U.S. revenue is expected to be in the range of $14.3-$14.5 million, reflecting growth of 15-16% compared to the prior year period, in line with 2018 growth trends. International revenue is expected to be $1.1 million.
Monday, January 7, 2019
Chembio gets CE Mark for test developed in collaboration with AstraZeneca
Chembio Diagnostics (CEMI) announced that it has received a CE mark for its diagnostic test developed in collaboration with AstraZeneca (AZN). Chembio and AstraZeneca have collaborated to develop a quantitative diagnostic test to detect an undisclosed biomarker, using Chembio’s patented DPP platform. The CE marked DPP System, which includes the new DPP(R) test and DPP Micro Reader, provides quantitative results in ten minutes from a small drop of fingertip or venous blood. In December 2017, Chembio announced an 18-month agreement with AstraZeneca, under which Chembio will receive up to $2.9M in funding from AstraZeneca, subject to satisfying certain milestones, to develop a quantitative reader-based point-of-care test utilizing Chembio’s patented DPP platform. The DPP platform is the same technology used for Chembio’s DPP HIV 1/2 Assay, which is FDA-approved, CLIA Waived, CE marked, and WHO pre-qualified.
Abiomed ups FY19 revenue view to $780M from $765M-$770M; Consensus $773.55M
https://thefly.com/landingPageNews.php?id=2844340
Cardiovascular Systems FY19 revenue guidance $243-247M Consensus $244.72M
CEO Scott Ward said, “Our revenue results year-to-date position CSI to deliver fiscal 2019 revenue in a range of $243 million to $247 million, an increase of 12% to 14% compared to fiscal 2018. We plan to provide formal guidance details when we report fiscal second-quarter results at the end of the month.”
Intercept sees read-out of data from Phase 3 Regenerate trial analysis in Q1
Intercept Pharmaceuticals announced two updates to its NASH development program. Intercept anticipates that it will read-out top-line data from the interim analysis of its Phase 3 REGENERATE trial evaluating obeticholic acid in non-cirrhotic NASH patients with advanced liver fibrosis in the first quarter of 2019. Intercept also expects to complete enrollment of its Phase 3 REVERSE trial evaluating OCA in NASH patients with compensated cirrhosis in 2019. “2019 is expected to be a transformative year for Intercept, as we look forward to announcing top-line results from the REGENERATE interim analysis this quarter and continuing to advance our leading Phase 3 development program for the treatment of NASH patients with advanced liver fibrosis and compensated cirrhosis where we believe there is the greatest unmet medical need,” said Mark Pruzanski, M.D., Intercept’s President and CEO.
Amag preliminary Q4 revenue $85M-$90M, consensus $101.9M
For Q4, AMAG expects an operating loss of between $17M-$27M. Adjusted EBITDA for Q4 is expected to be within the company’s forecasted range of between a loss of $5M and positive adjusted EBITDA of $5M.
Syndax provides 2019 clinical, corporate outlook
“2019 is slated to be a milestone-rich time for, with data expected from multiple trials within our ENCORE program of entinostat in combination with checkpoint therapy in platinum resistant ovarian cancer, triple negative breast cancer, and anti-PD-1-pretreated melanoma, all of which we believe represent underserved areas with significant market opportunity,” said Briggs W. Morrison, M.D., CEO of Syndax. “We also eagerly anticipate the next interim overall survival analysis in the second quarter from the Phase 3 E2112 trial of entinostat plus exemestane in HR+, HER2- breast cancer and remain highly encouraged by the potential to provide a survival benefit for HR+, HER2- breast cancer patients who have stopped responding to first line treatment with hormone therapy. Any positive overall survival assessment would enable the company to file for full regulatory approval.” Dr. Morrison added, “In addition, we remain on track for an IND filing for our Menin inhibitor, SNDX-5613, in the second quarter of 2019, followed by initiation of the clinical trial program. Acute leukemias characterized by MLL-rearrangements and nucleophosmin mutations represent areas of high unmet medical need, and the preclinical data we’ve generated thus far provide strong support that menin inhibition has the potential to serve as an effective therapy for patients lacking viable options. Finally, we continue to expect initial efficacy results for SNDX-6352 in chronic graft versus host disease in the second half of 2019.” Syndax ended 2018 with cash, cash equivalents and short-term investments of approximately $80M. For 2019, research and development expenses are expected to be $54M-$58M, and total operating expenses are expected to be $68M-$73M. Research and development expenses and total operating expenses for 2019 are expected to include approximately $2M-$6M, respectively, of non-cash stock compensation
Subscribe to:
Posts (Atom)