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GW Pharmaceuticals will report its financial results for Q3 2020 on November 3, 2020, with a conference call scheduled for 8:30 a.m. EST. The company focuses on developing cannabinoid-based therapeutics, notably EPIDIOLEX® for severe epilepsy syndromes. This product is approved in the U.S. and EU for certain seizure disorders. GW is advancing multiple clinical programs, including a Phase 3 trial in Rett syndrome, and aims for FDA approval of various other cannabinoid candidates.
Greenwich Biosciences has launched unspoken symphony, a web-based image-recognition technology designed to help individuals with epilepsy communicate through art by translating their artwork into melodies. Inspired by a 15-year-old girl with Lennox-Gastaut syndrome, the platform allows users to upload artwork and receive a unique musical composition in seconds. The initiative is in collaboration with various patient advocacy organizations and aims to provide innovative ways for the epilepsy community to connect. The service features a gallery of symphonies created by those living with epilepsy.
GW Pharmaceuticals has received approval from Australia's Therapeutic Goods Administration (TGA) for EPIDYOLEX® (cannabidiol) to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients aged two years and older. This marks the third global regulatory approval for the drug, following the FDA and European Commission approvals in 2018 and 2019, respectively. GW has partnered with Chiesi Australia to facilitate access and is pursuing reimbursement through the Pharmaceutical Benefits Scheme. The approval is based on data from four Phase 3 trials involving over 714 patients.
GW Pharmaceuticals has announced positive results from analyses of Phase 3 trials of nabiximols, aimed at treating multiple sclerosis-associated spasticity. Findings indicate that nabiximols was well-tolerated and led to significant reductions in spasticity for patients remaining on therapy. Additionally, the treatment showed no negative effects on cognition, depression, or suicidality. The results will be presented at MSVirtual2020 on September 11, with plans for further Phase 3 trials in the U.S. This treatment represents a potential breakthrough for a significant unmet therapeutic need.
GW Pharmaceuticals plc (Nasdaq: GWPH) has appointed David Gryska to its Board of Directors, effective September 10, 2020. He also joins the Audit Committee, bringing extensive pharmaceutical experience and financial leadership. Gryska previously served as CFO at major biopharmaceutical firms and currently sits on the boards of various companies. His expertise is expected to enhance GW's commercial growth and product pipeline expansion, particularly in cannabinoid science, which addresses significant unmet medical needs.
GW Pharmaceuticals reported a 68% increase in total revenue for Q2 2020, reaching $121.3 million, driven by strong sales of Epidiolex. The company recorded a net loss of $8.8 million during the quarter, contrasting with a net income of $79.7 million in Q2 2019, which was boosted by proceeds from a Rare Pediatric Priority Review Voucher. The FDA approved Epidiolex for treating seizures associated with TSC, with a launch anticipated soon. GW Pharmaceuticals is also advancing its pipeline, including nabiximols for MS spasticity.
GW Pharmaceuticals plc (Nasdaq: GWPH) will release its financial results and operational updates for Q2 2020 on August 6, 2020. The announcement will be accompanied by a conference call at 4:30 p.m. EDT. GW is recognized for its proprietary cannabinoid product platform, particularly EPIDIOLEX, which treats seizures in patients with Lennox-Gastaut and Dravet syndromes. The company aims to expand EPIDIOLEX's indications and is advancing multiple cannabinoid candidates in late-stage clinical trials.
GW Pharmaceuticals has outlined its U.S. strategy for nabiximols, aiming for potential NDA submission by 2021. The clinical program encompasses five Phase 3 trials targeting multiple indications, starting with MS spasticity. Following FDA meetings, GW is optimistic about the drug's commercial prospects. Today's webcast will detail the clinical program's design and guest experts. Nabiximols, a cannabis-derived treatment, is already available internationally and is expected to enter pivotal Phase 3 trials in the U.S. by late 2020.
GW Pharmaceuticals announces that the UK Home Office has reclassified EPIDYOLEX (cannabidiol) from Schedule 2 to Schedule 5 drug status, easing the burden on patients and healthcare providers. This change, effective immediately across the UK, allows easier dispensing and greater flexibility in prescriptions. The reclassification was motivated by low abuse potential and dependency risks, confirmed by the Advisory Council on the Misuse of Drugs (ACMD). GW remains committed to expanding the evidence base for cannabis-based medicines and obtaining further regulatory approvals.
