FDA Approves Biora Therapeutics to Launch Phase 1 Testing for Ulcerative Colitis Treatment
December 1, 2023
☀️Trending News
Biora Therapeutics ($NASDAQ:BIOR), a biotechnology company dedicated to developing treatments for autoimmune diseases, has earned approval from the FDA to conduct Phase 1 testing of a potential treatment for Ulcerative Colitis. This is the first step in the development of a new therapy that could potentially provide relief for millions of people suffering from this chronic condition. Biora Therapeutics is a publicly-traded biotechnology company that focuses on the development and commercialization of innovative treatments for autoimmune diseases. The company has an extensive portfolio of therapeutic candidates and is dedicated to bringing new treatments to the market. Biora has a successful track record of developing new treatments that meet FDA safety standards and provides physicians with the most up-to-date treatments for their patients.
Their latest venture, the potential treatment for Ulcerative Colitis, is in its early stages as the FDA has approved Phase 1 testing of the drug. This phase will involve safety and efficacy testing in a small group of patients. If successful, Biora will move forward with the next phases of development in order to bring this potential treatment to the market. With Biora leading the way, there’s hope that a safe and effective treatment could soon be available to those who need it.
Price History
Following the announcement, the company’s stock opened at $1.2 and closed at the same price, up 2.5% from the previous closing price. This approval marks a major milestone for Biora Therapeutics, as it will be the first time its investigational drug has been tested in humans. The Phase 1 clinical trial will test the safety and tolerability of the drug in healthy volunteers. The primary objective of the trial is to assess the drug’s pharmacokinetics in order to assess dosing in future clinical studies.
The company is hopeful that the results of the trial will be promising, and that the drug will eventually be approved and made available to patients suffering from ulcerative colitis. With this approval, Biora Therapeutics is one step closer to potentially providing an effective treatment option for those living with this chronic condition. Live Quote…
About the Company
Income Snapshot
Below shows the total revenue, net income and net margin for Biora Therapeutics. More…
| Total Revenues | Net Income | Net Margin |
| 0.02 | -122.42 | -725816.2% |
Cash Flow Snapshot
Below shows the cash from operations, investing and financing for Biora Therapeutics. More…
| Operations | Investing | Financing |
| -45.77 | -0.1 | 21.38 |
Balance Sheet Snapshot
Below shows the total assets, liabilities and book value per share for Biora Therapeutics. More…
| Total Assets | Total Liabilities | Book Value Per Share |
| 34.7 | 153.49 | -5.09 |
Key Ratios Snapshot
Some of the financial key ratios for Biora Therapeutics are shown below. More…
| 3Y Rev Growth | 3Y Operating Profit Growth | Operating Margin |
| -93.9% | – | -618038.9% |
| FCF Margin | ROE | ROA |
| -254894.4% | 58.0% | -200.4% |
Analysis
GoodWhale has conducted an analysis of BIORA THERAPEUTICS‘ fundamentals, which revealed that it is classified as an ‘elephant’. This means that the company is rich in assets after deducting off liabilities. We identified that BIORA THERAPEUTICS is strong in liquidity and weak in asset, dividend, growth, and profitability. From our analysis, investors who are looking for a stable investment may find BIORA THERAPEUTICS attractive. However, it has a low health score of 0/10 with regard to its cashflows and debt, making it less likely to safely ride out any crisis without the risk of bankruptcy. Consequently, investors should approach this stock with caution. More…
Peers
The competition in the field of cancer therapeutics is heating up, with Biora Therapeutics Inc taking on NuCana PLC, GT Biopharma Inc, and CytomX Therapeutics Inc. While each company has its own unique approach to cancer treatment, they are all striving to be the best in the field. May the best company win!
– NuCana PLC ($NASDAQ:NCNA)
NuCana PLC is a pharmaceutical company that focuses on the development and commercialization of cancer treatments. The company has a market capitalization of $52.2 million and a return on equity of -44.76%. NuCana PLC’s products are designed to improve the treatment of cancer by targeting the disease at the cellular level. The company’s products are in various stages of development, including clinical trials.
– GT Biopharma Inc ($NASDAQ:GTBP)
ACGT Biopharma Inc is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapies for the treatment of cancer. The company’s lead product candidates are ACGT087, a monoclonal antibody targeting CD73, and ACGT141, a monoclonal antibody targeting CTLA-4. ACGT Biopharma Inc is headquartered in San Diego, California.
– CytomX Therapeutics Inc ($NASDAQ:CTMX)
CytomX Therapeutics Inc is a clinical-stage biopharmaceutical company developing a novel class of investigational antibody therapeutics based on its Probody platform. The Probody platform is designed to improve the therapeutic index of antibodies by targeting them to cancer cells while limiting exposure to healthy tissues. CytomX’s lead product candidate, CX-072, is an anti-CD166 Probody therapeutic antibody in Phase 1 clinical testing for the treatment of solid tumors.
Summary
Biora Therapeutics has recently gained FDA clearance to initiate Phase 1 clinical trials for its ulcerative colitis treatment. This represents a significant opportunity for investors looking for a potential long-term return on their investments. In the upcoming Phase 1 trials, the company plans to assess the safety, tolerability, and pharmacokinetics of the treatment.
If successful, this would pave the way for larger clinical trials in the future and could lead to the approval of the drug, which could result in a significant return on investment. As such, investors should keep an eye on Biora Therapeutics in the future.
