Sientra reports Q2 EPS (68c), consensus (43c) » 16:1808/1008/10/20
Reports Q2 revenue…
Reports Q2 revenue $12.4M, consensus $8.75M. Jeff Nugent, Sientra's Chairman and Chief Executive Officer, said, "While the COVID-19 pandemic has posed unprecedented challenges, we are encouraged by our performance through this stage of the recovery and our competitive position as we exited Q2. We are particularly encouraged by the durability of the demand for our OPUS(R) breast implants and tissue expanders, as well as the effectiveness of our Drive the Recovery initiatives as we continued to take share from our competitors through new account additions and further penetration of our existing customers. We also successfully transitioned our miraDry business to focus on high-margin, recurring bioTip sales and have seen utilization rates return to pre-COVID-19 levels in key geographic markets, including the United States, as we exited Q2."
Spark Therapeutics appoints Gallia Levy as CMO » 08:3108/1008/10/20
Spark Therapeutics announced the appointment of Gallia Levy, M.D., Ph.D., as chief medical officer. Dr. Levy will be responsible for strategic and operational leadership across all functions in the product development lifecycle, including setting the global development strategy for current and future pipeline programs. Levy joins Spark Therapeutics from Genentech, also a member of the Roche Group, where she served as the Vice President and Global Head of the Rare Blood Disorders franchise in Product Development.
Guardion Health Sciences FDA approval landmark event, says Canaccord » 08:1908/1008/10/20
Canaccord analyst Mark…
Canaccord analyst Mark Massaro said the FDA approval for Guardant360 for comprehensive genomic profiling in patients with solid tumor cancer, is a landmark event in precision medicine. He expects the FDA approval to serve as a major catalyst to drive adoption from medical oncologists that were skeptical of its performance versus standard-of-care tissue based tests. Massaro reiterated his Buy rating and $125 price target on Guardant shares.
Genentech says etrolizumab trial met one primary endpoint, failed to meet other » 05:1408/1008/10/20
Genentech, a member of…
Genentech, a member of the Roche Group, announced topline results from its Phase III study program evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. Genentech said in a release, "Mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo. In the HIBISCUS I induction study, in people without prior anti-tumor necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, did not meet its primary endpoint. In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but not at maintenance. In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four Phase III clinical trials reported to date. Further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings. Etrolizumab continues to be studied as an investigational induction and maintenance treatment in people with moderately to severely active Crohn's disease with and without prior anti-TNF treatment in a global Phase III study (BERGAMOT) and open-label extension and safety monitoring study (JUNIPER), involving more than 1,100 people with Crohn's disease. In addition, Genentech is studying other investigational medicines in inflammatory bowel diseases and is committed to further understanding this disease."
Week in review: How Trump's policies moved stocks » 07:3208/0808/08/20
TCEHY, MSFT, AZN, BMY, LLY, GSK, RHHBY, KODK, AA, CENX, KALU, ARNC, FB, TWTR
Catch up on the top…
Guardant Health announces FDA approval for Guardant360 CDx for CGP » 14:2808/0708/07/20
Guardant Health announces…
Guardant Health announces that the U.S. Food and Drug Administration has approved Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling, or CGP, in patients with any solid malignant neoplasm. The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor alterations who may benefit from treatment with Tagrisso. "Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options," the company said. "The FDA approval of Guardant360 CDx is a landmark decision, demonstrating the value liquid biopsy delivers to oncologists and more importantly, the patients they treat. Traditional tissue biopsy-based tumor profiling, which is often invasive and has longer turnaround times, can contribute to delays in starting treatment and possibly suboptimal therapy. We applaud the FDA for their collaborative review process and for approving the first comprehensive genomic profiling liquid biopsy test. We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx," added Guardant Health CEO Helmy Eltoukhy.
Guardant Health halted, news pending 14:2208/0708/07/20
PTC wins FDA approval of spinal muscular atrophy treatment Evrysdi » 13:5808/0708/07/20
PTC Therapeutics (PTCT)…
PTC Therapeutics (PTCT) announced that the Food and Drug Administration has approved Evrysdi, the first at-home, orally administered treatment for spinal muscular atrophy in adults and children two months and older. Evrysdi will be available in the United States within two weeks for direct delivery to patients' homes through Accredo Health Group, an Express Scripts specialty pharmacy, PTC noted. Evrysdi will be marketed in the United States by Genentech, a unit of Roche Group (RHHBY). Outside the United States, Roche holds global commercialization rights to risdiplam. Shares of PTC Therapeutics halted for trade up 7% to $50.35.
Roche announces FDA approval of Evrysdi for Spinal Muscular Atrophy treatment » 13:5008/0708/07/20
PTCT, RHHBY, ESRX
Genentech, a member of…
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration has approved Evrysdi, or risdiplam, for treatment of spinal muscular atrophy, or SMA, in adults and children 2 months of age and older. A liquid medicine, Evrysdi is administered daily at home by mouth or feeding tube. Evrysdi is designed to treat SMA by increasing production of the survival of motor neuron protein, which is found throughout the body and is critical for maintaining healthy motor neurons and movement, the company said. Genentech leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics (PTCT). Evrysdi will be available in the United States within two weeks for direct delivery to patients' homes through Accredo Health Group, an Express Scripts (ESRX) specialty pharmacy.
Roche announces FDA approval of Evrysdi for Spinal Muscular Atrophy treatment 13:4808/0708/07/20