CytoDyn Inc. (OTCQB: CYDY) announced this morning that it has filed a legal complaint about an alleged breach of contract against its former contract research organization, Amarex Clinical Research.
The biotech company alleges that Amarex failed to perform its obligations under the agreement between the two parties, which resulted in the company suffering damages. Included as a respondent in the legal complaint is Amarex’s parent company, NSF International.
Filed in the U.S. District Court for the District of Maryland, the complaint for declaratory and injunctive relief seeks to adjudicate this breach. Meanwhile, the motion for a preliminary injunction seeks to require Amarex to provide the company access to databases of clinical trial data that were allegedly wrongfully withheld.
“We are aggressively pursuing these legal actions against Amarex. We believe their numerous failures have delayed the availability of leronlimab to thousands of patients for multiple indications and harmed our shareholders,” said CytoDyn CEO Nader Pourhassan.
Leronlimab is a humanized monoclonal antibody targeted against a specific receptor in a human’s T-cell to trigger an immune system response. The US Food and Drug Administration previously granted the firm a fast track designation to use the candidate drug as a possible treatment for HIV-related diseases and metastatic cancer.
The biotech firm also filed a demand for arbitration with the American Arbitration Association, alleging Amarex billed the company for services that it did not perform. Further, it contends that due to the research organization’s breach, the company suffered avoidable delays in obtaining regulatory approval of leronlimab.
Christopher Recknor, who the company said discovered Amarex’s deficiencies, stated that its goal following the incident is to diversify its contract research organization base. “With the current CytoDyn team in place for clinical development and operations, we expect results from our NASH study by the end of calendar 2021,” he added.
In September 2021, the firm also shared that it started phase 3 trial that will consider the potential of leronlimab in treating COVID-19 patients with severe symptoms.
CytoDyn last traded at $1.76 on the OTCQB.
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