Amag Pharmaceuticals announced the poster presentation of data from two Phase 2 randomized, placebo-controlled, dose ranging studies which showed safety and efficacy of ciraparantag reversing the effects of apixaban and rivaroxaban in healthy adults age 50-75 years. Ciraparantag is in development for use in patients treated with direct oral anticoagulants and low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding. Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clotting time. WBCT is a direct measure of anticoagulation/hemostasis and a global measure of clotting. Mean WBCT values in the ciraparantag groups decreased toward baseline 15 minutes after dosing, versus placebo which took five hours commensurate with the decline of anticoagulant drug concentration. For reversal, defined as achieving a WBCT less than or equal to10% above baseline within one hour after dosing and subsequently sustained through at least five hours, this response was achieved in 100% of subjects receiving ciraparantag doses greater than or equal to 60 mg for reversal of apixaban, and 100% of subjects receiving ciraparantag doses of 180 mg for reversal of rivaroxaban. Ciraparantag was well tolerated at all doses evaluated in these studies. The most frequent adverse events associated with ciraparantag were mild, transient sensations of warmth or flushing, which were observed more frequently with higher doses of ciraparantag. In the two studies, adult subjects were treated with apixaban or rivaroxaban and those who reached steady-state anticoagulation were randomized within each dose cohort in a 3:1 ratio to receive ciraparantag or placebo, which was administered three or four hours after last dose of the anticoagulant. Ciraparantag was administered as a single intravenous infusion over 10 minutes, followed by serial testing of WBCT over 24 hours. Doses of ciraparantag were evaluated at 30 mg, 60 mg and 120 mg for apixaban and 30 mg, 60 mg, 120 mg and 180 mg for rivaroxaban.

Takeda Pharmaceutical announced that 13 abstracts are being presented from the company's Hematology portfolio and pipeline at the International Society on Thrombosis and Haemostasis 2020 Virtual Congress. Among the data, Takeda spotlighted four abstracts to highlight its commitment to advancing personalized care through pharmacokinetic-guided prophylaxis in people living with hemophilia or von Willebrand Disease - including scientific updates in patients with hemophilia A from the Phase 3 PROPEL and Phase 3b CONTINUATION studies investigating potential benefits of personalized TAK-660 prophylaxis. Two population studies into the PK/pharmacodynamic profiles of recombinant von Willebrand factor, which provide data to assist in the optimization of rVWF personalized dosing strategies, were also presented. Data from a post-hoc analysis of the Phase III PROPEL trial evaluating the efficacy and target joint resolution with PK-guided TAK-660 prophylaxis in patients with hemophilia A show that targeting 8%-12% versus 1%-3% FVIII trough levels was associated with reduced bleeding into TJs, reduced annualized bleed rate irrespective of baseline TJ status, and TJ resolution within the first 6 months. An analysis exploring the potential benefits of personalized TAK-660 prophylaxis evaluated data on extended fixed dose or PK-tailored dosing from two respective studies - the Phase IIIb CONTINUATION and the Phase III PROPEL studies. Results from the two studies support the feasibility and efficacy of personalized TAK-660 prophylaxis by extending the fixed dose interval or by targeting elevated FVIII levels with PK-tailored dosing. On the other hand, for patients with VWD, rVWF replacement therapy corrects VWF activity, as measured mostly by VWF:Ristocetin Cofactor, and leads consecutively to an endogenous increase of FVIII activity to hemostatically effective levels. The goals of Takeda's PK studies in VWD are to understand the effects of rVWF dosing on VWF:RCo and FVIII activities and thus help patients living with VWD and their physicians achieve agreed treatment goals. Results from the modelling supported the feasibility of this PK/PD population model for describing VWF:RCo and FVIII activity in rVWF-treated patients with different VWD types, which could assist in the optimization of rVWF personalized dosing strategies. The population PK/PD models aimed to characterize VWF:RCo and endogenous FVIII activity-time curves following administration of rVWF, based on data from Phase I and Phase III studies. Results from the modelling supported the feasibility of this PK population model for describing activity-time profiles of small, medium and large multimers following rVWF dosing on VWF:RCo. The findings increase understanding of the effects of rVWF dosing on VWF:RCo and FVIII activities which could potentially optimize treatment regimens for individual patient needs. In addition to data from the four aforementioned studies, Takeda presented real-world evidence of extended half-life prophylaxis with TAK-660, which showed that switching from standard half-life FVIII to TAK-660 given at lower frequency and with weekly consumption resulted in reduced ABRs.vii Results were also presented from the American Thrombosis and Hemostasis Network ATHN 2: Factor Switching Study, which show that for the 52 participants in the study who switched from any FVIII concentrate to TAK-660, no new inhibitors were detected after 50 exposure days or 12 months. A further seven studies presented included a retrospective chart review of gastrointestinal bleeding in VWD, and pre-clinical and post-marketing updates on susoctocog alfa for the treatment of acquired hemophilia.

Gilat Satellite announced that further to its announcement of July 8, 2020, it was notified on July 11, 2020 that an amended complaint was filed by Comtech Telecommunications and its subsidiary, Convoy, against Gilat in the Court of Chancery of the State of Delaware. The amended complaint seeks an additional declaratory judgment that Gilat has suffered a "Material Adverse Effect" as defined in the Merger Agreement, as a result of the COVID-19 pandemic and, as a consequence, Comtech is not required to consummate the merger because certain closing conditions of the Merger Agreement cannot be satisfied. Gilat said it strongly rejects all such allegations and believes that no Material Adverse Effect under the Merger Agreement has occurred and that Comtech's complaint is nothing more than an effort to avoid its clear contractual obligation to acquire Gilat, due to Comtech's own rapidly deteriorating performance. "Comtech's continuous willful breaches have resulted and are continuing to result in significant monetary damages to Gilat and its shareholders, and are expected to amount to hundreds of millions of dollars if the merger is not consummated," Gilat added. "While Gilat has not interfered or taken any action to interfere with Comtech's pending application with the Russian Federal Anti-Monopoly Service or otherwise breached the Merger Agreement, Gilat believes that Comtech has willfully breached its obligations under the Merger Agreement so as to attempt to ensure that FAS approval is not timely obtained and Comtech will not be required to consummate the merger. Gilat intends to vigorously defend its position in connection with the claims raised by Comtech and all related matters." Gilat also intends to file a counter claim against Comtech seeking, among other things, a declaration that Comtech cannot terminate the Merger Agreement and, if the merger is not consummated, Comtech should pay Gilat monetary damages "for all losses that Gilat and its shareholders and option holders have suffered as a result of Comtech's willful breaches of the Merger Agreement, which Gilat will assert amount to hundreds of millions of dollars."