Core Insights - Protagonist Therapeutics (PTGX) shares have increased nearly 7% following the FDA approval of icotrokinra, developed in partnership with Johnson & Johnson (JNJ), for treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][6] FDA Approval and Product Details - Icotrokinra, marketed as Icotyde in the U.S., is the first targeted oral peptide designed to inhibit the IL-23 receptor [2][4] - The FDA approval was supported by data from four phase III studies within the ICONIC program, demonstrating significant skin clearance and a favorable safety profile [4] Financial Implications - Protagonist will receive a $50 million milestone payment from JNJ, with potential for up to $580 million more in regulatory and sales-based milestones [6][7] - Protagonist is entitled to tiered royalties on global net sales, ranging from 6% to 10%, with an average of approximately 7.25% at $4 billion in annual sales [7] Market Potential - JNJ believes Icotyde has the potential to revolutionize plaque psoriasis treatment as a once-daily oral alternative to existing injectables [8] - Icotyde is also being evaluated for other indications, including psoriatic arthritis and inflammatory bowel diseases, indicating broader market potential [9]

Core Viewpoint - Protagonist Therapeutics (PTGX) experienced a significant stock price increase following the FDA approval of its partner Johnson & Johnson's icotrokinra for treating moderate-to-severe plaque psoriasis, indicating positive market sentiment towards the company and its product pipeline [2]. Group 1: Stock Performance - PTGX shares rose by 4.7% to $101.68 in the last trading session, with trading volume higher than average, contributing to a total gain of 17% over the past four weeks [1][2]. - The consensus EPS estimate for PTGX has been revised 10.7% higher over the last 30 days, suggesting potential for future price appreciation [4]. Group 2: Financial Expectations - Protagonist Therapeutics is expected to report a quarterly loss of $0.65 per share, reflecting a year-over-year decline of 242.1%, with revenues projected at $5 million, down 82.3% from the previous year [3]. - Despite the anticipated losses, trends in earnings estimate revisions are correlated with near-term stock price movements, indicating that positive revisions could lead to stock price strength [3][4]. Group 3: Industry Context - Protagonist Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where Certara, Inc. (CERT) is another player, having closed 1.8% lower at $6.38, with a return of -0.5% over the past month [5]. - Certara's consensus EPS estimate has decreased by 18.5% over the past month, indicating a challenging outlook compared to Protagonist Therapeutics [6].

Jefferies upgraded NASDAQ:PTGX to a "Buy" rating, with the stock priced at $97.78.The FDA has approved ICOTYDE™, a significant milestone for Protagonist Therapeutics, triggering a $50 million milestone payment.Despite the positive news, PTGX's stock price slightly decreased by 0.14% to $97.09.Protagonist Therapeutics, Inc. (NASDAQ: PTGX) is a biopharmaceutical company focused on developing peptide-based drugs to address unmet medical needs. The company operates in the competitive pharmaceutical industry, wh ...

Core Viewpoint - Protagonist Therapeutics, Inc. has received FDA approval for its drug ICOTYDE™, which is expected to significantly enhance its product portfolio and financial outlook [2][3]. Group 1: Product Development - ICOTYDE™ is the first and only oral peptide targeting the IL-23 receptor, designed for treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and older [2]. - The approval was based on four phase 3 studies involving 2,500 patients, all of which met their primary endpoints and demonstrated a favorable safety profile [2]. Group 2: Financial Implications - The company will receive a $50 million milestone payment upon FDA approval and is eligible for royalties ranging from 6% to 10% on sales [3]. - Protagonist Therapeutics has the potential to earn up to $580 million in future milestone payments, which will further strengthen its financial position [3]. Group 3: Market Performance - Despite the positive news regarding FDA approval, PTGX's stock price has slightly decreased by 0.14%, currently priced at $97.09 [4]. - The stock has experienced volatility, with a trading range between a low of $90.58 and a high of $99.44 on the day of reporting [4]. - Over the past year, PTGX has reached a high of $99.45 and a low of $39.60, with a market capitalization of approximately $6.2 billion [4].

Core Insights - Protagonist has received FDA approval for ICOTYDE, a treatment for moderate to severe plaque psoriasis in adults and pediatric patients aged 12 and older who weigh at least 40 kilograms and are candidates for systemic therapy or phototherapy [1] Company Overview - The announcement was made during a presentation featuring key executives from Protagonist, including the President and CEO, CFO, and Clinical Development Adviser [1] Industry Context - The approval of ICOTYDE highlights the ongoing advancements in treatments for psoriasis, a condition that affects a significant number of patients and presents a substantial market opportunity for pharmaceutical companies [1]

Summary of Protagonist Therapeutics Conference Call Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Key Product**: ICOTYDE, an oral peptide-targeted therapy for moderate-to-severe plaque psoriasis Key Industry and Company Insights FDA Approval Announcement - Protagonist announced FDA approval of ICOTYDE for treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and older who weigh at least 40 kg [2][4] - ICOTYDE is the first oral peptide-targeted therapy that blocks the IL-23 pathway by targeting the IL-23 receptor, contrasting with existing injectable antibodies that target the IL-23 ligand [4][6] Clinical Development and Efficacy - The approval was supported by a comprehensive phase 3 program involving approximately 2,500 patients across four studies, meeting all primary endpoints and demonstrating a favorable safety profile [7][9] - ICOTYDE has a broad label based on studies in both adults and adolescents, including head-to-head studies showing superiority to the active comparator, Sotyktu [8] Financial Implications - The approval triggers a $50 million milestone payment from Johnson & Johnson (J&J) and initiates a royalty-based revenue stream [10] - Protagonist has earned a total of $387 million in milestone payments since the collaboration with J&J began in 2017, with an additional $580 million in potential future milestones [10][11] - The royalty structure includes tiered royalties ranging from 6% to 10% on global net sales, with a weighted average of 7.25% at $4 billion in annual sales [12] Strategic Partnerships - Protagonist emphasizes the importance of its collaboration with J&J, which is responsible for commercialization and ongoing clinical trials of ICOTYDE [13] - The partnership has been described as a win-win, highlighting the potential blockbuster category of ICOTYDE [13] Pipeline and Future Developments Additional Assets - Protagonist is expecting FDA approval for rusfertide, a hepcidin mimetic for polycythemia vera, in the third quarter of the year [14][15] - The company is developing new R&D assets, including an oral IL-17 peptide antagonist (PN881) and an oral triple GLP GIP GCG agonist (PN477) for obesity [16][17] Financial Position and Shareholder Value - Protagonist aims to fund its R&D programs without equity offerings, focusing on returning capital to shareholders through potential share buybacks [19][20] - The company is exploring partnerships for its IL-17 and obesity programs, with ongoing dialogues with multiple parties [107] Market Position and Competitive Landscape - Protagonist believes ICOTYDE can capture market share from existing injectables and attract patients currently not on treatment due to aversion to injections [53][54] - The company is focused on differentiating its products in a competitive landscape, particularly in the obesity space where unmet needs exist [77][96] Conclusion - The approval of ICOTYDE marks a significant milestone for Protagonist, validating its peptide technology platform and setting the stage for future growth and product-driven cycles [20][22] - The company is well-positioned financially and strategically to expand its pipeline and enhance shareholder value through innovative therapies and partnerships.

US FDA Approval of ICOTYDETM (Icotrokinra) For Treatment of Moderate -to - Severe Plaque Psoriasis Dinesh V. Patel, Ph.D. President & CEO Conference Call March 18, 2026 1 Legal Disclaimer This presentation and any accompanying oral presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements regarding: the timing a ...

ICOTYDE is the first and only IL-23R targeted oral peptide that delivers complete skin clearance and a favorable safety profile in a once-daily pill Approval supported by four phase 3 studies that met all primary endpoints and demonstrated a favorable safety profile in 2,500 patients $50 million milestone payment triggered by FDA approval; Protagonist is eligible to receive 6 - 10% royalties on sales and up to $580 million in future milestone payments Webcast and conference call to be held at 8:30 am ET on ...

Company Overview - Protagonist Therapeutics focuses on innovation through novel peptides, specializing in both injectable and oral peptides, with a history dating back to 2008 [3] - The company went public in 2016, with Barclays as one of the banks that facilitated the IPO [2] Recent Developments - Protagonist has two significant assets that demonstrated outstanding Phase III data last year, indicating progress in their clinical development [4]

Protagonist Therapeutics FY Conference Summary Company Overview - Protagonist Therapeutics focuses on innovation through novel peptides, with expertise in both injectable and oral peptides since 2008, a time when peptides were largely overlooked [8][9] - The company went public in 2016 with the assistance of Barclays [4] Key Assets and Developments - **Icotrokinra**: An oral IL-23 blocker, the first of its kind, with phase 3 data showing promise. Approval is sought for psoriasis, with additional studies in psoriatic arthritis, ulcerative colitis, and Crohn's disease [9][10][12] - **Rusfertide**: A weekly injectable mimetic of hepcidin, targeting polycythemia vera, with a partnership with Takeda established in January 2024. Priority review has been granted, potentially accelerating approval [14][15][16] - Both drugs are expected to be approved in Q3 2026, marking significant milestones for the company [15] Future Pipeline - Protagonist is developing an oral IL-17 program and has preclinical studies in IL-4, aiming to create a portfolio of oral peptides to differentiate from existing injectable options [19][22][27] - The company is also working on an oral triple GLP-GIP-GCG for obesity, with clinical studies expected to begin in the second half of the year [25][131] Clinical Strategy and Evaluation - The company emphasizes rigorous preclinical evaluation to ensure oral bioavailability and efficacy, taking longer than typical assessments to select the right candidates [36][38] - For icotrokinra, J&J is leading the launch strategy, leveraging extensive data from head-to-head studies against competitors [41][45] Competitive Landscape - Protagonist acknowledges competition in the hepcidin space but believes their approach of creating a mimetic offers a distinct advantage over others enhancing endogenous hepcidin production [62][66][70] - The company is confident in its market position due to its early development stage and unique drug mechanisms [78] Business Development and Partnerships - Protagonist plans to take assets to clinical proof of concept before seeking partnerships for larger indications, while considering retaining more backend economics through creative cost-sharing arrangements [102][123] - The company aims to avoid external fundraising, focusing on internal funding for studies [125] Obesity Market Insights - The obesity treatment landscape is seen as a significant opportunity, with Protagonist aiming to differentiate through oral peptides in a crowded market [128][131] - The company is developing both weekly subcutaneous and daily oral formulations, with a focus on creating a diverse portfolio to address various patient needs [133][137] Conclusion - Protagonist Therapeutics is positioned to leverage its innovative peptide technology and strategic partnerships to address unmet medical needs in various therapeutic areas, particularly in immunology and obesity, while maintaining a strong focus on clinical efficacy and market differentiation [131][140]