Reports Q1 revenue $461.4M, consensus $450.14M.
Thursday, May 2, 2019
Magellan Health backs 2019 adjusted EPS view $3.70-$4.69, consensus $3.92
Lowers 2019 revenue view to $7.0M-$7.2M from $7.2B-$7.5B, consensus $7.22B.
GlycoMimetics reports Q1 EPS (33c), consensus (34c)
“The first quarter of 2019 was one of focused activity in the clinical development arena. We continued to identify and initiate new sites and enroll participants in our Company-sponsored Phase 3 trial in relapsed or refractory AML patients. We also worked closely with our two consortia partners to expand our late-stage uproleselan program, culminating in our announcement that the NCI consortium dosed its first patient in its trial in late April. During the same period, we worked with clinical collaborators at Duke Cancer Institute to plan our next trial for GMI-1359, a dual antagonist of E-selectin and CXCR-4, and defined individuals with breast cancer and bone metastases as our initial target study population,” said CEO Rachel King.
Kaleido Biosciences reports Q1 EPS ($1.56), consensus (67c)
Cash and cash equivalents were $121.3M as of March 31. “The first quarter of 2019 was historic for Kaleido. During the four years since our inception, we built a library of over 1,000 Microbiome Metabolic Therapy candidates, completed seven non-IND human clinical studies, and established a pipeline with five programs spanning multiple disease areas. This rapid advancement of our platform and portfolio culminated with our Initial Public Offering and the initiation of our first human studies in two different target patient populations in the first quarter,” said Alison Lawton, president and CEO of Kaleido. “I am exceptionally proud of our talented and hard-working team, and we are grateful to everyone who has supported us along the way, including investigators, clinical study participants and investors. Looking ahead, we anticipate additional important milestones during 2019, including the initiation of our Phase 2 clinical trial under our cleared IND for KB195 in patients with urea cycle disorders (UCD) – as well as data from non-IND clinical studies we recently initiated for KB195 in UCD patients and KB174 in patients with cirrhosis.”
Kiniksa reports Q1 EPS ($1.27), consensus (80c)
“The first quarter of 2019 was marked by the advancement of our clinical-stage pipeline,” said Sanj K. Patel, CEO and Chairman of the Board of Kiniksa. “Progress included the initiation of our Phase 2a trial for KPL-716 in prurigo nodularis as well as the continued enrollment of our pivotal Phase 3 trial for rilonacept in recurrent pericarditis and our global Phase 2 trial for mavrilimumab in giant cell arteritis. Going forward, we expect to build upon this momentum with focused investment behind our product candidates, including commercial readiness activities for rilonacept, and continued execution.” Kiniksa is enrolling RHAPSODY, a global, randomized-withdrawal design, pivotal Phase 3 clinical trial of rilonacept in subjects with recurrent pericarditis. The primary efficacy endpoint is time-to-first-adjudicated pericarditis-recurrence in the RW period. Top-line data are expected in the second half of 2020. Kiniksa is enrolling a global Phase 2 proof-of-concept clinical trial of mavrilimumab in subjects with GCA. The primary efficacy endpoint is time-to-first-flare. Top-line data are expected in the second half of 2020. Kiniksa is enrolling a Phase 2a clinical trial of KPL-716 in subjects with prurigo nodularis. The primary efficacy endpoint is percent change from baseline in weekly average Worst-Itch Numeric Rating Scale. Top-line data are expected in the first half of 2020. Kiniksa plans to initiate an exploratory Phase 2 clinical trial in diseases characterized by chronic pruritus in the first half of 2019. The trial is designed to identify chronic pruritic conditions where interleukin-31 and/or oncostatin M may be playing a role and to investigate the efficacy, safety and tolerability of KPL-716 in reducing the moderate-to-severe pruritus experienced by these subjects. Top-line data are expected in the second half of 2020. Kiniksa is progressing its preclinical activities with KPL-404, a monoclonal antibody inhibitor of the CD40 co-stimulatory receptor, in T-cell-dependent, B-cell-mediated disorders. Kiniksa expects to file an investigational new drug application with the FDA in the second half of 2019 and initiate a Phase 1 clinical trial in the first half of 2020. Kiniksa expects that its cash, cash equivalents and short-investments will fund its current operating plan into 2021.
Abiomed: FDA approval of STEMI DTU Pivotal Randomized Controlled Trial
Abiomed announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading, or STEMI DTU, Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive delayed reperfusion after 30 minutes of left ventricular unloading with the Impella CP. The other half will receive immediate reperfusion, the current standard of care.
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