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Transactions In Connection with Share Buy-back Program
Globenewswire· 2025-04-07 11:43
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 ...
Serina Therapeutics to Present at the Jones Healthcare and Technology Innovation Conference
Newsfilter· 2025-04-07 10:30
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]
Vera Therapeutics Completes Full Enrollment in Pivotal ORIGIN Phase 3 Trial for Atacicept in IgAN
Globenewswire· 2025-04-03 12:00
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]
Vera Therapeutics Completes Full Enrollment in Pivotal ORIGIN Phase 3 Trial for Atacicept in IgAN
Newsfilter· 2025-04-03 12:00
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]
Phio Pharmaceuticals Announces Podium Presentations on INTASYL siRNA Lead Product Candidates PH-762 and PH-894
Newsfile· 2025-04-03 11:45
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]
FibroBiologics Announces Scientific Advancement in Confirmation Results of Brain Tissue Repair
Newsfilter· 2025-04-02 12:30
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 ...
Sensei Biotherapeutics to Participate in the Canaccord Genuity Horizons in Oncology Virtual Conference
Globenewswire· 2025-04-02 11:30
BOSTON, April 02, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that John Celebi, President and Chief Executive Officer, will participate in the New Radiotherapy and Targeted Therapy Approaches panel at the Canaccord Genuity Horizons in Oncology Virtual Conference on Monday, April 7 at 2:00 p.m. ET. About Sensei Biotherapeutics Sensei Bi ...
Vigil Neuroscience Presents Data on its Small Molecule TREM2 Agonist VG-3927 in Two Oral Presentations at AD/PD™ 2025 International Conference
Globenewswire· 2025-04-02 11:00
Core Insights - Vigil Neuroscience presented topline clinical data from the Phase 1 SAD/MAD trial of VG-3927, a potential treatment for Alzheimer's disease, at the AD/PD™ 2025 International Conference [1][2] Group 1: VG-3927 Overview - VG-3927 is an orally bioavailable small molecule TREM2 agonist with high potency and CNS penetrance, designed to target multiple contributors to Alzheimer's disease progression [2][8] - The drug's unique mechanism as both an agonist and a positive allosteric modulator may enhance microglial responses to aggregated amyloid and tau without increasing inflammation [8] Group 2: Phase 1 Trial Results - The Phase 1 trial included 115 participants, demonstrating a favorable safety and tolerability profile with no serious adverse events reported [5][7] - VG-3927 showed a predictable and dose-dependent pharmacokinetic profile, supporting once-daily dosing with an estimated cerebral spinal fluid to unbound plasma ratio of 0.91 [5][11] Group 3: Mechanism of Action - VG-3927 activates TREM2, engaging the brain's immune system to counteract multiple pathologies associated with Alzheimer's disease [3][4] - The drug promotes microglial uptake of both Aβ and Tau, indicating broad efficacy potential beyond targeting a single driver of Alzheimer's pathology [4][6] Group 4: Future Development Plans - Vigil Neuroscience plans to advance VG-3927 into Phase 2 development in the third quarter of 2025, aiming to provide a differentiated therapeutic option for Alzheimer's disease [2][6]
Here's Why Ginkgo Bioworks (DNA) is Poised for a Turnaround After Losing -28.84% in 4 Weeks
ZACKS· 2025-04-01 14:35
Group 1 - Ginkgo Bioworks Holdings, Inc. (DNA) has experienced a significant decline of 28.8% over the past four weeks, but it is now in oversold territory, indicating a potential trend reversal [1] - The Relative Strength Index (RSI) for DNA is currently at 20.73, suggesting that the heavy selling pressure may be exhausting itself, which could lead to a reversal towards the previous equilibrium of supply and demand [5] - There is strong consensus among Wall Street analysts that DNA will report better earnings than previously predicted, with the consensus EPS estimate increasing by 37.9% over the last 30 days [7] Group 2 - DNA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [8]
Unicycive Therapeutics to Present at the 24th Annual Needham Virtual Healthcare Conference
Globenewswire· 2025-04-01 11:00
Investor Contact: Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com Media Contact: Rachel Visi Real Chemistry redery@realchemistry.com SOURCE: Unicycive Therapeutics, Inc. LOS ALTOS, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chief Executive Officer will present at the 24 Annual Needham Virtual Healthcare Conference on ...