On April 24, 2023 Genmab A/S (Nasdaq: GMAB) reported its decision to file a request for review of the award dismissing its claims in the second arbitration arising under its license agreement with Janssen Biotech, Inc. for daratumumab (Press release, Genmab, APR 24, 2023, View Source [SID1234630422]).

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The review of the award will be conducted by a single appeal arbitrator under the rules of the CPR Institute for Dispute Resolution for Non-Administered Arbitration.

The arbitration remains confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Genmab does not intend to comment further or to provide additional information regarding the arbitration.

On April 24, 2023 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported an update on the FHD-609 program in synovial sarcoma and SMARCB1-deleted tumors (Press release, Foghorn Therapeutics, APR 24, 2023, View Source [SID1234630421]).

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Foghorn is pausing enrollment in the FHD-609 study in synovial sarcoma and SMARCB1-deleted tumors due to a grade 4 QTc prolongation event in a synovial sarcoma patient at the second highest dose. Enrollment of the dose escalation portion of the study has been completed and a maximum tolerated dose has been identified. Patients in the affected cohort were dose reduced and additional safety measures have been discussed with and provided to the study investigators. The Company promptly communicated the enrollment pause and risk mitigation actions to the FDA and European regulatory authorities. Consequently, the FDA placed the study on partial clinical hold in the United States, while allowing patients currently enrolled and benefiting from therapy to continue dosing and to remain on FHD-609. The Company is not at this time planning to pursue a dose expansion study independently.

On April 24, 2023 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported that the Company will host a conference call and live audio webcast on Wednesday, May 3, 2023 at 5:00 PM ET to report its first quarter 2023 financial results and provide a corporate update (Press release, Fate Therapeutics, APR 24, 2023, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-first-8 [SID1234630419]).

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In order to participate in the conference call, please register using the conference link here. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On April 24, 2023 FibroGen, Inc. (NASDAQ: FGEN) reported that it will present its first quarter 2023 financial results on Monday, May 8 after the market close (Press release, FibroGen, APR 24, 2023, View Source [SID1234630418]). FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company’s corporate and financial performance.

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the "Investor Relations" page of the Company’s website at www.fibrogen.com. To access the call by phone, please go to this link (registration link), and you will be provided with dial-in details. To avoid delays, we encourage participants to dial in to the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).

On April 24, 2023 European Commission reported that it has approved the funding of three new research projects coordinated by EORTC (Press release, EORTC, APR 24, 2023, View Source [SID1234630416]). Thanks to these grants, EORTC will perform three innovative pragmatic clinical trials optimising treatments for patients with refractory cancers starting summer of 2023. Public funding is essential to address clinically relevant questions with no commercial interest that can only be performed by independent organisations.

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Today, many drugs enter the market without evidence of their true clinical benefit for patients. There is a need to conduct independent pragmatic clinical trials studying the optimal way to use the drugs in a real-life setting thus improving patients’ quality of life but also the sustainability of healthcare systems.

To this end, EORTC submitted three proposals (DE-ESCALATE, LEGATO and STREXIT2) to the Horizon Europe call for pragmatic clinical trials. Under the leadership of EORTC key opinion leaders, the three funded projects will investigate intermittent treatment or treatments combination in three different cancers such as glioblastoma (M. Preusser, AT), prostate (B. Tombal, BE) and retroperitoneal sarcoma (A Gronchi, IT).

The pragmatic clinical trials will be under EORTC legal sponsorship, supported by EORTC infrastructure and network. Patient representatives are contributing to all clinical trials since study conceptualisation. Health economics research will be implemented across the three clinical trials in a standardised manner.

These projects are expected to reduce the so-called efficacy-efficiency gap, defined as the problematic difference between the outcomes generated from trials targeting strictly a selected patient population in highly controlled environments, and those observed in real-world clinical practice. Importantly, these projects will show the value of independent clinical research and the need for more treatment optimisation research in Europe.