コルセプト・セラピューティクス（CORT）2026年第3四半期決算説明会：売上高64%増、ガイダンスを維持

主要なポイント

• コルセプト・セラピューティクス（CORT）の2026年第3四半期売上高は3億4050万ドルとなり、前四半期比33%増、前年同期比64%増でした。
• Korlymおよびオーソライズド・ジェネリックの売上高は計2億4910万ドルとなった一方、Lifyorliは市場投入2四半期目で9140万ドルを売り上げました。
• 純利益は1億2680万ドルに増加し、2026年第2四半期の4300万ドルおよび2025年第3四半期の1970万ドルから拡大しました。
• 経営陣は、内分泌学および腫瘍学事業全体の好調さを理由に、2026年通期の売上高見通し11億〜12億ドルを再確認しました。
• 4月1日の発売以来、1,700名以上の医師が2,300名以上の患者にLifyorliを処方しました。経営陣は電話会議で具体的な時期を特定しなかったものの、同製品の売上高が10億ドルを超えると見込んでいます。
• クッシング症候群を対象として再提出されたrelacorilantの申請に対するFDAの判断は、12月17日のPDUFA期日までになされる見通しです。

主要財務データ

事業および業績の状況

内分泌学分野

経営陣は、高コルチゾール血症の診断および治療が依然として十分に行われていないと述べました。コルセプトはCATALYST試験の結果を引用し、コントロール困難な糖尿病患者の24%が高コルチゾール血症を患っており、ミフェプリストンが血糖コントロールを大幅に改善したことを示しました。

米国糖尿病学会（ADA）は2026年のコンセンサスレポートでCATALYSTを引用し、複数の血糖降下薬を使用しているにもかかわらず血糖値が高止まりしている患者に対して高コルチゾール血症のスクリーニングを推奨しました。米国臨床内分泌学会（AACE）も今年前半に発行したガイドラインでCATALYSTに言及していました。

コルセプトは、既存のクッシング症候群事業が2020年代末までに年間少なくとも20億ドルの売上高を生み出すと予想しています。経営陣は、relacorilantが利用可能になれば、成長が2030年に30億〜50億ドルへと加速する可能性があると述べました。これらは実績ではなく同社の目標数値です。

Lifyorliおよび腫瘍学分野

白金系抗がん剤抵抗性卵巣がんにおけるLifyorliの需要は引き続き堅調です。発売以来、大学病院、地域クリニック、その他の医療機関の1,700名以上の医師が、2,300名以上の患者に同製品を処方しました。

経営陣は、リピート処方の増加や、より早期の治療ラインでの使用拡大を報告しました。ベバシズマブを含むレジメンとの併用は現在限定的な事例にとどまっており、主要なレジメンはROSELLA試験と一致するLifyorliとnab-パクリタキセルの併用のままとなっています。

BELLA試験のArm Aでは、95名の患者がrelacorilantとnab-パクリタキセルおよびベバシズマブの併用投与を受けました。主な結果は以下の通りです：

• 無悪化生存期間の中央値：7.2ヶ月
• 奏効率：59%
• 6ヶ月全生存率：88%

ベバシズマブの治療歴がない患者における無悪化生存期間の中央値は8.1ヶ月に達し、奏効率は66%、6ヶ月全生存率は91%でした。主要解析時点で全生存期間の中央値には達していません。

BELLA試験のArm Bでは白金系抗がん剤感受性卵巣がんにおけるrelacorilantを評価しており、Arm Cでは子宮体がんを研究しています。TRIDENT試験では膵がんの一次治療を評価し、SYNERGY試験では固形がん全般におけるnenocorilantとニボルマブの併用を検証しています。経営陣は来年末までにこれらの試験結果が得られると見込んでいます。

MASHおよびALSパイプライン

第IIb相MONARCH試験において、miricorilantは用量依存的な肝脂肪の減少を示しました。治療前後に生検を受けた週2回100mg投与の患者群では、48週間後の絶対的線維化改善率が19.2%となりました。経営陣によると、有害事象の発現率はmiricorilant群とプラセボ群で同程度でした。

コルセプトは、1日100mgを3週間投与した後に1週間休薬するサイクルを24週間にわたって繰り返す別の第II相試験を計画しています。この試験は、高用量の間欠投与によってALT上昇を抑えつつ、肝脂肪および線維化指標を改善できるかを評価することを目的としています。

同社はまた、早期死亡率の大幅な低下を示したとされる第II相DAZALS試験の結果を受け、来年筋萎縮性側索硬化症（ALS）を対象とした第III相試験を開始する計画です。

業績見通し（ガイダンス）

コルセプトは2026年の売上高見通し（11億〜12億ドル）を再確認しました。最高財務責任者（CFO）のアタバック・モカリ氏は、中間値は業績に影響を与え得る要因を確率加重ベースで考慮したうえでの、現時点における経営陣のベストエスティメート（最良の予測）を反映していると述べました。

第3四半期の成長にもかかわらず、同社は見通しの範囲を引き上げませんでした。経営陣は、売上高見通しは今年すでに複数回引き上げられていたと指摘しました。

リスクおよび注視事項

• Relacorilantは引き続きFDAの審査を受けており、12月17日までに判断が示される予定です。経営陣は、審査スケジュールの確認以外に、進行中の規制当局との協議に関するコメントを控えました。
• 新たな高コルチゾール血症のスクリーニング勧告を日常の臨床実態に定着させるには時間を要する可能性があります。
• 新規の卵巣がん治療薬の登場により、治療シーケンス（投与順序）に影響が及ぶ可能性があります。コルセプトは、Lifyorliの差別化された作用機序と併用療法の可能性がその役割を支持するはずだと主張したものの、利用可能な競合データがまだ限られていることを認めました。
• miricorilantの次期試験では、耐容性を損なったりALTの上昇を実質的に悪化させたりすることなく、高用量化によって有効性を高められるかを検証します。
• 腫瘍学分野における複数の適応拡大機会は、来年末までに期待される臨床試験結果に依存しています。

アナリストQ&Aの要点

Lifyorliの立ち上げ状況：経営陣は成長の要因として、新規患者の獲得、リピート処方、ならびに治療シーケンスのより早期での使用拡大を挙げました。また、Lifyorliを白金系抗がん剤抵抗性卵巣がんの市場リーダーとして確立する目標を維持しました。

早期治療への位置付け：最高経営責任者（CEO）のジョセフ・K・ベラノフ氏は、BELLA試験の結果はLifyorliを卵巣がん治療のより早期段階へ移動させることを支持するものであり、その免疫調節作用および化学療法増感作用が長期的に大きな影響をもたらす可能性があると述べました。

ADCやその他の療法との併用の可能性：コルセプトは、グルココルチコイド受容体拮抗薬を化学療法、抗体薬物複合体（ADC）、および免疫療法と併用して評価する計画です。経営陣は、臨床試験によってどの組み合わせが最大の利益をもたらすかを特定すると述べました。

Relacorilantの市場投入戦略：クッシング症候群で承認された場合、コルセプトは既存のKorlym服用患者からの切り替えではなく、主に未治療患者への導入に注力する意向です。経営陣は、未治療患者の機会は現在のKorlymおよびオーソライズド・ジェネリックの顧客基盤よりも大幅に大きいと説明しました。

MASHの投与戦略：miricorilantの連日投与への移行計画は、MONARCH試験の用量反応性の結果、初期の第Ib相データ、および医師主導治験の結果を反映したものです。間欠投与スケジュールは、肝作用と耐容性のバランスをとるように設計されています。

決算説明会文字起こし全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Hello, and welcome to the Corcept Therapeutics Q3 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. It is now my pleasure to introduce CFO, Atabak Mokari.

Atabak Mokari

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the third quarter and providing a corporate update. A copy is available at corcept.com. Our complete financial results will be available when we file our Form 10-Q with the SEC.

Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. Statements during this call other than statements of historical fact are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to be materially different from those such statements expressed or implied. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, which are available at the SEC's website.

Please refer to those documents for more information. We disclaim any intention or duty to update forward-looking statements. Our revenue in the third quarter of 2026 was $340.5 million, a 33% increase from the second quarter and a 64% increase compared to the prior year period. Korlym and authorized generic revenue was $249.1 million. Lifyorli revenue was $91.4 million. We expect our growth to continue and are reiterating our 2026 revenue guidance of $1.1 billion to $1.2 billion.

Net income was $126.8 million in the third quarter of 2026 compared to $43 million in the second quarter and $19.7 million in the prior year period. Our cash and investments at September 30 were $662 million, an increase of $118 million in the quarter. We acquired $44 million of our common stock in the third quarter pursuant to our stock repurchase program, the exercise of stock Corcept stock options and vesting of restricted stock grants. I will now introduce Justin Gunn, President of our Endocrinology division. Justin assumed this role at the beginning of October. Prior to that, he was the Vice President of Sales for our Oncology division. Justin has more than 2 decades' experience as a biopharma executive in a variety of commercial roles, including the successful launch of 9 products in multiple therapeutic areas. Justin?

Justin Gunn

Thank you, Atabak. It's an exciting time to step into this new role. Over the past month, I've gotten to know many of my new colleagues and Corcept's outstanding endocrinology team. The endocrinology division delivered another quarter of record revenue, an accomplishment that I'm pleased to announce that I take no credit for. These skilled professionals have also helped create the conditions that will fuel future growth.

More physicians are prescribing our medicines and more patients are benefiting from them from ever before. And at the same time, realizing the full potential of our business will take, as it always has, hard work, creativity and perseverance, and I look forward to helping lead that effort. Hypercortisolism remains underdiagnosed and undertreated. Our CATALYST and MOMENTUM studies prove that hypercortisolism is far more prevalent than previously understood. And these landmark findings are poised to change diagnostic and treatment paradigms.

Of course, it takes time to incorporate scientific advances into new standards of care. Articles in leading journals such as publications in Diabetes Care describing our CATALYST results are invaluable first steps. But in my experience, the support of medical societies is required to really raise awareness among these busy physicians. So we were gratified that the American Diabetes Association cited our CATALYST findings in its consensus 2026 report in the management of type 2 diabetes released in October.

The report recommends screening for hypercortisolism in patients whose blood sugar remains high despite treatment with multiple glucose-lowering medications and states that the treatment of mifepristone reduced hemoglobin A1c substantially in these patients. The consensus report follows the American Association of Clinical Endocrinology's reference to CATALYST findings in its guidance for the management of diabetes issued in March of this year. As the ADA and the AACE recommendations become incorporated into medical practice, more patients are going to be screened, diagnosed and treated for hypercortisolism. So as a result, we expect our current Cushing's syndrome business to generate at least $2 billion in annual revenue by the end of this decade. The availability of relacorilant will drive faster growth to between $3 billion and $5 billion in 2030.

I'll now turn the call over to Roberto Vieira, President of our Oncology division. Roberto?

Roberto Vieira

Thanks, Justin. Lifyorli delivered exceptional growth in its second quarter on the market. Revenue grew to $91.4 million, a 92% increase. Demand for Lifyorli remains strong, reflecting the significant unmet need in platinum-resistant ovarian cancer and growing physician adoption. The reasons for Lifyorli rapid uptake are straightforward. It provides a compelling overall survival benefit driven by its unique mechanism of action, which both enhances the immune system ability to kill tumor cells and increases those cell sensitivity to chemotherapy. It is well tolerated with a very manageable safety profile.

Screening for a biomarker is not required. Virtually all tumor cells in ovarian cancer express the glucocorticoid receptor. Finally, Lifyorli is an oral medication, which makes it easy to administer. More than 1,700 physicians have prescribed Lifyorli to more than 2,300 patients since April 1 launch. That number continues to grow across specialties and treatment settings, including gynecologists, medical and hematologic oncologists at academic and non-teaching hospitals as well as community oncology clinics across the country. At the same time, repeat prescribing continues to increase, reflecting prescribers growing familiarity with and confidence in Lifyorli. We expect these trends to continue.

Another important trend we are seeing is the use of Lifyorli in earlier lines of therapy. Lifyorli is approved to treat patients in the second to fourth lines of treatment for platinum-resistant ovarian cancer. As it is typical of newly approved anticancer agents, many of the first patients to be prescribed Lifyorli had already received multiple lines of treatment. But the data showed that Lifyorli is particularly well suited to help patients at the earliest end of that range so that Lifyorli's ability to enhance their immune system response to cancer, a benefit which persists even after Lifyorli discontinued can have its optimal long-term effect.

Our BELLA trial results make the rationale for using Lifyorli earlier in treatment even stronger. Bevacizumab is a standard of care treatment for patients with earlier stage of ovarian cancer. In BELLA Arm A, Lifyorli was added to treatment with nab-paclitaxel and bevacizumab. Patients demonstrated substantial benefits in progression-free survival, objective response rate and overall survival. The patients with the best response were those earliest in their course of treatment in the platinum-resistant setting.

Physicians will consider this important finding as they sequence the treatments their patients receive. The increasing number and proportion of patients who received Lifyorli earlier in the treatment is yet another factor driving the growth of our business. Lifyorli's launch has exceeded expectations. We believe Lifyorli is on its way to becoming the market share leader in platinum-resistant ovarian cancer. We believe Lifyorli will generate more than $1 billion in [indiscernible].

I'll now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Joseph K. Belanoff

Thank you, Roberto, and thank you, everyone, for joining us. Since our founding, Corcept has worked to discover and develop molecules that harness glucocorticoid receptor, GR antagonism to treat serious diseases. The potential is enormous, and we have made important progress. It is now established that hypercortisolism is much more prevalent than previously believed and that modulating cortisol's activity can help many patients.

Lifyorli's emerging position as a new standard of platinum-resistant ovarian cancer highlights the potential of GR antagonism to treat many types of solid tumors, and our plans go well beyond Cushing's syndrome and oncology. We are heartened by the growing recognition of hypercortisolism within the medical community. As Justin described, the American Diabetes Association now recommends screening patients with difficult-to-treat diabetes for hypercortisolism and [ noted on our ] CATALYST study that 24% of patients with difficult to control diabetes were found to have hypercortisolism and that mifepristone significantly improved their glucose control. This is great news for patients. Other screening will identify previously undiagnosed patients, which will lead to better treatments and better outcomes. I am proud of the role Corcept played in making this major advance possible. The ADA's recommendations are a welcome development, but there is more to do. [indiscernible] We believe relacorilant is such treatment. Our resubmitted new drug relacorilant in Cushing's syndrome is based primarily on the positive outcome of our pivotal Phase III GRACE trial and confirmatory evidence from our Phase III GRADIENT trial.

Collectively, these data show that patients treated with relacorilant experienced meaningful durable improvements in the signs and symptoms of Cushing's syndrome without many of the serious adverse events associated with currently approved medications, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency or QT prolongation. We look forward to the FDA's decision by its December 17 PDUFA date.

Substantial preclinical and clinical data suggest that our proprietary selective GR antagonists benefit patients with cancer in at least 3 ways, by bolstering their immune system's ability to combat cancer, by sensitizing tumors to chemotherapy and by blocking growth pathways for cancer cells. We believe our medications have the potential to treat any solid tumor expressing the glucocorticoid receptor in combination with any anticancer agent. Lifyorli's approval in platinum-resistant ovarian cancer and a successful launch are just the first steps in realizing the potential of GR antagonism in solid tumors. We are widely evaluating relacorilant's immune boosting and chemosensitizing effects in combination with anticancer agents.

Our ongoing studies follow positive results from our ROSELLA, BELLA and Phase II trials in platinum-resistant ovarian cancer, one of the most challenging forms of cancer to treat. In Arm A of our BELLA Phase II trial, 95 patients received relacorilant plus nab-paclitaxel and bevacizumab. The regimen demonstrated clinically meaningful median progression-free survival, PFS of 7.2 months, an objective response rate, ORR, of 59% and overall survival, OS of 88% at 6 months.

Please note that the median overall survival was not yet reached at the time of the primary analysis of BELLA. The benefits were even more pronounced in patients who had not received bevacizumab previously. This group represented approximately half of the patients in the study. They had a median PFS of 8.1 months and ORR of 66% and a 6-month overall survival of 91%. This is yet another powerful demonstration of GR antagonism's potential to be combined with anticancer agents, resulting in substantial clinical benefit and equally important, it highlights the benefits of using GR antagonism earlier in the patient's treatment path. Our BELLA trial has 2 other arms. Arm B, which is nearing completion of enrollment, is studying the effect of relacorilant in patients with platinum-sensitive ovarian cancer, a still earlier stage of the disease.

Arm C, which has completed enrollment, is studying the effects of relacorilant in patients with endometrial cancer. Our TRIDENT trial is evaluating relacorilant as a potential first-line treatment for patients with pancreatic cancer. These trials will all produce results by the end of next year. We expect data from these current studies to be NCCN guideline enabling and to inform our future development decisions. Successful results in these additional indications would increase the number of patients that relacorilant may help by fivefold. As we stated, GR antagonism may also enhance the effectiveness of immunotherapy by counteracting the immunosuppressive effects of cortisol. SYNERGY, a Phase Ib study of our proprietary selective GR antagonist, nenocorilant, in combination with nivolumab, a PD-1 directed immunotherapy across a broad range of solid tumors is in progress. We expect results from SYNERGY by the end of next year.

Finally, GR signaling helps prostate cancer tumors escape the effects of the standard of care androgen deprivation. Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled Phase II trial of relacorilant plus the androgen receptor blocker, enzalutamide, in patients with early-stage prostate cancer. We expect results in this study by the end of next year. Cortisol activity is involved in the development and progression of metabolic dysfunction-associated steatohepatitis or MASH. This serious liver disorder affects millions of people worldwide and is a significant and rapidly growing cause of liver and cardiometabolic morbidity and mortality.

Miricorilant, our proprietary selective cortisol modulator, has demonstrated potent activity in the liver across several clinical studies. Our recently completed Phase IIb MONARCH study extended this finding. The trial enrolled 2 cohorts. Cohort A enrolled 82 patients with biopsy-confirmed MASH, randomized 2:1 to receive either 100 milligrams of miricorilant twice a week or placebo for 48 weeks. Cohort B enrolled 93 patients with presumed MASH, meaning MASH confirmed by scanning the liver without undertaking biopsies, randomized 2:1 to receive either 100 milligrams of miricorilant twice a week for 6 weeks and 200 milligrams of miricorilant twice a week for 18 weeks or placebo for 24 weeks.

Patients administered 200 milligrams of miricorilant twice a week experienced a significantly larger reduction in liver fat than patients who received 100 milligrams of miricorilant twice a week. Patients who received pre and post-treatment liver biopsies, these were the patients who received 100 milligrams of miricorilant twice a week, experienced fibrosis improvement of 19.2% in just 48 weeks. Miricorilant was very well tolerated in both cohorts. The rate of adverse events was virtually indistinguishable between the miricorilant and placebo arms. We are encouraged to see the dose-dependent reductions in liver fat and improvement in fibrosis observed at the very low doses of miricorilant administered in MONARCH. We will soon start a Phase II trial to evaluate a higher dose of miricorilant, 100 milligrams daily to see if miricorilant's fat and fibrosis reducing activity can be realized without sacrificing its excellent tolerability.

Patients with ALS often have elevated cortisol levels, which is why we believe cortisol modulation may benefit them. In our Phase II DAZALS trial, treatment with a cortisol modulator resulted in a profound reduction in early mortality, a true benefit for patients who early in their course of disease retain significant function and quality of life. There is a common misperception that death from ALS is always coterminous with severe functional decline. It isn't. Many patients die from complications such as pneumonia or cardiovascular events arising well before they have lost significant function and quality of life. If cortisol modulation prevented these complications or help patients to survive them, it would confer significant benefit.

We plan to begin a Phase III study next year. To sum up, our Cushing's syndrome business is growing, driven by increasing awareness of hypercortisolism true prevalence and the increasing understanding that as the root of many problems, it needs to be directly treated. The findings from our landmark CATALYST and MOMENTUM studies are increasingly influencing clinical practice and will propel growth for many years to come. Approval of relacorilant would lead to even faster growth.

Lifyorli adoption has been very rapid and broad for the treatment of patients with platinum-resistant ovarian cancer. The results from Arm A of our BELLA trial demonstrate GR antagonism's flexibility to produce substantial clinical benefit when combined with additional anticancer agents and its benefit in helping treat patients earlier in treatment. We believe that our GR antagonism platform can be used to treat any solid tumor expressing the glucocorticoid receptor in combination with any anticancer agent, and we look forward to helping many more patients with cancer in the near future. Our ongoing BELLA TRIDENT and SYNERGY studies will produce results by the end of next year. These studies have the potential to substantially increase the number of patients who can benefit from GR-directed therapy.

We are expanding our research to evaluate the treatment of additional solid tumors and additional treatment combinations to fully realize cortisol modulation's potential in oncology. In our Phase IIb MONARCH study in patients with MASH, very low doses of miricorilant demonstrated potent liver activity and were very well tolerated. We will evaluate higher doses of the compound with the goal of harnessing its full potential. We plan to start a Phase III trial in patients with ALS next year. The breadth of disease treatment using cortisol modulation is immense.

We thank the patients who participated in our trials, our clinical investigators, our academic collaborators and our employees. They make all our advances possible.

Operator, let's proceed to questions.

Operator

[Operator Instructions] And our first question comes from the line of Edward Nash with Canaccord Genuity.

質疑応答

Edward Nash

Congratulations on the really strong quarter. I wanted to ask, given more than 2,300 patients that have been treated with Lifyorli since the launch and the over $91 million in 3Q report, how should we think about the relationship between new patient starts, treatment duration and quarterly revenue as the launch matures?

Joseph K. Belanoff

Thank you. I want to pass the call back to Roberto Viera, who's the President of our Oncology division.

Roberto Vieira

Thank you, Ed. So as you alluded to, we had a very strong Q3 performance with a very fast increase in the number of patients that we have added. As we also discussed, we had a group of patients that were really the high unmet need with multiple lines of therapy. And that really just reflecting the state of the overall unmet need that we have in the market.

Now what's important is that we have now seen a growth in patients in early lines of therapy. We have also seen a growth in terms of repeaters as well in terms of repeat prescribing. So overall, we feel very confident in our goal of actually becoming the market leader and achieving the $1 billion potential that we have discussed in this call before.

Edward Nash

Great. And one more, if I could. The BELLA part A benefit appears most pronounced earlier in the platinum-resistant disease, including patients that -- without the prior bevacizumab. Does that change how you ultimately envision positioning Lifyorli in the treatment sequence?

Joseph K. Belanoff

Let me take this question, Edward. Thank you. The answer is yes. I think that we start really in some sense with the patients who had the most dire need patients at the end of their treatment. But I think that cortisol modulation affects many patients and the earlier, the better because this is really a disease-modifying treatment. That's really the reason why the overall survival curves are so distinctly different between the relacorilant arms and the standard best control arms.

So yes, I think with more and more study, we will move earlier and earlier in ovarian cancer. But I also just point out, we will move to other cancers as well where glucocorticoid receptor is expressed.

Operator

And our next question comes from the line of David Amsellem with Piper Sandler.

David Amsellem

So a couple for me. First on the guide. So you didn't raise the guide even though you had a nice growth from Lifyorli, good year-over-year growth for Korlym. So I guess I wanted to just know if we're missing anything here in terms of, say, Lifyorli, any pent-up demand effects that we should be cognizant of? Anything on Korlym in terms of your price erosion assumptions have changed? Just want to understand your thought process there regarding the guide being static. That's number one.

And then secondly, I'm sure you're aware of the Genmab data from a couple of weeks ago for Rina-S. I wanted to get your thoughts on what that could mean for Lifyorli longer term. And beyond that, are you envisioning novel combination studies with ADCs over time, whether by you, other companies or investigators?

Joseph K. Belanoff

Okay. Let's take those questions one at a time. The guidance question, please, Atabak?

Atabak Mokari

Sure. Happy to do. David. So our approach to guidance is the same as it's always been. The midpoint of the range is our best thinking. We consider many things that could drive our financial results in a probabilistic way. And ultimately, given the strength that we're seeing in both our endocrinology and oncology businesses, we've reiterated our guidance range of $1.1 billion to $1.2 billion. I'll remind you that we've increased our guidance range a few times already this year.

Joseph K. Belanoff

Okay. And the second question, Roberto, is about Genmab and what this might mean for Lifyorli.

Roberto Vieira

Thank you. So I'm not going to speak about the Rina-S data directly because, to be honest, there's not a lot of data available now. But I can speak about the overall development of the space in platinum-resistant ovarian cancer and how we see the evolution of Lifyorli's role there. So let me just remind ourselves that we're excited about seeing new drugs coming forward for this patient population that for a long time had no options at all.

Now for us to discuss the impact on Lifyorli, we cannot have that conversation without taking into account 3 very important considerations here. Number one, that unfortunately, none of these drugs are curing this terrible disease, which means that the patients will continue to need drugs with differentiated mechanisms such as ours, Lifyorli in order to actually optimize their care. And I want to -- the second point is specifically about this, Lifyorli is a drug that has a very different mechanism of action. It doesn't work as a chemotherapy or ADC, which all have similar mechanism of action. This is a very important advantage for Lifyorli.

The mechanism is not just helping to kill cancer cells, but as Joe alluded to before, it's modulating the immune system and impacting how patients fight their cancer over time. Now third, we have just demonstrated with the BELLA arm A that we plan to continue combining Lifyorli with other drugs and perhaps to some of these newer drugs as well. So when we combine these factors, the unrelenting unmet need, the differentiated MOA, including the impact of the immune system, but also the ability to combine Lifyorli with other drugs, we believe Lifyorli will continue to play a very relevant role and be a market leader in the future landscape.

Joseph K. Belanoff

Very good. And David, I just wanted -- maybe your third question, Roberto has answered most of it. But yes, we certainly intend to use Lifyorli GR antagonist really in general, as a mechanism in combinations with other drugs. We really think it's very helpful, whether it's chemotherapeutic agents, potentially ADCs, certainly immunotherapy. We just think we can add benefit to all of those treatments. The testing will prove which one is best, but it is definitely our idea to do that.

David Amsellem

Okay. That's helpful. If I may sneak in one more, and I'm sorry if I missed the commentary earlier on, but you said that there's some evidence of earlier usage of Lifyorli. Do you have a sense of how much usage you're seeing with bevacizumab containing regimen already? Is that a small minority or a more meaningful portion of the mix?

Joseph K. Belanoff

I'm going to pass this back to Roberto.

Roberto Vieira

Yes. As of now, the only anecdotal utilization, primarily the regimen that's being used today is the ROSELLA regimen, nab-paclitaxel plus Lifyorli.

Operator

And our next question comes from the line of Srikripa Devarakonda with Truist Securities.

Srikripa Devarakonda

Congratulations on the quarter. As we approach the December PDUFA date, I was wondering if you've had any labeling or any kind of discussions with the FDA ahead of the PDUFA date? And any feedback you can share regarding discussions around maybe the liver injury signal? And I have a question -- a pipeline question on the MASH program. You said that the trial showed dose-dependent reductions in liver fat and improvement in fibrosis at 48 weeks.

Can you remind me if this is absolute improvement or placebo adjusted? And also, given the fact that you're planning to start a Phase II trial with the 100 mg daily, can you just walk us through why the shift away from the twice weekly to the daily?

Joseph K. Belanoff

Okay. Kripa, first, welcome. Nice to hear from you. First question, I think, is best answered by Charlie Robb, who runs all of our regulatory activities and Chief Business Officer. Charlie, please go ahead.

Charles Robb

Before I answer your question directly, I just want to give folks a little bit of the history and context here. We submitted our NDA originally some 20 months ago, and we received at the end of last year, a complete response letter. And at the customary post-CRL meeting with the FDA, they asked us not for any new data, but to perform a specific analysis, this global statistical test. It's a very powerful way of looking at of the role a candidate drug such as relacorilant plays in a disease where there are really multiple endpoints. It looks at them all together to see what kind of effect the drug is having. And we performed that analysis. It covered glucose, weight and hypertension endpoints. The results were very positive.

In fact, we published a poster about the application to the GRACE study a few weeks ago, which is available on our website. And on the basis of those positive results, we submitted -- we resubmitted the NDA back in June, and the FDA accepted it for review, which has been ongoing ever since then. Now PDUFA date, as Joe mentioned, is December 17. And unfortunately, I can't comment beyond that. We're very close to the date we're going to find out. And I'm sorry, I can't give you any more color beyond that.

Joseph K. Belanoff

Okay. And the second question, Bill, was about dosing regimen in MASH.

William Guyer

Yes, yes. So thanks for the question, Kripa, and thank you for joining us today. So when you look at MASH and miricorilant, we learned some great things from the MONARCH study that you heard from Joe. Related to fibrosis improvement, that was an absolute fibrosis improvement for miricorilant. But to be honest, and we'll show this data when we present it at a scientific conference next year, placebo really didn't have much of a fibrosis improvement on biopsy.

Now why we're moving forward into 100 milligrams daily, I'll give you a little bit more color behind that. One, we looked at the MONARCH results showing a dose-dependent response rate. So higher doses means a higher response on liver fat and even liver fibrosis. We went back and looked at our Phase Ib data of our dose-ranging study, and we saw that 100 milligrams also saw great when we've given it daily, saw great results in liver fat reduction as well as noninvasive test improvement on liver fibrosis. But we also got new data from an investigator-initiated study where we looked at the mechanism of action of miricorilant giving 100 milligrams a day for 4 to 6 weeks, and we again saw significant reductions in liver fat and improvement in noninvasive tests of fibrosis.

Now when you put this all together, we also want to minimize any ALT rises. And so when we're going to do our next Phase II study, it's going to be looking at 100 milligrams a day every day for 3 weeks on, and then we will give a 1 week off dosing of basically of placebo. And therefore, we'll repeat that over 24 weeks to see if this 3 weeks on and 1 week off approach in that type of intermittent dosing can produce a significant drop in liver fat and an improvement in noninvasive testing for fibrosis. And that will then help guide us on how to then proceed into Phase III. We're going to start that study very quickly at the beginning of the year, finish it in the second half of the year, and that will then guide us on what to do next.

Joseph K. Belanoff

Yes. I just neglected to identify. This is Bill Guyer, who's our Chief Development Officer, who just spoke. And really, just to sum that up, what I would say is that we saw an exceptionally low dose benefit and virtually no distinguishing characteristics at all between side effects between medicine and placebo. And we really think that raising the dose will provide additional effects. And we're fairly confident, but it has, of course, be tested. We're not going to see much of an increase in terms of side effects. So that's basically where we're going. We're trying to optimize the dose, and that's really what Phase II is about.

Operator

And our next question comes from the line of RK with H.C. Wainwright.

Swayampakula Ramakanth

I just have one. This is regarding relacorilant launch for Cushing's syndrome. Just trying to understand with expecting a launch here, how should we think about balancing new diagnoses and also switching if correct, if relevant for patients from Korlym to relacorilant. And in general, how does that -- is there a titration step and education and all the interesting things that you generally do when you get new patients on this -- for this indication?

Joseph K. Belanoff

Okay. RK, thank you very much. And I want to just again reintroduce Justin Gunn, our new President of Endocrinology. Justin, your first question, of course, it in an earnings call.

Justin Gunn

RK, I appreciate the question. The opportunity for relacorilant in Cushing's syndrome is much larger than the current base of Korlym or the authorized generic. Now while relacorilant's profile does support the Korlym patients, that said, our focus will be on the treatment-naive patients. There's a vast number of underserved patients to be identified from all the information we shared from the CATALYST and the MOMENTUM data. So that will be our market going forward.

Joseph K. Belanoff

Okay. Well, thank you, everybody. Very good to hear. We're really looking for an exciting next quarter and speaking to you all at the time.

So thank you. Please look for our releases between now and then, but look forward to talking to you in another 3 months. Bye-bye.