Group 1 - Johnson & Johnson is in discussions to acquire Protagonist Therapeutics, indicating a potential strategic move in the biopharmaceutical sector [1]

The two companies are already codeveloping a treatment for ulcerative colitis. ...

Company Highlights - Cidara Therapeutics Inc. (CDTX) reached a 52-week high of $87.19 as it advances its development plan for CD388, a non-vaccine preventive treatment for seasonal influenza, with enrollment in a Phase 3 study expected to start by September 2025 targeting 6,000 participants [1] - Maze Therapeutics Inc. (MAZE) saw its stock rise to a 52-week high of $27.09 following positive Phase 1 clinical results for MZE782, an oral therapy for Phenylketonuria and chronic kidney disease, with plans to enter Phase 2 studies in 2026 [3][4] - Medpace Holdings Inc. (MEDP) is set to report Q3 2025 financial results on October 22, 2025, and has raised its full-year guidance twice, indicating strong operational momentum, with the stock hitting a 52-week high of $506.55 [5][6] - Monopar Therapeutics Inc. (MNPR) rebounded from potential Nasdaq delisting to a 52-week high of $73.75, planning to seek approval for ALXN1840 for Wilson disease in early 2026, supported by long-term clinical data [7][8] - Prenetics Global Limited (PRE) projects 2025 revenue between $85 million and $100 million, a significant increase from $30.6 million in 2024, with its new wellness brand IM8 Health on track for $100 million in annual recurring revenue [9][10] - Protagonist Therapeutics Inc. (PTGX) is nearing a major milestone with Icotrokinra for psoriasis, having submitted a regulatory application to the FDA and EMA in July 2025, with the stock reaching a 52-week high of $66.70 [11][12] - uniQure N.V. (QURE) announced positive results from its Phase I/II study of AMT-130 for Huntington's disease, planning to submit a Biologics License Application in Q1 2026, with the stock soaring over 200% to a 52-week high of $51.21 [13][14] - Rezolute Inc. (RZLT) surged to a 52-week high of $9.02 ahead of topline results from its pivotal Phase III trial for hypoglycemia treatment, expected in December [15][16] - United Therapeutics Corp. (UTHR) reached a 52-week high of $442.01 as anticipation builds for data from the TETON-2 study of nebulized Tyvaso in idiopathic pulmonary fibrosis, with positive results reported earlier [17][18]

Core Thesis - Protagonist Therapeutics, Inc. (PTGX) presents a compelling investment opportunity due to strong clinical progress and underappreciated fundamentals, with a market cap of $3.6 billion and $615 million in net cash as of June 2025 [2][4] Clinical Assets - PTGX's most valuable asset, Icotrokinra (Ico), is an oral IL-23R peptide antagonist partnered with JNJ, nearing FDA approval with robust Phase 2/3 data for multiple indications including psoriasis and Crohn's disease [2][3] - Ico's efficacy rivals or potentially surpasses injectable treatments like Skyrizi and Tremfya, positioning PTGX to capture significant market share in a $25 billion IL-23 class [3] Financial Projections - PTGX is projected to earn $400–$900 million in annual royalties from Ico, with additional upside from sales milestones and market expansion, leading to a plausible base-case DCF value of $3–4 billion [3][5] - Rusfertide, another asset partnered with Takeda, targets polycythemia vera and is expected to generate $100–$200 million in annual cash flow, along with a $400 million opt-out payment [3][4] Strategic Positioning - PTGX's platform includes oral IL-17, oral hepcidin, and obesity drug candidates, providing high optionality and potential for significant future upside [4] - The company has a strong balance sheet with minimal burn relative to upcoming catalysts, and management incentives are aligned with shareholder value [4] Market Catalysts - Multiple catalysts exist, including Ico approval and Rusfertide commercialization decisions, which the market has yet to fully price in [4][5] - The potential for strategic transactions, such as royalty sales or platform acquisitions, could further unlock value for PTGX [5]

Group 1 - B. Riley Securities analyst Mayank Mamtani initiated coverage on Theravance Biopharma, Inc. (TBPH) with a Buy rating and a price target of $28, while shares closed at $13.70 [3] - Leerink Partners analyst Faisal Khurshid initiated coverage on Protagonist Therapeutics, Inc. (PTGX) with an Outperform rating and a price target of $73, with shares closing at $59.68 [3] - Barclays analyst David Strauss initiated coverage on StandardAero, Inc. (SARO) with an Overweight rating and a price target of $32, while shares closed at $27.35 [3]

Core Insights - The company has received breakthrough designation for rusfertide for polycythemia vera, marking a significant regulatory milestone [1] - This is the second time the company has received this designation, indicating a positive shift in the agency's perception of the drug's safety and efficacy [1] - The reapplication for breakthrough designation was prompted by previous preclinical findings that led to the withdrawal of the designation, suggesting a proactive approach to regulatory engagement [1] Company Perspective - The CEO emphasized the importance of remaining vigilant and not taking achievements for granted, highlighting the unpredictable nature of research and development [2] - The company expresses gratitude for opportunities such as conference invitations, reflecting a commitment to maintaining strong industry relationships [2] - The ongoing development of rusfertide is viewed positively, indicating confidence in its potential impact on the market [2]

Group 1 - The company has received breakthrough designation for rusfertide for polycythemia vera, marking the second time this designation has been granted [1] - The previous breakthrough designation was revoked due to preclinical findings, indicating a need for the company to demonstrate safety and efficacy to regulatory agencies [1] - The reapplication for breakthrough designation suggests that the agency is now comfortable with the drug's profile and efficacy [1] Group 2 - The CEO emphasized the importance of remaining vigilant in research and development, regardless of past validations [2] - The company expresses gratitude for opportunities such as conference invitations, highlighting a proactive approach to stakeholder engagement [2]

Summary of Protagonist Therapeutics FY Conference Call Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Key Focus**: Development of innovative therapeutics, particularly in the areas of polycythemia vera (PV) and inflammatory bowel disease (IBD) Key Points and Arguments Drug Development and Breakthrough Designation - Protagonist Therapeutics is on the verge of obtaining approval for its first two drugs, with resveratide for polycythemia vera recently receiving breakthrough designation, indicating the FDA's confidence in its efficacy and safety [2][8][9] - The company achieved significant phase three results, meeting primary and secondary endpoints, including patient-reported outcomes, which are critical in the treatment of PV [6][7] - The breakthrough designation allows for expedited review, with an expected NDA filing by the end of the year and potential approval within a year, contingent on priority review [11][12] Market Opportunity in Polycythemia Vera - The prevalence of PV in the US is over 150,000 patients, with approximately 70% receiving treatment; however, two-thirds of these patients struggle to maintain hematocrit levels below 45% [13][14] - Protagonist estimates a market opportunity of $1 to $2 billion for resveratide, with a target population of around 50,000 patients who could benefit from the drug [15] Opt-In/Opt-Out Decision - The company is evaluating whether to opt in or out of a partnership with Takeda, with a potential opt-out fee of $400 million and higher milestone payments if they choose to opt out [19][20] - The decision will be made by mid-next year, with the NDA filing influencing the timeline [19] Oral Hepcidin Development - Protagonist is also developing an oral hepcidin, which is distinct from resveratide but related mechanistically; the company aims to explore its utility beyond PV [29][30] ICO and IBD Market - ICO, another key asset, has filed for NDA for psoriasis, with expectations for approval in July next year; it is the only oral IL-23 blocker, presenting a significant opportunity in both dermatology and IBD [31][32] - The phase two data for ICO in ulcerative colitis (UC) shows a 30% clinical remission rate, indicating strong potential in the IBD market [36][37] Differentiation in Obesity and Other Areas - Protagonist acknowledges the crowded obesity market but emphasizes differentiation through their unique oral GLP-1/GIP/GCG platform [41][42] - The company is developing both oral and subcutaneous formulations to cater to different patient preferences [45] Future Directions - Protagonist is committed to investing in internal R&D and exploring external innovations to strengthen its platform and pipeline [22][23] - The company is optimistic about the potential of its assets in both the PV and IBD markets, with ongoing clinical studies and strategic partnerships [50] Additional Important Insights - The company is focused on maintaining a strong cash position while exploring various avenues for growth, including potential buybacks and investments in new technologies [25][26] - Protagonist's approach to drug development emphasizes the importance of clinical data and market feedback, which shapes their strategic decisions [9][15]

Core Insights - The company is focused exclusively on peptide therapeutics, emphasizing the versatility of its platform which is agnostic to disease areas or targets [2][3] - The company aims to avoid scenarios where scientific success does not translate into practical utility for drugs, highlighting the importance of both scientific and commercial viability [2] Group 1 - The peptide platform is viewed as a renewable resource, with potential for greater value in the future [1] - The company seeks strong differentiation in its approach to peptide therapeutics, ensuring that scientific achievements align with market needs [3]

Summary of Protagonist Therapeutics Conference Call Company Overview - **Company**: Protagonist Therapeutics (PTGX) - **Event**: Citi Biopharma Back to School Summit - **Date**: September 03, 2025 Key Points Peptide Platform and Strategy - Protagonist focuses exclusively on peptide therapeutics, which are versatile and agnostic to disease areas or targets [2][3] - The company aims to differentiate its products from existing drugs by targeting biologically validated pathways, particularly those successful in injectable antibody drugs [5] - The strategy has evolved from gut-restricted peptides to orally bioavailable peptides, broadening the scope of potential opportunities [8] Rasvirtide Development - Rasvirtide has shown outstanding phase three data, leading to a breakthrough designation from regulatory agencies [12][13] - The drug addresses an unmet need in polycythemia vera, with positive interactions with regulatory agencies [13] - Protagonist and its partner Takeda are focused on increasing awareness and establishing relationships with key opinion leaders (KOLs) and physicians to drive market penetration [20][21] Partnership with Takeda - The partnership with Takeda is characterized by a collaborative spirit, leveraging Protagonist's historical knowledge of Rasvirtide and Takeda's resources [15][17] - Protagonist retains the option to opt-out of the partnership, which includes a significant financial incentive of $425 million, allowing flexibility in future decisions [22][24][30] ICO and Market Potential - ICO, an oral IL-23 blocker, is positioned to capture a significant market share due to its oral administration and efficacy in treating inflammatory bowel diseases [46][47] - The drug is expected to appeal to patients currently not seeking treatment due to dissatisfaction with existing options [46] - Protagonist's royalty structure with J&J ranges from 6% to 10%, with optimistic sales projections for ICO [45][46] Obesity Drug Development - Protagonist is entering the obesity market with a focus on developing both oral and injectable formulations, aiming to differentiate its product through unique mechanisms [58][60] - The company is conducting preclinical studies to ensure efficacy and tolerability, with plans to initiate phase one studies in the near future [69] Future Outlook - Protagonist is committed to maintaining flexibility in its partnerships and product development strategies, aiming to maximize shareholder value while leveraging the expertise of larger pharmaceutical partners [53][51] - The company is optimistic about the potential of its pipeline, particularly in the areas of rare diseases and obesity, with ongoing studies expected to yield valuable insights [69][70] Additional Insights - The company emphasizes the importance of partnerships for validation and resource access, while also planning to retain more control over its assets in future collaborations [50][52] - Protagonist's approach to drug development focuses on validated targets, reducing biological risk and enhancing the predictability of clinical outcomes [68]