Clinical Trials
82
8 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
8
9.8%
Completed
56
68.3%
Recruiting
10
12.2%
Terminated
7
8.5%
Withdrawn
1
1.2%
No approval data available
- The EMA's CHMP has recommended EU approval of relacorilant combined with nab-paclitaxel for patients with platinum-resistant ovarian cancer. - The opinion rests on Phase 2 and pivotal Phase 3 ROSELLA data showing improved progression-free and overall survival versus nab-paclitaxel alone. - ROSELLA randomized 381 patients 1:1 across sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. - The European Commission is expected to issue a final marketing authorization decision in the fourth quarter of 2026.
- A Complete Response Letter (CRL) is the FDA's formal notice that a drug application cannot be approved in its current form, citing deficiencies in safety, efficacy, manufacturing, or labeling. - CRLs can trigger severe market reactions, with single-day stock declines ranging from 2% (AbbVie) to 75% (Aldeyra Therapeutics), depending on the nature and severity of the deficiencies. - Companies can pursue Class 1 resubmissions for minor fixes (approximately two-month review) or Class 2 resubmissions for substantial changes (approximately six-month review), with successful resubmissions enabling significant stock recoveries. - Fortress Biotech's CUTX-101 and Capricor Therapeutics' deramiocel demonstrate that CRLs are not terminal, as both programs advanced toward approval following resubmission.
- Eli Lilly reported Q1 revenues of $19.8 billion, up 55.5% year-on-year, beating analyst estimates by 13.7% and posting the fastest revenue growth among branded pharma peers. - Merck delivered revenues of $16.29 billion, a 4.9% increase year-on-year, exceeding analyst expectations by 3% with a beat on EPS estimates. - Supernus Pharmaceuticals posted revenues of $207.7 million, up 38.6% year-on-year, driven by a 56% increase in combined growth product revenues, though EPS estimates were significantly missed. - The broader branded pharmaceuticals sector saw aggregate revenues beat consensus estimates by 3.6%, with tailwinds from precision medicine and AI adoption offset by pricing pressures and patent cliffs.
- The SPDR S&P Pharmaceuticals ETF (XPH) delivered a 38.00% one-year total return as of June 3, 2026, outperforming the First Trust NYSE Arca Biotech ETF (FBT) at 35.90%. - XPH carries a lower expense ratio of 0.35% compared to FBT's 0.55%, offering a cost advantage for long-term investors in the pharmaceutical space. - Both ETFs concentrate 42% of assets in their top 10 holdings, with Corcept Therapeutics appearing as a top-10 position in each fund. - The SPDR Biotech ETF (XBI) posted a 58.30% one-year return but experienced a 54.70% maximum drawdown over five years, highlighting the higher volatility of the biotech sub-sector.
- Corcept Therapeutics' dazucorilant demonstrated an 87% reduction in death risk after two years in ALS patients receiving 300mg daily compared to placebo in the Phase II DAZALS study. - The trial failed to meet its primary endpoint of functional improvement as measured by ALSFRS-R scores at 24 weeks, but showed significant survival benefit as a key secondary endpoint. - The company plans to initiate a pivotal Phase III study later this year following discussions with regulators to advance the selective cortisol modulator program. - The 249-patient randomized, double-blind study showed consistent survival benefits, with an 84% reduction in death risk observed after one year of treatment.
- The FDA issued a Complete Response Letter for Corcept Therapeutics' relacorilant, rejecting approval for treating hypertension secondary to hypercortisolism despite acknowledging that the pivotal GRACE trial met its primary endpoint. - The Agency concluded it could not arrive at a favorable benefit-risk assessment without additional evidence of effectiveness, even though data from the GRADIENT trial provided confirmatory evidence. - Corcept's CEO expressed surprise and disappointment at the outcome, stating the company will meet with the FDA as soon as possible to discuss the best path forward for getting relacorilant to patients. - The rejection represents a significant setback for Corcept's efforts to reduce reliance on its sole approved drug Korlym and transition to a multi-asset profitability company.
- Novartis reported positive Phase III VAYHIT2 trial results showing ianalumab plus eltrombopag prolonged immune thrombocytopenia disease control by 45% compared to placebo. - The combination therapy achieved a median time to treatment failure of 13.0 months, 2.8 times longer than the 4.7 months observed with placebo plus eltrombopag. - Multiple pharmaceutical companies are advancing ITP treatments through clinical trials, with over 30 companies developing 30+ pipeline therapies for this autoimmune bleeding disorder. - Recent clinical trial initiations include studies by Incyte, argenx, and Eli Lilly evaluating novel therapeutic approaches for primary immune thrombocytopenia.
- DelveInsight's 2025 pipeline report reveals over 20 companies are actively developing more than 30 therapeutic candidates for hereditary angioedema treatment across various clinical stages. - Recent clinical developments include CSL Behring's Phase 3b study of garadacimab (CSL312) announced in August 2025 and KalVista's pediatric trial of KVD900 for patients aged 2-11 years. - Leading pipeline therapies span multiple approaches including oral plasma kallikrein inhibitors, gene therapies, and monoclonal antibodies, with products in late-stage development showing promise for addressing unmet medical needs.
- The FDA approved osilodrostat (Isturisa) as a second-line treatment for adults with endogenous Cushing syndrome in April 2025, expanding treatment options for patients unable to undergo surgery. - Relacorilant demonstrated significant cardiometabolic benefits in Phase III trials, showing notable blood pressure reductions of -10.1 mm Hg systolic and -6.3 mm Hg diastolic compared to placebo increases. - Multiple companies including Corcept Therapeutics, Crinetics Pharmaceuticals, and AstraZeneca are developing novel therapies with over 4 investigational treatments in various clinical phases. - The Cushing syndrome pipeline includes diverse therapeutic approaches targeting cortisol synthesis inhibition and glucocorticoid receptor modulation across oral and parenteral administration routes.
- MBX Biosciences appointed Andreas Moraitis, M.D., as Senior Vice President of Clinical Development to lead advancement of canvuparatide for hypoparathyroidism treatment. - Dr. Moraitis brings over a decade of experience from Corcept Therapeutics, where he led clinical programs in rare endocrine diseases and supported NDA filing for relacorilant. - The appointment strengthens MBX's clinical capabilities as canvuparatide progresses through Phase 2 development for chronic hypoparathyroidism, addressing significant unmet medical needs. - MBX's pipeline includes multiple candidates targeting endocrine and metabolic disorders, with canvuparatide as the lead product candidate and additional programs in obesity and post-bariatric hypoglycemia.
