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Protagonist Therapeutics Stock Rallies Nearly 7% in a Week: Here's Why
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Key Takeaways
PTGX shares rose after JNJ's Icotyde won FDA approval for plaque psoriasis patients aged 12 years and older.
Protagonist earns $50M milestone, with up to $580M more, along with tiered royalties on sales.
Icotyde delivered strong phase III data and offers a once-daily oral alternative to injectables.
Shares of Protagonist Therapeutics (PTGX - Free Report) have gained nearly 7% over the past week. The upside came after the company announced that the FDA had approved its partner, Johnson & Johnson (JNJ - Free Report) ’s icotrokinra for the treatment of adults and pediatric patients aged 12 years and above with moderate-to-severe plaque psoriasis (PsO) who are eligible for systemic therapy or phototherapy.
Icotrokinra, an oral targeted peptide inhibitor of the IL-23 receptor and will be marketed as Icotyde in the United States. Following the FDA approval, the drug becomes the first and only targeted oral peptide designed to selectively inhibit the IL-23 receptor.
Over the past year, PTGX’s shares have surged 93.2% compared with the industry’s 11.4% growth.
Image Source: Zacks Investment Research
FDA Approval Supported by Robust ICONIC Program Data
Icotyde’s approval was based on robust data from four phase III studies, ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 — within the broader ICONIC development program — evaluating Icotyde across PsO and psoriatic arthritis indications. Across the four pivotal studies, treatment with Icotyde achieved all primary and co-primary endpoints, demonstrating significant skin clearance and a favorable safety profile with once-daily oral dosing in adults and adolescents with moderate-to-severe plaque PsO.
Strategic Collaboration With JNJ & Financial Upside for PTGX
Icotyde was co-developed by Protagonist and Johnson & Johnson, with PTGX leading early-stage development of the therapy while JNJ holds exclusive global rights for its late-stage development and commercialization across multiple indications under their 2017 collaboration agreement.
The FDA approval has triggered a $50 million milestone payment to Protagonist. The company also remains eligible to earn up to an additional $580 million in regulatory and sales-based milestone payments.
Protagonist is entitled to tiered royalties ranging from 6% to 10% on global net sales. This corresponds to a weighted average royalty of approximately 7.25% at $4 billion in annual sales, with the highest tier of 10% applicable to revenues exceeding that level.
JNJ believes that Icotyde/icotrokinra has the potential to revolutionize the treatment of plaque psoriasis as it is a once-daily oral pill, whereas most currently available effective options for the treatment of plaque psoriasis are injectables, such as AbbVie’s (ABBV - Free Report) Skyrizi and JNJ’s own Tremfya.
Beyond psoriasis, Icotyde is being further evaluated across multiple indications, including active psoriatic arthritis, moderate-to-severe active ulcerative colitis and Crohn’s disease, reflecting its broader potential in inflammatory disease markets. Icotyde is also under review in the European Union for the plaque psoriasis indication, providing an additional near-term catalyst for investors.
Protagonist Therapeutics, Inc. Price and Consensus
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Protagonist Therapeutics Stock Rallies Nearly 7% in a Week: Here's Why
Key Takeaways
Shares of Protagonist Therapeutics (PTGX - Free Report) have gained nearly 7% over the past week. The upside came after the company announced that the FDA had approved its partner, Johnson & Johnson (JNJ - Free Report) ’s icotrokinra for the treatment of adults and pediatric patients aged 12 years and above with moderate-to-severe plaque psoriasis (PsO) who are eligible for systemic therapy or phototherapy.
Icotrokinra, an oral targeted peptide inhibitor of the IL-23 receptor and will be marketed as Icotyde in the United States. Following the FDA approval, the drug becomes the first and only targeted oral peptide designed to selectively inhibit the IL-23 receptor.
Over the past year, PTGX’s shares have surged 93.2% compared with the industry’s 11.4% growth.
Image Source: Zacks Investment Research
FDA Approval Supported by Robust ICONIC Program Data
Icotyde’s approval was based on robust data from four phase III studies, ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 — within the broader ICONIC development program — evaluating Icotyde across PsO and psoriatic arthritis indications. Across the four pivotal studies, treatment with Icotyde achieved all primary and co-primary endpoints, demonstrating significant skin clearance and a favorable safety profile with once-daily oral dosing in adults and adolescents with moderate-to-severe plaque PsO.
Strategic Collaboration With JNJ & Financial Upside for PTGX
Icotyde was co-developed by Protagonist and Johnson & Johnson, with PTGX leading early-stage development of the therapy while JNJ holds exclusive global rights for its late-stage development and commercialization across multiple indications under their 2017 collaboration agreement.
The FDA approval has triggered a $50 million milestone payment to Protagonist. The company also remains eligible to earn up to an additional $580 million in regulatory and sales-based milestone payments.
Protagonist is entitled to tiered royalties ranging from 6% to 10% on global net sales. This corresponds to a weighted average royalty of approximately 7.25% at $4 billion in annual sales, with the highest tier of 10% applicable to revenues exceeding that level.
JNJ believes that Icotyde/icotrokinra has the potential to revolutionize the treatment of plaque psoriasis as it is a once-daily oral pill, whereas most currently available effective options for the treatment of plaque psoriasis are injectables, such as AbbVie’s (ABBV - Free Report) Skyrizi and JNJ’s own Tremfya.
Beyond psoriasis, Icotyde is being further evaluated across multiple indications, including active psoriatic arthritis, moderate-to-severe active ulcerative colitis and Crohn’s disease, reflecting its broader potential in inflammatory disease markets. Icotyde is also under review in the European Union for the plaque psoriasis indication, providing an additional near-term catalyst for investors.
Protagonist Therapeutics, Inc. Price and Consensus
Protagonist Therapeutics, Inc. price-consensus-chart | Protagonist Therapeutics, Inc. Quote
PTGX’s Zacks Rank
Protagonist Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.