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20/20 BioLabs to Host Virtual Investor Webinar on Thursday, February 26, 2026 at 2:00 p.m. Eastern Time
Globenewswire· 2026-02-20 13:31
Core Insights - 20/20 BioLabs, Inc. is an early market leader in AI-powered laboratory-based blood tests for early detection and prevention of cancers and chronic diseases [3][5] - The company will host a virtual investor webinar on February 26, 2026, to discuss its recent Nasdaq listing and product offerings [4][5] - The company offers two main products: OneTest™ for Cancer™, a multi-cancer early detection blood test, and OneTest for Longevity™, which measures inflammatory biomarkers [5][6] Company Overview - 20/20 BioLabs was listed on Nasdaq under the ticker symbol "AIDX" on February 19, 2026 [5] - The company operates a CAP-accredited and CLIA-licensed laboratory in Gaithersburg, MD, where tests are conducted [6] - The company also runs a Clinical Laboratory Innovation Accelerator (CLIAx) to support overseas diagnostics start-ups [7] Upcoming Initiatives - The OneTest for Longevity™ is expected to launch before the end of February 2026 [4] - The virtual investor webinar will include a question-and-answer session, allowing investors to engage directly with the company's leadership [4][5]
CytoDyn Presents Novel CCR5 Inhibition Mechanisms and Long-Term Survival Signals for Leronlimab in Metastatic Breast Cancer at AACR Immuno-Oncology Conference
Globenewswire· 2026-02-20 13:30
Core Insights - CytoDyn Inc. is advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, with potential applications in metastatic triple-negative breast cancer (mTNBC) and colorectal cancer (mCRC) [1][6] - New data presented at the AACR Immuno-Oncology Conference supports leronlimab's role in treating mTNBC, highlighting its ability to modulate immune checkpoint resistance and enhance responses to immune checkpoint inhibitors (ICIs) [2][5] Mechanistic Insights - Leronlimab targets the CCR5 receptor, which is crucial in regulating immune function and is implicated in cancer progression and immune resistance [2][6] - The study integrates patient-derived datasets with molecular and cellular analyses, suggesting that CCR5 blockade may influence T-cell exhaustion pathways and PD-L1/PD1 regulation, providing a rationale for combination therapies with ICIs [3][5] Clinical Findings - A pooled retrospective analysis of 28 heavily pretreated mTNBC patients showed a favorable safety profile for leronlimab, with no therapy-limiting toxicities and a 17.9% survival rate (5 out of 28 patients) after a median follow-up of over 63 months [6][5] - The data presented at the conference indicated that CCR5 expression correlates with elevated cytotoxic T-lymphocyte signatures and T-cell exhaustion profiles, suggesting immune states that may benefit from CCR5 inhibition [6] Future Directions - The consistency of mechanistic and clinical findings supports the continuation of leronlimab's clinical development, including further evaluation in combination immunotherapy settings [5][6] - CytoDyn is committed to improving patient quality of life through therapeutic innovation and aims to bring transformative treatments to patients worldwide [7]
Zelluna Receives UK MHRA and Ethics Approval to Initiate ZIMA-101 First-in-Human Clinical Trial
Globenewswire· 2026-02-20 13:30
Regulatory clearance enables start of clinical testing and marks transition to clinical-stage companyOn track for initial clinical data to emerge from mid-2026 Oslo, Norway, 20 February 2026 – Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) has approved the Company's Clinic ...
PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary Endpoint for Interim Analysis and Potential Accelerated Approval
Globenewswire· 2026-02-20 13:30
Core Viewpoint - PDS Biotechnology Corporation has amended its Phase 3 VERSATILE-003 clinical trial protocol to include progression-free survival (PFS) as an interim primary endpoint, which may facilitate an accelerated approval pathway for PDS0101 in treating HPV16-positive recurrent and/or metastatic head and neck cancer [1][2]. Group 1: Clinical Trial Details - The amendment allows for a potentially shorter duration of the VERSATILE-003 trial and aims to accelerate the timeline for regulatory submission while enhancing cost efficiency [2]. - The primary endpoint for full approval remains median overall survival (mOS), consistent with prior communications with the U.S. Food and Drug Administration (FDA) [1]. - The FDA did not object to the amended protocol during the standard 30-day wait period following the filing of the Investigational New Drug (IND) Application [1]. Group 2: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative cancer treatments, particularly targeting how the immune system can effectively kill cancer cells [3]. - The company's lead investigational product, PDS0101 (Versamune® HPV), is being developed in combination with a standard immune checkpoint inhibitor and a triple combination that includes PDS01ADC, an IL-12 fused antibody drug conjugate [3].
Kane Biotech Announces Publication of revyve® Wound Gel Article in the International Wound Journal
Globenewswire· 2026-02-20 12:25
Core Insights - Kane Biotech Inc. has published an article on its revyve Antimicrobial wound gel in the International Wound Journal, highlighting the gel's wound healing properties and antimicrobial activity [1][2] Group 1: Publication and Validation - The article titled "Wound Healing Property of a Novel Thermo-Reversible Wound Gel With Lasting Antimicrobial and Antibiofilm Activity" is authored by Dr. Jeyachchandran Visvalingam and includes contributions from the University of Miami [1] - The publication in a peer-reviewed journal underscores the scientific rigor of revyve technology and provides independent validation of the gel's safety and clinical potential [3] Group 2: Product Efficacy and Features - The revyve Antimicrobial Wound Gel demonstrates efficacy against a range of wound-related pathogens, achieving a 99.99% to 99.9999% reduction in bacterial counts within 30 minutes [7] - The gel exhibits sustained in vitro activity for up to 7 days, potentially reducing the frequency of dressing changes [7] - It is designed as a thermo-reversible gel that transitions from a liquid to a gel at body temperature, allowing for easy removal [7] Group 3: Company Overview - Kane Biotech is focused on developing novel wound care treatments that target biofilms, which contribute to antibiotic resistance and adverse clinical outcomes [4] - The revyve product line, including the Antimicrobial Wound Gel and Spray, has received U.S. FDA 510(k) clearance and Health Canada approval [4]
Sernova Biotherapeutics Announces Warrant Amendments
TMX Newsfile· 2026-02-20 12:00
Toronto, Ontario and Boston, Massachusetts--(Newsfile Corp. - February 20, 2026) - Sernova Biotherapeutics (TSX: SVA) (OTC: SEOVF) (FSE: PSH0) ("the Company"), a leading regenerative medicine company focused on developing its Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today announced that, subject to approval from the TSX, the Company intends to amend some of its outstanding warrants.The Company issued 20,852,100 warrants pursuant to a private placement unit offering on Sep ...
Immunic (NasdaqGS:IMUX) Earnings Call Presentation
2026-02-20 12:00
Immunic Therapeutics Developing Selective Oral Therapies in Immunology NASDAQ: IMUX | February 2026 Cautionary Note Regarding Forward-Looking Statements This presentation contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These include statements regarding management's intentions, plans, beliefs, e ...
Brainstorm Cell Therapeutics Announces $1 Million Strategic Financing at Premium to Market
Prnewswire· 2026-02-20 11:00
Core Viewpoint - Brainstorm Cell Therapeutics has secured a strategic private placement of $1 million, reflecting confidence in its operational momentum and the value of its NurOwn® platform [1] Financing Details - The financing is structured in two tranches, with the first payment of $500,000 already received and the second payment of $500,000 expected within 30 days [1] - The common stock was priced at $0.60 per share, a significant premium to the $0.54 closing price on February 9, 2026 [1] - The investment includes 120% warrant coverage for five years with an exercise price of $1.00 per share, indicating a nearly 100% premium to the recent market close [1] Company Strategy and Future Plans - The financing follows a period of strategic activity, including finalizing the Phase 3b trial design under a Special Protocol Assessment (SPA) and discussions regarding a Citizens Petition for Accelerated Approval [1] - Proceeds from the financing will support ongoing regulatory initiatives, prepayments for the upcoming Phase 3b trial of NurOwn® in ALS, and general corporate purposes [1] About NurOwn® Technology - NurOwn® technology involves autologous MSC-NTF cells, which are designed to deliver neurotrophic factors and immunomodulatory cytokines to target neurodegenerative diseases [1] - The platform has received Orphan Drug designation from both the FDA and the EMA, with a Phase 3 trial in ALS completed and a second Phase 3b trial set to launch [1] Company Background - Brainstorm Cell Therapeutics is focused on developing autologous adult stem cell therapies for neurodegenerative diseases, with a proprietary platform aimed at modulating neuroinflammation and promoting neuroprotection [1]
REGENXBIO Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - RGNX
Prnewswire· 2026-02-20 09:19
Core Viewpoint - REGENXBIO Inc. is facing a class action lawsuit for securities law violations, specifically for making false and misleading statements regarding the safety and efficacy of its RGX-111 product candidate, which led to a clinical hold by the FDA after a participant developed a tumor [1]. Group 1: Lawsuit Details - The class action lawsuit is based on violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 [1]. - The class period for the lawsuit is from February 9, 2022, to January 27, 2026, with a deadline for lead plaintiff appointments set for April 14, 2026 [1]. - The complaint alleges that REGENXBIO consistently made positive statements about RGX-111 while concealing adverse safety and efficacy information from investors [1]. Group 2: Impact on Shareholders - Shareholders who purchased RGNX shares during the class period are encouraged to contact the DJS Law Group regarding potential recovery of losses [1]. - The lawsuit highlights the potential financial impact on shareholders due to the misleading public statements made by the company [1].
Genmab (GMAB) Reports 19% Revenue Growth to $3.7B in 2025 Driven by Proprietary Medicine Sales
Yahoo Finance· 2026-02-20 09:10
Core Insights - Genmab (NASDAQ:GMAB) is identified as a promising growth stock for the next two years, with a reported total revenue growth of 19% in 2025, reaching $3.7 billion [1][4] - The significant revenue increase is attributed to a 54% rise in sales of proprietary medicines, particularly Abkinley, which generated $468 million, marking a 67% year-over-year increase [1][4] - The company’s royalty portfolio, especially Darzalex, is projected to achieve net sales of up to $16.4 billion in 2026 [1] Company Expansion and Developments - Genmab strategically expanded its operations, highlighted by the acquisition of ProfoundBio and its late-stage asset, Rina-S [2] - The company enhanced its clinical pipeline with three new Phase 3 trials and received FDA approval for Abkinley in second-line follicular lymphoma [2] Clinical Trial Outcomes - Genmab faced challenges with the Phase 3 EPCOR DLBCL-1 trial, where it met progression-free survival goals but did not achieve statistical significance for overall survival [4] - Ongoing discussions with regulatory authorities are addressing trial biases, including the effects of COVID-19 and subsequent therapies [4]