H.C. Wainwright & Co., LLC’s Post

Panmure Gordon has reaffirmed its 'buy' recommendation for BiVictriX Therapeutics plc (AIM:BVX, OTC:BVTXF), maintaining a target price of 66p after the company's full-year results for 2023. The year saw significant advancements in BiVictriX's lead asset, BVX001, targeting acute myeloid leukaemia (AML), alongside progress in its broader pipeline. Panmure flagged key operational achievements, including advancing BVX001 to investigational new drug-enabling studies and making headway with BVX002, aimed at solid tumours. More at #Proactive #ProactiveInvestors http://ow.ly/nT4g105v4ou

Sjogrens Syndrome Therapeutics Market report from 2022-2027 by Technavio - The market size to grow by USD 691.09 million during the forecast period: NEW YORK, Dec. 14, 2023 /PRNewswire/ -- The Sjogren's Syndrome Therapeutics Market size is anticipated to witness substantial growth between 2022 and 2027, projecting an estimated increase of USD 691.09 million at a compound annual growth rate (CAGR) of 6.53%. This market is driven by the...

MEMBER NEWS: ZyVersa Therapeutics Engages CRO, George Clinical, for Phase 2a Clinical Trial for Cholesterol Efflux Mediator VAR 200 -Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression. WESTON, Fla., Dec. 14, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics Inc. Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces selection of contract research organization (“CRO”) George Clinical to manage its Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD). The clinical trial is expected to begin in the first quarter of 2024. View full news release: https://lnkd.in/e9v_HMeu

Lisata Therapeutics, Inc. presentation by Dr. David J. Mazzo, Ph.D., President & CEO at the 10th Annual Oncology Innovation Forum Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, certepetide (formerly LSTA1), is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next two years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. View here: https://lnkd.in/dDkhmGte

Myelofibrosis Pipeline Forecast 2024: FDA Approvals, Therapies, and Leading Companies by DelveInsight | Galecto Biotech, Lynk Pharma, Samus Therapeutics, Taiga Biotech, Bristol-Myers Squibb, Sumitomo: (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Myelofibrosis pipeline constitutes 45+ key companies continuously working towards developing 45+ Myelofibrosis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. The … Continue reading → #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech

Congrats to Pacira BioSciences, Inc. on being the latest company to announce the award of an FDA RMAT. Pacira's PCRX-201 is the first #genetherapy product candidate to receive RMAT designation for osteoarthritis. This means we're officially up to 88 Publicly Announced RMAT Designations! However, the FDA states it has received 248 requests and issued 101, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 41% of RMAT applications get approved (101 approvals / 248 applications = 40.7%). Thus far, Rocket Pharmaceuticals is the only company to receive four RMATs, while two other companies (AlloVir, CRISPR Therapeutics) have received three RMATs to date. Additionally, 11 companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, Cook MyoSite, Humacyte, Mesoblast Limited, Ocugen, Orchard Therapeutics, and Sangamo Therapeutics, Inc. Therapeutics) have managed to secure two RMAT designations from the U.S. FDA. Read more at: https://lnkd.in/eY2DSKV

𝐙𝐲𝐕𝐞𝐫𝐬𝐚 𝐀𝐝𝐯𝐚𝐧𝐜𝐞𝐬 𝐏𝐡𝐚𝐬𝐞 𝟐𝐚 𝐓𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐃𝐢𝐚𝐛𝐞𝐭𝐢𝐜 𝐊𝐢𝐝𝐧𝐞𝐲 𝐃𝐢𝐬𝐞𝐚𝐬𝐞 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭" ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”) ZyVersa Therapeutics Inc., a clinical-stage biopharmaceutical company, announces Institutional Review Board (IRB) approval for the Phase 2a clinical trial protocol to assess the efficacy and safety of Cholesterol Efflux Mediator VAR 200 in diabetic kidney disease patients. The trial is set to commence in the first half of 2024. This milestone marks ZyVersa's first human trial for VAR 200, aiming to validate promising preclinical results across multiple animal models of kidney disease. Preclinical data demonstrated VAR 200's ability to: Lower cholesterol and lipid levels in the kidneys. Protect against kidney injury and fibrosis. Reduce proteinuria. Stephen C. Glover Steve Glover, ZyVersa’s Co-founder, Chairman, CEO, and President, highlights the significance of addressing kidney disease progression, affecting over 35 million adults in the U.S. annually. VAR 200 holds potential in mitigating kidney injury and slowing disease progression. #Nephrology #RenalHealth #ChronicKidneyDisease #DrugDevelopment #KidneyDiseaseTreatment #DiabeticKidneyDisease

Are you heading to Asembia's AXS24 Summit? Schedule a meeting with a Dedham Group expert to learn how our market access oncology and specialty therapeutics strategic consulting services can help you. https://ow.ly/b6qA50QYJVm #Asembia24

Ocugen secured the latest U.S. FDA RMAT designation for OCU400 on December 19, 2023, bringing us up to 84 publicly announced RMATs. However, the FDA states it has received 238 requests and issued 92, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 39% of RMAT applications get approved (92 approvals / 238 applications = 38.7%). Thus far, Rocket Pharmaceuticals is the only company to receive four RMATs, while two other companies (AlloVir, CRISPR Therapeutics) have received three RMATs to date. Additionally, 10 companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, Cook MyoSite, Humacyte, Mesoblast Limited, Ocugen, and Orchard Therapeutics) have managed to secure two RMAT designations from the U.S. FDA. Read more here: https://lnkd.in/eY2DSKV