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PDUFA Calendar 2026
December 2026
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Cogent Biosciences, Inc.
Bezuclastinib
Cogent Biosciences (COGT) is advancing bezuclastinib, a potent and selective small-molecule inhibitor targeting the KIT D816V mutation, which is prevalent in systemic mastocytosis and gastrointestinal stromal tumors (GIST). This first-in-class therapy is designed to inhibit the abnormal mast-cell activity that drives severe symptoms in Non-Advanced Systemic Mastocytosis (NonAdvSM), a rare hematologic disorder characterized by significant unmet medical need due to the limited availability of targeted treatment options. The focus on symptom relief and quality-of-life improvements underscores the urgency for effective therapies in this space. While specific market size figures for NonAdvSM remain undisclosed, its orphan status highlights a unique opportunity within the niche of KIT-mutated rare diseases. Currently, bezuclastinib is positioned at the PDUFA stage for NonAdvSM, with a New Drug Application (NDA) submitted in December 2025 and FDA acceptance anticipated by the end of February 2026. The pivotal SUMMIT trial has demonstrated notable clinical benefits across various symptom domains, although detailed metrics such as overall response rates, p-values, and confidence intervals have not yet been fully disclosed. While specifics regarding trial design—including randomization, blinding, sample size, and secondary endpoints—are not available, the topline results have generated considerable interest. The safety profile appears reassuring based on related GIST data, particularly from the PEAK trial, which has not indicated any major safety concerns. From a competitive standpoint, bezuclastinib stands out as a first-in-class therapy for KIT D816V in NonAdvSM, with no direct approved competitors identified. However, there are pipeline overlaps in GIST, where existing therapies like sunitinib have demonstrated a 50% reduction in the risk of progression or death. Bezuclastinib is positioned to lead in the second-line treatment of GIST, representing the first new option in over 20 years, as well as in mastocytosis. Although there are no direct precedents for NonAdvSM approvals, the recent Breakthrough Designation for the combination of bezuclastinib and sunitinib indicates FDA receptivity to KIT inhibitors. The estimated probability of approval (PoA) for bezuclastinib is 75-85%, reflecting the NDA acceptance milestone, positive symptom data from the SUMMIT trial, and the sponsor's strong financial position, with $900 million in cash projected to last into 2026. This financial backing supports commercial readiness for a potential launch in the second half of the year, contingent on approval. The proximity of the PDUFA date enhances the likelihood of success, although the absence of priority status and the pending data readouts from the SUMMIT and APEX trials in the first half of 2026 could influence outcomes. While Cogent has not yet achieved any prior approvals, it has demonstrated strong execution in its regulatory filings across various indications without noted rejections. Key risks include the possibility of insufficient efficacy or safety signals from the SUMMIT trial updates, as well as the emergence of competitive therapies in KIT-driven rare cancers. Nevertheless, upcoming catalysts, such as the anticipated trial updates in the first half of 2026, present potential upside. Overall, bezuclastinib's regulatory progress and the pressing unmet need in the orphan space support a compelling investment case for COGT as it approaches critical milestones in 2026.... Show more
NonAdvanced Systemic Mastocytosis (NonAdvSM)
The FDA has assigned a PDUFA target action date for the NDA of bezuclastinib in patients with NonAdvSM, indicating the date by which the FDA will make a decision on the drug's approval.
Gilead Sciences, Inc.
anito-cel
Anitocabtagene autoleucel, commonly referred to as anito-cel, is a BCMA-directed autologous CAR-T cell therapy developed by Gilead/Kite and Arcellx for the treatment of multiple myeloma. Currently, it is advancing through the regulatory process for a fourth-line indication in relapsed/refractory multiple myeloma. The Biologics License Application (BLA) is supported by data from the Phase 1 study (NCT04155749) and the pivotal Phase 2 study (NCT05396885), with the FDA having accepted the filing and set a Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026. This indicates that the program has successfully transitioned from clinical development to active regulatory review. The evidence supporting the approval of anito-cel appears robust. The pivotal iMMagine-1 study is an open-label Phase 2 trial involving heavily pretreated relapsed/refractory myeloma patients who have undergone at least three prior treatment regimens, including proteasome inhibitors, IMiDs, and anti-CD38 therapies. Preliminary reports from earlier phases and subsequent updates have indicated deep and durable responses, with manageable safety profiles. Presentations at the American Society of Hematology (ASH) meetings have further emphasized the therapy's durable responses in patients with triple-refractory disease. However, the publicly available data does not provide complete numerical efficacy and safety tables, preventing verification of specific overall response rates (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, and p-values. Nonetheless, the qualitative assessment suggests that the program has generated sufficient efficacy and safety data to warrant BLA review. In terms of safety, the primary risks associated with BCMA CAR-T therapies include cytokine release syndrome, neurologic toxicity, prolonged cytopenias, and an increased risk of infections. The available literature describes the safety profile of anito-cel as manageable, with no new safety signals reported. The case for approval is further bolstered by the significant unmet need within the target patient population and the therapy's potential to offer a competitive safety and efficacy profile compared to existing products. Regulatory designations for multiple myeloma are favorable, as the program has received Fast Track, Orphan Drug, and Breakthrough Therapy designations, along with Priority Review status. These designations are indicative of the therapy's potential to address a critical need in a patient population that has historically qualified for such designations. However, it is important to note that the BLA is not eligible for Accelerated Approval since it is being reviewed based on pivotal Phase 2 data rather than a traditional accelerated-approval pathway. The competitive landscape for anito-cel is strong yet crowded. While it is not the first-in-class BCMA agent, it is positioned as a best-in-class therapy if it can demonstrate favorable safety and durability compared to its peers. The market opportunity for multiple myeloma treatments is substantial, with estimates suggesting a global market size of approximately $20 billion. Historical precedents indicate that FDA approval decisions are heavily influenced by the depth of response, durability, manufacturing reliability, and toxicity management. Programs that exhibit clear efficacy alongside acceptable safety profiles have successfully gained approval, while those with less favorable benefit-risk ratios or unresolved safety concerns may face delays or rejection. Overall, the estimated probability of approval (PoA) for anito-cel stands at 88.0%. This high PoA is supported by the therapy's current regulatory status, favorable pivotal data, and the significant unmet need it addresses. The primary risks to consider include safety concerns, manufacturing consistency, and the potential for the FDA to request additional comparative evidence as competition in the field intensifies.... Show more
multiple myeloma
Drug: anito-cel. Indication: multiple myeloma. Timeline: 2026-12-23. An application for anito-cel, the multiple myeloma therapy Gilead is advancing with Arcellx, is under FDA review with a target action date of Dec. 23, 2026.
Viatris Inc.
MR-107A-02 (fast-acting meloxicam)
MR-107A-02 is a novel fast-acting oral formulation of meloxicam being developed by Viatris for the treatment of moderate-to-severe acute pain, particularly in postoperative settings such as bunionectomy and herniorrhaphy. This formulation is not a new molecular entity; rather, it represents an improved delivery system of meloxicam, a well-established non-steroidal anti-inflammatory drug (NSAID). The design aims to achieve more rapid absorption and faster onset of analgesic effects. Publicly available pharmacokinetic data supports this formulation strategy, demonstrating significantly faster absorption compared to reference meloxicam, with a median Tmax of 0.75 hours versus 4.0 hours, and a higher Cmax, all without reported adverse events in the pharmacokinetic study. This evidence supports the notion that MR-107A-02 is a more timely version of a known drug rather than a novel mechanism of action. The clinical development program for MR-107A-02 has progressed through two pivotal phase 3 studies: MR-107A-02-TFZ-3001 (NCT06215820) and MR-107A-02-TFZ-3002 (NCT06215859). Both studies were randomized, double-blind, placebo-controlled trials focused on postoperative pain in adults, with tramadol as an active comparator referenced in post-hoc analyses. The primary efficacy endpoint was pain intensity over time, measured as the Sum of Pain Intensity Difference (SPID) from 0 to 48 hours, alongside metrics for time to perceptible and meaningful pain relief. Top-line results indicated statistically significant and clinically meaningful improvements compared to placebo in both surgical models, with post-hoc analyses suggesting superiority over tramadol in SPID 0-48 and faster pain relief metrics. Safety profiles appeared acceptable, with treatment-emergent adverse event rates generally comparable to placebo and no major new safety signals reported in public summaries. However, detailed published effect sizes, confidence intervals, discontinuation rates, and comprehensive safety tables have yet to be released. The regulatory designations for MR-107A-02 concerning moderate-to-severe acute pain have not been disclosed, indicating that the drug does not currently hold Fast Track, Breakthrough Therapy, Priority Review, Orphan Drug, or Accelerated Approval status. The market opportunity for MR-107A-02 is substantial, as postoperative pain represents a large, high-volume, short-duration segment with a significant demand for opioid-sparing options. The drug is classified as best-in-class, reflecting its improved formulation of an existing NSAID rather than a first-in-class innovation. Viatris brings extensive pharmaceutical commercialization experience to the project, and there are no apparent red flags in the development program based on the sourced materials, which supports the likelihood of successful execution. Historical precedents in acute pain suggest that the FDA typically favors robust placebo-controlled evidence and consistent safety profiles; however, claims regarding opioid reduction must be convincingly supported, and labeling may remain conservative. On balance, the program's probability of approval is estimated at 78.0%, reflecting positive phase 3 efficacy data, acceptable tolerability, and the familiarity of the active ingredient, albeit tempered by safety concerns associated with the class and potential regulatory conservatism regarding labeling for post-surgical analgesics. Key risks include regulatory scrutiny on labeling and benefit-risk assessments, typical safety risks associated with NSAIDs, and potential challenges in commercial differentiation if MR-107A-02 is perceived as merely an incremental reformulation of existing NSAIDs. Upcoming catalysts include the anticipated NDA submission to the U.S. FDA by the end of 2025, with the timing for the FDA PDUFA decision and potential label/launch communication yet to be disclosed.... Show more
moderate-to-severe acute pain
Drug: MR-107A-02 (fast-acting meloxicam). Indication: moderate-to-severe acute pain. Timeline: 2026-12-27. FDA accepted Viatris' New Drug Application for MR-107A-02 (fast-acting meloxicam) for moderate-to-severe acute pain and assigned a PDUFA goal date of Dec. 27, 2026. The NDA is supported by Phase 3 program results presented at PAINWeek 2025.... Show more
Praxis Precision Medicines, Inc.
relutrigine
Relutrigine, also known as PRAX-562, is a sodium-channel functional state modulator under development by Praxis Precision Medicines for pediatric patients suffering from SCN2A- and SCN8A-related developmental and epileptic encephalopathies (DEEs). These conditions are characterized by early-onset, refractory seizures and significant neurodevelopmental impairment, representing an ultra-rare segment of the epilepsy market. Currently, the program is at the New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) stage. The FDA initially accepted the NDA with priority review, setting a target action date of September 27, 2026. However, following the submission of additional sensitivity analyses classified as a major amendment, the review period was extended by three months, moving the PDUFA date to December 27, 2026. The primary evidence supporting Relutrigine's efficacy comes from the EMBOLD study (NCT05818553), a Phase 2 randomized clinical trial involving pediatric participants diagnosed with early-onset SCN2A-DEE and SCN8A-DEE. Reports indicate that the study was halted early for efficacy based on an interim analysis and a recommendation from the Data Monitoring Committee, which bolstered the NDA submission. While detailed public reporting lacks a complete endpoint table, enrollment figures, p-values, hazard ratios, confidence intervals, and a full list of adverse events, the advancement of the program to NDA review suggests that the FDA found the data package adequate for filing and priority review. Relutrigine has received FDA Orphan Drug Designation and Breakthrough Therapy Designation for SCN2A-DEE and SCN8A-DEE. Additionally, priority review has been granted for this NDA. However, accelerated approval is not indicated in the available sources, and Fast Track designation remains unverified. The market analysis indicates a potential market size of $0.5 to $1.5 billion globally, reflecting the estimated niche rare-epilepsy market, although the exact SCN2A/SCN8A-specific global market has not been publicly established. The unmet need for effective treatments in this area is significant, as SCN2A/SCN8A DEEs are ultra-rare, severe pediatric epilepsies associated with a substantial seizure burden, developmental impairment, and limited targeted treatment options. Relutrigine is classified as a first-in-class therapy, as it targets a specific genetic population rather than serving as a broad antiseizure medication. Despite the compelling nature of this first-in-class opportunity, there are notable risks. These include the potential for FDA review complications following a major amendment and the three-month PDUFA extension to December 27, 2026. The limited dataset size in this ultra-rare pediatric population introduces uncertainty regarding the durability and generalizability of the findings. Furthermore, there are inherent safety and tolerability risks, as well as challenges related to commercial execution in a highly specialized epilepsy market. The estimated probability of approval (PoA) for Relutrigine is set at 85.0%. This figure reflects the high likelihood of approval due to the asset's current NDA review status, along with the support of breakthrough and orphan designations. However, it is tempered by the small dataset, the complexities associated with pediatric patients, and the additional uncertainty introduced by the FDA's review extension. Overall, while the program benefits from strong regulatory momentum, the scrutiny associated with small trials, particularly after amendments, warrants cautious optimism.... Show more
SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs)
Drug: relutrigine. Indication: SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). Timeline: December 27, 2026. The FDA extended the review period for the NDA for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs), setting an updated PDUFA target action date of December 27, 2026.... Show more
Vanda Pharmaceuticals Inc.
Quimilza™
Quimilza™ (imsidolimab) is currently under FDA review, with its Biologics License Application (BLA) having a target action date set for December 12, 2026. It is important to note that while the public record confirms this status, the available evidence does not allow for independent verification of all requested trial-level details, designations, and efficacy statistics. Consequently, fields lacking verification are marked as unknown rather than inferred. In terms of regulatory designations for generalized pustular psoriasis (GPP), the following information is pertinent: ```json { "FastTrackDesignation": false, "OrphanDrugDesignation": false, "BreakthroughTherapyDesignation": false, "PriorityReview": false, "AcceleratedApproval": false } ``` These "false" values should be interpreted as not publicly verified in the available evidence, rather than definitive denials from the FDA. Although there are confirmed orphan-related actions in Japan and Europe, these do not equate to U.S. FDA designations. The European action was reported in July 2026, while the Japanese designation occurred in May 2026. Market analysis reveals a challenging landscape. ```json { "marketsize": "Unknown; no reliable specific global dollar estimate verified", "unmetneed": true, "unmetneeddescription": "GPP is a rare, potentially life-threatening inflammatory disease with acute flares and limited durable treatment options.", "drug_classification": "First-in-class" } ``` The estimated probability of approval (PoA) stands at 72.0%. This figure, as of October 29, 2026, is an analyst estimate rather than a statistical probability from the FDA. It reflects the advanced regulatory stage and the reported publication of pivotal results, balanced against the lack of independently verified trial-level results, ongoing regulatory-review risks, and limited information regarding the application’s designations. Key risks associated with Quimilza™ include the potential for the FDA to identify deficiencies in efficacy, durability, safety, manufacturing, or labeling during the BLA review process. Additionally, the public record does not provide sufficient verified details on pivotal trial enrollment, endpoints, effect sizes, confidence intervals, discontinuations, or serious adverse events. Furthermore, commercial uptake may be limited due to the rarity of GPP, the need for specialist diagnosis, payer restrictions, and competition from other IL-36-pathway therapies. Looking ahead, there are significant upcoming catalysts. The FDA's PDUFA target action date is December 12, 2026. Should the drug receive approval, a potential U.S. commercial launch could occur in the first half of 2027, although this timeline remains contingent on FDA action and is not guaranteed. Quimilza™ is an IL-36 receptor antagonist being developed by Vanda Pharmaceuticals Inc. (VNDA) for the treatment of generalized pustular psoriasis (GPP). GPP is a rare systemic inflammatory skin disease characterized by widespread sterile pustules, recurrent flares, substantial morbidity, and potentially serious complications. The clinical need for effective therapies is significant, particularly those that can control acute episodes and reduce recurrence. The program has reached a critical regulatory stage, with Vanda’s BLA currently under FDA review. Public company materials indicate that pivotal-study results were published in NEJM Evidence on April 28, 2026. However, the available evidence does not verify the study’s NCT number, enrollment, randomization ratio, blinding, placebo-control structure, primary and secondary endpoints, or detailed adverse-event and discontinuation rates. These data gaps materially limit the precision of estimating approval odds and commercial differentiation. Mechanistically, imsidolimab blocks IL-36 receptor signaling, a pathway strongly implicated in the biology of pustular psoriasis. Based on the available information, it is classified as first-in-class for this specific mechanism, although the broader IL-36 therapeutic class is not without competition. Spesolimab, another IL-36 receptor antagonist, has established a regulatory precedent for acute GPP treatment, providing both validation and a direct competitive benchmark. The key commercial question remains whether Quimilza can demonstrate advantages in flare prevention, maintenance treatment, dosing convenience, safety, or access, rather than simply replicating acute-flare efficacy. The unverified FDA designation fields indicate that the market opportunity is real but difficult to quantify reliably, with no defensible global dollar estimate available. Given the rarity of GPP, the market opportunity is likely to be categorized as a specialty orphan market rather than a conventional large dermatology market. The 72.0% approval probability is justified by the acceptance and active review of the BLA, the proximity of the action date, and the existence of published pivotal results. However, this estimate remains below the level typically assigned to near-certain approvals due to the potential for the FDA review process to uncover manufacturing, safety, durability, or labeling issues, as well as the lack of verified quantitative trial evidence. The principal catalyst to watch is the December 12, 2026 PDUFA decision, with a potential launch window indicated for the first half of 2027, contingent upon FDA approval.... Show more
Generalized Pustular Psoriasis (GPP)
Drug: Quimilza™. Indication: Generalized Pustular Psoriasis (GPP). Timeline: December 12, 2026. The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.... Show more
Mineralys Therapeutics, Inc.
lorundrostat
Lorundrostat, also known as MLS-101, is an orally administered, highly selective aldosterone synthase inhibitor developed by Mineralys Therapeutics. This drug targets the enzyme CYP11B2, which is responsible for aldosterone production, thereby addressing aldosterone-driven blood pressure elevation rather than merely enhancing the blockade of conventional pathways. The FDA has accepted Mineralys’ New Drug Application (NDA) for the treatment of adult hypertension in combination with other antihypertensive drugs, with a standard Prescription Drug User Fee Act (PDUFA) target date set for December 22, 2026. The current status of the program indicates it is undergoing regulatory review rather than being in Phase 3 development. Market analysis suggests a significant opportunity for lorundrostat, with an estimated global market size of $5-10 billion for resistant or uncontrolled hypertension add-on therapy, yielding a midpoint estimate of approximately $7.5 billion. The unmet need in this area is substantial, as many patients remain uncontrolled despite being treated with multiple antihypertensive medications, particularly those suffering from resistant hypertension, obesity, chronic kidney disease (CKD), or excess aldosterone activity. Lorundrostat is classified as best-in-class, distinguishing it from first-in-class drugs, as it faces competition from other approved aldosterone synthase inhibitors, notably baxdrostat, which is anticipated to enter the market in 2026. The estimated probability of approval (PoA) for lorundrostat stands at 78.0%. This figure reflects the current understanding of the drug's regulatory pathway and clinical data, although it remains below the probability typically assigned to a product that has already received approval. Key risks associated with lorundrostat include regulatory and clinical-review risks, as the NDA is still under review, and approval could be delayed or denied due to concerns regarding the benefit-risk balance, labeling, dose selection, or the completeness of the safety database. Safety concerns specifically related to hyperkalemia, renal function, and endocrine effects are also pertinent, especially in patients with CKD or those receiving concomitant renin-angiotensin-system blockade. Additionally, commercial differentiation poses a risk, as emerging aldosterone synthase inhibitors like baxdrostat may impact lorundrostat’s pricing power and market share if they demonstrate superior outcomes, renal safety, or tolerability. Upcoming catalysts include the FDA's PDUFA action on the lorundrostat NDA, scheduled for December 22, 2026, with potential for launch and commercial availability to follow, although specific timing has not been disclosed. Additional data from expansion programs targeting CKD, cardiovascular conditions, or other indications may also emerge, but timelines for these developments remain unspecified. In summary, lorundrostat presents a meaningful investment opportunity within the hypertension treatment landscape. The combination of NDA acceptance, a large pivotal study population, a clinically relevant mechanism of action, and reported efficacy in reducing blood pressure supports the estimated PoA of 78.0%. However, the path to approval is not without challenges, as final FDA review outcomes, safety details, labeling considerations, and competitive differentiation remain to be fully resolved. The December 22, 2026 PDUFA action date represents a critical near-term catalyst for stakeholders.... Show more
treatment of hypertension in combination with other antihypertensive drugs
Drug: lorundrostat. Indication: treatment of hypertension in combination with other antihypertensive drugs. Timeline: December 22, 2026. Lorundrostat is under review by the U.S. Food and Drug Administration for the treatment of hypertension in combination with other antihypertensive drugs, with a PDUFA target date of December 22, 2026.... Show more
Corcept Therapeutics Incorporated
relacorilant
Relacorilant is an oral, small-molecule, selective glucocorticoid-receptor antagonist developed by Corcept Therapeutics for the treatment of endogenous hypercortisolism, commonly referred to as Cushing’s syndrome. This drug operates by blocking excess cortisol signaling at the receptor level, distinguishing it from steroidogenesis inhibitors such as osilodrostat, levoketoconazole, metyrapone, and ketoconazole. While it shares the glucocorticoid-receptor-antagonist mechanism with the approved therapy mifepristone (Korlym), relacorilant is classified as best-in-class due to its potentially more selective and better-tolerated profile. The global market for therapeutics targeting Cushing’s syndrome is estimated at approximately $1 billion, although published estimates vary significantly based on definitions and geographic considerations. The unmet need in this market remains substantial, as many patients do not achieve adequate control of their condition. Surgical options are not universally curative or feasible, and existing medications can lead to serious side effects, including endocrine, hepatic, cardiac, electrolyte, reproductive, or adrenal-suppression liabilities. Relacorilant's classification as best-in-class reflects its potential to address these unmet needs more effectively than existing therapies. The pivotal clinical program for relacorilant is the GRACE study (NCT03697109), a phase 3, multicenter, randomized-withdrawal trial involving patients with endogenous hypercortisolism and associated hypertension and/or hyperglycemia. The study enrolled approximately 152 patients, with 95 entering the initial treatment phase and 62 proceeding to the randomized-withdrawal phase. The primary endpoint was the maintenance of blood-pressure control during the withdrawal phase, with secondary assessments focusing on glycemic control and other clinical manifestations of cortisol excess. The GRACE study successfully met its primary endpoint, demonstrating a significant odds ratio of 0.17 for loss of blood-pressure control versus placebo (p=0.02). Additionally, the study reported clinically meaningful improvements in hypertension, hyperglycemia, and other manifestations associated with Cushing’s syndrome. Regulatory designations for relacorilant include FDA orphan-drug designation for Cushing’s syndrome, but it does not have Fast Track or Breakthrough Therapy designations. The resubmitted New Drug Application (NDA) is currently under review, with a previous PDUFA date set for December 30, 2025, but the application was resubmitted in June 2026. As such, the current review status should be considered as PDUFA/resubmission pending rather than approved. Key risks associated with relacorilant include regulatory uncertainty following the resubmission, clinical interpretation challenges regarding the scope of the label, potential adrenal insufficiency due to the mechanism of action, and competition from other therapies such as mifepristone, osilodrostat, pasireotide, levoketoconazole, and metyrapone. The treatment landscape is influenced by factors including disease phenotype, underlying causes, comorbidities, and physician familiarity with various therapies. The estimated probability of approval (PoA) for relacorilant stands at 82.0%, reflecting the positive outcomes from the GRACE study, a coherent biological mechanism, orphan designation, and an established commercial infrastructure. However, the PoA is tempered by the need for resubmission, potential constraints in label interpretation from the pivotal study design, and the clinically significant risk of adrenal insufficiency. Upcoming catalysts include FDA action on the resubmitted NDA and further regulatory or clinical updates from Corcept regarding the GRACE study, long-term extension data, and label negotiations, although specific timelines for these events have not been disclosed.... Show more
Cushing's syndrome
Drug: relacorilant. Indication: Cushing's syndrome. Timeline: 2026-12-17. Corcept resubmitted a New Drug Application for relacorilant in patients with Cushing’s syndrome and the company reports a PDUFA date of December 17, 2026 for that resubmission.
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