Earth Science Tech Inc (OTCMKTS:ETST) reported the plunge of 2.29% and closed at $1.24, with the total traded volume of 25,426.00 shares. During last trade its minimum price was $1.00 and it gained its highest price of $1.25 and has a total of 40.91 million outstanding shares.
On March 27, 2017 Earth Science Tech, Inc. (ETST), an innovative biotech company focused on cannabis (industrial hemp) and cannabinoid research and development, nutraceuticals, pharmaceuticals, and medical devices, and its two subsidiaries – Earth Science Pharmaceutical Inc. and Cannabis Therapeutics inc. – are proud to announce the projected timeline for the delivery of its MSN-2 medical device; the negotiation of a strategic partnership with Connexions Commerciales Internationales ct, Inc.; and the beginning of negotiations with partners in Africa and Japan.
The MSN-2 medicaldevicewasannounced in November 2016, (https://globenewswire.com/news-release/2016/11/21/891699/0/en/ETST-Announces-60-Patient-Clinical-Prelaunch-Study-for-its-MSN-2-Medical-Device-for-the-Diagnosis-of-Chlamydia-Gonorrhea-ETST-Elects-Dr-Michel-Aubé-as-New-CEO-CSO-and-Nickolas-Tabr.html). The above mentioned medical device can be used by women to extract a cell sample from herself, which then is shipped to a proprietary lab for analysis of sexually transmitted infections. Our device is proven to sample for chlamydia and is currently undergoing testing to certify the device for gonorrhea sampling.
ETST will inaugurate the manufacturing facility for the MSN-2 medical device within Q2 2017, and the initial product release for detecting Chlamydia only may begin as soon as Q3 2017. The MSN-2 will be marketed only overseas during the beginning. The FDA and Health Canada approvals required to market a Class II medical device in Canada and the USA require the factory to be ISO-13485 accredited, which will take more time, estimating within 12 to 18 months.
GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) showing jumped of -0.70% and closed at $116.25, after gaining total volume of 219,510.00 shares. Its earnings per share (EPS) is -$3.30 and its beta value stands at 2.68 points and has total market capitalization of $2.80 billion and a total of 302.46 million outstanding shares.
GW Pharmaceuticals PLC- ADR (GWPH) on March 29, 2017 announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to GW’s investigational product Epidiolex® (cannabidiol or CBD) in the treatment of Lennox-Gastaut Syndrome (LGS), a treatment-resistant, debilitating childhood-onset epilepsy.
“Following two positive Phase 3 trials of Epidiolex in patients with LGS, GW is committed to pursuing registration of Epidiolex in Europe in order to provide these patients access to an approved prescription CBD medicine,” stated Justin Gover, GW’s Chief Executive Officer. “In addition to preparing to submit a New Drug Application with the U.S. Food and Drug Administration in the middle of 2017, we are also planning a submission to the EMA shortly afterwards.”
In addition to this Orphan Drug Designation by the EMA in LGS, GW has also previously been granted Orphan Drug Designation by the EMA for Epidiolex in the treatment of Dravet syndrome. In the U.S., GW has received Orphan Drug Designation from the FDA for Epidiolex in the treatment of LGS, Dravet syndrome, Tuberous Sclerosis Complex, and Infantile Spasms, each of which are severe infantile-onset, drug-resistant epilepsy syndromes. Additionally, GW has received Fast Track Designation from the FDA for Epidiolex in the treatment of Dravet syndrome.
The EMA orphan drug designation is a status assigned to a medicine intended for use against a rare condition (prevalence of the condition in the European Union must not be more than 5 in 10,000) and allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life threatening or a chronically debilitating rare disease.
Insys Therapeutics Inc (NASDAQ:INSY) decreased -4.08% closed at $10.57 and traded with total volume of 595,929.00 shares, while the average trading remained 790,876.00 shares. During last trade its minimum price was $10.46 and it gained the highest price of $11.15. Its market capitalization was $745.04 million.
Insys Therapeutics Inc (INSY) on April 3, 2017 announced financial results for the three- and twelve-month periods ended December 31, 2016.
Highlights of and subsequent to the fourth quarter of 2016 include:
- Total net revenue decreased to $54.9 million, compared to $93.9 million for the fourth quarter of 2015;
- Net loss was $3.7 million, or $(0.05) per basic and diluted share, compared to net income of $18.1 million, or $0.25 per basic and $0.24 diluted share, for the fourth quarter of 2015;
- Cash, cash equivalents and investments were $236.7 million as of December 31, 2016;
- Announced that the Company is providing for the use of Cannabidiol Oral Solution at doses up to 40 mg/kg/day in compassionate use studies in subjects with refractory pediatric epilepsy following completion of 48 weeks of treatment in the ongoing long-term safety study;
- Targeting an NDA filing by end-2017 for Buprenorphine Sublingual Spray for the treatment of moderate to acute pain;
- The DEA issued an interim final rule that would result in Syndros™ (dronabinol oral solution) being placed in Schedule II of the Controlled Substances Act;
- Saeed Motahari will become President and Chief Executive Officer and be appointed to the Board of Directors, effective April 17, 2017; and
- For the first quarter of 2017, the Company experienced an approximate 32% decline in Subsys scripts as compared the fourth quarter of 2016. As a result, Insys anticipates a commensurate impact on net revenue for the first quarter of 2017.