HOUSTON, March 27, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that its 2025 Annual Meeting of Stockholders will take place on June 12, 2025, at 11 a.m. CDT, exclusively through a virtual format. The record date for determination of stockholde ...

Core Insights - Oragenics, Inc. is advancing its lead therapeutic candidate, ONP-002, for concussion treatment, highlighting significant progress in regulatory, clinical, financial, and partnership initiatives [1][2] Strategic and Operational Milestones - ONP-002 is a neuroprotective, anti-inflammatory compound designed for intranasal administration to treat concussion, classified as a mild traumatic brain injury (mTBI) [3] - The drug has undergone extensive preclinical studies, including evaluations for cardiotoxicity and genotoxicity, and successfully completed a Phase I human study with no serious adverse events [4] - The company has finalized drug production for the Phase IIa clinical trial and submitted the Investigator's Brochure to regulatory authorities in Australia, with first patient enrollment expected soon [5][6] Strategic Partnerships - A collaboration with BRAINBox Solutions was established to combine ONP-002's therapeutic capabilities with BRAINBox's diagnostic tools, aiming to enhance concussion care [7][9] Financial Position and Capital Structure - Oragenics raised approximately $5 million in Q1 2025 through a mix of equity and non-dilutive debt financing, including $2.6 million from At-the-Market (ATM) equity sales and $2.25 million in non-dilutive debt [8][10] - The company simplified its capital structure by converting all outstanding Series A and B preferred shares to common stock, enhancing transparency for shareholders [10][11] Upcoming Milestones - Key projected milestones include HREC approval in Australia and first patient enrollment in the Phase IIa trial expected in Q2 2025, with completion of Phase IIa enrollment anticipated by Q4 2025 [12] - Additional milestones include interim safety and biomarker readout in Q4 2025 – Q1 2026, initiation of Phase IIb in Q1 2026, and FDA Accelerated Approval Filing in Q3 2026 [12] Commitment to Value Creation - The company is focused on advancing ONP-002 with urgency and precision, aiming to deliver a clinical breakthrough in concussion care and generate long-term value for shareholders [13][14]

Core Insights - Polyrizon Ltd. is advancing its clinical strategy for PL-14, an intranasal allergy blocker aimed at treating seasonal allergic rhinitis, in preparation for regulatory approval and commercialization [1][2][3] Clinical Strategy - The company is structuring its clinical plan to support a pre-submission meeting with the U.S. FDA, which will be followed by the initiation of clinical trials [2] - Comprehensive clinical studies will assess efficacy, safety, user experience, and nasal residence time of PL-14 [5] Clinical Trials Timeline - Polyrizon expects to begin clinical trials in the U.S. and Europe between late 2025 and early 2026, after completing preclinical work and the upcoming FDA consultation [2] Product Technology - Polyrizon specializes in innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens in the nasal cavity [3] - The proprietary Capture and Contain (C&C) hydrogel technology is designed to function as a "biological mask" [3] Additional Development - The company is also developing the Trap and Target (T&T) technology for nasal delivery of active pharmaceutical ingredients, which is currently in pre-clinical development [3]

Core Insights - Alterity Therapeutics is advancing its lead drug candidate, ATH434, aimed at treating neurodegenerative diseases, specifically targeting Multiple System Atrophy (MSA) [1][4] - The last patient in the ATH434-202 Phase 2 trial has completed the study, with topline data expected to be reported in mid-2025 [1][2] Company Overview - Alterity Therapeutics is a clinical-stage biotechnology company focused on developing disease-modifying therapies for neurodegenerative diseases, particularly Parkinson's disease and related disorders [7] - The company is based in Melbourne, Australia, and San Francisco, California, and has a drug discovery platform aimed at creating treatments for neurological diseases [7] ATH434-202 Phase 2 Clinical Trial - The ATH434-202 trial is an open-label study involving 10 participants with advanced MSA, where participants received a 75 mg dose of ATH434 for 12 months [3] - The study aims to evaluate the effects of ATH434 on neuroimaging and protein biomarkers, alongside clinical measures, safety, and pharmacokinetics [3] - The primary objective is to assess the impact of ATH434 on brain volume in a more advanced patient population compared to previous trials [3] Drug Mechanism and Efficacy - ATH434 is designed to inhibit the aggregation of pathological proteins associated with neurodegeneration, specifically targeting α-synuclein pathology [4] - Preclinical studies have shown that ATH434 can reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain [4] - The drug has received Orphan Drug Designation for MSA treatment from the U.S. FDA and the European Commission [4] Disease Context - Multiple System Atrophy (MSA) is a rare, rapidly progressive neurodegenerative disease affecting at least 15,000 individuals in the U.S., characterized by autonomic dysfunction and impaired movement [5] - Currently, there are no approved drugs that can slow the progression of MSA, highlighting the potential significance of ATH434 in the treatment landscape [5]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

WARREN, N.J., March 26, 2025 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech company leveraging AI-driven immunotherapy drug discovery, is pleased to share that Founder and CEO, Ryan Saadi, MD, MPH, has been named to the 2025 Health Care Power List by NJBIZ. This recognition highlights Dr. Saadi’s leadership and commitment to advancing healthcare innovation and accessibility in New Jersey and beyond. This announcemen ...

Core Insights - Humacyte, Inc. is set to release its financial results for Q4 and the full year of 2024 on March 28, 2025, with a conference call scheduled for 8:30 AM ET [1][2] Company Overview - Humacyte is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][3] - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for extremity vascular trauma in December 2024 and is conducting late-stage clinical trials for other vascular applications [3] - Humacyte's ATEV has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, highlighting its potential in urgent arterial repair and advanced peripheral artery disease [3] Upcoming Events - The financial results webcast will be accessible 15 minutes prior to the conference call, with a replay available for at least 30 days on the company's investor website [2]

Core Insights - Wave Life Sciences announced positive results from the Phase 2 FORWARD-53 trial of WVE-N531, demonstrating significant improvements in muscle health and function in boys with Duchenne muscular dystrophy (DMD) [1][4][10] Group 1: Trial Results - The FORWARD-53 trial achieved all goals, showing a statistically significant and clinically meaningful improvement of 3.8 seconds in Time-to-Rise (TTR) compared to natural history, the largest effect observed relative to any approved dystrophin restoration therapy at 48 weeks [1][3][12] - A 28.6% reduction in muscle fibrosis was observed between weeks 24 and 48 (p<0.01), alongside a 50% decrease in serum creatine kinase (CK) levels (p<0.001) [3][12] - Dystrophin expression stabilized between 24 and 48 weeks, averaging 7.8%, with 88% of boys achieving over 5% average dystrophin [1][8] Group 2: Safety and Tolerability - WVE-N531 was reported to be safe and well-tolerated, with no serious adverse events and all treatment-related adverse events being mild to moderate [1][8] - The trial included 11 boys, all of whom advanced to the extension portion of the study receiving monthly doses of WVE-N531 [7][8] Group 3: Regulatory and Future Plans - Following feedback from the FDA, Wave plans to file a New Drug Application (NDA) in 2026 for accelerated approval of WVE-N531, supported by data for monthly dosing [1][5][6] - Wave expects to submit multiple clinical trial applications (CTAs) for other DMD candidates targeting different exons in 2026, aiming to establish a best-in-class exon skipping franchise [1][6][10] Group 4: Market Opportunity - WVE-N531 and other exon skipping programs could address approximately 40% of the DMD population, representing a market opportunity exceeding $2.4 billion in the United States alone [6][10]

Core Viewpoint - Humacyte, Inc. has initiated an underwritten public offering of its common stock to fund the commercialization of its product SYMVESS™ and other developmental projects [1][3] Group 1: Offering Details - Humacyte is offering shares of common stock and has granted underwriters a 30-day option to purchase an additional 15% of the shares sold [1] - The offering is managed by TD Cowen, Barclays, and BTIG as joint book-running managers, with H.C. Wainwright & Co. and The Benchmark Company as lead managers [2] - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [2] Group 2: Use of Proceeds - The net proceeds from the offering will be used for the commercialization of SYMVESS™ in vascular trauma, development of product candidates, and general corporate purposes [3] Group 3: Company Overview - Humacyte is focused on developing bioengineered human tissues and advanced tissue constructs to improve patient outcomes [6] - The company’s initial product candidates, acellular tissue engineered vessels (ATEVs), are in late-stage clinical trials for various vascular applications [6] - The ATEV for vascular trauma received FDA approval in December 2024, and the company is also pursuing preclinical development for other applications [6][7]

Century Therapeutics, Inc. (IPSC) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual inve ...