Core Viewpoint - Aprea Therapeutics announced preliminary data from the Phase 1 ACESOT-1051 trial for its WEE1 kinase inhibitor APR-1051, showing promising anti-tumor activity in patients with advanced endometrial cancer, particularly those with PPP2R1A mutations [1][5]. Trial Findings - The trial has reported a second unconfirmed partial response in a patient with advanced endometrial cancer at the 220 mg dose level, with a 50% reduction in target lesion measurements and a significant drop in the tumor biomarker CA-125 from 362 U/mL to 47 U/mL, representing an 87% decrease [2][3]. - The trial has treated a total of 22 patients at doses ranging from 10 mg to 220 mg, with the ongoing evaluation of safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity [6][10]. - Two patients with endometrial cancer harboring PPP2R1A mutations achieved unconfirmed partial responses at their first scan, observed at the 150 mg and 220 mg dose levels [8]. Safety and Tolerability - The treatment has been well tolerated, with only Grade 1 treatment-emergent adverse effects reported in the responding patient [3][7][14]. - The good safety profile supports the development strategy of differentiated WEE1 inhibition, aiming for an improved therapeutic index [5][7]. Future Directions - The company plans to expand enrollment in the 220 mg dose cohort, particularly focusing on patients with PPP2R1A endometrial and HPV-positive head and neck squamous cell carcinoma [9]. - Further updates from the trial are expected in the second quarter of 2026, reinforcing the ongoing commitment to advancing APR-1051 [4][10].

SALT LAKE CITY, Feb. 18, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the last patient has completed the final study visit (Last Patient Last Visit) in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). The randomized, double-blind, placebo-controlled study enrolled a total of 90 pa ...

Core Insights - Genelux Corporation is a late clinical-stage immuno-oncology company focused on developing next-generation oncolytic immunotherapies for patients with aggressive and difficult-to-treat solid tumors [3] Company Participation in Conferences - Genelux will participate in the Oppenheimer Healthcare Life Sciences Conference on February 25, 2026, featuring a virtual fireside chat with key executives [4] - The company will also present at the TD Cowen 46th Annual Health Care Conference on March 2, 2026, in Boston, MA [4] Clinical Trials - Olvi-Vec, Genelux's lead product, is currently being evaluated in two U.S.-based clinical trials: - OnPrime/GOG-3076, a Phase 3 trial for platinum-resistant/refractory ovarian cancer [3] - VIRO-25, a Phase 2 trial for non-small-cell lung cancer [3] - Additionally, Olvi-Vec is being evaluated in a China-based Phase 1b/2 trial for recurrent small-cell lung cancer [3] Proprietary Technology - The company's discovery and development efforts are centered around its proprietary CHOICE™ platform, which has led to the creation of an extensive library of oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec [3]

ANN ARBOR, Mich., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the company will be participating in the webcasted 2026 Citizens Life Sciences Conference on March 11, 2026, at 8:25 a.m. ET. The live webcast can be accessed on the investor and media section of the Esperion website. Access to the webcast replay will be available approximately two hours after the completion of the call and will be archived on the Company’s website for approximately 90 days. About Esperion Thera ...

VANCOUVER, British Columbia, Feb. 18, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (TSXV: NGEN) (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today announced that Adam Rogers, MD, President and Chief Executive Officer of NervGen, and other members of the Company’s executive leadership team, are scheduled to participate at multiple ...

Core Viewpoint - Appili Therapeutics Inc. has successfully closed the second tranche of a non-brokered private placement, raising gross proceeds of C$100,000 to support its drug development efforts for infectious diseases [1]. Group 1: Private Placement Details - The private placement involved the issuance of 4,000,000 units at a price of C$0.025 per unit, with each unit consisting of one Class A common share and one-half of a common share purchase warrant [2]. - Each whole warrant will allow the holder to acquire one common share at a price of C$0.05 for 36 months, pending shareholder approval [2][3]. - The company will seek shareholder approval for the warrants at the next Annual General Meeting, and if not approved, the warrants will not be exercisable [3]. Group 2: Use of Proceeds - The net proceeds from the private placement will primarily be used for working capital and to fund the development of certain product candidates [4]. Group 3: Broker Warrants - In connection with the closing, the company paid C$8,000 to finders and issued 320,000 broker warrants, which will allow holders to acquire common shares at a price of not less than C$0.02834 for 24 months, also subject to shareholder approval [4][5]. - Similar to the common warrants, the broker warrants will not be exercisable until shareholder approval is obtained [5]. Group 4: Company Overview - Appili Therapeutics is focused on developing therapies for life-threatening infections, with a portfolio that includes an FDA-approved treatment for antimicrobial resistant infections and a vaccine candidate for tularemia [7]. - The company aims to strategically develop a pipeline of novel therapies to address urgent infections with unmet needs [7].

A two-in-one mRNA vaccine developed by Moderna that targets seasonal influenza and COVID-19 produced robust and durable immune responses without safety concerns in a small mid-stage trial, the company... ...

Core Insights - NewAmsterdam Pharma is advancing its clinical and regulatory efforts for obicetrapib, with expected approval decisions from EMA, UK, and Switzerland regulators in the second half of 2026 [1][2] - The company reported a cash position of $728.9 million as of December 31, 2025, indicating financial strength to support ongoing operations and potential commercial launch [1][2] Clinical Development and Regulatory Updates - NewAmsterdam is developing obicetrapib as a low-dose, oral CETP inhibitor for patients at risk of cardiovascular disease (CVD) [3][10] - Marketing Authorization Applications (MAAs) for obicetrapib and its fixed-dose combination with ezetimibe have been accepted for review by EMA, UK, and Switzerland [2][3] - The company is preparing for a potential commercial launch in Europe alongside its partner Menarini [2][3] - Ongoing Phase 3 trials include PREVAIL, REMBRANDT, and RUBENS, with topline data from RUBENS expected by year-end 2026 [2][8] Financial Performance - NewAmsterdam reported a revenue of $22.5 million for the year ended December 31, 2025, a decrease from $45.6 million in 2024 [6][21] - Research and Development (R&D) expenses were $141.8 million in 2025, down from $151.4 million in 2024, primarily due to the completion of several Phase 3 trials [9][21] - Selling, General and Administrative (SG&A) expenses increased to $106.4 million in 2025 from $70.4 million in 2024, driven by higher personnel and marketing costs [13][21] Alzheimer's Disease Analysis - Positive data from the BROADWAY trial indicated significant reductions in p-tau217, a key Alzheimer's disease biomarker, supporting a link between CETP inhibition and neurodegeneration [7][12] - The analysis included 1,535 patients, with notable results in ApoE4 carriers, showing a 20.5% reduction in p-tau217 levels over 12 months compared to placebo [7][12][14] Upcoming Milestones - NewAmsterdam plans to announce additional data from its ongoing Phase 3 trials in 2026, including the potential initiation of a new clinical trial for obicetrapib in early Alzheimer's disease patients [5][8]

Core Insights - Axsome Therapeutics, Inc. is set to present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25, 2026, at 2:00 p.m. ET, highlighting its role in CNS disorder treatments [1] - The company focuses on developing differentiated products with novel mechanisms of action to improve patient outcomes in CNS conditions [3] Company Overview - Axsome Therapeutics is a biopharmaceutical company dedicated to addressing critical gaps in CNS care, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness, and migraine [3] - The company has multiple early and late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3] Investor Information - A live webcast of the upcoming presentation will be available on the company's website, with a replay accessible for approximately 30 days post-event [2]

Group 1 - Cullinan Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing potential first- or best-in-class therapies for autoimmune diseases and cancer [3] - The company will participate in a fireside chat at the Citi 2026 Virtual Oncology Leadership Summit on February 19, 2026, featuring CEO Nadim Ahmed and CMO Jeffrey Jones [1] - The fireside chat will be accessible via a webcast on the company's investor relations website [2] Group 2 - Cullinan Therapeutics leverages expertise in T cell engagers, which are established in oncology and are now being advanced into autoimmune diseases [3] - The company aims to deliver new standards of care for patients through a clinical-stage pipeline built on rigorous scientific approaches and purposeful innovation [3]