Visus Therapeutics, Inc.’s Post

𝐁𝐫𝐚𝐢𝐧𝐒𝐭𝐨𝐫𝐦 𝐂𝐞𝐥𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐥𝐢𝐠𝐧𝐬 𝐰𝐢𝐭𝐡 𝐅𝐃𝐀 𝐨𝐧 𝐂𝐌𝐂 𝐀𝐬𝐩𝐞𝐜𝐭𝐬 𝐟𝐨𝐫 𝐍𝐮𝐫𝐎𝐰𝐧® 𝐏𝐡𝐚𝐬𝐞 𝟑𝐛 𝐓𝐫𝐢𝐚𝐥 BrainStorm Cell Therapeutics (NASDAQ: BCLI) Brainstorm Cell Therapeutics has reached alignment with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b trial for NurOwn®, its investigational therapy for ALS. This follows the positive momentum from April 2024, when the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement, providing clarity on the trial's design and endpoints. "This in-person Type C meeting with the FDA was crucial as we finalize preparations for our pivotal Phase 3b trial of NurOwn. We are very pleased with the outcome and are now aligned on resolving all previously outstanding CMC questions," said Chaim Lebovits Chaim Lebovits, President & CEO of BrainStorm. "We are committed to working closely with the FDA and are excited to move forward with the Phase 3b trial to address the unmet needs of ALS patients." #ALS #StemCellTherapy #ClinicalTrials #FDA #NurOwn #BrainStormCellTherapeutics #Biotech #NeurodegenerativeDiseases

Today Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) shared an exciting analysis of a clinical trial conducted by Abbott supporting our belief that Cadrenal's lead drug candidate tecarfarin could be an important next-generation anticoagulant for patients with LVADs. Quoted in the news release lead investigator of the trial, Dr. Mandeep Mehra, states, "…Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anti-coagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study." Read more: https://lnkd.in/gypE4XZc   #cadrenal #nasdaq #cvkd #therapeutics #tecarfarin Quang Pham Matthew Szot

🔬 Poseida Therapeutics, Inc. Responds Swiftly to FDA Safety Review with Preliminary Data on P-BCMA-ALLO1! 🩸💉 In response to the FDA's recent safety review of approved CAR-T therapies, Poseida Therapeutics presents preliminary data for its allogeneic CAR-T candidate, P-BCMA-ALLO1, developed in collaboration with Roche. 💡 Distinguished by its nonviral approach, this candidate holds the potential for a more favorable safety profile compared to conventional methods. The phase 1 trial primarily targets patients facing relapsed or refractory multiple myeloma. #PoseidaTherapeutics #CAR-T #clinicaltrials

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) invites you to our presentation at the Sidoti Micro-cap Virtual Conference on August 15, 2:30-3:00 pm ET in Track 3.      Douglas Losordo, MD, Chief Medical Officer of Cadrenal Therapeutics, will provide an overview of our progress in developing our lead candidate, tecarfarin.      With FDA orphan drug and fast-track designations, tecarfarin is a novel oral vitamin K antagonist designed to meet critical unmet chronic anticoagulation needs in patients with implanted cardiac devices and rare cardiovascular conditions.      We look forward to discussing our clinical milestones and business development strategy with investor participants.     https://lnkd.in/g5yPtHDr    #CadrenalTherapeutics #Anticoagulation #Tecarfarin #CardiovascularHealth #PharmaInnovation #Biotech #OrphanDrug #FastTrack #Healthcare #SidotiConference #ClinicalTrials #CVKD #LVAD

If you missed the December 1st webinar from ReCode Therapeutics, the recording is now available at the link below! Watch today to learn about the clinical trials process. https://lnkd.in/gnZ5fKY6

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) invites you to our presentation at the Sidoti Micro-cap Virtual Conference on August 15, 2:30-3:00 pm ET in Track 3.      Douglas Losordo, MD, Chief Medical Officer of Cadrenal Therapeutics, will provide an overview of our progress in developing our lead candidate, tecarfarin.      With FDA orphan drug and fast-track designations, tecarfarin is a novel oral vitamin K antagonist designed to meet critical unmet chronic anticoagulation needs in patients with implanted cardiac devices and rare cardiovascular conditions.      We look forward to discussing our clinical milestones and business development strategy with investor participants.     https://lnkd.in/eFsv-hQB    #CadrenalTherapeutics #Anticoagulation #Tecarfarin #CardiovascularHealth #PharmaInnovation #Biotech #OrphanDrug #FastTrack #Healthcare #SidotiConference #ClinicalTrials #CVKD #LVAD

As an early investor in Dyne Therapeutics, CureDuchenne is pleased to share that Dyne announced positive data from their Phase 1/2 trial of DYNE-251 in individuals with #Duchenne amenable to skipping exon 51. Individuals treated with 20 mg/kg once every 4 weeks for 6 months showed a mean dystrophin expression of 3.7% of normal when unadjusted for muscle content; when adjusted for muscle contest, the mean was 8.72% of normal dystrophin. Improvements were observed in multiple functional endpoints in the 20 mg/kg cohort at 6 months, as well as the 10 mg/kg group which was escalated to 20 mg/kg during the open-label extension (6 months to 1 year). Dyne is initiating registrational cohorts and will update us later this year with their plans for pursuing FDA approval via the accelerated pathway. #exonskipping #CureDuchenne #DMD #FDA #ClinicalTrials https://lnkd.in/g94sfmix

Last week, Argenica Therapeutics lodged our Appendix 4C Quarterly Cashflow Report for the 12-month period ended 30 June 2024. One key highlight from the report was the progress made in our Phase 2 Clinical Trial. Here is an overview of the highlight Access the full report here ➡️ https://bit.ly/4ftygiq #ASX #AGN #investorupdate #stroke #clinicaltrial

Part 2 of CEO Howard Berman's recent interview with Pharmaceutical Executive's Don Tracy is live now on their website where they talk about next steps for Coya 302. Watch the video at this link: $Coya #Coyatherapeutics #ALS #neurodegenerative

Join this insightful webinar on organoid-based drug screening with Dr. Marrit Putker, an expert in organoid technology. You'll get to explore the organoid screening process from conception to application, bridging lab and clinical outcomes. You'll also learn about OrganoidXplore™ for high-throughput screening and its clinical relevance. Register now to receive an on-demand version if you can't attend live. #Organoids #DrugScreening