InflaRx N.V. IFRX shares gained 7.7% on Wednesday following the European Commission's (EC) approval of marketing authorization, under exceptional circumstances, for Gohibic (vilobelimab) to treat adult patients with acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2. The targeted patient population in the EU comprises individuals receiving systemic corticosteroids as standard-of-care therapy and undergoing invasive mechanical ventilation, with or without extracorporeal membrane oxygenation.
The EC’s approval makes Gohibic the first and only approved treatment for SARS-CoV-2-induced ARDS in the EU. We remind the investors that in November 2024, the advisory committee to the European Medicines Agency had adopted a positive opinion recommending approval of the drug for the above indication, under exceptional circumstances. Gohibic is a first-in-class anti-C5a monoclonal antibody.
More on the EC Nod for IFRX’s COVID-19-Induced ARDS Drug
The EU approval ofInflaRx’s Gohibic for the ADRS indication is based on the previously announced results of the phase III PANAMO study, which evaluated the drug’s efficacy in invasively mechanically ventilated COVID-19 patients in intensive care units. Per the data readout, vilobelimab treatment improved survival, reducing 28-day all-cause mortality by 23.9% compared to placebo in the global data set.
InflaRx shares have surged 62.6% in the past three months against the industry’s 13.5% decline.
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Please note that marketing authorization under exceptional circumstances is granted when the benefit-risk assessment is positive, but the rarity of the disease makes it challenging to gather comprehensive data under normal conditions. Per the terms of Gohibic’s approval in the EU, InflaRx will submit annual updates to the regulatory body in the EU on the planned clinical platform study by the Biomedical Advanced Research and Development Authority. The impending study includes vilobelimab as one of three potential new therapies for treating ARDS.
The exceptional marketing authorization for c applies across all 27 EU member states, including Iceland, Liechtenstein and Norway. InflaRx is exploring commercial partnerships and distribution options in the EU, with minimal anticipated impact on its cash burn rate.
Approval Status of IFRX’s Gohibic in the US for COVID-19
In the United States, InflaRx’s Gohibic has received Emergency Use Authorization from the FDA for treating critical adult COVID-19 patients, who have been hospitalized. This authorization remains valid only for the duration of the public health emergency declaration unless the declaration is ended or the authorization is revoked earlier.
Please note that Gohibic is an investigational drug that has not received FDA approval for any indication, including the treatment of COVID-19. The safety and effectiveness of Gohibic for hospitalized COVID-19 patients remain limited.
IFRX’s Other Clinical Pipeline Programs
Apart from the COVID-19 indication, InflaRx is also currently evaluating vilobelimab for pyoderma gangrenosum (PG) in a phase III study. Interim analysis results from the study are expected in the second quarter of 2025.
Vilobelimab enjoys the orphan drug designation for the PG indication in the EU as well as the United States. Additionally, the candidate enjoys the FDA’s Fast Track designation for the same indication.
The company is also evaluating another candidate, INF904, an oral C5aR inhibitor, for patients with moderate-to-severe chronic spontaneous urticaria and moderate-to-severe hidradenitis suppurativa in a phase IIa basket study. Initial data is anticipated in the summer of 2025.
Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and BioMarin Pharmaceutical BMRN, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have remained constant at 34 cents per share. During the same timeframe, loss per share for 2025 has remained constant at $1.84. In the past three months, shares of Castle Biosciences have plunged 24.4%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for CytomX Therapeutics’ 2024 loss per share have remained constant at 5 cents. Estimates for 2025 loss per share have remained constant at 35 cents during the same timeframe. In the past three months, shares of CytomX Therapeutics have surged 63.8%.
CTMX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have increased from $3.94 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 11.4%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
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