Industry

Earnings Analysis to Watch: GW Pharmaceuticals PLC- ADR (GWPH), Earth Science Tech Inc (ETST), Insys Therapeutics Inc (INSY)

GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) showing jumped of 0.04% and closed at $121.17, after gaining total volume of 168,930.00 shares. Its earnings per share (EPS) is -$3.28 and its beta value stands at 2.66 points and has total market capitalization of $2.83 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.”

OPERATIONAL HIGHLIGHTS

  • Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
  • Regulatory:
  • NDA submission for both Dravet and LGS indications expected mid 2017
  • Preparations advancing for expected EU regulatory submission in H2 2017
  • Clinical:
  • 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
  • Commercial:
  • 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
  • THC:CBD for Glioma
  • Positive Phase 2 placebo-controlled data in Recurrent Glioblastoma Multiforme (GBM) (see separate announcement issued)
  • Orphan Drug Designation from FDA and EMA
  • Multiple relevant patents granted or in process
  • Other cannabinoid pipeline product candidates:
  • CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected H2 2017
  • CBDV pre-clinical research ongoing within field of autism spectrum disorders. Phase 2 trials expected to commence in H2 2017
  • Orphan Drug Designation from FDA for CBDV for the treatment of Rett syndrome
  • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
  • Phase 1 trial commenced in October 2016
  • Orphan Drug and Fast Track Designations granted from FDA and EMA

Earth Science Tech Inc (OTCMKTS:ETST) reported the surge of 5.56% and closed at $1.90, with the total traded volume of 16,211.00 shares. During last trade its minimum price was $1.85 and it gained its highest price of $2.05 and has a total of 77.73 million outstanding shares.

On March 14, 2017 Earth Science Tech, Inc. (ETST), an innovative biotech company focused on cannabis (industrial hemp), cannabinoid research and development, nutraceuticals, pharmaceuticals, and medical devices is proud to announce its subsidiaries Cannabis Therapeutic, Inc. and Earth Science Pharmaceutical, Inc. the nomination of Kim Foster-Cunningham to the post of Project Manager for the MSN-2 medical device project; and Denis Babin of SDB Import/Export, Inc. as international marketing consultant for Cannabis Therapeutics and Earth Science Pharmaceutical products.

Ms. Foster-Cunningham’s immediate focus is preparatory phase of the pre-market clinical trial of the MSN-2 medical device. The MSN-2 device is a revolutionary medical instrument for the detection and diagnosis of Chlamydia and Gonorrhea, from previous announcement, (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 Tabraue as President.)

Ms. Foster-Cunningham, whom holds a degree in sales and marketing, is recognized for her expertise in business networking and her solid business expertise. She is a sought-after speaker throughout the USA and Canada, delivering conferences on her proactive approach to general health and self-care. Passionate about individual sports, she is a half marathon runner and a triathlete. Always enthusiastic about transmitting her passion for health and business development, this project is “her new baby”.

Insys Therapeutics Inc (NASDAQ:INSY) increased 0.38% closed at $10.61 and traded with total volume of 725,276.00 shares, while the average trading remained 1.18 million shares. During last trade its minimum price was $10.31 and it gained the highest price of $10.92. Its market capitalization was $764.36 million.

Insys Therapeutics, Inc., a specialty pharmaceutical company, develops and commercializes supportive care products. The company markets Subsys, a sublingual fentanyl spray for breakthrough cancer pain in opioid-tolerant cancer patients in the United States. Its lead product candidate is Syndros, an orally administered liquid formulation of dronabinol. The company is also developing Cannabidiol Oral Solution, a synthetic cannabidiol for childhood catastrophic epilepsy syndromes; and other product candidates, including other dronabinol line extensions and sublingual spray product candidates. Insys Therapeutics, Inc. is headquartered in Chandler, Arizona.

 

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