On Tuesday, Shares of Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), skyrocketed 50.04% to $19.91.
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 The Procter & Gamble Company (NYSE:PG), inclined 1.25% to $79.10, during its last trading session.
The Procter & Gamble Company, is celebrating a decade of working with Habitat for Humanity on the construction, repair or cleaning of homes. What began as a grassroots effort in a small town in the United States has grown into a global partnership, involving 2,000 P&G employees in 18 countries around the world.
“P&G brands have always been in the business of assisting families keep their houses clean and feeling like home. Through our partnership with Habitat for Humanity, we’re bringing that same pride and comfort to families in need of secure housing,” said Steve Bishop, P&G Group President and Habitat supporter. “Whether it’s assisting a family in Canada build a new home or cleaning homes for the elderly in Singapore, we’re proud of the difference P&G people and brands are making in the lives of families around the world.”
By providing products, education and solutions for home care, P&G brands are assisting Habitat families create the experience of home by sharing the resources and knowledge necessary for upkeep and cleaning. Through this partnership, P&G employees work side-by-side with Habitat families to build or repair their homes and share kits of P&G brands on move-in day. Kits comprise products such as Mr. Clean, Swiffer, Bounty, Charmin and Tide – which will assist families take care of their home for up to six months.
The Procter & Gamble Company, together with its auxiliaries, manufactures and sells branded consumer packaged goods. The company operates through five segments: Beauty; Grooming; Health Care; Fabric Care and Home Care; and Baby, Feminine and Family Care.
Finally, California Resources Corporation (NYSE:CRC), ended its last trade with 0.13% gain, and closed at $7.44, as oil futures marked their first gain in four sessions Tuesday as traders bet that data due out this week will show another weekly drop in U.S. crude supplies.
July crude tacked on 45 cents, or 0.8%, to settle at $59.97 a barrel on the New York Mercantile Exchange after tallying a loss of more than 3% over the past three trading sessions.
California Resources Corporation operates as an oil and natural gas exploration and production company in the State of California. It produces oil, natural gas, and natural gas liquids. The company holds interests in about 2.4 million net acres.
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