 Nov 2013 08:30am EDT 

Zalicus Inc announced positive results of a Phase 1b clinical study with Z944, a oral T-type calcium channel modulator in development for the treatment of pain. The Phase 1b study is an experimental clinical model utilizing Laser-Evoked-Potentials (LEP) to provide both objective and subjective assessments of the activity of Z944 in induced pain states. Based on these results, Zalicus is planning to advance a modified-release formulation of Z944 into Phase 2 clinical development in an appropriate pain indication in 2014. In addition, a second United States patent for Z944 (U.S. Patent number 8,569,344) covering methods of treating pain was issued on October 29, 2013, providing additional patent protection for Z944 in the United States until at least 2029.  Full Article

Zalicus Inc's Z160 Receives Orphan Drug Designation For Management Of Postherpetic Neuralgia
Friday, 27 Sep 2013 09:44am EDT 

Zalicus Inc announced that Z160, its state-dependent, selective N-type calcium channel (Cav 2.2) modulator in development for chronic neuropathic pain has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia. Postherpetic neuralgia (PHN) is a painful neuropathic condition resulting from an outbreak of the herpes zoster virus, otherwise known as shingles. Zalicus announced it had completed patient enrollment in two Phase 2 clinical studies of Z160 for chronic neuropathic pain indications including postherpetic neuralgia and lumbosacral radiculopathy on September 3, 2013. Top-line results of both studies are expected in the fourth quarter of 2013.  Full Article

Zalicus Inc Grants Composition-of-Matter Patent for Z944
Wednesday, 20 Feb 2013 08:00am EST 

Zalicus Inc announced that it has been granted a patent by the U.S. Patent and Trademark office (USPTO) covering its product candidate Z944. United States patent number 8,377,968 entitled N-Piperidinyl Acetamide Derivatives as Calcium Channel Blockers provides broad coverage for Z944 including compositions of matter and certain therapeutic methods of use through April 2029. Z944 is a novel, oral, T-type calcium channel blocker which has demonstrated efficacy in a number of preclinical inflammatory pain models and other disease models. Z944 completed Phase 1 single and multiple ascending dose clinical studies in late 2012 and the Company plans to continue further clinical development with Z944 during 2013.  Full Article

Zalicus Inc Reports Top Line Phase 2b Trial Results With Synavive In Rheumatoid Arthritis
Monday, 10 Sep 2012 08:00am EDT 

Zalicus Inc announced top line results from its randomized, double-blind, placebo-controlled, Phase 2b clinical trial of Synavive in rheumatoid arthritis (RA). The Phase 2b trial demonstrated that patients treated with Synavive achieved a statistically significant improvement in signs and symptoms of moderate to severe RA compared to placebo, as measured by Disease Activity Score (DAS28-CRP), after 12 weeks of treatment, which represents a -0.9 change from baseline for Synavive (approximately 17% improvement) compared to a -0.5 change from baseline for placebo (approximately 10% improvement), but missed the key secondary endpoint of demonstrating a meaningful clinical benefit, assessed by DAS28-CRP, compared to prednisolone 2.7mg, the active glucocorticoid component in Synavive. The Phase 2b clinical trial titled SYNERGY (SYNavivE for Reducing siGns and sYmptoms of rheumatoid arthritis trial), was a 12-week, five-arm, global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Synavive as a treatment for the signs and symptoms of RA in subjects with moderate to severe disease. All study subjects remained on stable dose DMARD therapy (e.g., methotrexate) in the six weeks leading up to and during study participation. The trial enrolled 259 subjects and was conducted in approximately 50 centers throughout the United States, Europe and Latin America.  Full Article

Zalicus Inc Announces FDA Approval Of 32mg Dose Strength Of EXALGO
Monday, 27 Aug 2012 08:30am EDT 

Zalicus Inc announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO (hydromorphone HCl) Extended-Release Tablets (CII), for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The FDA approved the three existing doses of EXALGO (8, 12 and 16 mg) in March 2010. Mallinckrodt subsequently submitted the sNDA in January 2012 with post-marketing data to support the original application’s compendium of clinical trials demonstrating safety, efficacy and tolerability. Using OROS technology, EXALGO provides a steady release of hydromorphone throughout the day once steady-state is achieved after three to four days. Additionally, EXALGO has physical properties that may make it difficult to extract the active ingredient using common forms of physical and chemical tampering, including chewing, crushing and dissolving. All EXALGO dosage strengths, including the new 32mg tablet which will be available soon, are subject to the recently approved Risk Evaluation and Mitigation Strategy (REMS) program for all long-acting and extended-release opioids.  Full Article

Zalicus Inc. Initiates Phase 1 Multiple Ascending Dose Study With Z944, A Novel, Oral T-Type Calcium Channel Blocker
Tuesday, 10 Jul 2012 08:30am EDT 

Zalicus Inc. announced that it is has initiated a Phase 1 multiple ascending dose (MAD) clinical study with Z944, its novel, oral, T-type calcium channel blocker. The initiation of this MAD study follows the successfully completed Phase 1 single ascending dose study in which Z944 was determined to be generally well-tolerated and a maximum tolerated dose was achieved. Assuming Z944 successfully completes the MAD study, Z944 could enter Phase 2 clinical development in the first quarter of 2013. Z944, is a novel, oral, T-type calcium channel blocker that has demonstrated preclinical efficacy in multiple inflammatory pain models. A Phase 1 clinical trial evaluating the safety and tolerability of Z944 is ongoing. If Z944 successfully completes this Phase 1 clinical trial, Zalicus is planning to advance Z944 into Phase 2 clinical development. The wide distribution of T-type calcium channels found in brain, heart, endocrine cells and other tissues provides the possibility of developing therapeutics for multiple indications, including treatment of pain.  Full Article

Zalicus Inc. Completes Phase 1 Single Ascending Dose Study With Z944
Tuesday, 19 Jun 2012 08:00am EDT 

Zalicus Inc. announced that it has successfully completed a Phase 1 single ascending dose (SAD) clinical study with Z944, oral, T-type calcium channel blocker. The study results indicate that Z944 was generally well-tolerated and a maximum tolerated dose was achieved. Z944 will advance into a Phase 1 multiple ascending dose (MAD) study in the third quarter of 2012. Assuming Z944 successfully completes the MAD study, Z944 could enter Phase 2 clinical development in the first quarter of 2013. Z944, is a novel, oral, T-type calcium channel blocker that has demonstrated preclinical efficacy in multiple inflammatory pain models. A Phase 1 clinical trial evaluating the safety and tolerability of Z944 is ongoing. If Z944 successfully completes this Phase 1 clinical trial, Zalicus is planning to advance Z944 into Phase 2 clinical development.  Full Article

Zalicus Inc. Advances Z160 Into Multiple Phase 2a Clinical Trials For Treatment Of Pain
Wednesday, 2 May 2012 07:30am EDT 

Zalicus Inc. announced that it is advancing Z160, N-type calcium channel blocker into multiple Phase 2a clinical trials for chronic pain indications. Zalicus has selected formulation for clinical use and is planning to initiate two Phase 2a clinical trials with Z160 for the treatment of neuropathic pain; the first of which is expected to begin enrolling patients in the third quarter of 2012. Zalicus completed Phase I pharmacokinetic and safety studies with a number of formulations and has selected the optimal formulation to move into further clinical development. The selected formulation was well tolerated and demonstrated a six fold improvement in Z160’s bioavailability compared to the previously studied formulation of Z160.  Full Article

Zalicus drops pain drug after trial fails; shares tumble

- Zalicus Inc said it would stop developing its most advanced product, an experimental pain drug, after it failed to show a benefit over a placebo in two mid-stage trials.

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