Earnings Estimates Highlights: GW Pharmaceuticals PLC- ADR (GWPH), Earth Science Tech Inc (ETST), Insys Therapeutics Inc (INSY)
GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) showing dropped of -0.95% and closed at $115.98, after gaining total volume of 407,374.00 shares. Its earnings per share (EPS) is -$3.29 and its beta value stands at 2.68 points and has total market capitalization of $2.76 billion and a total of 302.46 million outstanding shares.
GW Pharmaceuticals PLC- ADR (GWPH) on February 7, 2017 announced financial results for the first quarter ended 31 December 2016.
“As we look forward to 2017, our primary focus is on completing the Epidiolex NDA, which we expect to submit to the FDA in the middle of this year. With three positive Phase 3 trials delivered in 2016, we remain confident in the prospects for Epidiolex’s approval and are accelerating our preparations for a highly successful launch,” stated Justin Gover, GW’s Chief Executive Officer. “Beyond Epidiolex, the value of GW’s cannabinoid platform is further illustrated by promising new clinical data in the field of oncology and we continue to advance a number of additional clinical programs that will yield data this year.”
- Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
- NDA submission for both Dravet and LGS indications expected mid 2017
- Preparations advancing for expected EU regulatory submission in H2 2017
- Positive results in a pivotal Phase 3 Dravet syndrome trial and in two pivotal Phase 3 LGS trials
- Substantial new data presented at the American Epilepsy Society Annual Meeting in December 2016
- Manufacturing scale-up on track to deliver significant commercial launch inventory
- Pre-NDA CMC meeting held with FDA in November 2016
- Successful UK regulatory GMP inspection of GW manufacturing facility in December 2016. On track for FDA GMP inspection anticipated in H2 2017
- Expanded access program and open label extension:
- Over 1,200 patients now on Epidiolex treatment
- 97 percent of patients who complete Phase 3 trials have entered long term extension
- US commercial team build well underway and pre-launch preparations advancing well
- EU commercial team now being established
- Follow-on indications:
- Phase 3 trial in TSC ongoing
- Two part Phase 3 trial in IS commenced in December 2016
- Intellectual Property:
- Patent portfolio being prosecuted with claims directed to the use of CBD in the treatment of epilepsy seizure subtypes and epilepsy syndromes
Earth Science Tech Inc (OTCMKTS:ETST) reported the plunge of -6.25% and closed at $1.50, with the total traded volume of 12,266.00 shares. During last trade its minimum price was $1.38 and it gained its highest price of $1.61 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.
Insys Therapeutics Inc (NASDAQ:INSY) increased 1.89% closed at $10.22 and traded with total volume of 508,451.00 shares, while the average trading remained 915,530.00 shares. During last trade its minimum price was $9.86 and it gained the highest price of $10.28. Its market capitalization was $735.40 million.
Insys Therapeutics, Inc. is a commercial-stage specialty pharmaceutical company. The Company develops and commercializes supportive care products. The Company’s product Subsys, is a sublingual fentanyl spray for breakthrough cancer pain (BTCP) in opioid-tolerant patients and a single-use product that delivers fentanyl, an opioid analgesic, for transmucosal absorption underneath the tongue. The Company markets Subsys through its field sales force focused on supportive care physicians in the United States. Subsys delivers a liquid fentanyl formulation in approximately 100, 200, 400, 600, 800, 1,200 and 1,600 micrograms (mcg) dosages. The Company’s lead dronabinol product candidate is Syndros, which is under review for approval at the Food and Drug Administration. In addition, the Company is evaluating sublingual spray, inhaled and intravenous formulations of dronabinol in preclinical studies.