Corcept Therapeutics Announces Presentations of Results of Pivotal Phase 3 GRACE Trial Evaluating Relacorilant in Patients with Hypercortisolism (Cushing’s Syndrome)
Corcept Therapeutics (NASDAQ: CORT) announced that results from the Phase 3 GRACE trial of relacorilant, a selective cortisol modulator for treating hypercortisolism (Cushing’s syndrome), will be presented at two major conferences in June 2024. The presentations will take place at the Endocrine Society (ENDO) annual meeting in Boston on June 3, and at the Heart in Diabetes (HiD) conference in Philadelphia on June 7. Key findings will be shared by Dr. Rosario Pivonello and Dr. Ralph DeFronzo, highlighting the impact of relacorilant on hypertension and hyperglycemia. Detailed results will be accessible on Corcept’s website post-events.
- Phase 3 GRACE trial results of relacorilant will be presented at two major conferences.
- Presence of respected researchers like Dr. Rosario Pivonello and Dr. Ralph DeFronzo adds credibility.
- Potential positive impact on stock due to the high-profile nature of the conferences.
- Press release lacks detailed financial or clinical efficacy data, making it difficult to gauge the full impact.
- No specific information on improvements or success rates in the trial provided.
Insights
The Phase 3 GRACE trial is a pivotal study for Corcept's selective cortisol modulator relacorilant, targeting patients with hypercortisolism (Cushing’s syndrome). The significance of these results lies in the potential shift in treatment paradigms for this condition, which can lead to severe metabolic and cardiovascular complications. Notably, successful Phase 3 results typically precede FDA approval, which can dramatically influence a company's market valuation.
Relacorilant's efficacy and safety profile will be crucial. Cushing's syndrome has limited treatment options, making any positive outcome a substantial step forward. For retail investors, the presentation at major conferences like the Endocrine Society and Heart in Diabetes signals confidence in the data's robustness and potential market impact. However, it’s essential to monitor for any detailed safety concerns which can impact the drug's approval and market acceptance.
In the short term, positive trial results can boost investor confidence and drive stock prices. Long-term, FDA approval and successful commercialization will be key. Investors should note the competitive landscape for cortisol modulators, where relacorilant's unique positioning could offer it a significant market advantage.
From a financial standpoint, a successful Phase 3 trial can lead to substantial revenue growth for Corcept Therapeutics. Positive results may pave the way for FDA approval, which could lead to the commercialization of relacorilant. This will likely attract investor interest, pushing up the stock price as the market anticipates future earnings. A new drug for hypercortisolism could open a significant revenue stream, given the unmet medical need in this area.
The announcement of these results at high-profile conferences also suggests that Corcept is positioning itself to gain strong industry support, potentially influencing future collaborations or acquisitions. For retail investors, this translates to increased market visibility and validation of the company's research and development capabilities.
However, investors should remain cautious of the costs associated with moving from clinical trials to market. These include manufacturing, marketing and potential regulatory hurdles. The company's financial health and ability to manage these costs will be critical in sustaining growth.
While the primary focus is on endocrinologic disorders, the selective modulation of cortisol has implications across various diseases, including certain cancers. Cushing's syndrome, characterized by excessive cortisol levels, can contribute to both metabolic and oncologic complications. Relacorilant, by targeting the glucocorticoid receptor, might offer a therapeutic advantage not only in treating hypercortisolism but potentially in oncology settings where cortisol modulation is beneficial.
For oncologists, the results from the GRACE trial could indicate a new avenue for treating cancer patients with hypercortisolism, improving their quality of life and potentially their response to cancer treatments. This could lead to broader applications and expanded market opportunities for relacorilant. Investors should consider the potential for cross-indication use, which can enhance the drug's marketability and long-term revenue prospects.
MENLO PARK, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the results from GRACE, the Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with hypercortisolism (Cushing’s syndrome), will be presented at the Endocrine Society (ENDO) annual meeting in Boston (June 3) and the Heart in Diabetes (HiD) conference in Philadelphia (June 7).
ENDO 2024, Boston Convention & Exhibition Center
Late-Breaking Poster Presentation: Open-label Results From GRACE, A Phase 3 Double-blind, Randomized-withdrawal Study Of The Selective Glucocorticoid Receptor Modulator Relacorilant For The Treatment Of Endogenous Hypercortisolism (Cushing Syndrome)
Date & Time: Monday, June 3, 2024, 12:00-1:30 pm ET
Presenter: Rosario Pivonello, MD, PhD, Principal Investigator of the GRACE study and Professor of Endocrinology at Università Federico II di Napoli, Italy
Session: P108 - Late-Breaking Poster Presentations: Day 3
8th Heart in Diabetes Conference, Hilton Penn’s Landing
Oral Presentation: Hypercortisolism Impact on Hypertension and Hyperglycemia and Beyond
Date & Time: Friday, June 7, 2024, 3:50-4:00 pm ET
Presenter: Ralph DeFronzo, MD, chief of the Diabetes Division and professor of medicine at UT Health San Antonio
Session: Hypercortisolism Implication to Cardiorenal & Metabolic Diseases
Oral Presentation: Medical Treatment of Hypercortisolism with Relacorilant: Final Results of the Phase 3 GRACE Study
Date & Time: Friday, June 7, 2024, 4:00-4:20 pm ET
Presenter: Rosario Pivonello, MD, PhD, Principal Investigator of the GRACE study and Professor of Endocrinology at Università Federico II di Napoli, Italy
Session: Hypercortisolism Implication to Cardiorenal & Metabolic Diseases
Each of the above presentations will be available on Corcept.com following the event.
About Relacorilant
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to Cushing’s syndrome, including ovarian, adrenal and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. Relacorilant has orphan drug designation in the United States and the European Union for the treatment of Cushing’s syndrome.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, California. For more information, visit Corcept.com.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, our ability to operate our business; risks related to the study and development of Korlym, relacorilant, dazucorilant, miricorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website.
In this press release, forward-looking statements include those concerning: relacorilant, including its clinical attributes and potential to become a treatment for patients with Cushing’s syndrome or any other disorder, regulatory oversight of relacorilant, its commercial prospects and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
CONTACT
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
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