Core Insights - INmune Bio, Inc. has made significant progress in 2025, focusing on developing therapies for neuroinflammatory and immunologic diseases, particularly through its programs XPro™ for Alzheimer's disease and CORDStrom™ for Recessive Dystrophic Epidermolysis Bullosa (RDEB) [1][10] CORDStrom™ Program - CORDStrom™, an allogeneic umbilical cord-derived mesenchymal stromal cell therapy for RDEB, achieved substantial progress in 2025, including successful completion of three commercial pilot-scale runs in preparation for regulatory filings [2] - The company plans to submit a Marketing Authorization Application (MAA) to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) by mid-summer 2026, followed by a Biologics License Application (BLA) to the U.S. FDA towards the end of 2026 [2][3] XPro™ Program - XPro™ demonstrated potential as a differentiated therapy for Alzheimer's disease, with a Phase 2 study (MINDFuL) revealing meaningful signals in a predefined subpopulation of amyloid-positive early AD patients [4][6] - In this subpopulation, XPro™ showed an effect size of 0.27 on the EMACC cognitive scale after 6 months, which compares favorably to the effect sizes of approved anti-amyloid therapies [6][7] - The results support XPro's proposed mechanism of action, which involves selectively inhibiting soluble TNF to reduce neuroinflammation while preserving beneficial TNF signaling [8] Financial Position - As of September 30, 2025, INmune Bio had approximately $27.7 million in cash and cash equivalents, positioning the company well for continued execution and enabling it to achieve key milestones through year-end 2026 [9]

Core Insights - Propanc Biopharma, Inc. has filed its fourth new provisional patent application in two months, focusing on innovative formulations of pancreatic proenzymes, which are critical for addressing challenges in stability and transport for biomedical applications [1][2] - The company aims to double its intellectual property portfolio from approximately 90 to over 200 patents, covering various aspects of its proenzyme technology, which targets and prevents metastasis from solid tumors [2][3] - Propanc's lead asset, PRP, is designed to selectively attack cancer stem cells and circulating tumor cells while sparing healthy tissue, offering a potential long-term therapy with reduced toxicity compared to conventional treatments [3][4] Company Developments - The recent patent applications are part of a strategy to secure leadership in a field with significant unmet medical needs, particularly for aggressive cancers with limited treatment options [2][3] - Preparations for a Phase 1b First-In-Human study of PRP in advanced cancer patients are advancing rapidly, with expectations for further updates on the clinical pathway and broader pipeline soon [3] Industry Context - Propanc is developing a novel approach to cancer treatment by targeting cancer stem cells through proenzyme activation, which addresses the underlying drivers of cancer proliferation and spread [4]

MORRISVILLE, N.C., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company revolutionizing care for patients with challenging respiratory and vascular diseases, announced today the company will present three posters at the Pulmonary Vascular Research Institute (PVRI) 2026 Annual Congress to be held January 28 through February 1, 2026, in Dublin, Ireland. The presentations highlight clinical data in pulmonary arterial hypertension (PAH) and pulmonary hypertension as ...

Arcutis Biotherapeutics (ARQT) announced that on January 23, 2026, the Company and Kowa Pharmaceuticals America mutually agreed to terminate their promotion agreement. The agreement covered sales and promotion of ZORYVE by Kowa to primary care physicians and pediatricians in the United States. Following the termination, Arcutis plans to assume responsibility for sales and promotion of ZORYVE in the pediatric and primary care settings. The Company is finalizing its plans for promotion to these clinicians an ...

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the amendment of its loan and security agreement with Hercules Capital, Inc. (NYSE:HTGC), strengthening its balance sheet and liquidity. Under the terms of the amended loan agreement, up to an additional $75 million will become available upon FDA's approval of MOLBREEVI, the Company's investigational therapy in autoimmune pul. ...

AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 ___________________________ Polaryx Therapeutics, Inc. (Exact name of registrant as specified in its charter) ___________________________ (State or other jurisdiction of incorporation or organization) As filed with the Securities and Exchange Commission on January 27, 2026 Registration No. 333-291681 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Primary Standard Industrial Classification Code Numbe ...

“On Track with HCM” Features Practical Insights for Managing Everyday Life with the Disease, Inspired by the Experience with HCM of McLaughlin-Levrone’s Father, Willie McLaughlin SOUTH SAN FRANCISCO, Calif., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the launch of “On Track with HCM,” demonstrating the company’s long-standing commitment to the HCM community. The campaign features four-time Olympic gold medalist Sydney McLaughlin-Levrone, and her father, three ...

BRIDGEWATER, N.J., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), today announced that the Company will release its fourth quarter and full year 2025 financial results on Friday, February 27, 2026, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET. The financial results and live webcast will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com. Individuals may regis ...

NEW YORK, Jan. 27, 2026 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced a series of key senior leadership appointments that underscore the company’s continued and growing expertise in cardiovascular medicine and late-stage clinical development. The company also provided an update on the strategic partnership announced in June 2025 with Perceptive Xontogeny Venture Fund ...

Core Insights - MYQORZO™ (aficamten) has been approved by the U.S. FDA for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), aimed at improving functional capacity and symptoms [1][4][5] - The drug is available in multiple dosages (5 mg, 10 mg, 15 mg, and 20 mg) and is a once-daily oral allosteric and reversible inhibitor of cardiac myosin motor activity, which reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction in patients with oHCM [2][17] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [21] - The launch of MYQORZO marks a significant milestone for Cytokinetics, reflecting its commitment to patients and the culmination of extensive scientific and clinical development efforts [3][21] Product Details - MYQORZO is indicated specifically for adults with symptomatic oHCM, and it works by inhibiting cardiac myosin to alleviate symptoms associated with the condition [5][17] - The drug has been engineered for predictable exposure response, rapid onset of action, and reversibility, making it a novel treatment option for patients [17] Clinical and Safety Information - The approval of MYQORZO was based on positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine [4] - Important safety information includes a boxed warning for the risk of heart failure due to reduced left ventricular ejection fraction (LVEF), necessitating regular echocardiogram assessments during treatment [6][9][10] Distribution and Support Programs - MYQORZO is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program, which includes specific requirements for prescribers, patients, and pharmacies [11][15] - Cytokinetics has established a personalized support program, MYQORZO & You™, to assist patients in navigating their treatment journey and provide education and financial assistance [4][21]