Katelyn Baker
Well-Known Member
Shares of INSYS Therapeutics Inc are trading 15 percent higher this morning, after the company announced that its cannabis-based medication has been approved by the United States Food and Drug Administration (FDA). The innovative drug, which is called Syndros, is an orally taken liquid form of a pharmaceutical marijuana extract used for the treatment of AIDS symptoms.
INSYS's trading volume is also soaring today, with more than 3.4 million shares already exchanged since pre-market trading began — a considerable increase when compared to the stock's average trading volume of about 661,000 shares per day. Before today's spike in INSYS's share price, the company's stock had tumbled 62 percent in the last twelve-month period.
Syndros, a dronabinol oral solution, helps patients' anorexia symptoms related to weight loss from AIDS. The drug, which is a pharmaceutical formulation of tetrahydrocannabinol (THC), was approved by the American regulatory agency as a therapy to stimulate patients' hunger, as well as a treatment for the nausea and vomiting that is involved with cancer chemotherapy — which is prescribed to patients who do not respond well enough to standard antiemetic (anti-vomitin) treatments.
"We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS," said Dr. John N. Kapoor, Chairman, Chief Executive Officer and President of INSYS Therapeutics.
As an orally-administered dronabinol solution approved by the FDA, Syndros is the first of its kind. The dosage can be modified to achieve the optimal clinical effect in patients. Once the product is opened, it does not need to be refrigerated for four weeks. Mr. Kappor believes that these important characteristics — combined with patient support services — will be key differentiators for both patients and doctors, and "will be key drivers of a successful market launch and sustained growth."
In October 2014, the FDA rejected the company's New Drug Application (NDA) for the Dronabinol oral solution. The regulatory authority said the rejection was due to the submission of an inadequate or incomplete pediatric study plan. INSYS believed they submitted the necessary information, and didn't believe it needed to engage in any further clinical trials. In June of last year, the company resubmitted the NDA.
News Moderator: Katelyn Baker 420 MAGAZINE ®
Full Article: INSYS Therapeutics Jumps On FDA Approval Of Cannabis-Based Drug
Author: Timothy Walker
Contact: (212) 406-1198
Photo Credit: None Found
Website: Economic Calendar
INSYS's trading volume is also soaring today, with more than 3.4 million shares already exchanged since pre-market trading began — a considerable increase when compared to the stock's average trading volume of about 661,000 shares per day. Before today's spike in INSYS's share price, the company's stock had tumbled 62 percent in the last twelve-month period.
Syndros, a dronabinol oral solution, helps patients' anorexia symptoms related to weight loss from AIDS. The drug, which is a pharmaceutical formulation of tetrahydrocannabinol (THC), was approved by the American regulatory agency as a therapy to stimulate patients' hunger, as well as a treatment for the nausea and vomiting that is involved with cancer chemotherapy — which is prescribed to patients who do not respond well enough to standard antiemetic (anti-vomitin) treatments.
"We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS," said Dr. John N. Kapoor, Chairman, Chief Executive Officer and President of INSYS Therapeutics.
As an orally-administered dronabinol solution approved by the FDA, Syndros is the first of its kind. The dosage can be modified to achieve the optimal clinical effect in patients. Once the product is opened, it does not need to be refrigerated for four weeks. Mr. Kappor believes that these important characteristics — combined with patient support services — will be key differentiators for both patients and doctors, and "will be key drivers of a successful market launch and sustained growth."
In October 2014, the FDA rejected the company's New Drug Application (NDA) for the Dronabinol oral solution. The regulatory authority said the rejection was due to the submission of an inadequate or incomplete pediatric study plan. INSYS believed they submitted the necessary information, and didn't believe it needed to engage in any further clinical trials. In June of last year, the company resubmitted the NDA.
News Moderator: Katelyn Baker 420 MAGAZINE ®
Full Article: INSYS Therapeutics Jumps On FDA Approval Of Cannabis-Based Drug
Author: Timothy Walker
Contact: (212) 406-1198
Photo Credit: None Found
Website: Economic Calendar
