Core Insights - FibroBiologics, Inc. has opened a new laboratory facility to enhance its research capabilities for chronic disease therapeutics using fibroblast technology [1][2][3] - The new facility spans over 10,000 square feet and will support in-house GMP manufacturing for drug product candidates [2][3] - The expansion aims to accelerate innovation, increase research efficiency, and reduce reliance on external partners [3] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing treatments and potential cures for chronic diseases through fibroblast cells and materials [6] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [6] Future Plans - The company plans to hire additional researchers to support the new laboratory and its mission to combat chronic diseases [2][3] - The expansion is expected to facilitate the exploration of a broader pipeline of therapeutic candidates and enhance collaboration among research teams [3]

Core Insights - Oragenics, Inc. is focused on developing novel intranasal therapies for brain-related disorders, particularly targeting mild traumatic brain injury (mTBI) or concussion [1][4] - The company’s lead candidate, ONP-002, utilizes intranasal administration for rapid absorption and targeted delivery to the brain [3][4] Industry Developments - The 3rd Nasal Formulation & Delivery Summit highlighted innovations in intranasal drug delivery, emphasizing CNS therapeutics, emergency-use treatments, and applications for infectious diseases [2] - Dr. James Kelly, Chief Medical Officer of Oragenics, participated in a panel discussion, sharing insights on optimizing intranasal drug delivery and its benefits for neurological treatments [2][3] Company Commitment - Oragenics' involvement in the summit reflects its dedication to advancing non-invasive CNS therapeutics and engaging with the intranasal research community [3]

Core Insights - Oragenics, Inc. is focused on developing novel intranasal therapies for brain-related disorders, particularly its lead candidate ONP-002 for mild traumatic brain injury (mTBI) [1][4] - The company participated in the 3rd Nasal Formulation & Delivery Summit, highlighting its commitment to innovation in non-invasive CNS therapeutics [1][3] Company Developments - Dr. James Kelly, Chief Medical Officer of Oragenics, shared insights on optimizing intranasal drug delivery and its advantages in neurological treatment during the summit [2] - ONP-002 is designed for rapid absorption and targeted brain delivery through intranasal administration, aiming to improve outcomes for concussion patients [3][4] Industry Context - The summit gathered industry leaders to discuss innovations in intranasal drug delivery, focusing on CNS therapeutics, emergency-use treatments, and infectious disease applications [2]

Core Insights - NKGen Biotech, Inc. presented updated Phase 1 clinical data for troculeucel, a novel NK cell therapy for moderate Alzheimer's disease, at the AD/PD™ 2025 conference [3][4] - The highest dose of troculeucel administered was 6 billion cells per treatment, with significant cognitive improvements observed in two out of three patients after 12 months [1][4][5] - The company plans to evaluate troculeucel's safety and efficacy in a randomized, placebo-controlled Phase 2a trial [2][4] Group 1: Clinical Trial Results - In the Phase 1/2a trial, three patients received troculeucel intravenously every three weeks, with two patients completing 17 doses and one patient completing 10 doses [4] - After 12 months, two patients improved from moderate to mild Alzheimer's disease, with one patient achieving a CDR-SB score of 4.5 [1][4][5] - No drug-related adverse reactions were reported, and all patients showed stable or improved cognitive scores across various scales [4][5] Group 2: Biomarker Analysis - At 6 months, all patients exhibited decreased levels of Glial Fibrillary Acidic Protein (GFAP) in both CSF and plasma, correlating with cognitive improvements [4][5] - Improvements in the CSF and plasma Amyloid Beta (Aβ) 42/40 ratio were noted at 12 months, while p-Tau levels remained stable [4][5] Group 3: Company Overview - NKGen Biotech is focused on developing innovative autologous and allogeneic NK cell therapeutics for neurodegenerative disorders and cancers [6][7] - Troculeucel is the International Nonproprietary Name (INN) for SNK01, marking a significant step towards market introduction [6]

Company Announcement COPENHAGEN, Denmark; April 7, 2025 – Genmab A/S (Nasdaq: GMAB). On March 25, 2025, Genmab announced the initiation of a share buy-back program to repurchase up to 2.2 million shares to reduce capital and to honor our commitments under the Restricted Stock Unit program. The share buy-back program is expected to be completed no later than July 10, 2025. The following transactions were executed under the program from March 31 to April 4, 2025: Trading PlatformNo. of sharesAverage price (D ...

Core Points - Serina Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing its proprietary POZ Platform™ for drug optimization [3] - The CEO, Steve Ledger, will present at the Jones Healthcare and Technology Innovation Conference on April 9, 2025 [1] - The company is headquartered in Huntsville, Alabama, and is developing a pipeline of drug candidates for neurological diseases and other indications [3] Company Overview - Serina Therapeutics is developing a pipeline of wholly owned drug product candidates aimed at treating neurological diseases and other conditions [3] - The POZ Platform™ has the potential to enhance the efficacy and safety profiles of various therapeutic modalities, including small molecules, RNA-based therapeutics, and antibody-drug conjugates (ADCs) [3] - The company operates from the HudsonAlpha Institute of Biotechnology campus in Huntsville, Alabama [3] Event Information - A live webcast of the CEO's presentation will be available for registered attendees, with an archived replay accessible for 90 days post-event [2]

Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Enrollment and Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - Participants are randomized to receive either atacicept 150 mg or placebo via self-administered weekly subcutaneous injections for a 104-week double-blind period, followed by a 52-week open-label extension [2] Efficacy and Safety Data - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, with a key secondary endpoint assessing kidney function via estimated glomerular filtration rate (eGFR) over 104 weeks [3] - The Phase 2b ORIGIN trial demonstrated significant reductions in proteinuria and stabilization of eGFR, supporting the efficacy of atacicept [6] Future Plans and Market Position - The company plans to submit a BLA for atacicept in the second half of 2025, with a potential commercial launch in 2026 [2][8] - Vera Therapeutics retains all global developmental and commercial rights to atacicept and is also developing MAU868, a monoclonal antibody targeting BK virus [9]

Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [9] - Atacicept is a recombinant fusion protein that targets B-cell activating factors, aiming to reduce autoantibody production associated with autoimmune diseases like IgAN and lupus nephritis [5][9] - The company is also developing MAU868, a monoclonal antibody for BK virus infections, and holds an exclusive license for a next-generation fusion protein targeting BAFF and APRIL [9] Clinical Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, while the key secondary endpoint assesses kidney function via estimated glomerular filtration rate (eGFR) through 104 weeks [3] - The ORIGIN Phase 2b trial previously demonstrated significant reductions in proteinuria and stabilization of kidney function, reinforcing the potential of atacicept as a best-in-class therapy for IgAN [6]

Core Insights - Phio Pharmaceuticals Corp. is a clinical-stage siRNA biotechnology company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology to combat cancer [1][4] - The company announced podium presentations for its lead INTASYL product candidates, PH-762 and PH-894, at the 11th Annual Immunotherapy of Cancer (ITOC) Conference in Munich, Germany [1] Product Candidates - PH-762 is an INTASYL siRNA compound targeting PD-1, currently undergoing evaluation in an ongoing clinical trial (NCT 06014086) as a neoadjuvant intratumoral therapy for cutaneous malignancies, showing promising preclinical efficacy and favorable tolerability [2][4] - PH-894 selectively silences BRD4, enhancing NK cell activation and proliferation without off-target effects, representing a novel approach to improve adoptive cell therapy [3] Conference Presentations - Melissa Maxwell, Phio's Director of Research and Program Management, will present on PH-762 during the Plenary Session 3, focusing on its preclinical advances and ongoing clinical evaluation [2] - PH-894 will be discussed in Plenary Session 11, highlighting its potential to increase NK cell activity for adoptive cell therapy [3]

HOUSTON, April 02, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced a significant advancement in neurodegenerative disease research. Leveraging the well-established Cuprizone animal model, FibroBiologics has demonstrated that intravenous fibroblasts can facili ...