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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, a clinical-stage biopharmaceutical company, plans to start Phase II trials for its pancreatic cancer treatment, ABV-1703, in Q2 2023 at Cedars-Sinai Medical Center. This follows positive early studies demonstrating the therapeutic effects of an ingredient derived from the Maitake mushroom. Previous trials indicated no dose-limiting toxicity and promising immune system enhancement. Additionally, studies for other treatments targeting lung cancer and breast cancer are expected to begin later in 2023, underscoring ABVC's commitment to developing effective oncology solutions.
ABVC BioPharma has received Ethics Committee approvals from Ramathibodi Hospital and Srinagarind Hospital for its Phase II Vitargus Clinical Trial in Thailand, announced on August 2, 2022. The company anticipates receiving a Thai FDA investigational product import license within 30 days to commence the study titled “A Prospective Multi-Site Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV1701 Ocular Endotamponade.” Additionally, similar protocol submissions are ongoing for Australia.
CEO Dr. Howard Doong expressed optimism about the trial’s initiation in Asia and potential US studies by 2024.
ABVC BioPharma, Inc. (Nasdaq: ABVC) reported its Q2 2022 financial results, showing revenues of $312,860, up from $31,441 in Q2 2021, attributed mainly to a service agreement with Rgene. Operating expenses rose 14% to $2,351,353, driven by increased administrative and R&D costs. Despite these increases, the net loss decreased by 5% to $1,947,333. Key operational highlights include progress in Vitargus® Phase II studies in Australia and Thailand and advancements in ADHD treatments involving collaborations with renowned research hospitals.
ABVC BioPharma announced the Ethics Committee of Srinagarind Hospital approved the Vitargus® Phase II Clinical Study Protocol in Thailand. This study will involve 20+ patients undergoing vitreo-retinal surgery and is one of two sites; the other is awaiting approval. Additionally, the protocol is under review by Australia's Bellberry HREC for further approval. This progress is crucial for ABVC to meet clinical trial enrollment goals.
ABVC Biopharma (NASDAQ: ABVC) announced that the global Retinal Surgical Instruments market is projected to grow from USD 1.59 billion in 2021 to USD 2.46 billion by 2028, driven by increased retinal disorders and surgeries.
This growth supports ABVC's Vitargus, a gel-like product designed to improve patient comfort during retinal surgeries and eliminate the need for post-operative face-down positioning.
Phase II clinical trials are underway, with plans for global out-licensing agreements by 2024.
ABVC Biopharma (NASDAQ: ABVC) announced the progress of its Phase II Part II clinical study for its ADHD treatment, ABV-1505. As of now, 22 out of 32 screened subjects have been enrolled, with one completing the 8-week treatment. The study, which is double-blind and placebo-controlled, aims to enroll around 100 patients and is conducted at five hospitals in Taiwan and the University of California, San Francisco. The ADHD drug market is projected to grow from USD 16.4 billion in 2018 to USD 24.9 billion by 2025. Dr. Howard Doong expressed optimism about ongoing recruitment rates.
ABVC Biopharma, Inc. (NASDAQ: ABVC) reported a valuation of $9.50 per share in a Zacks Small-Cap Research report dated June 7, 2022. The report highlighted potential FDA approval for ABV-1505 and Vitargus, predicting product revenues of $3.2 million in 2023 and $14.5-$16 million in 2024. ABVC is conducting a Phase II study for Vitargus® to improve patient comfort post-surgery and has advanced ABV-1505 through Part 1 of Phase II for ADHD. The company emphasizes positive growth potential but acknowledges inherent risks in clinical trials and commercialization.
ABVC BioPharma has received approval from the Thailand Central Research Ethics Committee for its Vitargus® Phase II Clinical Study. This approval includes the study protocol and other essential documents. The trials will take place at Ramathibodi Hospital and Srinagarind Hospital, with over 20 patients expected to participate. The clinical studies in Thailand will run parallel to Australian sites, aiming for expedited patient results. The global market for retinal surgery devices is projected to reach $3.7 billion by 2027, driven by an aging population.
ABVC Biopharma (NASDAQ: ABVC) announced the expansion of its partnership with Rgene Corporation under a Clinical Development Service Agreement. This agreement will facilitate the development of three cancer drug products (RGC-1501 for NSCLC, RGC-1502 for pancreatic cancer, and RGC-1503 for colorectal cancer) through Phase II studies, with ABVC eligible for up to $3 million in milestone payments over three years. Additionally, ABVC will provide a $1 million convertible loan to Rgene, potentially increasing its ownership stake. The new partnership aims to enhance financial profitability while advancing oncology programs.
ABVC Biopharma (NASDAQ: ABVC) announced the submission of its Vitrargus Phase II study to the Australian Bellberry Human Research Ethics Committee (HREC). Approval from the HREC will enable a Clinical Trial Notification (CTN) submission to the Australian Therapeutic Goods Administration (TGA), marking a key step toward study initiation. The Phase II study aims to assess the safety and effectiveness of ABV-1701 Ocular Endotamponade compared to traditional SF6 Gas OE. The study is scheduled to commence in August 2022 and conclude by the end of 2023, targeting markets projected to reach $3.7 billion by 2027.
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