FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Cardiff Oncology Inc. (NASDAQ:CRDF) on Tuesday closed around 32% lower after the management update and trial update.Mani Mohindru, a board member since 2021, was named interim CEO, effective immediately. Mark Erlander, CEO, and James Levine, CFO, have stepped down.To maintain financial continuity, Brigitte Lindsay was promoted to Chief Accounting Officer. She has been with the company for more than 14 years and most recently served as Senior Vice President of Finance. Cardiff Oncology has begun a search for ...

Group 1 - The conference call is focused on the data update for Onvansertib, a drug developed by Cardiff Oncology [1] - The call is led by the Interim CEO, Mani Mohindru, along with key members of the Cardiff Oncology team including the Chief Medical Officer and Chief Scientific Officer [2] - The company will be making forward-looking statements regarding guidance, results, and timing of data readouts for Onvansertib clinical studies, which are subject to significant risks and uncertainties [3]

Summary of Cardiff Oncology Update Call Company Overview - **Company**: Cardiff Oncology (NasdaqCM:CRDF) - **Focus**: Development of onvansertib, a highly specific oral PLK1 inhibitor, primarily for RAS-mutated metastatic colorectal cancer (mCRC) patients Key Points Management Transition - Cardiff Oncology announced a management transition to better position the company for late-stage development of onvansertib [5][6] - Mani Mohindru appointed as Interim CEO, emphasizing the need for leadership aligned with the company's evolving operational and financial needs [4][5] Clinical Trial Updates - Promising phase 2 data from the CRDF-004 trial for onvansertib in first-line RAS-mutated mCRC patients was discussed [5][7] - The trial evaluated onvansertib in combination with standard care regimens (FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab) [8] - Dose-dependent benefits observed, particularly with the 30 mg dose of onvansertib combined with FOLFIRI plus bevacizumab, showing an overall objective response rate of 72.2% compared to 43.2% with FOLFOX and 42.1% with FOLFIRI alone [10][11] Efficacy and Safety Data - Median progression-free survival (PFS) has not yet been reached in the onvansertib arms, indicating extended benefit compared to a median PFS of about 11 months for standard care [10] - The PFS hazard ratio was reported at 0.37 for the 30 mg onvansertib plus FOLFIRI bev arm, indicating a significant reduction in disease progression risk [11] - Safety profile remains favorable, with no unexpected toxicities reported; grade 3 or higher adverse events were infrequent [12] Future Plans - Cardiff plans to initiate a registrational study later in 2026, comparing onvansertib plus FOLFIRI to standard care regimens [12][14] - The study protocol will likely include both FOLFIRI and FOLFOX in the control arm to provide comprehensive data for regulatory review [13] - Anticipation of more mature clinical data from the CRDF-004 study by mid-2026 [14] Strategic Considerations - Discussions regarding potential partnerships to support the phase 3 trial and broaden development beyond initial indications are ongoing [33] - The company is focused on building a leadership team with experience in late-stage development and commercialization [76] Additional Insights - The transition in leadership is not due to issues with onvansertib but rather a strategic move to capitalize on promising data [6] - The focus on durability of response is emphasized, with stable disease being a significant factor in treatment efficacy [24][25] - The company is committed to maintaining operational continuity during the management transition [7] Conclusion Cardiff Oncology is positioned for significant growth with onvansertib, supported by promising clinical data and a strategic management transition aimed at enhancing its late-stage development efforts. The upcoming registrational study and potential partnerships are critical steps in advancing the drug's market potential.

Core Insights - Cardiff Oncology, Inc. announced positive results from the CRDF-004 Phase 2 clinical trial, demonstrating that onvansertib combined with FOLFIRI/bevacizumab (bev) shows dose-dependent improvements in overall response rates and progression-free survival (PFS) in patients with RAS-mutated metastatic colorectal cancer (mCRC) [1][3][4] Group 1: Clinical Trial Results - The trial showed that the 30 mg dose of onvansertib with FOLFIRI/bev is selected for further registrational trials based on its efficacy [2][3] - In the intent-to-treat analysis, onvansertib with FOLFIRI/bev outperformed both standard of care (SoC) regimens, with a confirmed objective response rate (ORR) of 44.4% for the 30 mg dose [1][3] - Median PFS for the 30 mg onvansertib group was not reached, indicating a potential benefit over SoC [3][4] Group 2: Safety and Tolerability - Onvansertib was reported to be safe and well-tolerated, with no significant additive toxicity observed in the trial [1][3] - Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event [5] Group 3: Future Plans - Cardiff Oncology plans to initiate a registrational program later this year, pending finalization of trial design in consultation with the FDA [2][3] - The company expects to provide final data and registrational plans in the first half of 2026 [1][3] Group 4: Industry Context - There is a significant unmet need for improved first-line treatment options for patients with RAS-mutated mCRC, as current treatments have not significantly advanced in over two decades [5] - Onvansertib's novel mechanism of action and promising preliminary results support the need for further investigation in a large Phase 3 trial [5]

SAN DIEGO, Jan. 27, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced a leadership transition designed to support the Company’s next phase of growth and advancement toward late-stage development and key clinical and corporate milestones. Mani Mohindru, PhD, a member of Cardiff Oncology’s Board of Directors since 2021 and a seasoned biotech executive, has been ...

Core Insights - Cardiff Oncology (CRDF) has shown significant developments, particularly in 2025 with the first readout of their randomized, phase 2 trial in first-line colorectal cancer [1] Company Overview - Cardiff Oncology is focused on advancing its clinical trials and has a strong emphasis on the science behind its business operations [1] Industry Context - The biotech sector, particularly in oncology, is characterized by high stakes and the necessity for thorough analysis of clinical trials to identify potential investment opportunities [1]

Core Insights - Cardiff Oncology (CRDF) has shown significant developments, particularly in 2025 with the first readout of their randomized, phase 2 trial in first-line colorectal cancer [1] Company Overview - Cardiff Oncology is focused on advancing its clinical trials and has a strong emphasis on the science behind its business operations [1] Industry Context - The biotech sector, particularly in oncology, is characterized by high stakes and the necessity for thorough analysis of clinical trials to identify potential investment opportunities [1]

Summary of Cardiff Oncology Conference Call Company Overview - **Company**: Cardiff Oncology (NasdaqCM: CRDF) - **Focus**: Development of onvansertib, a first-in-class PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer [2][35] Key Points and Arguments Product and Mechanism - **Onvansertib**: A highly selective PLK1 inhibitor designed for first-line treatment of RAS-mutated metastatic colorectal cancer [2][4] - **Mechanism**: PLK1 is an enzyme that drives tumor cell division and survival; onvansertib inhibits this enzyme, leading to reduced tumor growth and metastasis [3][4] Clinical Trials and Efficacy - **Clinical Trials**: Initial trials showed strong efficacy signals in RAS-mutated metastatic colorectal cancer, particularly in BEV-naive patients [3][11] - **Response Rates**: In a second-line trial, onvansertib combined with standard care showed a 73% response rate in BEV-naive patients compared to 16% in BEV-exposed patients [11] - **Progression-Free Survival (PFS)**: Nearly doubled in BEV-naive patients compared to historical controls [11] Market Opportunity - **Unmet Need**: Colorectal cancer has a low five-year survival rate of only 15%, with no new therapies introduced in over 20 years for RAS-mutated patients [5][6] - **Target Population**: Approximately 50% of newly diagnosed colorectal cancer patients have RAS mutations, indicating a significant market opportunity [6][35] Regulatory and Development Path - **FDA Alignment**: Received clear guidance from the FDA to pivot from second-line to first-line clinical development, addressing a larger patient population [4][18] - **Ongoing Trials**: The ongoing first-line trial is designed to assess the efficacy of onvansertib in combination with standard chemotherapy [19][20] Safety and Tolerability - **Safety Profile**: Onvansertib is well tolerated, with no significant increase in neutropenia compared to control groups [30][31] - **Combination Therapy**: The drug can be combined with existing chemotherapies without compromising safety, allowing for longer treatment durations [40][41] Financial and Strategic Partnerships - **Partnership with Pfizer**: Pfizer holds a 3% equity stake in Cardiff Oncology and is involved in trial execution through its Pfizer Ignite program, providing high-quality data without strings attached [33][34] Future Outlook - **Next Steps**: Plans to update on trial progress in Q1 of the following year, with a focus on durability data and potential registrational trials [36] - **Investment Opportunity**: The company is positioned to make a significant impact in the treatment of colorectal cancer, presenting a compelling investment opportunity [42][43] Additional Important Information - **Patents**: Two new patents were issued, extending the intellectual property protection for onvansertib until at least 2043 [17] - **Clinical Data Publication**: Findings have been published in the Journal of Clinical Oncology, highlighting the significance of the research [16] This summary encapsulates the critical insights from the conference call, emphasizing Cardiff Oncology's innovative approach to treating colorectal cancer and the potential for significant market impact.

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers [4] - Clinical data from a Phase 1 trial of onvansertib in chronic myelomonocytic leukemia (CMML) will be presented at the 67th American Society of Hematology Annual Meeting [1][3] Clinical Trial Results - In a Phase 1 dose escalation trial involving 9 patients, onvansertib as a monotherapy was well-tolerated and showed preliminary efficacy in approximately 40% of patients, with one patient achieving an optimal marrow response at the 9 mg/m dose [2] - The results support onvansertib's activity as a single agent in both hematologic and solid tumors, although the company does not plan to develop onvansertib specifically for CMML [2] Presentation Details - The poster presentation titled "Phase 1 clinical trial assessing the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in Relapsed/Refractory myeloproliferative chronic myelomonocytic leukemia (CMML)" will be delivered by Mrinal Patnaik, MD, MBBS, from Mayo Clinic [3] - The presentation is scheduled for December 8, 2025, from 6:00-8:00 PM EST as part of the Myelodysplastic Syndromes session [3] Company Overview - Cardiff Oncology's lead asset, onvansertib, is being evaluated in combination with standard of care therapies for indications such as RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple negative breast cancer [4] - The company's development strategy aims to target tumor vulnerabilities to overcome treatment resistance and provide superior clinical benefits compared to standard therapies [4]