Wed, Sep. 28, 5:40 PM
Mon, Sep. 26, 12:48 PM
Mon, Sep. 26, 11:00 AM
Mon, Sep. 26, 9:13 AM
Mon, Sep. 26, 7:45 AM
- GW Pharmaceuticals (NASDAQ:GWPH) announces positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
- In this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint for both dose levels with high statistical significance. During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42% compared with a reduction of 17% for placebo, and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37% compared with a reduction of 17% for control.
- This trial follows the announcement in June of positive results in the first pivotal Phase 3 trial of Epidiolex for the treatment of seizures associated with LGS, and the March announcement of positive results in the treatment of seizures associated with Dravet syndrome. GW expects to submit a New Drug Application (NDA) to the FDA in H1 2017.
- Shares are up 13% premarket on increased volume.
Wed, Sep. 7, 3:32 PM
- GW Pharmaceuticals (GWPH +20.6%) is up on more than double normal volume amidst rumors that it is working with an investment bank after unnamed companies contacted it about a possible transaction.
- The company's lead product candidate is Phase 3-stage Epidiolex (cannabidiol) in development for the treatment of certain kinds of epilepsy, infantile spasms and tuberous sclerosis complex. A U.S. marketing application is on tap for H1 2017 for Lennox-Gastaut syndrome and Dravet syndrome, two forms of childhood epilepsy.
- Fellow cannabidiol developers Insys Therapeutics (INSY +4.8%) and Zynerba Pharmaceuticals (ZYNE +9%) are also up. Insys' candidate is in development for the treatment of cocaine dependence. Zynerba's (ZYN002) is a topical gel formulation for the potential treatment of knee pain due to arthritis and Fragile X syndrome.
Tue, Aug. 9, 10:23 AM| Tue, Aug. 9, 10:23 AM | 1 Comment
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Tue, Jul. 12, 5:39 PM
- GW Pharmaceuticals (NASDAQ:GWPH) announces its plan to sell $150M of American Depositary Shares (ADSs) in a U.S. public offering. Underwriters over-allotment will be an additional $22.5M of ADSs. Price and terms have yet to be announced.
- Shares are down 3% after hours on modest volume.
- Update: On July 13, the company announced that the offering is 2.8M ADSs at $90 per ADS generating gross proceeds of $252M. Each ADS represents 12 ordinary shares. Underwriters over-allotment is an additional 420K ADSs. Closing date is July 18. Shares are down 6% on more than triple normal volume.
- Update: On July 18, GW announced that it raised $289.8M. The underwriters over-allotment was fully exercised.
Tue, Jul. 12, 5:36 PM
Fri, Jul. 1, 10:13 AM
- Aldyra Therapeutics (NASDAQ:ALDX) initiated with Buy rating and $16 (158% upside) price target by Stifel Nicolaus.
- Shire plc (NASDAQ:SHPG) re-initiated with Buy rating and 6300p (36% upside) price target by Goldman Sachs.
- Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Outperform rating and $16 (129% upside) price by Baird.
- Ultragenyx (NASDAQ:RARE) initiated with Buy rating and $72 (41% upside) price target by Bank of America.
- NantHealth (NASDAQ:NH) initiated with Buy rating and $17 (36% upside) price target by Canaccord Genuity. First Analysis rates it Overweight with an $18 (44% upside) price target. Cowen and Company rates it Outperform with a $19 (52% upside) price target.
- Clearside Biomedical (Pending:CLSD) initiated with Buy rating and $13 (84% upside) price target by Stifel Nicolaus. Cowen & Company rates it Outperform. Wedbush rates it Outperform with $28 (296% upside) price target.
- GW Pharmaceuticals (NASDAQ:GWPH) initiated with Sell rating and $40 (57% downside risk) price target by Janney Capital.
Mon, Jun. 27, 9:13 AM
Mon, Jun. 27, 8:14 AM
- GW Pharmaceuticals (NASDAQ:GWPH) is up 18% premarket on robust volume in response to its announcement of positive top-line data from a Phase 3 clinical trial assessing lead product candidate, Orphan Drug-tagged Epidiolex (cannabidiol), for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
- The study achieved its primary endpoint of a statistically valid reduction in the monthly frequency of drop seizures over the 14-week treatment period compared to placebo (p=0.0135).
- The trial randomized 171 LGS patients 1:1 to receive either 20 mg/kg/day of Epidiolex (n=86) or placebo (n=85) added to their current anti-epileptic drug treatment. The median baseline drop seizure frequency per month was 74, which was reduced 44% in the Epidiolex arm compared to a 22% reduction for placebo. Drop seizures were defined as atonic (brief lapse in muscle tone), tonic (body stiffens) and tonic-clonic (muscles stiffen accompanied by jerky movements) seizures involving the entire body, trunk or head that led or could have led to a fall, injury, slumping in a chair or hitting the patient's head on a surface.
- CEO Justin Glover says, "We are delighted to announce positive results in this Phase 3 trial of Epidiolex in patients with Lennox-Gastaut syndrome, and particularly pleased that this result is consistent with our recent Phase 3 pivotal data for Epidiolex in Dravet syndrome. We now look forward to advancing Epidiolex towards the submission of an NDA with the FDA in the first half of 2017."
- Full results will be presented at future medical conferences and will be submitted for publication.
- Results from a second Phase 3 study in LGS should be released in Q3.
Tue, Jun. 21, 8:18 AM
- GW Pharmaceuticals (NASDAQ:GWPH) edges up 3% premarket on light volume in response to its announcement that it has formalized a fourth target indication, infantile spasms (IS), for lead product candidate Epidiolex (cannabidiol). The FDA has designated Epidiolex an Orphan Drug for the treatment of IS. A two-part Phase 3 study should commence in Q4.
- IS is an epilepsy-type of seizure in infancy and childhood known as West syndrome. The condition constitutes 2% of childhood epilepsy cases. It affects 2K - 4K American kids each year. The long-term prognosis is poor.
- Epidiolex is currently under development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex.
Fri, Jun. 3, 8:01 AM
- GW Pharmaceuticals (NASDAQ:GWPH) initiated with Buy rating and $181 (87% upside) price target by Cantor Fitzgerald.
- Bluebird bio (NASDAQ:BLUE) initiated with Hold rating and $42 (13% downside risk) price target by Cantor Fitzgerald.
- Kite Pharma (NASDAQ:KITE) initiated with Outperform rating and $61 (11% upside) price target by Raymond James.
- Spark Therapeutics (NASDAQ:ONCE) initiated with Hold rating and $58 (5% upside) price target by Jefferies.
- Zoetis (NYSE:ZTS) initiated with Buy rating and $58 (21% upside) price target by Stifel Nicolaus.
- Cardiome Pharma (NASDAQ:CRME) initiated with Buy rating and $9.50 (87% upside) price target by H.C. Wainwright.
- Premier (NASDAQ:PINC) initiated with Overweight rating and $41 (24% upside) price target by Barclays.
- Gilead Sciences (NASDAQ:GILD) initiated with Buy rating and $109 (25% upside) price target by Gabelli & Co.
- Intellia Therapeutics (NASDAQ:NTLA) initiated with Outperform rating and $39 (39% upside) price target by Credit Suisse.