NEW YORK, Feb. 19, 2026 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of American Depositary Shares (“ADS”) of Mereo BioPharma Group plc (NASDAQ: MREO) between June 5, 2023 and December 26, 2025, inclusive (the “Class Period”), of the important April 6, 2026 lead plaintiff deadline. SO WHAT: If you purchased Mereo ADSs during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arra ...

Financial Data and Key Metrics Changes - In 2025, Prothena reported a net cash used in operating and investing activities of $163.7 million, which was favorable compared to the guidance range of $170 million to $178 million [37] - The net loss for 2025 was $244.1 million, aligning with the guidance range of $240 million to $248 million [37] - As of December 31, 2025, Prothena had $308.4 million in cash, cash equivalents, and restricted cash, exceeding the guidance of $298 million [38] Business Line Data and Key Metrics Changes - Prothena's clinical pipeline saw significant progress, with two partnered programs, prasinezumab and coramitug, advancing into phase 3 clinical trials [6][7] - The phase 2 clinical trial for BMS-986446 in early Alzheimer's disease was fully enrolled in 2025, with completion expected in the first half of 2027 [8] - The company introduced its CYTOPE technology, demonstrating potential for precise targeting of intracellular disease pathways [9][30] Market Data and Key Metrics Changes - The phase 3 PARAISO trial for prasinezumab is expected to enroll approximately 900 participants, with primary completion anticipated in 2029 [16] - The phase 3 CLEOPATTRA trial for coramitug is intended to enroll about 1,280 ATTR-CM patients, with primary completion also expected in 2029 [23] - Prothena's partnered clinical programs have the potential to deliver up to approximately $3 billion in future milestone payments [12] Company Strategy and Development Direction - Prothena aims to capture value from clinical partnerships, with potential clinical milestone payments of up to $105 million in 2026 [10][40] - The company plans to implement a share redemption program and invest in its preclinical portfolio to support ongoing partnering efforts [40] - Prothena is focused on advancing its knowledge of the preclinical portfolio to explore research collaborations and licensing agreements [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the robust pipeline addressing significant unmet needs for millions of patients [40] - The company highlighted the importance of upcoming milestones and the potential for significant medical advances in areas with high unmet needs [45] - Prothena remains well-capitalized with a strong cash position, focusing on delivering long-term shareholder value [41] Other Important Information - Prothena's collaborations with Bristol Myers Squibb progressed, with BMS-986446 receiving Fast Track designation from the U.S. FDA for Alzheimer's treatment [8] - The company is engaged in research collaborations exploring multiple approaches for applying its CYTOPE technology [11] Q&A Session Summary Question: Key milestones for partnered program trials for PARAISO and CLEOPATTRA - Management outlined expectations for sharing more information on CYTOPE activities and data from the tau program with Bristol Myers Squibb in 2027, along with the phase 3 readouts expected in 2029 for coramitug and prasinezumab [42][44] Question: Keeping the amyloid beta story alive against competitors - Management discussed the advantages of the PRX012 transferrin-based approach, emphasizing its potential for improved amyloid removal and reduced ARIA rates compared to competitors [51][55] Question: Data sharing from the phase one study of PRX019 - Management confirmed that data from the PRX019 study will be shared with Bristol Myers Squibb, who holds global rights to the program [62][68] Question: Data necessary to secure a partnership for the CYTOPE platform - Management highlighted the importance of demonstrating robust CNS activity and specificity in targeting TDP-43 aggregates, which could facilitate partnerships [71][75]

Financial Data and Key Metrics Changes - The company reported a significant year-over-year total revenue growth of 22%, with full-year 2025 revenues of $407.3 million, compared to $333.6 million in 2024 [32] - XPHOZAH revenues grew to $274.2 million, an increase of 73% compared to the full year of 2024 [33] - The net loss for 2025 was $61.6 million, or $0.26 per share, compared to a net loss of $39.1 million, or $0.17 per share, for 2024 [36] Business Line Data and Key Metrics Changes - IBSRELA achieved a remarkable revenue growth of 73% compared to 2024, with a 61% year-over-year growth in the fourth quarter [7][11] - XPHOZAH experienced a 9% increase in total dispenses and a 41% increase in paid dispenses when excluding Medicare compared to 2024 [18] - The IBS-C market grew by 11% in 2025, with nearly 7 million prescriptions written [13] Market Data and Key Metrics Changes - The IBS-C market continues to grow in double digits, indicating a robust demand for treatment options [12] - The company noted that 77% of patients on a secretagogue report continuing symptoms, highlighting a significant unmet need in the market [13] Company Strategy and Development Direction - The company aims to significantly grow IBSRELA and maintain momentum for XPHOZAH, with a focus on expanding its pipeline to address unmet medical needs [5][10] - A new patent for the commercial formulations of IBSRELA and XPHOZAH, expiring in 2042, was issued, which is part of the strategy to build a comprehensive intellectual property portfolio [8] - The company plans to invest in three key areas: optimizing prescriber engagement, improving prescription pull-through, and increasing patient activation [14][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching the revenue guidance for IBSRELA of $410 million to $430 million in 2026, representing at least 50% year-over-year growth [37] - The company anticipates that IBSRELA will reach $1 billion in revenue by 2029, driven by continued adoption among IBS-C patients and potential growth from patients with CIC [39] - Management emphasized a disciplined approach to capital allocation and investments to drive growth and achieve profitability [31][42] Other Important Information - The company finished 2025 with a strong cash position of $264.7 million, an increase from $250.1 million at the end of 2024 [37] - The company has generated positive cash flow for two consecutive quarters due to growing revenue [37] Q&A Session Summary Question: Confidence in IBSRELA volume growth to reach $430 million guidance - Management expressed strong confidence in the guidance, citing the large patient population needing alternatives to current treatments [47] Question: Cadence of R&D and SG&A step-ups for 2026 - Management indicated a 25% increase in operating expenses, with a focus on growth in both commercial and R&D areas [56] Question: Expectations for the CIC trial and dose levels - Management clarified that the trial includes multiple doses to evaluate efficacy and safety, with a focus on finding the optimal dose [66] Question: Distinctions in the CIC market compared to other treatments - Management highlighted the need for different mechanisms of action in treating CIC, similar to IBS-C, due to the fluidity between the two conditions [73] Question: Long-term growth for XPHOZAH post-2026 - Management noted that they do not benefit from Medicare base rate adjustments and are focused on ensuring patient access regardless of coverage [88]

Financial Data and Key Metrics Changes - In 2025, Prothena reported a net cash used in operating and investing activities of $163.7 million, which was favorable compared to the guidance range of $170 million to $178 million [37] - The net loss for 2025 was $244.1 million, aligning with the guidance range of $240 million to $248 million [37] - As of December 31, 2025, Prothena had $308.4 million in cash, cash equivalents, and restricted cash, exceeding the guidance of $298 million [38] - For 2026, the expected net cash used in operating and investing activities is projected to be between $50 million and $55 million, with an estimated net loss of $67 million to $72 million [38][39] Business Line Data and Key Metrics Changes - Prothena's clinical pipeline saw significant advancements, with two partnered programs, prasinezumab and coramitug, moving into phase III clinical trials [6][7] - The phase II TargetTau-1 clinical trial for BMS-986446 in early Alzheimer's disease was fully enrolled in 2025, with completion expected in the first half of 2027 [8] - The company introduced its CYTOPE technology, demonstrating potential for precise targeting of intracellular disease pathways [9][30] Market Data and Key Metrics Changes - The phase III PARAISO trial for prasinezumab is expected to enroll approximately 900 participants, with primary completion anticipated in 2029 [16] - The phase III CLEOPATRA trial for coramitug is set to enroll around 1,280 ATTR-CM patients, with primary completion also expected in 2029 [23] - Prothena's partnered clinical programs have the potential to deliver up to approximately $3 billion in future milestone payments, in addition to any royalties [12] Company Strategy and Development Direction - Prothena aims to capture value from clinical partnerships, with potential clinical milestone payments of up to $105 million in 2026 [10][41] - The company plans to implement a share redemption program and invest in its preclinical portfolio to support ongoing partnering efforts [10][41] - Prothena is focused on advancing its knowledge of the preclinical portfolio to explore research collaborations and licensing agreements [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the robust pipeline addressing significant unmet needs for millions of patients [40] - The company highlighted the importance of upcoming milestones and the potential for significant medical advances in areas with high unmet needs [46] - Management emphasized the strategic importance of the share redemption program and the potential for clinical milestone payments from partners [47][48] Other Important Information - Prothena's cash position as of year-end 2025 was $308.4 million, allowing for prudent capital utilization to support future potential economics from partner programs [11] - The company is engaged in research collaborations exploring multiple approaches for applying its CYTOPE technology [10] Q&A Session Summary Question: Key milestones for partnered program trials for PARAISO and CLEOPATRA - Management outlined that significant activities are expected in 2026 and 2027, including data from the CYTOPE activities and the phase II tau program with Bristol Myers Squibb [44][46] Question: Keeping the amyloid beta story alive against competitors - Management discussed the advantages of the PRX-012 transferrin-based approach and the potential for improved profiles compared to existing therapies [51][55] Question: Data sharing from the phase I study of PRX-019 - Management indicated that data will be shared with Bristol Myers Squibb, who holds global rights to the program, and will decide on public dissemination [62][68] Question: Data necessary for securing a partnership for the CYTOPE platform - Management highlighted the importance of robust in-vivo data demonstrating the technology's ability to target intracellular disease pathways effectively [71][75]

Connecticut-based Braidwell reported selling 1,412,746 shares of CG Oncology (NASDAQ:CGON) in its February 17, 2026, SEC filing, an estimated $58.46 million trade based on quarterly average pricing. What happened According to a February 17, 2026, SEC filing, Braidwell reduced its position in CG Oncology by 1,412,746 shares during the fourth quarter of 2025. The estimated transaction value was $58.46 million, based on the stock’s average closing price in the quarter. The fund’s quarter-end value in CG Onc ...

Travere Therapeutics Corporate Overview February 2026 Forward-Looking Statements This presentation contains forward-looking statements, including but not limited to statements about: continued progress with the FILSPARI launch in IgAN; statements regarding our products and products in development as potential foundational treatments and/or treatment standards; additional development and regulatory milestones, including expected data from additional studies and the expected timing thereof; plans and expectat ...

Core Insights - Bicara Therapeutics presented preliminary data from a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab for treating first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), showing rapid, deep, and durable responses with a well-tolerated safety profile [1][3][4] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa being its lead program [12][13] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration and improve survival outcomes by combining an EGFR-directed antibody with a TGF-β ligand trap [2][10] Clinical Data - The Phase 1b expansion cohort data indicated a 48% confirmed overall response rate (ORR) for the 2000mg every other week (Q2W) dosing regimen, with 26% of patients achieving a complete response (CR) and 77% of responders showing at least 80% tumor shrinkage [3][4] - The safety profile of the 2000mg Q2W regimen was consistent with previous findings for ficerafusp alfa combined with pembrolizumab [3][4] - Updated biomarker results confirmed that the 2000mg Q2W regimen maintains TGF-β inhibition and immune activation while delivering deep responses [5] Future Development Plans - The company plans to develop a loading and every-three-week maintenance regimen for ficerafusp alfa, pending regulatory alignment [1][6] - Ongoing enrollment in the pivotal FORTIFI-HN01 study continues to evaluate ficerafusp alfa at 1500mg weekly in combination with pembrolizumab [6][11] Industry Context - HNSCC is one of the most common cancers globally, with a rising incidence expected to reach one million new cases annually by 2030, highlighting a significant unmet need for effective therapies [8][9]

Core Viewpoint - Olema Pharmaceuticals, Inc. is focused on developing targeted therapies for breast cancer and will present at the TD Cowen 46 Annual Health Care Conference on March 3, 2026 [1] Company Overview - Olema Oncology is a clinical-stage biopharmaceutical company dedicated to improving outcomes for breast cancer patients and is advancing a pipeline of novel therapies [3] - The lead product candidate, palazestrant (OP-1250), is an orally available complete estrogen receptor antagonist and selective estrogen receptor degrader, currently in two Phase 3 clinical trials [3] - Olema is also developing OP-3136, a potent KAT6 inhibitor, which is in a Phase 1 clinical study [3] - The company is headquartered in San Francisco with operations in Cambridge, Massachusetts [3]

NEEDHAM, Mass., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the launch of an underwritten public offering of $100 million of its common stock. Candel also intends to grant the underwriters a 30-day option to purchase up to an additional $15 million in shares of its common stock on the same terms and condi ...

Core Insights - Ardelyx, Inc. reported a significant revenue growth of 73% for IBSRELA in 2025, reaching $274.2 million, contributing to total revenues of $407.3 million for the year [1][3][10] - The company is focused on expanding its product offerings and has launched development programs for new indications and next-generation therapies [1][7][8] - Ardelyx anticipates continued growth in 2026, with projected IBSRELA revenues between $410 million and $430 million, indicating at least 50% growth compared to 2025 [4][6] Financial Performance - Total revenue for 2025 was $407.3 million, up from $333.6 million in 2024, driven primarily by IBSRELA's performance [10][14] - IBSRELA revenue for 2025 was $274.2 million, a 73% increase from $158.3 million in 2024, while XPHOZAH revenue was $103.6 million, down from $160.9 million in 2024 [3][14] - The company reported a net loss of $61.6 million for 2025, compared to a net loss of $39.1 million in 2024, with significant expenses related to commercialization and R&D [10][14][28] Product Development and Pipeline - Ardelyx is advancing its pipeline, including a Phase 3 trial for IBSRELA in chronic idiopathic constipation (CIC), with enrollment expected to complete by the end of 2026 [7][8] - The company has initiated a development program for RDX10531, a next-generation NHE3 inhibitor, with plans for an Investigational New Drug submission in the second half of 2026 [8][24] - The long-term strategy focuses on delivering novel therapies to patients with unmet medical needs and generating sustained shareholder value [2][22] Market Outlook - Ardelyx expects IBSRELA to achieve $1 billion in annual revenue by 2029, supported by increased prescribing depth and patient engagement [4][6] - The company aims to enhance its market presence through strategic initiatives and broaden its portfolio of innovative medicines [2][4]