OPKO Health (NasdaqGS:OPK) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Company ParticipantsAdam Logal - SVP and CFOElias Zerhouni - Vice Chairman and PresidentGary Nabel - CIOPhillip Frost - Chairman and CEOYvonne Briggs - Director of Investor RelationsNone - Company RepresentativeConference Call ParticipantsBrian Cheng - Executive Director and Senior Biotech AnalystEdward Tenthoff - Managing Director and Senior Research AnalystMaury Raycroft - Equity Research AnalystYale Jen - Senior Biotech Analys ...

Protara Therapeutics Conference Call Summary Company Overview - **Company**: Protara Therapeutics - **Ticker**: TARA - **Industry**: Biotechnology Key Assets and Development Programs TARA-002 - **Indications**: - Non-muscle invasive bladder cancer (NMIBC) - Lymphatic malformations - **Development Stage**: Late-stage development for both indications [3][4] Mechanism of Action - TARA-002 is a genetically distinct strain of inactivated Streptococcus pyogenes, engineered to retain its immune-stimulating properties [4] - It has been used in Japan for decades as a standard of care for lymphatic malformations and adjunctively with chemotherapy for various cancers [5] Clinical Trials and Data - **ADVANCED-2 Study**: - Focuses on BCG-unresponsive NMIBC patients - Reported a 68% complete response rate at 6 months from 22 patients [9] - Preliminary 12-month complete response rate of 33% from 15 evaluable patients [9] - **ADVANCED-3 Study**: - Aims to utilize TARA-002 in the frontline setting as an alternative to BCG, targeting a significant population due to BCG shortages [6][16] - **STARBORN-1 Study**: - Focused on macrocystic and mixed cystic lymphatic malformations, with ongoing patient enrollment and upcoming FDA engagement for a registrational path [41] Market Opportunity - **Unmet Need**: - Approximately 35% of BCG-eligible patients do not receive BCG due to shortages or intolerance, translating to an annual population of 11,000 to 15,000 patients [25][26] - Potentially addressing tens of thousands of patients annually, including those exposed to BCG [27] - **Competitive Landscape**: - TARA-002 is positioned as a viable alternative in the NMIBC setting, with a focus on ease of use and reliability compared to existing treatments [32] Regulatory Insights - The FDA has indicated that a head-to-head trial against BCG is not necessary, which may facilitate a smoother path to approval [19] Other Programs IV Choline Chloride - **Target Population**: Approximately 35,000 patients in the U.S. on long-term chronic TPN [56] - **Clinical Need**: High prevalence of choline deficiency and liver dysfunction in patients on parenteral nutrition [56] - **Intellectual Property**: Orange Book listed product claim patent extending to 2041, providing exclusivity [62] Financial Considerations - The company is optimistic about pricing strategies based on established benchmarks in the NMIBC setting, allowing flexibility in both NMIBC and lymphatic malformations markets [46] Conclusion - Protara Therapeutics is actively advancing its clinical programs, particularly TARA-002, which addresses significant unmet needs in oncology. The company is well-positioned to capture market share in both NMIBC and lymphatic malformations, with a favorable regulatory outlook and a strong pipeline of assets.

NANTES, France, February 26, 2026 – 6pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced that the Independent Data Monitoring Committee (IDMC) has issued a second positive recommendation for the ongoing pivotal Phase 3 ARTEMIA trial evaluating Tedopi® in advanced non-small cell lung cancer (NSCLC). The IDMC advised that the study should continue as planned, with no protocol changes. In line with the predefined study oversight plan, the IDMC, composed of independent clinical ...

Adagene FY Conference Summary Company Overview - **Company**: Adagene (NasdaqGM:ADAG) - **Focus**: Development of immuno-oncology drugs, specifically targeting microsatellite stable colorectal cancer (MSS-CRC) with low response rates to current therapies [2][3] Key Points and Arguments Drug Development and Efficacy - **Lead Compound**: ADG126, a masked anti-CTLA-4 antibody, is being developed in combination with KEYTRUDA (pembrolizumab) for late-line MSS-CRC without liver metastases [3][4] - **Response Rates**: ADG126 has shown a response rate between 15% and 30% depending on dosage, with a median overall survival of 20 months in the lowest dose cohort [3][5] - **Safety Profile**: The discontinuation rate is less than 10%, with no grade 4 or 5 adverse events reported, indicating a favorable safety margin [5][15] Market Opportunity - **Target Population**: Approximately 10,000 patients in the U.S. represent the MSS-CRC without liver metastases, a challenging tumor type for immuno-oncology agents [12] - **Historical Context**: Current standard of care has a median overall survival of 10-14 months, highlighting the need for more effective treatments [2][11] Collaboration and Funding - **Sanofi Investment**: Sanofi committed to an equity investment of up to $25 million, with the first tranche of $17 million received at $2 per share. This funding supports the ongoing phase 2 trial of ADG126 [6][7] - **Trial Collaboration**: Sanofi will evaluate ADG126 in combination with their bispecific PD-1 IL-15 in over 100 patients with solid tumors [6][7] Competitive Landscape - **CTLA-4 Mechanism**: CTLA-4 therapies like Yervoy (ipilimumab) and Imjudo (tremelimumab) generate close to $4 billion in revenues, indicating a robust market for effective CTLA-4 inhibitors [8][9] - **Differentiation**: ADG126 is positioned as a safer alternative with a better safety margin compared to existing CTLA-4 therapies, which have shown high toxicity [10][76] Future Developments - **Upcoming Data**: Updates on ADG126's efficacy and safety are expected in the coming months, including data from triplet combinations and a phase 2 trial in neoadjuvant colorectal cancer patients [20][23] - **Regulatory Pathway**: Plans for a randomized phase 3 trial focusing on overall survival as the primary endpoint are in discussion with the FDA [62][73] Additional Important Insights - **Combination Potential**: ADG126 is seen as a versatile partner for various combinations beyond PD-1, including potential combinations with VEGF and TGF inhibitors [36][38] - **Strategic Partnerships**: The company aims to pursue more licensing deals and trial collaborations to expand its market reach and evaluate novel regimens [23][24] This summary encapsulates the critical insights from the Adagene FY Conference, highlighting the company's strategic direction, drug development progress, and market potential in the oncology space.

SHANGHAI, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the company has entered into the strategic collaboration with Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK). Under the collaboration, the parties will jointly evaluate the synergistic therapeutic potential of Junshi Bio ...

Core Viewpoint - TransCode Therapeutics has published a manuscript detailing a novel tumor-selective immunotherapy approach that activates innate immune signaling specifically within cancer cells, enhancing drug delivery imaging capabilities [1]. Group 1: Research and Development - The published study in the journal Molecular Imaging and Biology describes a template-driven RIG-I agonist strategy that selectively activates RIG-I signaling in tumor cells by utilizing overexpressed oncogenic microRNAs, such as miRNA-21, as assembly templates [1]. - This new approach aims to address challenges associated with RIG-I agonists, including off-target immune activation and inefficient systemic delivery [1]. - The findings suggest a method to engage innate immune pathways directly within tumor cells while minimizing systemic toxicity, potentially advancing RIG-I-based immunotherapy towards clinical relevance [1]. Group 2: Clinical Trials and Therapeutic Candidates - TransCode's TTX delivery platform, which is currently under evaluation in clinical trials, is expected to enhance the translational feasibility of this immunotherapy approach [1]. - The company's lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a well-documented biomarker of metastasis [1]. - TransCode's portfolio includes other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells [1].

and balstilimab (BOT+BAL) program entering 2026. The ses...[Back to Newsroom]## Wish your news had this kind of reach?[Sign Up][Learn About Business Wire] adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit [www.agenusbio.com] or @agenus_bio. Information that may be important to investors will be ...

SOUTH SAN FRANCISCO, Calif., Feb. 19, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology”; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that ALX Oncology leadership will participate in the Wells Fargo Executive Biotech Summit, TD Cowen 46th Annual Health Care Conference, and UBS Biotech Summit. The details of the meetings are as follows: Wells Fargo Executive Biotech Summit F ...

SOUTH SAN FRANCISCO, Calif., Feb. 19, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced plans to report its fourth quarter and full year 2025 financial results and a business update on Friday, February 27th, 2026 before market open. The company will host a teleconference in conjunction with its financial results press release. F ...

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Pursuant to the article L. 233-8 II of the French "Code de Commerce†and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or "AMF†) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate†or the "Company†) releases its total number of shares outstanding as well as its voting rights as of February 19, 2026: Total number of shares outstanding: 93,743,243 ordinary shares 6,140 Preferred ...