Welcome to our dedicated page for ABVC BioPharma news (Ticker: ABVC), a resource for investors and traders seeking the latest updates and insights on ABVC BioPharma stock.
ABVC BioPharma, Inc. (NASDAQ: ABVC) is a clinical-stage biopharmaceutical company dedicated to developing therapeutic solutions in the fields of oncology/hematology, central nervous systems (CNS), and ophthalmology. Founded in 2015 and headquartered in Fremont, California, the company is focused on addressing unmet medical needs through its pipeline of innovative drugs and medical devices.
ABVC BioPharma, along with its subsidiaries like BioLite, Inc. and BioFirst Corporation, has an active pipeline comprising six drugs and one medical device (ABV-1701/Vitargus®) under development. ABVC harnesses licensed technology from renowned research institutions such as Stanford University, the University of California at San Francisco, and Cedars-Sinai Medical Center to conduct proof-of-concept trials up to Phase II of clinical development. The company’s flagship product, Vitargus®, is a groundbreaking vitreous substitute for retinal detachment surgery and is currently undergoing global clinical trials.
The company’s drug candidates include:
- ABV-1501 – A combination therapy for triple-negative breast cancer.
- ABV-1504 – Designed for treating major depressive disorder (MDD).
- ABV-1505 – Targets attention deficit hyperactivity disorder (ADHD).
- ABV-1702 – For the treatment of myelodysplastic syndromes (MDS).
- ABV-1703 – Focused on the treatment of pancreatic cancer.
- ABV-1601 – Aimed at treating depression in cancer patients.
ABVC has entered several strategic partnerships and licensing agreements to advance its pipeline. These include co-development agreements with Rgene Corporation and BiohopeKing Corporation for ABV-1501, and collaborative efforts with BioFirst Corporation for the co-development of BFC-1401 vitreous substitute for vitrectomy and ABV-1701 Vitargus for retinal detachment or vitreous hemorrhage.
Recent achievements include a global licensing agreement with AiBtl BioPharma Inc. for CNS drugs targeting MDD and ADHD, valued at $667 million, and the acquisition of a U.S. patent for the use of PDC-1421 (Polygala extract) in treating ADHD. ABVC is also involved in strategic investments such as the acquisition of real estate in Taoyuan City, Taiwan, to develop plant factories for its botanical drug pipeline.
ABVC BioPharma is committed to bringing high-efficacy, low-toxicity botanically based solutions to the market, improving health outcomes for patients worldwide. The company’s focus on strategic partnerships, innovative research, and global clinical trials positions it as a significant player in the biopharmaceutical industry.
ABVC BioPharma announced a new aseptic manufacturing process for Vitargus®, a gel used in retinal surgeries. This process improves product stability and reduces manufacturing time while eliminating gamma ray sterilization. Dr. Howard Doong, CEO, noted that this advancement supports transforming Vitargus into a high-volume commercial product. Early clinical studies show that Vitargus enhances patient comfort and visual recovery. The Phase II study in Australia and Thailand will further assess safety and effectiveness, with plans for Phase III trials involving over 175 patients.
ABVC Biopharma, Inc. (NASDAQ: ABVC) announced a $3.0 million clinical services contract with NeuCen BioMed Co. Ltd. for two drug products, CEN501 and NEU001, to advance their Phase II clinical studies under U.S. FDA IND requirements. CEN501 is a nasal strip for treating allergic rhinitis, already validated in Taiwan, while NEU001 is an orphan drug for nasopharyngeal carcinoma. Over three years, BioKey will receive payments based on regulatory milestones, and ABVC will lend NeuCen $1.0 million through convertible debentures, potentially acquiring a 9% stake in NeuCen.
ABVC Biopharma (NASDAQ: ABVC) announced the completion of site initiation visits at all five clinical study sites in Taiwan for its Phase II clinical study on ADHD medicine, PDC-1421. This double-blind, placebo-controlled trial aims to evaluate the tolerability and efficacy of PDC-1421 in approximately 100 patients in Taiwan and the U.S., following a successful Phase II Part 1 study approved by the FDA in October 2020. The ADHD drug market is projected to grow from USD 16.4 billion in 2018 to USD 24.9 billion by 2025, reflecting a 6.4% CAGR.
ABVC BioPharma (NASDAQ: ABVC) announced a virtual meeting on April 27, 2022, involving principal investigators for its Phase II study of Vitargus®, a biodegradable ocular endotamponade. This meeting aims to enhance coordination among Australian and Thai sites, which will enroll approximately 40 patients as part of a broader goal to include 175 patients by the end of 2023. Vitargus® aims to improve patient comfort and visual acuity, eliminating the need for postoperative positioning and a second surgery. The global retinal surgery device market is projected to reach $3.7 billion by 2027.
ABVC BioPharma, Inc. (Nasdaq: ABVC) reported its financial results for the year ended December 31, 2021, highlighting a revenue decline of 26% to $355,797 due to decreased contract services from COVID-19 impacts. Operating expenses rose to $12.06 million, largely from increased stock-based compensation and R&D costs. The net loss increased by 14% to $12.04 million. However, working capital improved significantly to $5.93 million, aided by financing activities. Notable developments include the award for Vitargus® and a new distribution agreement for a dietary supplement in China and Taiwan.
ABVC Biopharma, a clinical stage biopharmaceutical company, will participate in the Maxim Group 2022 Virtual Growth Conference from March 28-30, 2022. CEO Dr. Howard Doong is scheduled to present on March 29 at 11:00 am ET, focusing on Vitargus, a gel-like substance designed to assist during retinal surgeries. ABVC is developing six drugs and one medical device, aiming for Phase III trials with Vitargus globally. For one-on-one meetings, interested parties can contact Investor Relations.
ABVC Biopharma, Inc. (NASDAQ: ABVC) announced the Principal Investigator Meeting for the Phase II Part 2 ADHD study of ABV-1505 set for February 14, 2022. The study, involving approximately 100 patients, aims to further evaluate the therapeutic value of PDC-1421. Results from Part 1 indicated an 83.3% improvement in ADHD symptoms, supporting the drug's effectiveness and safety. The trial is expected to begin in Q1 2022 and conclude by the end of the year, aligning with the growing ADHD drug market projected to reach $24.9 billion by 2025.
ABVC BioPharma (NASDAQ: ABVC) has announced the addition of two clinical sites in Thailand for its Phase II study of Vitargus®, a biodegradable vitreous substitute for retina surgery. These sites will join two already confirmed in Australia, with enrollments expected to begin in Q2 2022 following regulatory approvals. The study aims to assess Vitargus®'s safety and efficacy compared to traditional options. With a projected market growth of retinal surgery devices reaching $3.7 billion by 2027, ABVC is positioning itself strongly in this sector.
ABVC Biopharma (NASDAQ: ABVC) announced the presentation of Vitargus®, the first biodegradable vitreous substitute, at the APVRS Congress on December 11, 2021. Dr. Andrew Chang led the discussion on the promising early results indicating improved recovery and comfort for patients. ABVC plans a Phase II clinical study in Australia starting in Q1 2022 to further evaluate Vitargus's safety and efficacy compared to traditional methods. The global market for retinal surgery devices is projected to reach $3.7 billion by 2027, driven by an aging population.
ABVC BioPharma, Inc. (NASDAQ: ABVC) announced that its vitreous substitute, Vitargus®, received the 2021 “National Innovation and Renewal of Diligence” award from Taiwan's Institute for Biotechnology and Medicine Industry. This award highlights Vitargus®'s unique properties, which enhance recovery and visual acuity post-retina surgery. ABVC plans to start a multi-country Phase II clinical study in 2022 to validate Vitargus® against standard treatments. The global retinal surgery device market is projected to reach $3.7 billion by 2027, driven by an aging population.
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