Key Takeaways CELC filed an NDA for gedatolisib in HR , HER2- advanced breast cancer, with an FDA decision due in 2026.Phase III VIKTORIA-1 data showed strong PFS gains, supporting gedatolisib as a second-line option.Celcuity completed enrollment in another VIKTORIA-1 cohort, with more cancer studies underway.Celcuity (CELC) has made significant clinical and regulatory progress in the past few months. In November, Celcuity submitted a new drug application (“NDA”) to the FDA seeking approval for its lead pip ...

Core Insights - Viatris Inc. (VTRS) has announced four significant regulatory achievements in its pipeline, highlighting its R&D progress for 2025 and its commitment to advancing its portfolio globally [2][9]. Regulatory Approvals - The FDA has approved Viatris' octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot, which is used for treating acromegaly and certain types of diarrhea related to tumors [3][4]. - This approval marks VTRS' first injectable product utilizing microsphere technology and is the fourth injectable approval for the company in 2025, enhancing its generics portfolio with complex, high-value products [4]. - The FDA has accepted VTRS' new drug application (NDA) for a low-dose estrogen weekly contraceptive patch, aimed at women with a BMI below 30 kg/m², with a target action date set for July 30, 2026 [5][6]. - The patch delivers approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol daily, representing a new option for women seeking lower estrogen doses [6][7]. - The FDA has cleared an investigational new drug (IND) application for MR-146, a gene therapy candidate for neurotrophic keratopathy, with a phase I/II clinical trial planned for the first half of 2026 [8][9]. - Viatris has also received acceptance for its Japanese NDA for pitolisant in obstructive sleep apnea syndrome (OSAS), with plans to submit a separate NDA for narcolepsy by year-end [10][11]. Company Performance - Viatris has demonstrated strong performance over the past six months, with shares increasing by 34.6%, compared to the industry growth of 6.1% during the same period [12]. - The company's expansion in Emerging Markets and robust growth in Greater China are positively impacting sales, with new drug approvals expected to further enhance its portfolio [13].

Core Insights - Corcept Therapeutics (CORT) has submitted a new drug application (NDA) to the FDA for its lead candidate, relacorilant, in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer [1][7] - The NDA submission is based on positive data from the pivotal phase III ROSELLA study, which met its primary endpoint of improved progression-free survival [3][2] - The company aims to diversify its product offerings beyond its sole marketed drug, Korlym, to reduce reliance on it for growth [9][7] NDA Submissions and Studies - In December 2024, CORT submitted an NDA for relacorilant to treat hypercortisolism (Cushing's syndrome), which was accepted by the FDA in March 2025 with a target action date of December 30, 2025 [5][2] - The NDA for platinum-resistant ovarian cancer is supported by data from the ROSELLA study and other phase II studies [2][3] - CORT is also conducting additional studies, including the BELLA study, which evaluates relacorilant in combination with nab-paclitaxel and Roche's Avastin for the same indication [10] Financial Performance - Year to date, CORT shares have increased by 44.4%, significantly outperforming the industry average rise of 4.1% [4] - Korlym generated sales of $157.2 million in Q1 2025, reflecting a year-over-year increase of 7.1% due to strong demand [8] Pipeline and Future Prospects - CORT is exploring relacorilant in combination with Xtandi for early-stage prostate cancer and evaluating its selective cortisol modulator dazucorilant for amyotrophic lateral sclerosis (ALS) [11] - Another candidate, miricorilant, is being studied for metabolic dysfunction-associated steatohepatitis [12] - A potential approval for relacorilant could expand CORT's patient base and reduce dependence on Korlym for long-term growth [9]