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 (NASDAQ: ABVC) announced that its subsidiary, BioKey, will produce maitake mushroom-derived dietary supplements in tablet and liquid forms. These supplements, rich in beta-glucans, are aimed at improving cardiovascular health and supporting the immune system. BioKey has secured a three-year distribution agreement with Define Biotech Co. Ltd. for exclusive rights in China and Taiwan, with a commitment to purchase $3 million worth of products. The manufacture will take place in BioKey's GMP facility in Fremont, CA, potentially leading to financial profitability by the end of 2022.
ABVC BioPharma, Inc. (Nasdaq: ABVC) reported its Q3 2021 results, revealing revenues of $98,999, a drop from $115,553 in Q3 2020, primarily due to COVID-19's impact on its CDMO sector. Operating expenses surged 48% to $2,069,160, driven by higher selling, general, and administrative costs as well as research and development expenses. The net loss narrowed to $1,886,244 from $2,131,131 year-over-year. Highlights included a successful NASDAQ listing, initiation of Phase II clinical trials for Vitargus® in Australia, and strengthened intellectual property protections.
ABVC BioPharma (Nasdaq: ABVC) announced receipt of $4,245,000 from the exercise of 673,723 Series A warrants at $6.30 each, adding to their previous underwritten offering of 1,100,000 shares that raised $6,875,000. This brings total gross proceeds to approximately $11,120,000 as of November 9, 2021. The company focuses on botanically-based solutions and has an active pipeline with six drugs and one medical device in development, intending to conduct trials at renowned research institutions.
ABVC BioPharma announced regulatory approval from Taiwan's Central IRB for its ABV-1505 ADHD Phase II Part 2 clinical study, set to commence in Q1 2022 at five medical centers. This randomized, double-blind study will include 100 patients and follows a successful Part 1 study demonstrating significant improvement in ADHD symptoms. Results showed an 83.3% improvement in ADHD-RS-IV scores. The CEO expressed optimism for securing additional approvals in the US, emphasizing the therapeutic benefits of their botanical sourcing approach.
ABVC Biopharma has announced a joint venture with Lucidam, enhancing its business development efforts in Japan. Under this agreement, ABVC will hold 49% of BioLite Japan, down from 50%, while Lucidam will possess 51%. The joint venture aims to identify and license early-stage drug and medical technology opportunities, with a focus on New Chemical Entities and diagnostic tools. Dr. Toru J. Seo will lead the venture, leveraging his extensive industry experience. This partnership is expected to accelerate ABVC's pipeline expansion.
ABVC Biopharma (NASDAQ: ABVC) announced the completion of clinical site selection for its ABV-1505 ADHD Phase II Part 2 study. This multi-nation study will involve approximately 100 patients and is set to commence in Q1 2022, following the IRB submissions. The principal investigators are from prestigious institutions, including UCSF and major medical centers in Taiwan. ABVC aims to demonstrate the efficacy and safety of ABV-1505, emphasizing its focus on botanical sourcing in drug development. The study's completion is anticipated by late 2022.
ABVC BioPharma has announced the filing of new PCT applications aimed at protecting its medicines for treating major depressive disorder (MDD) and ADHD. The applications relate to the oral administration of Radix Polygalae extract (PDC-1421), the active ingredient in both drugs. A Phase II clinical study for the MDD treatment showed a significant reduction in depression scores compared to placebo. CEO Dr. Howard Doong highlighted the strategic importance of these filings for extending global market exclusivity to 2040~2041.
ABVC BioPharma, a clinical-stage biopharmaceutical company, announced an update report by Zacks Small Cap Research on Aug. 30, 2021. The company is developing six drug candidates and one medical device (Vitargus®) targeting oncology/hematology and CNS. ABVC collaborates with renowned institutions like Stanford for its clinical trials, aiming for Phase III trials globally for Vitargus®. The press release includes forward-looking statements, emphasizing uncertainties in clinical development and regulatory approval, alongside risks of competition and manufacturing challenges.
ABVC BioPharma, Inc. (NASDAQ: ABVC) announced an update on its vitreous substitute, Vitargus®, indicating early clinical success in eliminating the need for face-down positioning after surgery and offering better recovery comfort and visual acuity. The company selected its first clinical study site in Australia for a Phase II study expected to start in Q1 2022, and is preparing additional FDA-required data. ABVC is also in discussions with large pharmaceutical companies for potential partnerships. The retinal surgery device market is projected to reach $3.7 billion by 2027.
ABVC Biopharma, Inc. reported its unaudited financial results for Q2 2021, generating revenues of $31,441, down from $226,513 in Q2 2020, largely due to COVID-19's impact on its CDMO sector. Operating expenses rose by 46% to $2,066,310, driven by increased marketing and R&D costs. The net loss decreased to $2,052,956, compared to $2,184,057 in the prior year. Notably, the company made progress in clinical studies for its medical device Vitargus and depression treatment for cancer patients. A public offering raised $6,021,585 to fund clinical trials and business operations.
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