ABVC BioPharma, Inc. - ABVC STOCK NEWS

ABVC BioPharma has received FDA approval for its IND application regarding BLEX 404, which will be tested in patients with advanced EGFR-mutated non-small cell lung cancer. The study, co-developed with Rgene Corporation, allows ABVC to progress its clinical trial under IND 161602, with a milestone payment of $600,000 received from Rgene. Targeting the growing NSCLC market, expected to reach $13.68 billion by 2030, ABVC aims to further its clinical development pipeline, which includes six drugs and a medical device.

ABVC BioPharma (NASDAQ: ABVC) announced the approval of its Vitargus® Phase II Clinical Study Protocol by the Thailand FDA. Import licenses for the Vitargus device and SF6-Gas comparator have been issued for the two study sites in Thailand, enabling the initiation of the study by year-end 2022.

Twenty patients are expected to participate in the vitreo-retinal surgery study. Additionally, Australian sites are anticipated to receive approvals from the TGA in early 2023, with plans for further international study sites later in the year.

ABVC BioPharma reported its Q3 2022 financial results, revealing a revenue drop to $42,269, down from $98,999 in Q3 2021. Operating expenses surged by 81% to $3,747,369, largely due to increased selling and administrative costs connected to recent stock issuance. The net loss escalated to $3,776,524, reflecting a 100% increase year-over-year. On a positive note, ABVC has made progress in clinical studies, including approvals for Vitargus® Phase II in Australia and Thailand, and initiated a Phase II ADHD study in Taiwan, with 35 subjects enrolled.

ABVC Biopharma, Inc. (NASDAQ: ABVC) announced a Notice of Allowance for its patent ABV-1504, aimed at treating Major Depressive Disorder using Radix Polygalae extract. This patent extends the protection for ABV-1504 in the US until 2041, allowing for global commercialization without generic competition. The drug has shown safety and tolerability in trials with doses ranging from 380 mg to 3800 mg. The antidepressant market is projected to grow from $13.69 billion in 2018 to $15.88 billion by 2025, highlighting potential market opportunity for ABVC's therapeutic solutions.

ABVC Biopharma announced that the Cedars-Sinai Medical Center has approved the Phase I study of ABV-1601, aimed at treating depression in cancer patients. This open-label study will involve 12 patients and focus on evaluating the safety of PDC-1421, the main ingredient in ABV-1601. A Phase II trial is planned for 2023 to compare results with Wellbutrin XL. The prevalence of emotional distress in cancer patients is significant, with 40% to 60% affected. The approval marks a notable step for ABVC in their clinical development journey.

ABVC Biopharma, Inc. (NASDAQ: ABVC) announced on October 5, 2022, that its Vitrargus Phase II study plan received approval from the Australian Bellberry Human Research Ethics Committee. A Clinical Trial Notification was submitted to the Australian Therapeutic Goods Administration to begin the study. The Phase II study will evaluate the safety and effectiveness of ABV-1701 Ocular Endotamponade for retinal detachment treatment. The study will involve at least 40 subjects across Australia and Thailand, with initiation planned for early 2023.

ABVC Biopharma (NASDAQ: ABVC) has reported enrollment progress in the Phase II Part 2 clinical study for its ADHD treatment, ABV-1505. The study, now involving 30 enrolled subjects from 43 screened, is taking place at five medical centers in Taiwan and UCSF. The Part 1 study showed positive results, with significant improvements in ADHD symptoms. The ongoing study aims to enroll approximately 100 patients and is expected to complete by Q3 2023. The ADHD drug market is projected to grow significantly, reaching $24.9 billion by 2025.

ABVC BioPharma (Nasdaq: ABVC) reviewed its progress and future goals in a recent letter to shareholders, highlighting its focus on developing botanical medicines for oncology, CNS, and ophthalmology. The company has partnerships with leading organizations and a pipeline addressing major diseases such as cancer and depression. ABVC is conducting Phase II trials for several drugs, including ABV-1505 for Major Depression Disorder, and aims to complete additional trials in 2023. They've raised over $66 million and streamlined operations, paving the way for potential commercialization of key products.

ABVC BioPharma has confirmed a new clinical site in Australia for its Phase II study of Vitargus®, a biodegradable vitreous substitute for retina re-attachment surgery. Located at the Sydney Eye Hospital, this site joins others in Australia and Thailand. The hospital has a strong track record in ophthalmology trials, with the potential to enroll 10 subjects weekly. Dr. Howard Doong emphasized the significance of this site's participation, as the retinal surgery device market is projected to reach $3.7 billion by 2027.