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Bionomics Limited American Depository Shares (symbol: BNOX) is a global clinical-stage biopharmaceutical company dedicated to developing novel treatments for serious diseases. The company's primary focus lies in treating central nervous system (CNS) disorders such as anxiety, depression, and Alzheimer's disease, as well as various forms of cancer.
Bionomics boasts a highly productive drug discovery platform, including its proprietary Multicore® chemistry capability, which fuels its diverse pipeline of drug candidates. The company's portfolio ranges from early-stage to advanced clinical development programs, positioning Bionomics as a leader in innovative drug discovery.
A key strength of Bionomics is its strategic partnerships with large pharmaceutical companies. These collaborations enable Bionomics to expedite the development and market introduction of its drug candidates, allowing the company to concentrate on its core strength of innovative research and discovery.
Among its recent achievements, Bionomics is progressing its Phase 2b trial of BNC210, a promising treatment for Post-Traumatic Stress Disorder (PTSD). The trial aims to evaluate the safety and efficacy of 900 mg BNC210 administered twice daily as monotherapy for PTSD. The trial involves 212 participants across 27 sites in the United States and 7 sites in the United Kingdom.
Financially, Bionomics generates all of its revenue from Australia, with a robust growth phase backed by substantial research and development investments. The company is committed to providing better treatment options for diseases with unmet medical needs, driven by a team of experts dedicated to making a difference in patients' lives.
For the latest updates and detailed information about Bionomics Limited, please visit their official website at www.bionomics.com.au.
Bionomics (Nasdaq: BNOX), a clinical-stage biotechnology company, issued a shareholder letter highlighting recent achievements and strategic vision. Key points include:
1. Strengthened US-based management and implemented cost-cutting measures.
2. Advanced lead program BNC210, initiating a Phase 3 trial in social anxiety disorder (SAD).
3. Secured funding for Phase 3 SAD study completion.
4. In final stages of redomiciling to the U.S. and launching Neuphoria Inc.
5. BNC210 is described as a 'pipeline in a pill' with unique anxiolytic and antidepressant properties.
6. Anticipating Phase 3 SAD trial readout in Q3 2025.
7. Planning to commence Phase 3 trial in PTSD in second half of 2025 or sooner.
8. Partnership with MSD on α7 receptor PAMs expected to enter Phase 2 soon.
Bionomics (Nasdaq: BNOX) has announced its intention to re-domicile from Australia to the United States via a proposed scheme of arrangement. If approved, shareholders will receive proportionate shares in Neuphoria Therapeutics Inc., a new Delaware-incorporated parent company. The re-domiciliation aims to:
- Eliminate Australian compliance costs
- Increase alignment with U.S. pharmaceutical companies
- Enhance attractiveness to U.S. investors and potential strategic partners
- Simplify corporate structure and reduce administrative costs
The scheme proposes 1 Neuphoria share for every 1,440 Bionomics shares or 8 ADSs. Subject to shareholder and regulatory approvals, the scheme is expected to be implemented in early December 2024. The Board unanimously recommends shareholders vote in favor of the scheme.
Bionomics (Nasdaq: BNOX), a clinical-stage biotech company focusing on novel allosteric ion channel modulators for CNS disorders, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024, both virtually and in-person at the Lotte New York Palace Hotel.
Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, will deliver a company presentation available on demand from September 9 at 7:00 AM ET. The company's management will also be available for one-on-one meetings during the conference. Interested investors should contact H.C. Wainwright representatives. A replay of the presentation will be posted on Bionomics' website under the 'Events' page of the Investors Center section.
Bionomics (BNOX) announced successful outcomes from an End-of-Phase 2 meeting with the FDA for its lead asset BNC210 in treating post-traumatic stress disorder (PTSD). The FDA provided favorable feedback on the Phase 3 study design and safety monitoring plans, potentially paving the way for a New Drug Application (NDA) submission with a single Phase 3 trial. Key agreements include:
1. Using CAPS-5 as the primary endpoint and CGI-S as a key secondary endpoint
2. Testing two doses: 900 mg BID (efficacious dose) and 600 mg BID (lower dose)
3. Implementing a hepatic safety monitoring plan
Bionomics plans to initiate the Phase 3 program in Q4 2024, marking its transformation into a pre-commercial organization. The company believes BNC210 could potentially transform PTSD treatment, a disorder affecting about 7% of Americans in their lifetime.
Bionomics (Nasdaq: BNOX), a clinical-stage biotechnology company, has announced a corporate update and discussion of end-of-Phase 2 (EoP2) meeting outcomes with the FDA regarding the advancement of BNC210 for post-traumatic stress disorder (PTSD) treatment into Phase 3. The update will be provided on July 31, 2024, at 8:00 am ET via a conference call and webcast presentation.
Interested parties can access the call using the provided toll-free and international numbers, along with the conference ID. A webcast link is also available, and a replay will be posted on Bionomics' website Events page under the Investors section after the presentation.
Bionomics (Nasdaq: BNOX) has initiated patient screening for the Phase 3 AFFIRM-1 trial evaluating BNC210 for the acute treatment of social anxiety disorder (SAD). The trial aims to enroll 330 adult patients in the U.S., with topline results expected in Q3 2025. BNC210 is a fast-acting, non-sedating, non-addictive α7 nicotinic receptor modulator. The study follows successful Phase 2 results and an End-of-Phase 2 meeting with the FDA. BNC210 has FDA Fast Track designation for both SAD and PTSD. The company recently completed a capital raise to support this clinical development.
Bionomics (Nasdaq: BNOX) has entered into a securities purchase agreement for a private placement potentially worth up to $70 million. The private placement is divided into three tranches, with the first tranche already securing $7.5 million. The second and third tranches are contingent on meeting specific regulatory and clinical milestones, potentially adding another $50 million. Leerink Partners is the exclusive placement agent. The funds will support Bionomics' clinical development pipeline, business activities, and general corporate purposes. The first tranche proceeds and existing cash reserves are expected to fund the company through Q3 2025.
Bionomics announced that CEO Spyridon Papapetropoulos will present at the 2024 ASCP Annual Meeting. The event, taking place from May 28-31 in Miami Beach, will feature discussions on Bionomics' promising CNS disorder treatments. Key presentations include positive results from a Phase 2b study of BNC210 for PTSD and ongoing Phase 3 trials for Social Anxiety Disorder. These studies highlight BNC210 as an Alpha7 Nicotinic Receptor Negative Allosteric Modulator. Presentations will occur on May 28, 29, and 30 at the Loews Miami Beach Hotel. Posters will be available on Bionomics' website.
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