In the past six months,
InflaRx’s ( IFRX Quick Quote IFRX - Free Report) shares have surged 110.1% against the industry’s 7.2% fall. Image Source: Zacks Investment Research
This upside is attributable to the emergency use authorization (“EUA”)
granted by the FDA in April 2023 to Gohibic (vilobelimab) for the treatment of critically ill COVID-19 patients. Per the FDA, Gohibic can be administered intravenously to treat COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support).
The EUA helped InflaRx transform from a clinical-stage biopharmaceutical company into a commercial-stage one. The treatment was commercially launched in the United States in the late second-quarter 2023. As a result, the company did not generate any revenues during this quarter.
InflaRx is currently in discussions with the FDA about submitting a biologics license application (“BLA”) for full approval of Gohibic in this COVID-19 indication. Management has also submitted a marketing authorization application (“MAA”) for Gohibic in a similar COVID-19 indication in the European Union, which was validated by the European Medicines Agency (EMA) last month.
Apart from COVID-19, management is also evaluating vilobelimab in various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (“PG”) and cutaneous squamous cell carcinoma (“cSCC”).
InflaRx has initiated the preparatory activities for a late-stage study on vilobelimab in PG indication. Management expects to enroll the first patient before the end of this month.
InflaRx submitted a Phase III clinical trial protocol to the FDA, initiated the preparatory activities and expects the first patient to be enrolled in Q3 2023. A mid-stage study is ongoing, which is evaluating the drug in cSCC indication.
Other than vilobelimab, InflaRx has only other candidate in its pipeline, INF904, an oral C5aR inhibitor, which is currently being evaluated in a single (SAD) and multiple ascending dose (MAD) phase I study in healthy volunteers. Management intends to develop INF904 for complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.
With lower cases of severe COVID-19 infections, InflaRx expects moderate demand for Gohibic in 2023. In the meantime, management continues to invest in the necessary infrastructure to make Gohibic available to hospitals across the United States.
Zacks Rank & Stocks to Consider
InflaRx currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include
ANI Pharmaceuticals ( ANIP Quick Quote ANIP - Free Report) , Annexon ( ANNX Quick Quote ANNX - Free Report) and Annovis Bio ( ANVS Quick Quote ANVS - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
In the past 30 days, estimates for ANI Pharmaceuticals’ 2023 earnings per share have risen from $3.39 to $3.73. During the same period, the earnings estimates per share for 2024 have improved from $4.12 to $4.35. Year to date, shares of ANIP have surged 60.1%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, witnessing an earnings surprise of 91.56% on average. In the last reported quarter, ANI Pharmaceuticals’ earnings beat estimates by 100.00%.
In the past 30 days, estimates for Annexon’s 2023 loss per share have narrowed from $2.18 to $1.98. During the same period, the loss estimates per share for 2024 have improved from $2.05 to $1.80. Year to date, shares of ANNX have lost 46.8%.
Earnings of Annexon beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an earnings surprise of 15.51% on average. In the last reported quarter, Annexon’s earnings beat estimates by 12.96%.
In the past 30 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of ANVS have lost 7.7%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.