ENLV = Enlivex Therapeutics announced positive interim efficacy data from the Company’s ongoing Phase Ib clinical trial in patients with severe sepsis. The interim analysis is based on a dataset of 43 patients with severe sepsis, all hospitalized at Hadassah Medical Center, which is one of the largest and most prestigious hospitals in Israel. Six patients admitted to Hadassah’s intensive care unit with sepsis have been administered with off-the-shelf Allocetra upon their admission, while 37 patients were matched controls that received standard of care treatment during 2016-2019 but did not receive OTS Allocetra. The primary safety parameter was 28 days mortality. None of the OTS Allocetra -treated patients died during this period, compared to 11 of 37 in the matched control group who died during this period. OTS Allocetra treatment resulted in improved efficacy in all analyzed parameters, which included the sequential organ failure assessment score, as well as recovery from sepsis, number of days of hospitalization in the intensive care unit, and others. The matching of the 37 patients to the OTS Allocetra-treated group was based on similar organ failure clinical SOFA score at admission, overall clinical state, age group, sex, and source of severe sepsis. All matched patients were treated at the same hospital as the Allocetra-treated group.
KPTI = Following the positive results from the Phase 2b SADAL study that were first presented at the America Society of Hematology 2018 Annual Meeting and then updated in June at the 2019 International Conference on Malignant Lymphoma, Karyopharm expects to submit a New Drug Application to the FDA by the end of 2019 requesting accelerated approval for selinexor as a treatment for patients with relapsed or refractory DLBCL after at least two prior multi-agent therapies and who are ineligible for stem cell transplantation including CAR-T therapy. The Company also expects to submit an MAA to the EMA in 2020 requesting conditional approval for selinexor in the same indication. In addition to orphan drug designation, selinexor was granted fast track designation for this indication by the FDA in 2018.
RACE = Ferrari N.V. (NYSE/MTA: RACE) today announces its consolidated preliminary results(5) for the third quarter and nine months ended September 30, 2019, summarized as follows.
- Total shipments of 2,474 units, up +9.4%
- Net revenues of Euro 915 million, up +9.2% or +7.1% at constant currency
- Adj. EBITDA of Euro 311 million, up +11.5% with an EBITDA margin of 33.9%
- Adj. diluted EPS of Euro 0.90 (+16.9%)
- Industrial free cash flow generation of Euro 138 million
The Guidance 2019 is upgraded as follows:
- Net revenues: ~Euro 3.7 billion (from > Euro 3.5 billion)
- Adj. EBITDA: ~Euro 1.27 billion (from Euro 1.2-1.25 billion)
- Adj. EBIT: ~Euro 0.92 billion (from Euro 0.85-0.9 billion)
- Adj. diluted EPS: Euro 3.70-3.75(3) per share (from Euro 3.50-3.70 per share)
- Industrial free cash flow: > Euro 0.6 billion (from > Euro 0.55 billion)
On November 4, 2019, at 3.00 p.m. CET, management will hold a conference call to present the Q3 2019 results to financial analysts and institutional investors. The call can be followed live and a recording will subsequently be available on the Group website http://corporate.ferrari.com/en/investors.