Evoke Pharma May Be One Of The Safest Biotech Bets Of 2014
Bio Bull • 23 Comments
Bio Bull • 23 Comments
Wed, Feb. 17, 12:45 PM
Oct. 7, 2015, 12:45 PM
Oct. 1, 2015, 12:40 PM
Sep. 23, 2015, 12:40 PM
Sep. 15, 2015, 9:25 AM
- Thinly traded nano cap Evoke Pharma (NASDAQ:EVOK) is up 18% premarket on light volume in response to its announcement that the design and the primary endpoint of its Phase 3 clinical trial assessing lead product candidate EVK-001 (metoclopramide nasal spray) in diabetic gastroparesis is consistent with recently-released FDA draft guidance on developing therapies for gastroparesis.
- The company believes that this reduces its regulatory risk related to the FDA's criteria for evaluating the effectiveness of and ultimately approving such therapies.
Aug. 18, 2015, 12:45 PM
Aug. 18, 2015, 10:37 AM
- The FDA grants Evoke Pharma (EVOK +24.8%) a full waiver of the requirement to conduct pediatric studies to support its planned New Drug Application (NDA) for its lead product candidate, EVK-001. The company requested the waiver on the basis that the product's intended indication, diabetic gastroparesis, is an adult disease.
- EVK-001, currently in Phase 3 development, is a novel formulation of metoclopramide that is delivered via a nasal spray. Two Phase 3s, one in women and one in men, should be completed in November. The NDA should follow sometime in 2016.
- Diabetic gastroparesis is a disorder in which the movement of food from the stomach is slowed or stopped. The most frequent cause is damage to the vagus nerve, which controls the movement of food (motility) through the digestive tract.
Jun. 24, 2015, 12:02 PM
- Thinly traded nano cap Evoke Pharma (EVOK +21%) moves up on an 8x surge in volume in apparent response to its announcement that Phase 2b trial results evaluating its lead product candidate, EVK-001, for the treatment of diabetic gastroparesis in women have been published in the July issue of Clinical Gastroenterology and Hepatology. The data were originally disclosed in January 2014.
- The randomized, 285-subject (202 women, 83 men), double-blind placebo-controlled study in patients with type 1 or type 2 diabetes with a previous diagnosis of gastroparesis met its primary efficacy endpoint of demonstrating that women treated with EVK-001 experienced a statistically significant improvement in symptom scores versus placebo. 80% of diabetic gastroparesis cases are women. The male cohort failed to meet the endpoint.
- EVK-001 (metoclopramide) is a novel formulation that is delivered via a nasal spray. Oral and intravenous versions of metoclopramide have been available for sale since 1980.
Mar. 5, 2015, 12:45 PM
Dec. 2, 2014, 12:47 PM
Apr. 22, 2014, 12:46 PM
Jan. 22, 2014, 12:47 PM
Jan. 22, 2014, 9:09 AM
Nov. 19, 2013, 12:45 PM
Sep. 25, 2013, 12:06 PM
- Foundation Medicine (FMI +79%) — which markets molecular information-enabled products to physicians and biopharma firms — opens at $31.50, well above its expected range of $14-16. Through June 30, the company had logged sales of $11.1M and incurred an operating loss of $17.1M.
- Evoke Pharma (EVOK -5.8%) — which develops treatments for GI diseases — opens at $11.15, below its expected range of $12-14.
Evoke Pharma, Inc. operates as a pharmaceutical company, which focuses on the development of drugs to treat gastrointestinal, or GI, disorders and diseases. It develops EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in... More
Industry: Drug Related Products
Country: United States
Other News & PR