During Tuesday’s Afternoon trade, Shares of Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), skyrocketed 52.60% to $20.25.
Aerie Pharmaceuticals, stated that the U.S. Food and Drug Administration (FDA) has agreed in written and verbal communications that Aerie may change the primary endpoint range of its second Phase 3 registration trial of RhopressaTM, named Rocket 2. With this agreement, the Company is changing the primary endpoint range to comprise patients with baseline intraocular pressures (IOPs) ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg. The former range for the primary endpoint of above 20 mmHg to below 27 mmHg will now represent a secondary endpoint range for Rocket 2.
Highlights
- The Rocket 2 primary endpoint range is now changed to the same range where the Phase 3 registration trial results of Rocket 1 demonstrated success, ranging from above 20 mmHg to below 25 mmHg. In the Rocket 1 trial, in this range, RhopressaTM demonstrated non-inferiority to timolol, and numerical superiority over timolol at the majority of time points. According to the Baltimore Eye Survey, nearly 80 percent of newly diagnosed glaucoma patients have unmedicated baseline IOPs below 26 mmHg.
- The FDA also agreed that the Company may use a hierarchically-based statistical approach in determining whether this three-arm trial is adequately powered at the revised primary endpoint range. Using this methodology, the Company believes that the new primary endpoint range is adequately powered, and there is no need to recruit additional patients into Rocket 2. Three-month efficacy results for Rocket 2 are predictable by the end of the third quarter of 2015.
- An additional RhopressaTM Phase 3 registration trial, named Rocket 4, is predictable to commence in the third quarter of 2015, along with the first RoclatanTM Phase 3 registration trial, named Mercury 1.
Aerie Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of first-in-class therapies for the treatment of glaucoma and other eye diseases.
Shares of Boston Scientific Corporation (NYSE:BSX), inclined 0.92% to $17.53, during its current trading session.
Boston Scientific Corporation, presented new data demonstrating that the Precision Spectra™ Spinal Cord Stimulator (SCS) System offered 1.5 times better overall pain relief and 2 times better low back pain relief than the previous generation Precision Plus™ SCS system. The improved outcomes with the Precision Spectra System were achieved in conjunction with the use of the proprietary Illumina™ 3D neural targeting software, designed to target pain with point-and-click simplicity. Results from the LUMINA cohort of the Precision Spectra System observational study were presented this week at the International Neuromodulation Society 12th World Congress in Montreal, Canada.
The LUMINA cohort comprises three patient groups: 213 successive patients treated with the Precision Spectra System for up to 24 months post-implant; 130 successive patients treated with the previous generation system, Precision Plus™, in a comparative evaluation with the Precision Spectra System; and 25 successive patients treated with the Precision Spectra System and the new CoverEdge 32 Surgical Leads for up to 6 months post-implant.
Boston Scientific Corporation develops, manufactures, and markets medical devices for use in various interventional medical specialties worldwide. The company operates in three segments: Cardiovascular, Rhythm Administration, and MedSurg.
Finally, Altera Corp. (NASDAQ:ALTR), gained 0.16%, and is now trading at $51.63.
Altera Corporation, declared that its Arria® 10 FPGAs have been chosen by Silkan, a provider of real-time data transmission, for its new deterministic real-time high-speed Ethernet interconnection technology. The Silkan CETRAC switch is a plug-and-play solution, using an Ethernet cable to connect critical systems in aerospace and defense (A&D) and instrumentations and controls (I&C) markets. It was developed to provide safe connectivity, low latency, and rapid delivery of information between these onboard systems, without any data corruption. The solution also supports avionics applications that must meet the requirements for Design Level Assurance (DAL) A and B, two of the highest safety levels in avionics. Silkan will demonstrate the new offering at the Paris Air Show June 15 to June 21, in Hall 4C #83.
Arria 10 FPGAs enable Silkan to meet Ethernet IEEE802.3 standards with a one-chip programmable platform, and to achieve new levels of performance, and improve connectivity safety and reliability, while offering a lower cost of ownership. CETRAC switches can also support non-critical applications needed in flight, offering guaranteed data integrity and low latency.
CETRAC is also offered as an IP core and is embeddable in Line-Replaceable Unit (LRU), which is a modular component on an airplane, ship or spacecraft. CETRAC offers full retro-compatibility with the company’s Arion100 product, an integrated, industrial, and real-time environment providing complete virtualization for a system.
Altera Corporation, a semiconductor company, designs and sells programmable logic devices (PLDs), HardCopy application-specific integrated circuit (ASIC) devices, power system-on-chip devices (PowerSoCs), pre-defined design building blocks, and associated development tools.
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