Core Insights - Actuate Therapeutics, Inc. announced that data from its Phase 2 study of elraglusib in metastatic pancreatic cancer will be presented at the 2026 ASCO GI Cancers Symposium [1] - The study evaluates elraglusib in combination with gemcitabine/nab-paclitaxel, a standard chemotherapy regimen for this type of cancer [1] Presentation Details - Oral Presentation: Results from the randomized Phase 2 study (1801 Part 3B) of elraglusib plus gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in previously untreated metastatic pancreatic ductal adenocarcinoma [2] - Date/Time: January 9, 2026, 4:15 PM-5:00 PM (PST) [2] - First Author: Devalingam Mahalingam, MD, PhD, Gastrointestinal Oncologist at Northwestern University [2] Poster Presentation - Title: Mutational analysis and identification of potential biomarkers in patients with metastatic pancreatic cancer treated with elraglusib and gemcitabine/nab-paclitaxel [3] - Date/Time: January 9, 2026, 11:30 AM-1:00 PM; 5:00 PM-6:00 PM (PST) [4] - First Author: Andrey Ugolkov, MD, PhD, Senior Director, Clinical Science at Actuate Therapeutics [4] Company Overview - Actuate Therapeutics is focused on developing therapies for high-impact, difficult-to-treat cancers [4] - The lead investigational drug, elraglusib, is a novel GSK-3β inhibitor targeting pathways involved in tumor growth and resistance to conventional therapies [4]

• Ameluz® and RhodoLED® New Drug Application (NDA) and Investigational New Drug Application (IND) have successfully been transferred to Biofrontera Inc.• Assignment to Biofrontera Inc. of 11 granted US patents, 10 pending US patent applications and various trademarks associated with Ameluz® and the RhodoLED® Lamp Series has been applied for registration with the relevant authorities, including the US Patent Office (USPTO)• In addition, 19 international patent applications and/or registered designs for Rhodo ...

MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today announced completion of a productive in-person pre-IND meeting with the United States Food and Drug Administration (FDA) for a planned study evaluating DM199 in preeclampsia. Minutes from the meeting affirmed the FDA's request for one additional non-clinical, 1. ...

Core Viewpoint - Biodexa Pharmaceuticals PLC has announced a public offering priced at $10 million, aimed at funding its development programs and general corporate purposes [2][3]. Offering Details - The offering consists of 157,000 ADS Units, each comprising one American depositary share (representing 100,000 ordinary shares) and two Series L warrants [2]. - Additionally, there are 2,891,781 Pre-Funded Units, each consisting of one pre-funded warrant to purchase one ADS and two Series L Warrants [2]. - The public offering price for each ADS Unit is set at $3.28, while each Pre-Funded Unit is priced at $3.2799 [2]. Financial Proceeds - The expected gross proceeds from the offering, before deducting fees and expenses, are approximately $10 million [3]. - The net proceeds will be utilized for development programs, working capital, and other corporate purposes [3]. Closing and Agent Information - The offering is anticipated to close on December 19, 2025, pending customary closing conditions [4]. - Maxim Group LLC is acting as the sole placement agent for this offering [4]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs [7]. - The company's lead programs include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, tolimidone for type 1 diabetes, and MTX110 for aggressive rare/orphan brain cancer [7]. Product Details - eRapa is an oral formulation of rapamycin, an mTOR inhibitor involved in cellular metabolism and tumorigenesis [8]. - Tolimidone is a selective inhibitor of Lyn kinase, showing potential for glycaemic control in diabetes [9]. - MTX110 is a formulation of panobinostat designed for direct delivery to tumors, bypassing the blood-brain barrier [10][11].

Core Insights - Aprea Therapeutics has made significant progress in its clinical programs and is optimistic about its growth potential in 2026 [2][10] Group 1: Clinical Programs - The lead program, APR-1051, a next-generation WEE1 inhibitor, is showing promising anti-tumor activity in the ongoing ACESOT-1051 dose-escalation study, with a notable 15% reduction in tumor burden observed [3][4] - The treatment has been well tolerated with no dose-limiting toxicities reported, and disease stabilization has been noted in several patients, with the longest duration of treatment reaching 222 days [3][4] - The company is expanding its clinical focus on HPV-positive patients due to early positive responses, aligning with preclinical data from MD Anderson Cancer Center [5] - Upcoming catalysts for APR-1051 include further safety and efficacy data expected in Q1 2026 and completion of dose escalation in 2026 [6] Group 2: ATR Inhibitor Program - The ATRN-119 program has reached its recommended Phase 2 dose for once-daily dosing, with a strategic shift towards evaluating combination therapies [7] - Enrollment in monotherapy dosing arms of the ABOYA-119 study is paused to conserve cash amid challenging fundraising conditions [7] - Future strategies may include combination therapies with DNA-damaging agents, supported by preclinical data indicating enhanced anti-tumor immune responses [8][9] Group 3: Financial Position - Aprea has completed a $3.1 million gross private placement financing, extending its cash runway into Q1 2027 [10][11] - The company emphasizes financial discipline and aims to enhance investor relations to better communicate its value proposition [11][12] Group 4: Company Overview - Aprea is focused on developing innovative cancer treatments that target cancer cell vulnerabilities while minimizing damage to healthy cells [14] - The company's lead programs, APR-1051 and ATRN-119, are both in clinical development for solid tumor indications [15]

Core Viewpoint - Pulmatrix and Cullgen have agreed to waive the "No Solicitation" clause in their Merger Agreement to explore alternative transactions while seeking approval from the China Securities Regulatory Commission (CSRC) for their merger [1][2]. Merger Agreement Details - The Merger Agreement between Pulmatrix and Cullgen was signed on November 13, 2024, and amended on April 7, 2025 [3]. - The Form S-4 filing related to the merger was declared effective in May 2025, and stockholders approved the merger in June 2025 [2][4][5]. - The closing of the merger is contingent upon Nasdaq's approval and CSRC's approval [5]. Financial Position - As of September 30, 2025, Pulmatrix had a total cash and cash equivalents balance of $4.8 million, which is expected to fund operations into at least the fourth quarter of 2026 [6]. Clinical Assets and Technology - Pulmatrix's proprietary iSPERSE™ technology is designed for inhaled therapeutic products aimed at treating migraine and respiratory diseases [13]. - The company has a pipeline that includes PUR3100, a Phase 2-ready asset for acute migraine treatment, and PUR1800, a Narrow Spectrum Kinase Inhibitor for chronic obstructive pulmonary disease [8][16]. - Pulmatrix's patent portfolio related to iSPERSE™ includes approximately 146 granted patents and about 50 pending applications [9]. Collaboration and Future Development - Pulmatrix is collaborating with Cipla on the development of PUR1900, an inhaled formulation of itraconazole, which is undergoing clinical trials in India [16].

WTX-124 initial Phase 1b expansion arm data showed 30% overall response rate as a monotherapy in a defined subset of post-ICI advanced or metastatic cutaneous melanoma patients, with potential best-in-class tolerability profileWTX-330 Phase 1b/2 trial initial data demonstrated additional evidence of antitumor activity and highly favorable tolerability profile, building upon monotherapy activity demonstrated in first-in-human Phase 1 clinical trialAdditional Phase 1/1b data update for WTX-124 and completion ...

BERKELEY HEIGHTS, N.J., Dec. 18, 2025 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced interim results for the Company’s ongoing real-world evidence study being conducted in conjunction with U.S. Renal Care’s (USRC) use of DefenCath in adult hemodialysis patients with central venous catheters. CorMedix and USRC commenced the real-world evidence stu ...

OV350 showed a good safety profile, supporting the advancement of the Company’s KCC2 portfolio, including the first oral direct activator, OV4071There were no treatment-related laboratory findings, no safety findings, and no treatment-related serious adverse events (SAEs)Exploratory quantitative electrophysiology results suggest OV350 had central activity and spectral power consistent with expected physiological effects of KCC2 modulation; aligned with expected drug exposure in the brainPharmacokinetics for ...

Two applicants will each receive a Grant of $50,000 to support the development of outstanding clinical cancer research to improve the treatment of NMIBCApplications for the fellowship are due on February 27, 2026 SCHAUMBURG, Ill. and IRVINE, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- The Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), a national alliance of leading academic and community based uro-oncologists, and CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical co ...