| Over a month ago | ||||
Chief Development Officer… Chief Development Officer Klencke, along with Dr. Kiladjian of Saint-Louis Hospital, Dr. Mesa, Director of the Mays Cancer Center and Dr. Verstovsek of the MD Anderson Cancer center provide an overview of the Momelotinib data presented at the recently held ASH Annual Meeting on December 16 at 10 am. Webcast Link | ||||
Chief Development Officer… Chief Development Officer Klencke, along with Dr. Kiladjian of Saint-Louis Hospital, Dr. Mesa, Director of the Mays Cancer Center and Dr. Verstovsek of the MD Anderson Cancer center provide an overview of the Momelotinib data presented at the recently held ASH Annual Meeting on December 16 at 10 am. Webcast Link | ||||
H.C. Wainwright analyst… H.C. Wainwright analyst Joseph Pantginis assumed coverage of Sierra Oncology with a Buy rating and $29 price target. Sierra is in a strong position to deliver a differentiated drug for the treatment of myelofibrosis with a projected launch in 2023, Pantginis tells investors in a research note. | ||||
Chief Development Officer… Chief Development Officer Klencke, along with Dr. Kiladjian of Saint-Louis Hospital, Dr. Mesa, Director of the Mays Cancer Center and Dr. Verstovsek of the MD Anderson Cancer center provide an overview of the Momelotinib data presented at the recently held ASH Annual Meeting on December 16 at 10 am. Webcast Link | ||||
Sierra Oncology reported… Sierra Oncology reported an updated efficacy analyses of momelotinib in myelofibrosis patients with thrombocytopenia. The data were presented in a poster presentation at the 2020 American Society of Hematology, or ASH, Annual Meeting by Jean-Jacques Kiladjian, MD, PhD, Consultant Hematologist, Head, Clinical Investigation Center, Saint Louis Hospital, Paris, France. "These exciting data provide a novel insight into a patient population where momelotinib's unique receptor inhibition profile-JAK1, JAK2 & ACVR1-may be particularly relevant. The observation of preserved activity in patients with reduced platelet counts is provocative and potentially differentiating. The wealth of information contained in the SIMPLIFY studies will enable further analyses and potentially identify additional populations of interest to be presented at future scientific meetings. We now look forward to completing enrollment in the pivotal Phase 3 MOMENTUM study and subsequent topline data to support our plan to file for regulatory approval of momelotinib for the treatment of myelofibrosis," said Stephen Dilly, MBBS, PhD, CEO at Sierra Oncology. | ||||
Sierra Oncology reported… Sierra Oncology reported updated overall survival data for momelotinib in both JAKi-naive and patients previously treated with ruxolitinib. The data were presented in an oral presentation at the 2020 American Society of Hematology Annual Meeting. The SIMPLIFY-1 and SIMPLIFY-2 Phase 3 studies evaluated momelotinib against ruxolitinib or best available therapy for a 24-week randomization treatment phase, followed by an opportunity for extended momelotinib treatment for all patients. Robust OS was observed in both JAKi-naive and previously ruxolitinib-treated patients. In S1, the median OS has not been reached in the MMB arm and 53.1 months in the control arm. In S2, the median OS was 34.3 months in originally MMB-randomized patients and 37.5 months in the BAT/RUXaMMB arm, representing the best reported OS in this previously RUX-treated setting. Sustained transfusion independence was observed with extended MMB treatment. In S1, TI response at Week 24 was 67% in the MMB arm and 49% in the control arm. 40% of MMB-treated patients achieved a splenic response at any time during S1. The median duration of TI has not been reached after greater than3 years of follow up. In S2, TI response at Week 24 was 43% in the MMB arm and 21% in the control arm. Compound safety was favorable for MMB with limited hematological toxicity and lack of cumulative toxicity. Patients were randomized 1:1 and 2:1 to receive MMB versus RUX or BAT for 24 weeks followed by extended momelotinib treatment. Both trials had primary endpoints of Splenic Response Rate and secondary endpoints of Total Symptom Score and Transfusion Independence Rate. | |
Reports Q3 revenue $100K… Reports Q3 revenue $100K vs. $0 a year ago. "We continue to make good progress in our pivotal MOMENTUM Phase 3 trial for momelotinib and anticipate completing target enrollment by approximately mid-2021 and reporting top-line data in H1 2022, subject to any unforeseen impact from COVID-19," said CEO Stephen Dilly. "In addition, we anticipate presenting new analyses from previously completed Phase 3 studies of momelotinib at the American Society of Hematology annual meeting in December 2020. We are also developing our internal capabilities to support potential future regulatory filings and commercialization of momelotinib in the U.S., with key hires made recently in Regulatory Affairs, Technical Operations, Legal, Pharmacovigilance, Commercial, Business Development and Medical Affairs. We remain well capitalized to complete enrollment for the MOMENTUM trial, report top-line results and to prepare for filing and pre-commercialization." |
| Over a quarter ago | ||||
Sierra Oncology announced… Sierra Oncology announced the appointments of Kevin Norrett as Chief Business Officer and William Turner as Chief Regulatory and Technical Operations Officer. Most recently, Kevin was Chief Commercial Officer at Angion Biomedica, a clinical stage company with a focus in acute organ injury and fibrosis. Turner was Senior Vice President of Technical Operations and Regulatory Science at Aimmune Therapeutics for several years. | ||||
"We believe… "We believe momelotinib, if approved, may provide an important treatment option for underserved myelofibrosis patients, in particular those with anemia and thrombocytopenia, and as such is well-positioned to generate significant value," said CEO Stephen Dilly. "During Q2, we continued to advance the MOMENTUM Phase 3 trial and are on track to deliver top-line results in the first half of 2022. In anticipation of these pivotal data, we are preparing for the regulatory submission process and the potential commercialization of momelotinib, and subsequent to the end of the quarter, we substantially strengthened our senior management team to support these activities". "We made significant progress during the first half of 2020 operationalizing the global MOMENTUM Phase 3 trial and, while the potential impact of the COVID-19 pandemic continues to be uncertain, we are pleased with the current pace of enrollment," said Barbara Klencke, Chief Development Officer. "During the EHA virtual conference, two world-leading physicians in the treatment of myelofibrosis reported long-term data that continue to reinforce momelotinib's differentiated durability, safety and efficacy profile. We plan to report updated analyses in late 2020 comparing the symptomatic benefits of momelotinib to ruxolitinib from the SIMPLIFY-1 Phase 3 trial that will further emphasize momelotinib's differentiated and competitive profile." | ||||
Catch up on today's… Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Sony (SNE) resumed with a Conviction Buy at Goldman Sachs. 2. Sierra Oncology (SRRA) initiated with a Buy at H.C. Wainwright. 3. Arcturus Therapeutics (ARCT) resumed with a Buy at Roth Capital. 4. MSG Entertainment (MSGE) was initiated with an Equal Weight at Morgan Stanley while MSG Sports (MSGS) was initiated with an Overweight. 5. Sprouts Farmers Market (SFM) was initiated with a Buy at MKM Partners, while Walmart (WMT) and Costco (COST) were initiated with a Neutral and Target (TGT) was initiated with a Sell. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here. | ||||