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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.

Disclosures:

1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

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Disclosures For H.C.Wainwright & Co., InflaRx N.V., September 29, 2022

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.

The Firm does not make a market in InflaRx N.V. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request.

H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.

H.C. Wainwright & Co., LLC's and its affiliates' salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst's judgment as of the date of this report and are subject to change without notice.

Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

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