Tue, Aug. 9, 10:23 AM| Tue, Aug. 9, 10:23 AM | 1 Comment
Tue, Aug. 9, 7:15 AM
Mon, Aug. 8, 5:30 PM
- ACM, AER, AMAG, AMRC, AMSC, ARES, BDSI, BERY, BITA, BR, CECE, CHTR, CNK, COH, CORE, EGRX, ENZY, EVEP, EXC, GLPI, GWPH, HCP, HHS, HPT, HRI, HWCC, INCY, IONS, IPXL, JEC, LABL, LAMR, LGIH, LNCE, LNG, LRN, LXP, MCC, MPAA, MWW, NCLH, NCT, NRG, NXST, NYLD, OCUL, PDCE, PMC, PPL, RDNT, RRGB, RSTI, SATS, SNI, SSH, STE, TDG, TESO, TGH, TLP, TRCO, UNVR, VRTU, VRX, W, WAC, WPRT, WWAV, ZBRA
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.
Tue, May 31, 5:37 PM
Thu, May 5, 10:04 AM
Thu, May 5, 7:26 AM
Wed, May 4, 5:30 PM
- AAC, AAON, AAWW, ABC, ACIW, ACRE, ACTA, AGIO, AMCX, AMRC, AMRN, ANIP, ANSS, APA, APO, AVP, AXLL, BABA, BCRX, BDX, BR, CBB, CCC, CCOI, CDK, CHD, CHK, CLDT, CNAT, CNNX, CNSL, COT, CVC, CWEI, DDD, DIN, DISCA, DNR, EAC, ENOC, EPAM, ESNT, EVA, FIG, FLDM, G, GCAP, GWPH, HII, HL, HWCC, ICON, IT, ITG, ITT, JEC, JMBA, K, LAMR, LFUS, LINC, LIOX, LMOS, LQDT, LXP, MBLY, MDC, MFC, MGA, MGLN, MGM, MITL, MLM, MMS, MRK, MWW, NICE, NILE, NRG, NTCT, NYLD, OGE, ONE, OXY, PGNX, PGTI, PRFT, PRIM, PWR, RDEN, RDUS, REGN, RFP, RGEN, RLGY, RSTI, RWLK, SBH, SEAS, SFM, SHLX, SNH, SNI, SNR, SNSS, SPH, SQBG, STOR, TDC, TDY, TE, THS, TIME, TLP, TWI, UNT, USAC, USAK, USCR, VER, VG, VLP, WIN, WPC, WRLD
Mon, Apr. 25, 2:06 PM
- The FDA designates GW Pharmaceuticals' (GWPH -0.9%) Epidiolex (cannabidiol) an Orphan Drug for the treatment of Tuberous Sclerosis Complex (TSC), a rare genetic condition characterized by the formation of non-malignant tumors in different organs that frequently cause seizures.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
- A Phase 3 study in TSC was initiated earlier this month.
- Previously: GW Pharma initiates late-stage study of Epidiolex in seizure-characterized genetic disorder (April 11)
Mon, Apr. 11, 3:18 PM
- GW Pharmaceuticals (GWPH +0.5%) commences a Phase 3 clinical trial assessing lead product candidate Epidiolex (cannabidiol) for the treatment of Tuberous Sclerosis Complex (TSC), a rare genetic condition characterized by formation of non-malignant tumors in different organs. When the tumors form in the brain, they frequent cause seizures, delays in mental development and autism. TSC affects ~50K Americans and ~1M people globally. 80 - 90% of TSC sufferers will develop epilepsy in their lifetimes.
- The 16-week dose-ranging trial will evaluate Epidiolex against placebo in ~200 subjects. The primary endpoint is the change from baseline in seizure frequency during the treatment period.
- Epidiolex is currently in late-stage development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, both forms of epilepsy.
- Read now Soaring Stock Price Of GW Pharma Confirm It As Best Medical Marijuana Play
GW Pharmaceuticals Plc engages in the business of discovering, developing and commercializing novel therapeutics from proprietary cannabinoid product platform in a broad range of disease areas. The company operates through the following segments: Commercial, Sativex Research & Development and... More
Industry: Drug Manufacturers - Other
Country: United Kingdom