FDA Gives Green Light to Karuna Therapeutics’ Schizophrenia Drug Review
December 3, 2023
🌥️Trending News
Karuna Therapeutics ($NASDAQ:KRTX), a clinical-stage biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) diseases, has recently received a major boost in its mission. The U.S. Food and Drug Administration (FDA) has given its approval to Karuna Therapeutics to begin a review of its investigational drug, KarXT, for the treatment of schizophrenia. This marks a major milestone for the company as it moves forward in its development of therapies that address psychiatric illnesses and neurological disorders. Karuna Therapeutics is primarily focused on developing treatments that target two receptors in the brain: muscarinic acetylcholine and glutamate. KarXT is the company’s lead product candidate, and its primary goal is to improve cognitive deficits associated with schizophrenia.
It works by activating both of these receptors simultaneously, which leads to an improved response to antipsychotic medications and potentially reduces the risks of adverse effects from long-term use of antipsychotic drugs. The FDA’s approval of KarXT for review is an important step forward for Karuna Therapeutics. It is the first step in the drug approval process, and if it is successful, it could potentially lead to treatments that address the root cause of schizophrenia, instead of just managing symptoms. With this new development, Karuna Therapeutics is one step closer to providing new treatments that offer hope to those suffering from this debilitating disorder.
Price History
On Wednesday, Karuna Therapeutics made a major announcement that the U.S. Food and Drug Administration (FDA) had given the green light to the review of its new schizophrenia drug. This news sent Karuna’s stock price surging; it opened at $186.7 and closed at $188.6, up 1.7% from its prior closing price of $185.4. This approval marks a major milestone in Karuna’s mission to bring innovative treatments to people living with schizophrenia.
It has the potential to be the first of its kind to be approved by the FDA, as it is formulated with a novel combination of ingredients that provide an improved therapeutic benefit. This news reflects a positive outlook for Karuna Therapeutics and its groundbreaking work in bringing relief to those living with schizophrenia. Live Quote…
About the Company
Income Snapshot
Below shows the total revenue, net income and net margin for Karuna Therapeutics. More…
| Total Revenues | Net Income | Net Margin |
| 5.93 | -396.07 | -6676.8% |
Cash Flow Snapshot
Below shows the cash from operations, investing and financing for Karuna Therapeutics. More…
| Operations | Investing | Financing |
| -353.52 | -559.38 | 468.89 |
Balance Sheet Snapshot
Below shows the total assets, liabilities and book value per share for Karuna Therapeutics. More…
| Total Assets | Total Liabilities | Book Value Per Share |
| 1.39k | 62.78 | 35.1 |
Key Ratios Snapshot
Some of the financial key ratios for Karuna Therapeutics are shown below. More…
| 3Y Rev Growth | 3Y Operating Profit Growth | Operating Margin |
| 0.0% | – | -7589.8% |
| FCF Margin | ROE | ROA |
| -6000.1% | -20.5% | -20.3% |
Analysis
At GoodWhale, we analyzed KARUNA THERAPEUTICS’s fundamentals to give investors a better idea of the company’s health. Our Star Chart revealed that KARUNA THERAPEUTICS has an intermediate health score of 5/10, suggesting that it is likely to safely ride out any crisis without the risk of bankruptcy. According to our analysis, KARUNA THERAPEUTICS is strong in asset and growth, but weak in dividend and profitability. With this in mind, we classified KARUNA THERAPEUTICS as a ‘rhino’, a type of company that has achieved moderate revenue or earnings growth. As such, investors looking for a company that is growing steadily but not astronomically, may find KARUNA THERAPEUTICS attractive. With this information, investors can make an informed decision on whether or not KARUNA THERAPEUTICS is an appropriate investment for their portfolio. More…
Peers
In the race to develop new and improved treatments for a variety of diseases, Karuna Therapeutics Inc is up against some stiff competition. Verona Pharma PLC, Reviva Pharmaceuticals Holdings Inc, and Aptose Biosciences Inc are all working on their own cutting-edge therapies that could one day revolutionize the way we treat illness. While it remains to be seen who will come out on top in this fierce competition, one thing is for sure: the patients who stand to benefit from these breakthroughs are the real winners.
– Verona Pharma PLC ($NASDAQ:VRNA)
Verona Pharma PLC is a clinical stage pharmaceutical company that focuses on the development of drugs for the treatment of respiratory diseases. The company’s lead product, RPL554, is a novel, inhaled dual inhibitor of the enzymes phosphodiesterase 3 and 4, which are key regulators of airway smooth muscle tone. RPL554 is currently in Phase II clinical trials for the treatment of asthma and chronic obstructive pulmonary disease.
Verona Pharma PLC’s market cap as of 2022 is 790.27M. The company’s ROE for the same period is -28.69%.
– Reviva Pharmaceuticals Holdings Inc ($NASDAQ:RVPH)
Reviva Pharmaceuticals Holdings Inc is a holding company that operates through its subsidiaries in the pharmaceutical industry. The company focuses on the development of drugs for the treatment of neurological and psychiatric disorders. It has a market cap of 86.88M as of 2022 and a ROE of -63.24%. The company’s products include drugs for the treatment of Alzheimer’s disease, Parkinson’s disease, and schizophrenia.
– Aptose Biosciences Inc ($TSX:APS)
Aptose Biosciences Inc is a clinical-stage biotechnology company that focuses on the development of personalized therapeutics for the treatment of cancer. The company’s market cap is 71.07M as of 2022 and has a Return on Equity of -59.91%. The company’s focus on developing personalized therapeutics makes it an attractive option for investors interested in the healthcare sector.
Summary
Karuna Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) disorders. Karuna recently announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT, an oral medication to treat acute symptoms of schizophrenia. Investment analysis of the company reveals a strong potential for KarXT to become a leading therapy for schizophrenia treatment and other psychiatric illnesses. The company’s clinical trials have demonstrated positive efficacy, with the drug showing an overall improvement in symptoms with minimal side effects.
Additionally, Karuna has a deep pipeline of promising CNS-focused products that could deliver further value for investors.
