Thirteen new option listings and four option delistings on May 28th » 08:3005/2805/28/20
CFRX, FREQ, HARP, HOOK, HSTO, IFRX, KNSA, KZR, LQDA, OVID, PRVL, CNAT, CORV, CTRC, UNT
New option listings for…
New option listings for May 28th include ContraFect (CFRX), Centric Brands Inc (CTRCQ), Frequency Therapeutics Inc (FREQ), Harpoon Therapeutics Inc (HARP), HOOKIPA Pharma Inc (HOOK), Histogen Inc (HSTO), InflaRx NV (IFRX), Kiniksa Pharmaceuticals Ltd (Class A Stock) (KNSA), Kezar Life Sciences Inc (KZR), Liquidia Technologies Inc (LQDA), Ovid Therapeutics (OVID), Prevail Therapeutics Inc (PRVL), and Unit Corp (UNTCQ). Option delistings effective May 28th include Conatus Pharmaceuticals Inc (CNAT), Correvio Pharma Corporation (CORV), Centric Brands Inc (CTRC), and Unit Corp (UNT).
|Over a week ago|
Kiniksa files to sell 1.6M shares of common stock for holders 17:2005/2105/21/20
Kiniksa 2.4M share Spot Secondary priced at $18.25 » 06:1105/1405/14/20
The deal range was…
The deal range was $17.25-$18.25 and the size was increased to 2.4M shares from 1.8M shares. Goldman Sachs, JPMorgan and BofA acted as joint book running managers for the offering.
Fly Intel: After-Hours Movers » 19:0405/1305/13/20
KNSA, ARVN, SDC, JACK, VRTU, ONEM, PANL, FCAU, MA, IMGN, ALLO, IMUX, OII, FLO, CSCO, RVLV, BRP, JAKK, RKDA
Check out this evening's…
Kiniksa files to sell 1.8M shares of Class A common stock » 17:1305/1305/13/20
Goldman Sachs & Co.,…
Goldman Sachs & Co., J.P. Morgan Securities, and BofA Securities are acting as joint book-running managers for the offering. Wedbush Securities and JMP Securities are acting as co-managers for the offering.
Kiniksa reports vixarelimab data in diseases characterized by chronic pruritus » 08:0505/1105/11/20
The exploratory Phase 2…
The exploratory Phase 2 trial in diseases characterized by chronic pruritus enrolled patients experiencing moderate-to-severe pruritus and assigned them to one of the following cohorts based upon their diagnosis: plaque psoriasis, chronic idiopathic pruritus, lichen simplex chronicus, chronic idiopathic urticaria, or lichen planus. Each cohort was evaluated as an independently randomized sub-study. Patients received a loading dose of vixarelimab 720 mg or placebo subcutaneously followed by vixarelimab 360 mg or placebo SC weekly for 8 weeks. The primary efficacy endpoint was percent change from baseline in weekly-average WI-NRS at Week 8. The plaque psoriasis cohort achieved a statistically significant reduction in weekly-average WI-NRS at Week 8. Least squares-mean change from baseline in weekly-average WI-NRS at Week 8 was -66.5% in vixarelimab recipients compared to -29.0% in placebo recipients. In the chronic idiopathic pruritus cohort, the LS-mean change from baseline in weekly-average WI-NRS at Week 8 was -52.4% in vixarelimab recipients compared to -48.8% in placebo recipients. The lichen simplex chronicus, chronic idiopathic urticaria and lichen planus cohorts showed encouraging efficacy results as measured by percent change from baseline in weekly-average WI-NRS at Week 8. Comparative summary statistics were not performed due to the small number of patients enrolled in each cohort. Vixarelimab was well-tolerated, and no dose-limiting adverse events were recorded. Kiniksa is conducting additional responder and biomarker analyses across indications to help determine next steps, including a potential dose-ranging Phase 2b trial. The data presentations from the open-label treatment protocol of mavrilimumab in COVID-19 pneumonia and hyperinflammation and the exploratory Phase 2 trial of vixarelimab in diseases characterized by chronic pruritus are available through the Investors and Media section of Kiniksa's website.
Kiniksa reports data for mavrilimumab in COVID-19 pneumonia » 08:0305/1105/11/20
Kiniksa Pharmaceuticals provided additional data from the open-label treatment protocol with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha, in patients with severe coronavirus 2019 pneumonia and hyperinflammation. The company also provided data from the exploratory Phase 2 trial for vixarelimab, an investigational fully-human monoclonal antibody that targets oncostatin M receptor beta, in diseases characterized by chronic pruritus. The mavrilimumab open-label treatment protocol was a prospective, interventional, single-active-arm, single-center pilot experience in Italy. Thirteen non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation were treated with a single intravenous dose of mavrilimumab upon admission to the hospital. Twenty-six contemporaneous non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation and with similar characteristics upon admission to the hospital, including comorbidities, baseline inflammatory markers and respiratory dysfunction, were evaluated as a control group. All patients in the treatment protocol received optimum local standard of care, including protease inhibitors and antiviral therapies. Over the course of the 14-day follow-up period, mavrilimumab-treated patients experienced greater and earlier clinical improvements than control-group patients, including earlier weaning from supplemental oxygen, shorter hospitalizations, and no deaths. At day 14 of the follow-up period, 85% of mavrilimumab-treated patients and 42% of control-group patients had attained the clinical improvement endpoint. Mavrilimumab-treated patients reached the clinical improvement endpoint earlier compared to control-group patients. During the 14-day follow-up period, there was a 0% incidence of death in mavrilimumab-treated patients compared to 27% in control-group patients. Eight percent of mavrilimumab-treated patients received mechanical ventilation, compared to 35% of control-group patients. Mavrilimumab-treated patients were discharged from the hospital earlier than control-group patients. Mavrilimumab was well-tolerated in all patients, without infusion reactions. P-values above are unadjusted for multiplicity. Kiniksa is engaged with the U.S. Food and Drug Administration and is preparing for a potential registrational development program for mavrilimumab in COVID-19 pneumonia and hyperinflammation. In parallel, academic investigators in the U.S. and Italy are planning investigator-initiated placebo-controlled studies.
|Over a month ago|
Kiniksa expects data from Phase 1 trial of KPL-404 in 2H20 » 07:4004/2804/28/20
Kiniksa is conducting a…
Kiniksa is conducting a single-ascending-dose Phase 1 clinical trial of KPL-404 in healthy volunteers. The first-in-human trial will provide safety data and pharmacokinetics as well as receptor occupancy and T-cell Dependent Antibody Response. The company continues to expect data in the second half of 2020.
Kiniksa continues to expect data from Phase 2 trial of vixarelimab in 1H20 » 07:4004/2804/28/20
Kiniksa continues to…
Kiniksa continues to expect data from cohorts of an exploratory Phase 2 trial of vixarelimab in diseases characterized by chronic pruritus in the first half of 2020.
Kiniksa, Kite expect to commence Phase 2 trial in 2H20 » 07:3904/2804/28/20
Kiniksa (KNSA) and Kite,…
Kiniksa (KNSA) and Kite, a Gilead company (GILD), expect to commence a Phase 2 trial evaluating the investigational combination of Yescarta and mavrilimumab in relapsed or refractory large B-cell lymphoma in the second half of 2020. The objective of the trial is to determine the effect of mavrilimumab on the safety of Yescarta. Preclinical evidence shows the potential for interruption of granulocyte macrophage colony stimulating factor signaling to disrupt chimeric antigen receptor T cell-mediated inflammation without disrupting anti-tumor efficacy.