Year: 2025

As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly  The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analyses The Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathway The Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026 The FDA and Clene participated in a Type B end of Phase 2 meeting in the third quarter of 2025 to discuss the Company’s MS clinical development program and ongoing plans for MS development of CNM-Au8 Cash and cash equivalents of $7.9 million as of September 30, 2025 Cash runway extended into the second quarter of 2026, including $1.2 million...

WILMETTE, Ill., Nov. 13, 2025 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced third quarter 2025 financial results and recent developments. Recent Developments ALXN1840 for Wilson Disease On September 14-15, 2025, the Company presented new data on the long-term neurological efficacy and safety of ALXN1840 (tiomolybdate choline) at the 150th American Neurological Association (ANA) Annual Meeting. Matthew Lorincz, M.D., Ph.D., Professor of Neurology and Co-Director of the Wilson Disease Center of Excellence at the University of Michigan delivered the poster and oral presentations. The new findings presented at ANA highlight the long-term neurological benefit of...

Announced U.S. Food and Drug Administration (FDA) Acceptance for Reviewof New Drug Application (NDA) for GTx-104 FDA Established April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Neurocritical Care Annual Meeting Granted Sixth U.S. Patent Covering IV Dosing Regimen for GTx-104 PRINCETON, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) — Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced the financial results and business highlights...

MIAMI, Nov. 13, 2025 (GLOBE NEWSWIRE) — Inter&Co Inc. (NASDAQ: INTR | B3: INBR32), the leading super app providing financial and digital commerce services to over 41 million customers, today reported its results for the third quarter of 2025. 3Q25 Highlights: Inter printed another quarter of outstanding growth across all key metrics, while maintaining its disciplined approach to sustainable profitability.Client Growth: Added a record 1.2 million new active clients in the quarter, bringing the total active client base to 24 million, a testament to the platform’s compelling value proposition. Net Income: Reached R$336 million (US$63.2 million1), representing 39% year-over-year growth, successfully balancing investments in growth with operational efficiency. Credit Expansion: The credit portfolio expanded 30% YoY, triple...

Company plans to initiate Phase 1 clinical study of semaglutide implant for chronic weight management in the first half of 2026 and parallel investments in studies to enable rapid initiation of Phase 2 dose-ranging study, pending Phase 1 results and regulatory feedback 3Q 2025 private placement, together with October financings, generated approximately $25.7M in cash and cash commitments to support accelerated development of NPM-139 while securing financial position into 2027 ALAMEDA, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) — Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a biopharmaceutical company developing miniaturized, ultra long-acting drug implants, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. Vivani Chief Executive Officer Adam Mendelsohn,...

Third quarter 2025 GAAP net income of $4.05 million or $0.30 per basic weighted average common share and Distributable Earnings(1) of $4.12 million or $0.31 per basic weighted average common share WEST PALM BEACH, Fla., Nov. 13, 2025 (GLOBE NEWSWIRE) — Sunrise Realty Trust, Inc. (Nasdaq: SUNS) (“SUNS” or the “Company”), a lender on the Tannenbaum Capital Group (“TCG”) Real Estate platform, today announced its results for the quarter ended September 30, 2025. SUNS reported generally accepted accounting principles (“GAAP”) net income of $4.05 million or $0.30 per basic weighted average common share and Distributable Earnings of $4.12 million or $0.31 per basic weighted average common share for the third quarter of 2025. Brian Sedrish, Chief Executive Officer of SUNS, said, “Our accomplishments during the third quarter demonstrate...

Reported late-breaking Phase 2 data at SITC for vilastobart demonstrating a 40% ORR in heavily pretreated patients with MSS mCRC without liver metastases and high plasma tumor mutational burden  Presented Phase 1 data at SITC for efarindodekin alfa showing promising monotherapy anti-tumor activity and generally well-tolerated safety profile in patients with advanced solid tumors Announced new preclinical data at SITC for masked T cell engager programs supporting best-in-class potential and showing efficient masking, potent anti-tumor activity and broad therapeutic index Anticipate cash runway into the first quarter of 2027 WALTHAM, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) — Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people...

Phase 1 clinical trial to evaluate the PK of a combination of denifanstat and resmetirom ongoing with data readout expected 1H 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Ascletis announced completion of its pre-NDA consultation with China’s NMPA and plans to submit an NDA for denifanstat in China for treatment of moderate-to-severe acne vulgaris SAN MATEO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) — Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended September 30, 2025, and provided recent corporate updates. “This is a dynamic period for Sagimet as we explore the therapeutic potential of FASN inhibition across different...

OMAHA, NE, Nov. 13, 2025 (GLOBE NEWSWIRE) — FitLife Brands, Inc. (“FitLife” or the “Company”) (NASDAQ: FTLF), a provider of innovative and proprietary nutritional supplements and wellness products, today announced financial results for the third quarter ended September 30, 2025. Highlights for the third quarter ended September 30, 2025 include:On August 8, 2025, the Company completed the acquisition of substantially all of the assets of Irwin Naturals (“Irwin”), and Irwin’s operating results for the period of August 9 through September 30 are included in FitLife’s consolidated financials for the third quarter of 2025. Total revenue was $23.5 million, an increase of 47% compared to the third quarter of 2024.   Wholesale revenue was $13.2 million, representing 56% of revenue and an increase of 156% compared to the third quarter...