Humanigen Inc. (NASDAQ: HGEN) stock surged by 6.35% at last close while the HGEN stock price gains by 6.60% in the pre-market trading session. Humanigen, Inc. is a clinical-stage pharmaceutical firm dedicated to the treatment and prevention of cytokine storm, an immunological hyper-response.
HGEN stock’ Current Update
Humanigen confirmed recently that it has agreed to execute a Managed Access Program for lenzilumab (“LenzMAP”) with Clinigen Group, a worldwide pharmaceutical Services, and Products firm.
Where the medical provider feels there are no acceptable alternatives and rules allow, LenzMAP will provide access to lenzilumab on a case-by-case basis for hospitalized COVID-19 patients. Over 20 million cases of COVID-19 have been recorded in these countries so far. Lenzilumab is an experimental drug that has yet to be approved or licensed in any nation.
Clinigen will oversee important aspects of the program, such as regulatory supervision, logistics, and access management, under the terms of the deal. Clinigen’s expertise in engaging with regulatory authorities in the appropriate countries will be used by Humanigen to make lenzilumab available in each of the 16 countries listed above. Clinigen now manages more than 161 additional companies’ controlled access programs. Clinigen works with over 20,000 healthcare practitioners across 5,000 institutions in over 120 countries.
Cameron Durrant, Chief Executive Officer, Humanigen commented,
They’re still working hard to get lenzilumab to COVID-19 patients in Europe, the United Kingdom, and the United States. They’ve finished their rolling MAA application to the UK’s Medicines and Healthcare Products Regulatory Agency, are working on their MAA submission to the European Medicines Agency, and aim to present further data to the FDA to promote potential emergency use authorization in the United States.
Pete Belden, Executive Vice President Services Division, Clinigen commented,
They are happy to collaborate with Humanigen to provide this critical therapy option, which will assist to meet a huge unmet need for COVID-19 patients in hospitals across Europe. Clinigen’s strength in collaborating with biotechnology firms to deliver services that enable faster and broader access to essential medications is highlighted by this partnership.
