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 the initiation of site visits for its Phase II Part 2 clinical study targeting ADHD at UCSF Medical Center on March 29, 2023. This study, led by Professor Keith McBurnett, involves approximately 100 patients across the U.S. and Taiwan, with 45 participants enrolled and 37 completing the eight-week study. The study follows the successful Phase II Part 1 trial, previously accepted by the FDA in October 2020. Dr. Howard Doong emphasized the fast enrollment pace and the potential therapeutic benefits of plant-derived medicines. The ADHD market is projected to grow from $13 billion in 2022 to $15 billion by 2025.
ABVC BioPharma, a clinical-stage biopharmaceutical company, announced the successful Phase 1 Site Initiation Visit (SIV) for ABV-1601 at Cedars-Sinai Medical Center on March 31, 2023. This Phase I open-label study will evaluate the safety of PDC-1421 in 12 cancer patients experiencing moderate to severe depressive symptoms. Dr. Howard Doong, CEO, expressed satisfaction with the completed SIV and noted collaboration with three investigators from Cedars-Sinai's cancer institute to facilitate patient enrollment.
The company anticipates launching the Phase II study in Q4 2023, comparing PDC-1421's effectiveness to Wellbutrin XL. Previous trials for PDC-1421 indicated a 13.2-point reduction in depression ratings among patients, showcasing safety and tolerance. The antidepressant market, valued at $13.7 billion in 2018, is expected to grow to $15.9 billion by 2025.
ABVC BioPharma, a clinical-stage biopharmaceutical company, announced a successful Phase II Site Initiation Visit (SIV) for its product Vitargus® at Ramathibodi Hospital in Thailand on March 22, 2023. This study aims to evaluate the safety and effectiveness of Vitargus® in patients with retinal detachment compared to Sulphur Hexafluoride gas. The company is initiating patient enrollment across multiple sites, targeting at least 40 participants. Early studies show Vitargus® may enhance patient comfort and visual acuity, potentially eliminating the need for additional surgery post-treatment.
ABVC BioPharma is focused on developing innovative solutions in oncology, CNS, and ophthalmology, with an active pipeline of six drugs and the Vitargus® medical device under development.
ABVC BioPharma, Inc. reported a significant increase in revenues, generating $969,783 for the fiscal year ended December 31, 2022, up 173% from $355,797 in 2021, mainly due to increased contract services. However, operating expenses rose to $15,797,780, up 31% from $12,056,679 in the prior year, largely due to higher stock-based compensation and R&D expenses. The net loss increased by approximately 36% to $16,312,374. Cash and cash equivalents fell to $85,265 from $5,828,548. The company is progressing in clinical trials for its products, with expectations to complete Phase II trials of Vitargus by the end of 2023.
ABVC BioPharma (NASDAQ: ABVC) announced the successful Phase II Site Initiation Visit for Vitargus® at Srinagarind Hospital, Thailand, on March 9-10, 2023. The study aims to evaluate the safety and effectiveness of ABV-1701 Ocular Endotamponade in retinal detachment patients, enrolling at least 40 participants across four sites in Australia and Thailand. Vitargus® is a biodegradable vitreous substitute, improving patient comfort and visual recovery compared to existing methods. The global retinal surgery device market is projected to reach $3.7 billion by 2027, fueled by a growing elderly population. The company plans to advance its product through Phase III clinical trials.
ABVC Biopharma, Inc. (NASDAQ: ABVC) announced that its subsidiary, BioKey, received approval from the Taiwan Ministry of Health and Welfare for its Maitake Mushroom Dietary Supplement Tablet on February 6, 2023. This approval allows commercial sales in Taiwan under the brand name "DFN." The company has entered a three-year distribution agreement with Define Biotech Co. Ltd., involving $3 million in product orders. BioKey will manufacture the tablets in a controlled environment at its facility in Fremont, California. The global dietary supplements market was valued at $140.3 billion in 2020, with expected growth at a CAGR of 8.6% from 2021 to 2028.
On February 28, 2023, ABVC BioPharma (NASDAQ: ABVC) announced significant updates regarding its clinical developments in major depressive disorder (MDD), attention deficit hyperactivity disorder (ADHD), and oncology. The company completed Phase II trials for its MDD treatment, ABV-1504, and is negotiating with the FDA to begin Phase III. ABV-1505 for ADHD is in Phase II trials, expanding to UCSF soon. A Phase I study for ABV-1601 targeting cancer patient depression is set for Q1 2023. Additionally, ABVC commenced Phase II trials for pancreatic cancer treatment ABV-1703. The company expects to finalize its Vitargus Phase II trial by year-end. A recent $3.175 million financing is anticipated to support these milestones.
ABVC BioPharma (NASDAQ: ABVC) has closed a funding agreement with Lind Global Fund II, LP, securing gross proceeds of $3.175 million. The investment aims to support ongoing Phase II clinical trials for Vitargus, a medical device for retinal surgeries, and for ABV-1505, a treatment for ADHD. The agreement includes a senior convertible note of $3.704 million convertible at $1.05 per share, and a warrant for 5,291,667 shares at the same price. The financing is crucial for advancing ABVC's clinical pipeline, which includes six drugs and one medical device.
ABVC BioPharma, Inc. (NASDAQ: ABVC) announced the approval of its Phase II study for the Vitargus® medical device by the Australian Therapeutic Goods Administration (TGA) on February 9, 2023. Vitargus is the first biodegradable vitreous substitute designed to enhance patient comfort during retina reattachment surgery. The study aims to compare the safety and effectiveness of Vitargus against the commonly used SF6 Gas. It will enroll at least 40 subjects across two sites in Australia and includes hospitals in Thailand. The retinal surgery devices market is projected to reach $3.7 billion by 2027, driven by a growing geriatric population.
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