INOVIA's (INO) Rare Disease Drug Gets EC's Orphan Tag, Stock Up
INOVIA Pharmaceuticals INO announced that European Commission has granted orphan drug designation for INO-3107, the company's product candidate for the treatment of Recurrent Respiratory Papillomatosis (“RRP”). INO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11,the HPV types that cause RRP and other HPV-related disease.
The European Committee for Orphan Medicinal Products had provided positive opinion on INOVIO's application for orphan drug designation in the European Union (EU) for INO-3107.
In the EU, the orphan drug designation is granted for the treatment, prevention and diagnosis of diseases that are life-threatening or chronically debilitating and affect no more than five in 10,000 people. The orphan drug designation will grant INOVIA market exclusivity in the EU for up to 10 years for the above indication, along with financial and regulatory incentives, including protocol assistance at reduced charges and access to centralized marketing authorization.
In the United States, INO-3107 had previously received orphan drug designation from the FDA in July 2020, making it the first RRP product candidate to receive orphan designations from both the United States and EU regulatory bodies.
Shares of INOVIA jumped approximately 12% in the after-market hours, following the positive news. In the past year, shares of INOVIA have plunged 61.8% compared with the industry’s 5% fall.
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Per management, the orphan drug grant by both regulatory bodies signifies the high unmet medical need of those suffering from this debilitating disease, that is RRP.
RRP is a rare debilitating disease that is primarily caused by HPV-6 and/or HPV-11 virus/viruses. Symptoms of this disease include the development of small, wart-like growths, or papillomas, in the respiratory tract. Papillomas, although not cancerous, can cause severe life-threatening airway obstruction and respiratory complications in patients suffering from RRP, thereby significantly deteriorating the quality of life for patients.
Currently, the only treatment is surgical removal of the papillomas, which often grows back as the underlying infection still exists. INO-3107 is designed to target and cure the infection, with the aim of potentially preventing or slowing the growth of new papillomas.
Inovio Pharmaceuticals, Inc. Price and Consensus
Inovio Pharmaceuticals, Inc. price-consensus-chart | Inovio Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
INOVIA currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics ALLO, Akero Therapeutics AKRO and ADMA Biologics, Inc. ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.32. In the past year, shares of Allogene Therapeutics have fallen by 17.8%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the past year, shares of Akero Therapeutics have rallied by 442.1%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the past year, shares of ADMA Biologics have gained by 110.4%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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