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Protagonist Therapeutics' PTG-300 Gets FDA's Orphan Drug Tag

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Protagonist Therapeutics, Inc. (PTGX - Free Report) announced that the FDA has granted an orphan drug designation to its injectable hepcidin mimetic PTG-300 for the treatment of polycythemia vera. The candidate is an injectable synthetic peptide mimetic of the natural hormone hepcidin, which is also being developed for treating hereditary hemochromatosis.

Notably, orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States. This tag also makes the company entitled to certain other benefits including tax credits related to clinical trial expenses and an exemption from the FDA user fee.

As per the press release, recently, the company announced initial data from a phase II study, which evaluated PTG-300 for the above-mentioned indication. In the study, PTG-300 demonstrated robust clinical response and clinically meaningful dose-related control of hematocrit levels on individual patient.

Shares of Protagonist Therapeutics have skyrocketed 129.6% so far this year compared with the industry’s rally of 8.2%.

Meanwhile, the company discontinued the clinical development of PTG-300 for beta-thalassemia and myelodysplastic syndromes. The company redirected majority of its efforts to develop PTG-300 for the polycythemia vera and hereditary hemochromatosis indication.

Apart from PTG-300, Protagonist Therapeutics is developing two other candidates, namely PTG-200 and PN-943 for addressing inflammatory bowel diseases.

Notably, in the fourth quarter of 2019, Protagonist Therapeutics in collaboration with Janssen Biotech, a wholly owned subsidiary of Johnson & Johnson (JNJ - Free Report) , initiated a phase II study on PTG-200, an oral IL-23 receptor antagonist, for the treatment of moderate-to-severe Crohn's disease.

Protagonist Therapeutics is also developing PN-943, an oral alpha-4-beta-7 integrin antagonist, for the treatment of inflammatory bowel disease. The company plans to begin a phase II study on the same for treating ulcerative colitis.

Zacks Rank & Stocks to Consider

Protagonist Therapeutics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Ligand Pharmaceuticals Incorporated (LGND - Free Report) and NuCana PLC (NCNA - Free Report) , bothf currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings estimates have been revised 7.2% upward for 2020 and 10% for 2021 over the past 60 days. The stock has gained 6.7% year to date.

NuCana’s loss per share estimates have narrowed 17% for 2020 and 18.1% for 2021 over the past 60 days.

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