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Nxera Pharma to Regain Full Rights to GPR52 Agonist Program for Schizophrenia
Globenewswire· 2025-12-18 23:34
Core Viewpoint - Nxera Pharma's GPR52 agonist program for schizophrenia will not be licensed by Boehringer Ingelheim, leading to the reversion of all rights and data back to Nxera [1] Group 1: GPR52 Agonist Program - NXE'149 and other GPR52 agonists were developed using Nxera's NxWave™ structure-based drug design platform to address positive, negative, and cognitive symptoms of schizophrenia [2] - A Phase 1 trial of NXE'149 showed a favorable safety profile with no severe adverse events and demonstrated dose-proportional exposure and a long half-life supporting once-daily dosing [3] - The expression of GPR52 in brain regions linked to various schizophrenia symptoms suggests NXE'149 may treat all three symptom domains, offering a potential new therapeutic option [4] Group 2: Future Plans and Financial Impact - Nxera plans to explore strategic opportunities, including a formal out-licensing process for the GPR52 program in 2026 [5] - The decision by Boehringer Ingelheim does not impact Nxera's consolidated financial results for the current accounting period [5] - CEO Christopher Cargill expressed optimism about the potential of the GPR52 program despite the setback, highlighting the strong scientific and clinical foundations established [6] Group 3: Company Overview - Nxera Pharma is focused on developing specialty medicines to meet unmet medical needs in Japan and globally, leveraging its NxWave™ discovery platform [7][10] - The company has an extensive pipeline of over 30 active programs targeting major unmet needs in areas such as obesity, neurology, and immunology [9] - Nxera employs approximately 400 people across key locations including Tokyo, London, and Basel [10]
Cartesian Therapeutics Announces the Appointment of Adrian Bot to Board of Directors
Globenewswire· 2025-12-18 21:05
FREDERICK, Md., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced the appointment of Adrian Bot, M.D., Ph.D., to the Company’s Board of Directors. Dr. Bot is a biopharma executive with three decades of experience in research and development (R&D) with a focus on immune, cell, gene therapy and nanomedicines. He will serve as a member of the Science and Technolog ...
vTv Therapeutics and M42's IROS Announce Submission of Phase 2 Clinical Study Protocol for Cadisegliatin in Type 2 Diabetes to the United Arab Emirates Department of Health
Globenewswire· 2025-12-18 21:05
HIGH POINT, N.C., Dec. 18, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company, today announced a Phase 2 clinical study protocol developed in collaboration with M42’s Insights Research Organization & Solutions (IROS), a leading United Arab Emirates (UAE)-based contract research organization, has been submitted to the Department of Health (DOH) Abu Dhabi. The study is designed to evaluate the safety and efficacy of cadisegliatin, a potential first-in-class o ...
Athira Pharma Shares Jump 70% On Phase 3 Asset Acquisition Deal
RTTNews· 2025-12-18 17:18
Athira Pharma, Inc. (ATHA) shares surged 69.53 percent, gaining $2.88 to trade at $7.01 on Thursday, after the clinical-stage biopharmaceutical company announced an agreement to acquire global development and commercialization rights to lasofoxifene, a Phase 3 ready asset for metastatic breast cancer. The stock was trading at $7.01, up sharply from a previous close of $4.14 on the Nasdaq. Shares opened at $7.22 and moved within a day's range of $6.77 to $8.35. Trading volume spiked to about 53.19 million s ...
INVESTOR REMINDER: Berger Montague Notifies Telix Pharmaceuticals Ltd. (TLX) Investors of a Class Action Lawsuit and Deadline
TMX Newsfile· 2025-12-18 16:52
Philadelphia, Pennsylvania--(Newsfile Corp. - December 18, 2025) - National plaintiffs' law firm Berger Montague PC announces that a class action lawsuit has been filed against Telix Pharmaceuticals Ltd. (NASDAQ: TLX) ("Telix" or the "Company") on behalf of investors who purchased Telix securities during the period of February 21, 2025 through August 28, 2025 (the "Class Period").Investor Deadline: Investors who purchased Telix securities during the Class Period may, no later than January 9, 2026, seek to ...
Actuate Therapeutics Phase 2 Metastatic Pancreatic Cancer Data Selected for Oral and Poster Presentation at ASCO GI 2026
Globenewswire· 2025-12-18 13:45
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]
Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio
Globenewswire· 2025-12-18 13:45
• 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 ...
DiaMedica Therapeutics Provides DM199 Preeclampsia Program Update Following Pre-IND Meeting with FDA
Businesswire· 2025-12-18 13:45
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. ...
Biodexa Announces Pricing of $10 Million Public Offering
Globenewswire· 2025-12-18 13:30
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].
Aprea Therapeutics CEO Issues Letter to Shareholders Highlighting Pipeline Progress in 2025 and Outlook for 2026
Globenewswire· 2025-12-18 13:30
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]