WAYNE, Pa., Feb. 23, 2026 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that it will host a conference call and webcast tomorrow, Tuesday, February 24, 2026, at 8:00am ET to disc ...

Core Insights - The conference call was held to discuss the positive topline results from the SOL-1 Phase III clinical trial of AXPAXLI (OTX-TKI) for wet AMD [2][3]. Group 1: Company Overview - Ocular Therapeutix is presenting topline data from its Phase III clinical trial, indicating a significant advancement in its product pipeline [2]. - The call features remarks from key executives and clinical researchers involved in the SOL program, highlighting the collaborative effort in the trial [3]. Group 2: Clinical Trial Details - The SOL-1 trial results are positioned as a pivotal moment for Ocular Therapeutix, potentially impacting the treatment landscape for wet AMD [2]. - The involvement of prominent figures in the ophthalmology field, such as Dr. Arshad Khanani and Dr. Darius Moshfeghi, underscores the credibility and importance of the trial results [3].

Summary of Tango Therapeutics Conference Call Company Overview - **Company**: Tango Therapeutics (NasdaqGM:TNGX) - **New CEO**: Malte Peters, who has been a board member since 2018 and emphasizes continuity in strategy following the transition from former CEO Barbara. Key Priorities and Strategic Focus - **Regulatory Approval**: The primary focus is to achieve regulatory approval for vopimetostat, either as a monotherapy or in combination with RAS inhibitors [4][5]. - **Clinical Development**: Transitioning Tango into a late-phase drug development company is a key priority, with a pivotal trial protocol developed for second-line pancreatic cancer [4][6]. Clinical Trials and Data - **Pivotal Trial for Pancreatic Cancer**: A pivotal trial protocol for second-line pancreatic cancer has been developed, with positive feedback from the FDA regarding trial design and statistical analysis [6][11]. - **Combination Trials**: A combination trial of vopimetostat with RevMed's RAS inhibitors (daraxonrasib and zoldonrasib) has been initiated, showing early signs of clinical activity [6][16]. - **Monotherapy Study**: A 300-patient study is planned, focusing on progression-free survival (PFS) and overall survival [9][12]. - **Promising Data**: Previous monotherapy data indicated a 25% overall response rate (ORR) and approximately 7 months PFS in pancreatic cancer [12]. Market and Competitive Landscape - **Global Trial Design**: The study will be conducted globally, including the USA, Europe, and Asia Pacific, to enhance patient recruitment [11]. - **Chemo-Free Regimen**: There is significant interest in developing a chemotherapy-free regimen for pancreatic cancer, which could greatly benefit patients [37][41]. - **Comparison with Competitors**: Tango is pursuing a different strategy than competitors like BMS, focusing on non-chemotherapy combinations due to scientific and financial considerations [40][41]. Future Directions and Opportunities - **Expansion into Other Tumor Types**: The company is exploring opportunities in other tumor types with MTAP deletions, showing promising signals in head and neck cancer [45][46]. - **TNG456 Development**: The TNG456 clinical trial is in dose escalation, with plans to explore its potential in glioblastoma and non-small cell lung cancer [42][43]. - **Combination with Abemaciclib**: There are plans to pursue a combination with abemaciclib based on preclinical data suggesting potential benefits [49]. Upcoming Updates - **Data Releases**: Updates on pancreatic cancer monotherapy data, combination data with Revolution Medicines, and TNG456 dose escalation data are expected later this year [51][56]. Conclusion - **Exciting Year Ahead**: The company anticipates a year filled with significant developments and data releases, positioning itself for potential breakthroughs in cancer treatment [56].

Core Viewpoint - The FDA's refusal to review Moderna's application for its new mRNA flu vaccine has left the company's president in shock, citing confusion over the agency's decision regarding trial adequacy and control measures [1][6][7]. Group 1: FDA's Decision - The FDA stated that Moderna's application lacked an "adequate and well-controlled" trial, specifically not comparing the new vaccine to the best-available standard of care at the time of the study [2][9]. - The FDA indicated that the trial should have used a high-dose flu vaccine as a comparator, particularly for individuals over 65, as these are considered more effective for older adults [10][11]. - The FDA's letter did not express concerns about the safety or efficacy of the vaccine, but emphasized that the trial design did not meet their guidelines [6][9]. Group 2: Moderna's Response - Moderna's president expressed surprise and confusion over the FDA's decision, noting that the company had previously discussed trial designs with regulators and received written confirmation that their approach was acceptable [5][9]. - The company reportedly invested over a billion dollars in the clinical trial, which involved more than 40,000 participants and reached the pivotal Phase 3 stage [5][14]. - Moderna warned that the FDA's decision could deter future investments in new medicines and cures, suggesting a significant impact on innovation in the pharmaceutical industry [6]. Group 3: Implications and Reactions - The Health and Human Services spokesperson criticized Moderna for not following FDA guidance, stating that the trial exposed older participants to increased risks by using a substandard control [11][12]. - The recent policy changes under Health and Human Services Secretary Robert F. Kennedy, Jr. have led to the termination of nearly $500 million in federal funding for mRNA vaccine development, affecting multiple companies including Moderna [12][13]. - The decision has drawn criticism from health officials, who argue that it undermines the potential of mRNA vaccines in pandemic preparedness [13].

Top-line Results for the Phase 2 VALIANT Trial in Severe Asthma February 11, 2026 © 2026 Upstream Bio, Inc. No Image Disclaimer This presentation contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "continue," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," ...

Core Viewpoint - Vistagen Therapeutics, Inc. is facing a securities class action lawsuit due to alleged misleading statements regarding its clinical trial program for its lead drug candidate, with a lead plaintiff deadline set for March 16, 2026 [1][8]. Group 1: Allegations of Misleading Statements - Management allegedly created an overwhelmingly positive impression about the clinical trial program, emphasizing "notable enhancements" and "operational changes" intended to improve enrollment quality and limit variability [3]. - The company claimed that positive results from a prior Phase 3 trial, combined with operational improvements, positioned the subsequent study as a confirmatory trial with a strong likelihood of success [4]. Group 2: Omitted Risks - The complaint alleges that while promoting the trial's positive aspects, the company failed to disclose material risks inherent in the clinical trial design, specifically known issues with public speaking challenge endpoints that often show elevated placebo responses and site variability [5]. - Defendants are accused of continuing to promote the trial modifications and presenting the study as likely to succeed while concealing these known risks from investors [6].

Core Insights - OKYO Pharma Ltd is set to launch a Phase 2b/3 clinical trial for neuropathic corneal pain after a successful Type C meeting with the FDA, indicating a clear path forward for the program [1][3]. Regulatory Meeting - The Type C meeting with the FDA allowed OKYO Pharma to engage directly with the agency, addressing critical components such as primary endpoints, manufacturing, and statistical plans [3]. - The feedback from the FDA was positive, providing guidance to proceed with the clinical study without unexpected surprises [4]. Next Steps - The company plans to finalize site selection and budget, with guidance to enroll 120 subjects and clarity on the primary endpoint, allowing for protocol finalization [5]. - The goal is to initiate the first patient visit by mid-year, aiming to complete the study by year-end and target top-line results in Q1 2027 [5]. Patient Impact - The company emphasizes the significant unmet need in neuropathic corneal pain, motivated by direct feedback from patients regarding the severe impact of the condition on their quality of life [6].

Core Viewpoint - Cardiff Oncology Inc. experienced a significant decline of approximately 32% in stock price following management and trial updates, indicating investor concern over leadership changes and clinical trial focus [1][9]. Management Changes - Mani Mohindru has been appointed as interim CEO, effective immediately, following the resignation of CEO Mark Erlander and CFO James Levine [1][2]. - Brigitte Lindsay has been promoted to Chief Accounting Officer to ensure financial continuity, having been with the company for over 14 years [2]. Clinical Trial Update - Cardiff Oncology provided an update on the CRDF-004 trial, which is a Phase 2 study evaluating onvansertib in combination with standard care regimens for patients with RAS-mutated metastatic colorectal cancer [3]. - The trial showed a 72.2% confirmed objective response rate in the 30 mg dose group of onvansertib with FOLFIRI/bevacizumab, compared to 43.2% in the standard care group, approaching statistical significance (p-value = 0.051) [4]. - Progression-free survival was statistically significant for the 30 mg onvansertib plus FOLFIRI/bevacizumab group (p-value = 0.048), with median progression-free survival not yet reached in the treatment groups [5]. Future Plans - Based on the trial results, the company plans to advance the 30 mg dose of onvansertib with FOLFIRI/bevacizumab into a registrational trial for first-line patients with RAS-mutated metastatic colorectal cancer, pending FDA consultation [6]. - The focus will be narrowed to onvansertib in combination with FOLFIRI, which may reduce the total addressable market in the frontline setting to 12%-20% from a previous estimate of 40%-50% [8]. Analyst Commentary - Analysts from William Blair expressed concerns regarding the abrupt management changes and the narrowed focus on onvansertib with FOLFIRI, leading to a reduction in the probability of success from 50% to 45% [8]. - Despite the concerns, William Blair maintains an Outperform rating for the stock [9].

Rare diseases are, individually, rare. Collectively, however, they are anything but. A novel sort of clinical trial in Britain aims to tackle the tricky economics of drugs designed for one person https://t.co/V7cRyJZ4zUIllustration: Agnes Jonas https://t.co/zX5NuIknhC ...

Rare diseases are, individually, rare. Collectively, however, they are anything but. A novel sort of clinical trial in Britain aims to tackle the tricky economics of drugs designed for one person https://t.co/hHUSm2Gje2 ...