Corcept Presents Results from Phase 2 Study of Dazucorilant in Patients with Amyotrophic Lateral Sclerosis (ALS) at ENCALS 2025 Annual Meeting
DAZALS did not meet its primary endpoint of improved outcome in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to patients who received placebo
DAZALS met its secondary endpoint of improved overall survival at week 24 of the study in patients who received 300 mg of dazucorilant compared to patients who received placebo
Exploratory analysis at the one-year mark shows continued significant improvement in overall survival between patients who received 300 mg of dazucorilant and those who received placebo only
Corcept seeking guidance from United States and European regulators on optimum path forward
REDWOOD CITY, Calif., June 05, 2025--(BUSINESS WIRE)--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, presented results from its DAZALS study of dazucorilant in patients with ALS at the European Network to Cure ALS (ENCALS) 2025 annual meeting. The presentation can be found here.
DAZALS is a randomized, double-blind, placebo-controlled Phase 2 study in which 249 patients with ALS were randomized to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo, daily for 24 weeks. Patients who completed the treatment period were eligible to enroll in a long-term extension study in which all patients received 300 mg of dazucorilant. The primary endpoint in DAZALS was the difference in ALSFRS-R between patients who received dazucorilant and those who received placebo. Overall survival was a secondary endpoint.
Although DAZALS did not meet its primary endpoint, patient survival significantly improved. At week 24 of the study, no deaths had occurred in the 83 patients who received 300 mg of dazucorilant, while there were five deaths in the 82-patient placebo group (p-value of 0.02).
An exploratory analysis conducted at the one-year mark shows the survival benefit has continued. Patients randomized to 300 mg of dazucorilant lived significantly longer than patients who received placebo and did not switch to 300 mg of dazucorilant in the extension study. The difference between groups was pronounced, with a hazard ratio of 0.16 (p-value: 0.0009). See Figure 1.
A similar survival benefit was observed in patients who received 300 mg of dazucorilant for greater than 24 weeks, either in the treatment period or in the extension study, compared to patients who received either placebo or 150 mg of dazucorilant for 24 weeks and did not receive dazucorilant in the extension study (hazard ratio: 0.36; p-value 0.02). See Figure 2. The extension study is ongoing.
Dazucorilant has demonstrated an acceptable safety profile, with 92 percent of adverse events being mild to moderate in severity. The frequency of severe and serious adverse events in patients who received dazucorilant was similar to those who received placebo. Mild to moderate, dose-related, transient abdominal pain was the most common adverse effect.
"The improvement in overall survival, first noted in the DAZALS study at six months, continues to be seen at one-year. This finding deserves our full attention in service to patients with this tragic disease. Progress in the development of new ALS treatments is of critical importance," said Leonard H. van den Berg, M.D., Ph.D., Professor and Chair in the Department of Neurology, UMC Utrecht Brain Centre, Utrecht, The Netherlands, and Principal Investigator in the DAZALS study.
"Medications that can extend life for patients with ALS are urgently needed. We are working with regulatory authorities to determine the optimal path for advancing dazucorilant," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "We would like to thank the patients, their families and care partners, as well as the investigators, doctors and clinic staff involved in this study."
About the DAZALS Study
DAZALS is a randomized, double-blind, placebo-controlled Phases 2 trial in which 249 patients with ALS were randomized 1:1:1 to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for 24 weeks. Patients who completed the treatment period were eligible to enroll in the long-term extension study in which all patients received 300 mg of dazucorilant. Baseline patient characteristics, including the ENCALS risk score, time from diagnosis, ALSFRS-R total score, and bulbar onset, were consistent across study arms.
The DAZALS primary endpoint was the difference in change from baseline during the study's 24-week treatment period in ALSFRS-R score between patients who received dazucorilant and those who received placebo. Key secondary endpoints include overall survival and quality of life. DAZALS was conducted at sites in Europe, the United States and Canada.
About Amyotrophic Lateral Sclerosis (ALS)
ALS, also known as Lou Gehrig's disease or motor neuron disease, is a fatal degenerative neurologic disorder that affects more than 55,000 people in the United States and Europe. ALS causes muscles to weaken and, as the disease progresses, severely impairs patients' ability to speak, eat, move and breathe. There is increasing evidence that patients with ALS, particularly those with rapid disease progression, exhibit elevated or abnormal cortisol levels. A patient's life expectancy after diagnosis is two to five years.
About Dazucorilant
Dazucorilant 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 it as a potential treatment for ALS and other neurologic disorders. Dazucorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. The U.S. Food and Drug Administration has granted dazucorilant Fast Track Designation and orphan drug status for the treatment of ALS in the United States.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, 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 endogenous hypercortisolism. Corcept is headquartered in Redwood City, 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, which are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties 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 the development of dazucorilant as a treatment for patients with ALS, including the pace, conduct, timing and outcome of DAZALS and its associated long-term extension study, as well as oversight or requirements that may be imposed by the FDA or other regulatory authorities. We disclaim any intention or duty to update forward-looking statements made in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250605516942/en/
Contacts
Investor inquiries:ir@corcept.com Media inquiries:communications@corcept.com www.corcept.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
25 minutes ago
- Yahoo
European ETFs Set to Gain as ECB Cuts Rate Again
The European Central Bank (ECB), as widely expected, again cut its interest rate by 25 bps to 2% in a move to shore up a weakening economy. The move marks the eighth consecutive quarter-point cut in the past year. The ECB also signaled it is nearing the end of its rate-cutting cycle as inflation decision underscores growing concern over the eurozone's sluggish recovery in the face of global headwinds, most notably, the destabilizing effects of ongoing U.S. trade policies under President Donald Trump. The ECB's dovish stance will push European stocks and ETFs higher. With rates at their lowest in years and inflation subdued, European bonds, especially corporate debt, may gain renewed investor interest. A weaker euro will likely boost multinational earnings denominated in stronger foreign such, we have highlighted five European ETFs that stand to benefit from the ECB's decision. These are Vanguard FTSE Europe ETF VGK, iShares MSCI Eurozone ETF EZU, iShares Core MSCI Europe ETF IEUR, SPDR EURO STOXX 50 ETF FEZ and JPMorgan BetaBuilders Europe ETF BBEU. These funds could be excellent buys for investors seeking to reap benefits from the current measures. Economic growth has slowed across the eurozone, especially in France, Germany and Italy, and the outlook for next year is weak, according to forecasts by the European Union (EU). Eurozone inflation fell to 1.9% in May, slipping below the ECB's 2% target for the first time in nine months. Additionally, Trump's protectionist trade agenda has led to rate cuts by the ECB. The White House's imposition of fresh tariffs on European industrial goods and autos, along with retaliation from EU partners, has curtailed exports and dampened business investment. The eurozone's export-driven model, especially in manufacturing-heavy Germany, has proven vulnerable. A further escalation in global trade tensions could further hit euro area growth by dampening exports and dragging down investment and consumption (read: 6 Factors to Play Europe ETFs Now).The ECB's latest rate cut brings borrowing costs in the eurozone to less than half the level in the United States and the United Kingdom, where the Federal Reserve and Bank of England have held rates at 4.25%–4.5% and 4.25%, respectively. "While the uncertainty surrounding trade policies is expected to weigh on business investment and exports, especially in the short term, rising government investment in defense and infrastructure will increasingly support growth over the medium term," the ECB said. Vanguard FTSE Europe ETF (VGK)Vanguard FTSE Europe ETF offers exposure to companies located in the major markets of Europe by tracking the FTSE Developed Europe All Cap Index. It holds a broad basket of 1241 stocks with key holdings in financials, industrials, health care, and consumer discretionary sectors. Vanguard FTSE Europe ETF has AUM of $25.5 billion and trades in an average daily volume of 4 million shares. It charges 6 bps in annual fees and has a Zacks ETF Rank #3 (Hold) with a Medium risk MSCI Eurozone ETF (EZU)iShares MSCI Eurozone ETF provides exposure to developed market countries using the euro for currency and follows the MSCI EMU index. The fund holds about 223 securities in its basket with financials, industrials, information technology and consumer discretionary taking a double-digit allocation each. From a country look, France and Germany take the biggest share in the basket with 31.3% and 29.3%, respectively. iShares MSCI Eurozone ETF is one of the most popular ETFs in the broader European space, with AUM of $7.9 billion and an average daily volume of 2 million shares. It charges investors 51 bps in annual fees and has a Zacks ETF Rank #3 with a Medium risk outlook (read: Europe ETF (EZU) Hits New 52-Week High). iShares Core MSCI Europe ETF (IEUR)iShares Core MSCI Europe ETF tracks the MSCI Europe Investable Market Index, holding a broad basket of 1019 European companies. It has key holdings in financials, industrials, and health care sectors with double-digit exposure each. The United Kingdom is the top country accounting for 22.8%, followed by France (15.6%), Germany (14.9%), and Switzerland (14%). iShares Core MSCI Europe ETF has AUM of $6.7 billion and trades in an average daily volume of 1 million shares. It charges 9 bps in annual fees and has a Zacks ETF Rank # EURO STOXX 50 ETF (FEZ)SPDR EURO STOXX 50 ETF follows the EURO STOXX 50 Index, which measures the performance of some of the largest companies across the components of the 20 EURO STOXX Supersector Indexes. The fund appears rich with AUM of $4.6 billion and average daily volume of around 1.4 million shares. It charges 29 bps in annual fees and holds 50 securities in its basket with key holdings in financials, industrials, information technology and consumer discretionary sectors. In terms of country allocation, France and Germany lead with 36.9% and 29.1% share, respectively, followed by the Netherlands (23.3%), Spain (8.7%) and Italy (8.4%). SPDR EURO STOXX 50 ETF has a Zacks ETF Rank # BetaBuilders Europe ETF (BBEU)JPMorgan BetaBuilders Europe ETF provides investors exposure to developed European equity markets by tracking the Morningstar Developed Europe Target Market Exposure Index. It holds 396 stocks in its basket with key holdings in financials, industrials and consumer discretionary sectors. Here again, the United Kingdom is the top country accounting for 22.3% share, followed by France, Germany, and Switzerland with 14% share each. JPMorgan BetaBuilders Europe ETF has amassed $4.6 billion in its asset base and charges 9 bps in fees from investors. It trades in a heavy volume of nearly 330,000 shares a day on average and has a Zacks ETF Rank #3. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report SPDR EURO STOXX 50 ETF (FEZ): ETF Research Reports iShares MSCI Eurozone ETF (EZU): ETF Research Reports Vanguard FTSE Europe ETF (VGK): ETF Research Reports iShares Core MSCI Europe ETF (IEUR): ETF Research Reports JPMorgan BetaBuilders Europe ETF (BBEU): ETF Research Reports This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
32 minutes ago
- Yahoo
Ukraine completes preparations to join EU's roam like at home zone
The European Commission received formal notification from Ukraine confirming the completion of all legislative procedures required to join the EU's Roam Like at Home zone. Source: Rikard Jozwiak, an editor at Radio Free Europe/Radio Liberty, as reported by European Pravda Details: Moldova is expected to submit a similar notification soon, with both countries set to join the roaming-free zone simultaneously. According to Jozwiak, Ukraine and Moldova will become part of the EU roaming zone from 1 January 2026. The roaming zone encompasses all 27 EU member states, as well as Norway, Iceland and Liechtenstein. This marks the first time the zone will expand to include candidate countries for EU membership. "I know that the word 'historic' is overused these days but this is exactly that," Jozwiak said. On 2 June 2025, President Volodymyr Zelenskyy signed the Law of Ukraine On Amendments to Certain Laws of Ukraine on the Implementation of the European Union's Legislation on Electronic Communications (reg. No. 12150). The European Commission is now expected to initiate a decision on mutual provision of the internal market regime for roaming between the EU and Ukraine, effectively enabling full accession to the roam like at home policy. Once implemented, Ukrainians will be able to use roaming services at domestic tariff rates when travelling in EU countries, with no variation in costs or conditions based on the country of residence within the EU. Background: Since Russia's war of aggression began, millions of Ukrainians in the EU have communicated with relatives in Ukraine without additional roaming charges, thanks to agreements between operators. This temporary arrangement, prompted by the displacement of many Ukrainians to European countries, was last extended in July 2024 for one year. Support Ukrainska Pravda on Patreon!
Yahoo
32 minutes ago
- Yahoo
Senate GOP Sorts Out Which Poison Pills It Can Swallow To Pass House's ‘Big Beautiful' Bill
Senate Republicans began the work this week of deciphering what exactly House Republicans' have stuffed into President Trump's massive spending package — and what elements of it they can live with. One thing is clear: Senate Majority Leader John Thune (R-SD) and Republican leadership have their work cut out for them. And in a few key cases, senators might soon find themselves caught between what Trump demands of them, and what's good for their reelection prospects. Similar to the competing pain points that surfaced among members of the House Republican conference, several Senate Republicans have gone on the record to object in various ways to either the bill's extensive gutting of social safety net programs or — on the other end of the spectrum — the extent to which it will add to the deficit, a Republican sin many in the party have built their brands opposing. At this point, it looks almost inevitable that senators will make changes to the One Big Beautiful Bill Act, which House Republicans drafted after weeks of intraparty quarrels. That means the House will have to vote on the bill again. Any major shifts could backfire, breaking the delicate balance on which House Speaker Mike Johnson (R-LA) built the bill. Thune can only lose three votes from his caucus and still pass the legislation. Here are four places in which Republicans are likely to have to cut a deal, potentially tweaking just how destructive the final bill is. Several Senate Republicans have been publicly declaring that they are opposed to the ways in which the bill currently cuts social safety net programs, while, in most cases, still suggesting there are some cuts they'd support. Several Republican senators, including Sens. Susan Collins (R-ME), Lisa Murkowski (R-AK) and Josh Hawley (R-MO), have already indicated they won't get behind certain kinds of cuts to Medicaid and other programs, which are widely utilized by their constituents. 'I am not going to vote for Medicaid benefit cuts,' Hawley told reporters in the Senate basement in March. 'Work requirements, I'm totally fine with. But 21% of Missourians either get Medicaid or CHIP so I am not going to vote for benefit cuts for people who I think are qualified.' Sen. Jim Justice (R-WV) has made similar statements, telling reporters on Wednesday that he is ok with freezing the provider taxes House Republicans took up in their bill but not cutting them back. Meanwhile Sen. Tommy Tuberville (R-AL), who recently announced a gubernatorial bid in his state, has said he is opposed to the way in which the legislation cuts Supplemental Nutrition Assistance Program (SNAP). The House bill includes deep cuts to that program, including a cost-sharing plan that would require states to cover a portion of SNAP benefit costs; the benefits are currently completely covered by the federal government. 'Everybody that's going to be in state government is going to be concerned about it,' Tuberville said, according to Politico. 'I don't know whether we can afford it or not.' In recent days, some Senate Republicans have also indicated that they are exploring ideas to slash what they claim is 'waste, fraud and abuse' in Medicare —- despite President Donald Trump's previous vows to 'love and cherish' the program and promises not to touch it. Sen. Thom Tillis (R-NC) on Thursday said that Republicans are looking at changes to Medicare, telling The Hill there are 'a number' of reforms he'd like to see to programs maintained by the Centers for Medicare & Medicaid Services. 'I think anything that can be — that's waste, fraud and abuse are open to, obviously, discussions,' Thune also told reporters of Medicare. Meanwhile Sen. Kevin Cramer (R-ND) took a stronger stance, saying Republicans shouldn't be afraid of cutting waste from the program. 'Why don't we go after that? I think we should,' Cramer told NBC. 'Some people are afraid of the topics; I'm not,' he added, noting that they would focus on waste, fraud and abuse. That phrase — 'waste, fraud and abuse' — has, of course, become the go-to terminology for Republicans who want to justify their cuts to largely popular programs, despite the fact that rooting out supposed 'waste, fraud and abuse' roughly translates to hidden, hard-for-the-public-to-understand cuts. This new proposal, too, is already stirring some pushback. 'What a terrible idea. We should not be touching Medicare,' Hawley told NBC. Sens. John Curtis (R-UT), Jerry Moran (R-KS), Tillis and Murkowski have warned leadership about provisions of the bill that would gut Biden-era clean energy tax credits passed in the Inflation Reduction Act. The House bill's cuts were largely added to the House bill at the last minute in order to appease House Freedom Caucus members who were threatening to sink the bill on the House floor unless leadership made more cuts. They include plans to repeal residential energy-focused credits and several electric vehicle-related credits — both used by individual taxpayers — as well as almost immediately phasing out the clean electricity production and investment tax credit that aims to boost zero-emission electricity production from industry, utilities and manufacturing. 'I want to make sure that we are making good on the investments that we have made with those tax credits,' Murkowski told reporters in the Senate basement on Wednesday when asked about the tax credits. Meanwhile, Tillis — one of the most vulnerable Republicans in 2026 — on Wednesday indicated he wanted to see negotiations around the requirements and duration for the programs in question. He also specifically called out the foreign entity restrictions House Republicans put in the bill, which experts described to TPM as a 'bad faith' and 'unworkable' provision that Republicans say will prevent nations like China, Iran, North Korea and Russia from having access to the tax subsidies. Tillis described them as 'a big problem.' 'As I understand it, the level of granularity proposed by the House renders the programs inoperative,' Tillis told reporters on his way up to a floor vote. While several Senate Republicans are opposing cuts to programs that are crucial for their states, others, on the other end of the spectrum, are calling for more spending cuts than what are included in the House Republican package. (These Republicans have, lately, found a surprising ally in the president's erstwhile advisor, Elon Musk.) Sens. Rand Paul (R-KY) and Ron Johnson (R-WI) are loudly asking for deeper cuts, saying they are worried about the impact of the megabill on the deficit. 'I refuse to accept $2 trillion-plus deficits as far as the eye can see as the new normal. We have to address that problem, and unfortunately this bill doesn't do so,' Johnson, a member of the Senate Finance Committee, said Wednesday during an ABC News interview. Paul has made a career of libertarian budget hawkery, and is objecting, in particular, to a provision of the bill that raises the debt ceiling, something that must happen this summer in order for the U.S. to avoid default. He has previously indicated he does not believe 'expanding the debt ceiling more than we've ever done it before' is fiscally conservative. 'This will be the greatest increase in the debt ceiling ever, and the GOP owns this now,' Paul told reporters after the House passed their version of the bill.
