Vertex completed enrollment for the two Phase 3 studies of the next-generation corrector VX-659 in triple combination with tezacaftor and ivacaftor in people with cystic fibrosis with one F508del mutation and one minimal function mutation and in people with two F508del mutations. Vertex expects to report data from both Phase 3 studies of the VX-659 triple combination regimen in late 2018. Vertex expects to complete enrollment of the two Phase 3 studies of the next-generation corrector VX-445 in triple combination with tezacaftor and ivacaftor in Q4 and to report data from these studies in 1Q19. Vertex plans to evaluate data from both the VX-659 and VX-445 Phase 3 triple combination programs to choose the best regimen to submit for potential regulatory approval. The data expected in late 2018 for VX-659 and in 1Q19 for VX-445 are expected to provide the basis for submission of a New Drug Application to the FDA for people with one F508del mutation and one minimal function mutation no later than mid-2019. Vertex expects to disclose in late 2018 and 1Q19 only the topline results for the primary 4-week efficacy endpoints of the VX-659 and VX-445 Phase 3 studies, respectively, and whether the safety and efficacy profiles observed support a potential NDA submission. In 2H19, Vertex intends to disclose additional safety and efficacy data, including secondary endpoints, for each study following the completion of both the VX-659 and VX-445 Phase 3 triple combination programs.
Thursday, September 6, 2018
RedHill Biopharma advances to second stage of Yeliva carcinoma study
RedHill Biopharma announced that the ongoing single-arm Phase IIa study with orally-administered Yeliva for the treatment of advanced cholangiocarcinoma has achieved its pre-specified efficacy goal for the first stage of the two-stage study design, and as a result, the study will continue to its second stage, enrolling the full cohort of 39 evaluable patients.The primary efficacy endpoint of the study is defined as either partial or complete response, or stable disease at four months treatment with Yeliva. Enrollment of all subjects is expected to be completed by mid-2019. The single-arm Phase IIa study is evaluating the activity of Yeliva as a single agent in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma. All subjects enrolled in the study have received up to two lines of other systemic therapy for advanced disease. The study is being conducted at renowned clinical institutions in the U.S.
Illumina price target raised to $400 after management meetings at Cowen
Cowen analyst Doug Schenkel raised his price target on Illumina to $400 from $315 following meetings with management. The analyst said the meetings increased his conviction regarding the outlook for roughly 15% sequencing consumable revenue growth. He also said elasticity is good and there is room to further innovate on the NovaSeq platform. Schenkel, who said Illumina seems to be at a positive tipping point, reiterated his Outperform rating on the shares.
Intuitive Surgical submits robotic-assisted platform to FDA premarket
Intuitive Surgical announced it has submitted a premarket notification to the FDA for the company’s new flexible robotic-assisted, catheter-based platform, designed to navigate through very small lung airways to reach peripheral nodules for biopsies. Lung cancer is the world’s leading cause of cancer deaths. The majority of suspicious lesions found in the lung are small and difficult to access, which can make obtaining a diagnosis challenging.
Baxter receives FDA clearance for new Actifuse bone graft substitute
Baxter has received FDA clearance of Actifuse Flow Bone Graft Substitute for use in a variety of orthopedic surgical procedures. Actifuse Flow utilizes the proprietary silicate-substituted technology of Baxter’s Actifuse Bone Graft Substitute, which enhances silicon levels to accelerate bone formation. Baxter expects Actifuse Flow to be available to U.S. customers by year-end.
Allergan announces launch of SkinMedica LUMIVIVE System
Allergan announces the launch of the new SkinMedica LUMIVIVE System, an innovative skincare product designed with two distinct formulas – one to shield skin from blue light and environmental aggressors during the day and another to recharge the skin’s essential repair process at night. During the day, LUMIVIVE offers full atmospheric protection and fights the signs of aging for optimal skin health and vitality. At night, LUMIVIVE supports the skin’s ability to repair itself overnight, restoring the appearance of a glowing, youthful complexion. Unlike any other product on the market, the innovative LUMIVIVE System formulas work around the clock to support optimal skin vitality and radiance, and doesn’t fade throughout the day or wash off, providing 24-hour protection and revitalization.
HCA Healthcare price target raised to $150 from $116 at Argus
Argus analyst Jasper Hellweg raised his price target on HCA Healthcare to $150 and kept his Buy rating, saying the company’s recent acquisition of Mission Heath in North Carolina strengthens its regional presence. The analyst also cites the managements expectations of healthcare services demand rising 2.0-2.5% annually on “population growth, strong economic conditions, higher medical utilization, and an increase in the number of patients with chronic conditions.” Hellweg raises his FY18 EPS view on HCA Healthcare to $9.24 from $8.74, adding that its valuation is “attractive” at 14.4-times expected FY18 earnings vs. 17.5-times peer group average.
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