Core Insights - Ardelyx, Inc. has been granted a new patent for IBSRELA and XPHOZAH, which will expire on November 26, 2042, covering the formulation of tenapanor [1][2] Company Overview - Ardelyx is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [1][15] - The company has two commercial products approved in the U.S.: IBSRELA and XPHOZAH [15] Product Information IBSRELA (tenapanor) - IBSRELA is an oral formulation that acts as a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), reducing sodium absorption and retaining luminal water content, which helps in softening stool consistency [3][11] - It has been shown to alleviate abdominal pain by decreasing visceral hypersensitivity and intestinal permeability in animal models [3] XPHOZAH (tenapanor) - XPHOZAH is a phosphate absorption inhibitor that works locally in the gut to reduce phosphate absorption through the paracellular pathway [4][14] - It is administered as a single tablet taken twice daily, with diarrhea being the most common side effect reported in clinical trials [4][13] Patent and Intellectual Property - The newly granted patent reflects a Patent Term Adjustment due to delays from the USPTO, extending protections for Ardelyx's portfolio of medicines [2] - The patent will be submitted for listing in the FDA's Orange Book for both IBSRELA and XPHOZAH [1]

Core Viewpoint - Allarity Therapeutics has opened enrollment for a Phase 2 clinical trial evaluating the combination of stenoparib and temozolomide for recurrent small cell lung cancer (SCLC) [1][2]. Group 1: Trial Details - The trial is conducted in collaboration with the U.S. Department of Veterans Affairs (VA) and is fully funded through the VA's Special Emphasis Panel on Precision Oncology [2]. - It is registered as NCT06681220 and is open for enrollment at 11 VA sites across the U.S. [2][7]. - The study will assess the safety and efficacy of stenoparib in combination with temozolomide in patients with recurrent SCLC who have progressed after frontline treatment [3]. Group 2: Drug Mechanism and Benefits - Stenoparib is a dual PARP and WNT pathway inhibitor, which may enhance the activity of temozolomide while potentially offering a more favorable safety profile [3][4]. - The drug's ability to cross the blood-brain barrier may provide therapeutic potential for patients with brain metastases, a common complication in advanced SCLC [5]. - The study includes a blood-based biomarker developed in the VA Lung Precision Oncology Program to select patients most likely to benefit from the combination therapy [3]. Group 3: Company Insights - The CEO of Allarity Therapeutics emphasized the importance of this trial in exploring stenoparib's potential as a combination agent, particularly in settings where tolerability has been a limiting factor [4]. - The Principal Investigator noted that patients with relapsed SCLC have very few effective treatment options, and stenoparib's unique mechanism of action could provide significant benefits [4]. - Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [8].

Core Insights - Kyverna Therapeutics has appointed Mayo Pujols as Chief Technology Officer, effective February 9, 2026, to support the launch of its CAR T-cell therapy, miv-cel [1][2][3] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with its lead candidate being miv-cel (mivocabtagene autoleucel, KYV-101) [7] - The company aims to revolutionize treatment for B-cell-driven autoimmune diseases and is advancing its neuroimmunology franchise with ongoing registrational trials [7] Leadership Transition - Mayo Pujols brings over 30 years of experience in technical operations, particularly in cell and gene therapies, succeeding Karen Walker, who is retiring but will assist in the transition [2][3] - Pujols has held significant roles in various biopharmaceutical companies, including COO at Castle Creek Biosciences and CTO at Rocket Pharmaceuticals, where he guided gene therapy programs through regulatory milestones [3][4] Miv-cel Therapy - Miv-cel is a fully human, autologous CAR T-cell therapy targeting CD19, designed for potency and tolerability, and is under investigation for B-cell-driven autoimmune diseases [6] - The therapy has the potential to achieve deep B-cell depletion and reset the immune system, aiming for durable, drug-free remission in autoimmune conditions [6] Inducement Grant - In connection with Pujols' appointment, Kyverna will grant him an option to purchase 300,000 shares of common stock, which will vest over four years [5]

PRINCETON, N.J., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced the presentation of new data from clinical and real-world studies of Galafold® (migalastat) in Fabry disease and POMBILITI® + OPFOLDA® (cipaglucosidase alfa plus miglustat) in late-onset Pompe disease. Data are being presented at the 22nd Annual WORLDSymposium™ 2026. “Amicus continues to advance the science and understanding of both Fabry and Pompe diseases, and we are proud to showcase new data for our me ...

Company Overview - IN8bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases [3] - The company's lead program, INB-100, targets acute myeloid leukemia using haplo-matched allogeneic γδ T cells post-hematopoietic stem cell transplant [3] - IN8bio is also advancing autologous DeltEx DRI γδ T cells for glioblastoma in its INB-200 and INB-400 programs, along with INB-600, which focuses on novel γδ T cell engagers for oncology and autoimmune indications [3] Conference Participation - William Ho, CEO and co-founder of IN8bio, will present at the Noble Emerging Growth Virtual Equity Conference on February 5, 2026, at 3:00 p.m. ET [1] - The company will also participate in the IO360° Conference on February 12, 2026, where it will present on its DeltEx Drug Resistant Immunotherapy (DRI) approach to solid tumors and share results from a Phase 1/2 study in newly diagnosed glioblastoma [2]

OSLO, Norway and INCHEON, South Korea, Feb. 3, 2026 /PRNewswire/ -- The Coalition for Epidemic Preparedness Innovations (CEPI) and Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), today announced a partnership to strengthen vaccine manufacturing preparedness for future epidemic and pandemic threats. The collaboration will see Samsung Biologics join CEPI's Vaccine Manufacturing Facility Network (VMFN) with the aim of accelerating the availability of pr ...

Core Insights - Anavex Life Sciences Corp. will release its financial results for the first quarter of fiscal 2026 on February 9, 2026, at 8:30 am ET [1] - A conference call will be held on the same day to review financial results and discuss recent corporate developments, followed by a Q&A session [2] Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for various CNS disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, and Rett syndrome [4] - The company's lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and has shown potential in treating other CNS disorders [4] - ANAVEX®3-71 is another promising drug candidate targeting SIGMAR1 and M1 muscarinic receptors, demonstrating disease-modifying activity against Alzheimer's disease in preclinical trials [4]

Core Viewpoint - Invivyd, Inc. has received guidance from the U.S. FDA regarding the LIBERTY Phase 3 clinical trial for VYD2311, a monoclonal antibody candidate aimed at preventing COVID-19, which will compare its safety and immunologic profile against mRNA COVID vaccines [1][2][5] Group 1: LIBERTY Trial Overview - The LIBERTY trial will assess the safety and immunologic profile of VYD2311 compared to commercially available mRNA COVID vaccines, including the simultaneous administration of both [1][5] - The trial is designed to provide insights into the safety and tolerability of monoclonal antibody-mediated prophylaxis versus mRNA vaccines, building on the previous DECLARATION trial [2][5] - Total enrollment for the LIBERTY trial is expected to be around 210 participants [7] Group 2: Background on VYD2311 - VYD2311 is a novel monoclonal antibody candidate developed to address the need for new COVID-19 prevention options, with a focus on delivering effective titer levels through intramuscular administration [4][6] - The antibody was engineered using Invivyd's proprietary technology platform, optimized for neutralizing contemporary virus lineages [6] Group 3: Regulatory Context and Safety Monitoring - The FDA has requested specific monitoring for adverse events of special interest, particularly myocarditis and pericarditis, in the LIBERTY trial due to concerns raised during the COVID pandemic regarding mRNA vaccines [2][5] - No similar monitoring requests have been made for other Invivyd trials that do not include an mRNA vaccine arm [2][5] Group 4: DECLARATION Trial Details - The DECLARATION trial is a Phase 3, randomized, triple-blind, placebo-controlled study evaluating the efficacy and safety of VYD2311 in preventing symptomatic COVID-19, with an expected enrollment of 1770 participants [3][8] - Participants will receive either a single or monthly dose of VYD2311 via intramuscular injection, compared to a placebo [3][8]

Core Insights - LeonaBio, Inc. has appointed Mark F. Kubik as Chief Business Officer to lead its business development strategy, focusing on licensing, partnership strategy, and corporate development initiatives [1][3] Company Overview - LeonaBio is a clinical-stage biopharmaceutical company based in Bothell, Washington, dedicated to developing novel therapeutics for diseases with high unmet medical needs, including treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (ALS) [10] Leadership Appointment - Mark F. Kubik brings over 25 years of biopharma business development and corporate strategy experience, having previously served as a strategic consultant to LeonaBio [2][4] - His appointment is seen as pivotal for advancing the Phase 3 development of lasofoxifene for metastatic breast cancer and building a diversified pipeline in oncology and neurodegeneration [3] Strategic Vision - Mr. Kubik expressed excitement about joining LeonaBio at a critical juncture, emphasizing the urgency of advancing lasofoxifene as a therapeutic candidate for treatment-resistant metastatic breast cancer [3] - The company aims to expand its portfolio and explore strategic collaborations under his leadership [3] Inducement Stock Option - LeonaBio announced an equity inducement award to Mr. Kubik, granting him stock options to purchase 30,000 shares at an exercise price of $4.74, effective from February 1, 2026 [6][7] - The vesting schedule includes one-fourth of the shares vesting on the first anniversary and one forty-eighth each month thereafter, contingent on continued service [8] Educational Background - Mr. Kubik holds an MBA in Finance and a BA in Molecular, Cellular and Developmental Biology from the University of Colorado, Boulder, and has completed Executive Education in Negotiation and Influence Strategies at Stanford University [5]

VANCOUVER, BC / ACCESS Newswire / February 3, 2026 / Lobe Sciences Ltd. (CSE:LOBE)(OTCQB:LOBEF)(Frankfurt:LOBE.F) ("Lobe" or the "Company"), a biopharmaceutical company advancing programs in diseases with unmet medical needs, today reported unaudited financial results for the first quarter of fiscal 2026 ended November 30, 2025 (Q1:2026) and provided an update on operational progress for the quarter. ...