Biopharma Asks for Emergent Use in US of New COVID Drug
Source: Edward White
September 30, 2022 (Investorideas.com Newswire) The requested approval is specifically for critically ill patients, a population for which the U.S. Food and Drug Administration granted the therapeutic fast track status, noted an H.C. Wainwright & Co. report.
InflaRx NV (IFRX:NASDAQ) requested from the U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) for its lead drug candidate vilobelimab (IFX-1) for the treatment of critically ill COVID-19 patients, reported H.C. Wainwright & Co. analyst Edward White in a September 29, 2022 research note.
Vilobelimab is the biopharma's intravenously administered anti-C5a monoclonal antibody.
In light of the news, H.C. Wainwright & Co. maintained its Buy rating and US$8 per share price target on InflaRx. In comparison, the drug company's current share price is about US$2.60.
"We anticipate a launch in 2023 for vilobelimab for COVID-19 patients with sales of US$14 million ($14M) that year and US$122M in 2028," White wrote.
InflaRx's EUA application for vilobelimab in COVID-19 comes on the heels of two events, noted White. One was the FDA granting the drug fast track designation for the treatment of critically ill, intubated, and machine-ventilated COVID-19 patients. The other was a positive Type B meeting the company had with the agency in the summer.
The German firm is also pursuing vilobelimab in COVID in Europe and is in talks with the European Medicines Agency about how best to proceed to obtain marketing authorization approval for the European Union (EU).
Phase 3 Data Show Efficacy
Supporting InflaRx's advancement of vilobelimab are positive data from the Phase 3 PANAMO trial, in which 368 severely ill COVID-19 patients participated at sites throughout the EU, South America, and other regions.
Results recently published in The Lancet Respiratory Medicine included a relative reduction in 28-day all-cause mortality, the primary endpoint, of 23.9% versus placebo. In Western European countries, the relative reduction in 28-day all-cause mortality was higher, at 43%. Also, the drug was shown to be safe.
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Disclosures For H.C.Wainwright & Co., InflaRx N.V.
H.C. Wainwright & Co, LLC (the "Firm") is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Edward White , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
A research analyst of the firm and/or the research analyst's household has a financial interest in and own the securities of InflaRx N.V. (including, without limitation, any option, right, warrant, future, long or short position). As of August 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of InflaRx N.V..
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from InflaRx N.V. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from InflaRx N.V. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
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