Interpace Diagnostics Group Inc (NASDAQ:IDXG) shares rose nearly 8% in after-hours trading Wednesday, after the company announced that it is launching a new biomarker to be ordered along with its current molecular thyroid testing options.
The TERT marker is a strong molecular predictor of the aggressiveness of thyroid cancer and adds additional insights in to a patients’ molecular profile. Currently, the ThyGenX™ mutation panel includes the following markers that are predictive of thyroid cancer from cytologically indeterminate thyroid nodules, including BRAF, HRAS, KRAS, NRAS, RET/PTC, PAX8/PPARy, and PIK3CA. By adding TERT, the panel will not only continue to be a strong positive predictor of thyroid cancer, but will also provide evidence that a positive result indicates the cancer is likely to be more aggressive in nature.
Telomerase reverse transcriptase or TERT encodes the reverse transcriptase component of telomerase, which adds telomere repeats to chromosome ends, enabling cell replication. Published data suggests that TERT mutations can extend the life span of the tumor cell and allow time for other mutations to develop. Mutations in the TERT promoter region are found in thyroid cancers and seem to act synergistically when they occur with the BRAF V600 mutation. The coexistence of mutations in TERT and BRAF genes have been shown to dramatically increase the risk of thyroid cancer aggressiveness, tumor recurrence and thyroid cancer-specific deaths.
Physicians will be able to order TERT as part of the ThyGenX mutation panel or on an individual basis. To date, the Company has performed the ThyGenX/ThyraMIR test combination assay on over 10,000 patients on behalf of over 250 physicians and hospitals nationwide.
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are pleased to be launching this enhancement to our Thyroid services at the request of our customers. This marker will provide physicians and their patients with incremental insights into their risk for particularly aggressive thyroid cancer.”
Aerie Pharmaceuticals Inc (NASDAQ:AERI) shares skyrocket in after-hours trading, rising nearly 25%, after the drug maker reported the successful primary efficacy results of the Company’s 90-day Phase 3 “Mercury 2” registration trial for its fixed-dose combination product candidate, Roclatan™. The results of Mercury 2 were consistent with the successful 90-day efficacy results from the Mercury 1 trial, a 12-month Phase 3 registration trial for Roclatan™, which reported topline efficacy findings in September 2016. Mercury 2 achieved its primary efficacy endpoint of demonstrating statistical superiority over each of its components, including Aerie product candidate Rhopressa™ (netarsudil ophthalmic solution) 0.02%, and market-leading prostaglandin analogue (PGA) latanoprost, all of which were dosed once daily in the evening. The IOP-lowering effect of Roclatan™ was 1 to 3 mmHg (millimeters of mercury) greater than monotherapy with either latanoprost or Rhopressa™ throughout the duration of the study. The study evaluated patients with maximum baseline intraocular pressures (IOPs) ranging from above 20 to below 36 mmHg.
“With this positive Mercury 2 data, we now have two successful pivotal trials for Roclatan™. The topline efficacy results demonstrated in Mercury 2 are consistent with Mercury 1, confirming the potential for Roclatan™ to become the most efficacious IOP-lowering therapy to enter the market, if approved. Now that the efficacy results for both Mercury 1 and 2 have proven successful, and if the Mercury 1 12-month safety results are also successful, we expect to submit our Roclatan™ NDA (new drug application) in the first half of 2018,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “In addition to the excellent efficacy observed in Mercury 2 for both Roclatan™ and Rhopressa™, we were also delighted to see relatively low discontinuation rates for the 90-day Mercury 2 trial of 9.8 percent and 10.6 percent for Roclatan™ and Rhopressa™, respectively.”
Richard A. Lewis, M.D., Aerie’s Chief Medical Officer, added, “Roclatan™ is distinguished by its ability to lower intraocular pressure to levels previously unseen with current glaucoma therapies, including market-leading latanoprost. This product holds the promise of potentially becoming the first prostaglandin fixed-dose combination available in the United States. The safety profile of Roclatan™ observed in Mercury 2 once again points to a safe and tolerable product.”