Avastin (bevacizumab)

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FDA Accepts Corcept's NDA for Relacorilant in Ovarian Cancer
ZACKS· 2025-09-11 17:01
Key Takeaways FDA accepted Corcept's NDA for relacorilant in platinum-resistant ovarian cancer.NDA backed by positive phase III ROSELLA and phase II study data with relacorilant nab-paclitaxel.Decision on CORT's NDA for relacorilant in ovarian cancer is expected from the FDA by July 11, 2026.Corcept Therapeutics (CORT) announced that the FDA has accepted the new drug application (NDA) seeking approval for its lead pipeline candidate, relacorilant, for treating patients with platinum-resistant ovarian cancer ...
OTLK Stock Crashes 54% as FDA Issues Second CRL for Eye Disease Drug
ZACKS· 2025-08-29 15:41
Key Takeaways OTLK stock dropped 54.1% after the FDA issued a second CRL for ONS-5010 in wet AMD.The CRL cited insufficient efficacy as ONS-5010 missed the NORSE EIGHT non-inferiority endpoint.OTLK will meet with the FDA for clarity regarding requirements.Shares of Outlook Therapeutics (OTLK) tumbled 54.1% after the FDA issued a second complete response letter (CRL) rejecting its biologics license application (BLA) resubmission for ONS-5010 in wet age-related macular degeneration (wet AMD).The CRL cited a s ...
CORT's Q2 Earnings Top Mark, Revenues Lag, '25 View Cut, Stock Down
ZACKS· 2025-08-01 17:05
Core Insights - Corcept Therapeutics (CORT) reported Q2 2025 earnings of $0.29 per share, exceeding the Zacks Consensus Estimate of $0.23, but down from $0.32 in the same quarter last year [1][7] - Revenues for the second quarter increased by 18.7% year over year to $194.4 million, although this figure fell short of the Zacks Consensus Estimate of $204 million [1][4] - The revenue was solely derived from product sales of the Cushing's syndrome drug, Korlym [1] Financial Performance - Revenue from Korlym missed the model estimate of $211.7 million [4] - Research and development expenses rose by 3.1% year over year to $60.5 million [4] - Selling, general, and administrative expenses surged by approximately 55.1% year over year to $103.8 million [4] - Total operating expenses increased by 30.8% year over year to $167.8 million in Q2 [4] - Cash and investments as of June 30, 2025, totaled $515 million, down from $570.8 million as of March 31, 2025 [5] Guidance and Market Reaction - Corcept lowered its total revenue guidance for 2025 to a range of $850-$900 million from the previous $900-$950 million [6][8] - This revision may have negatively impacted investor sentiment, leading to a 4.7% decline in stock price during pre-market trading on August 1 [8] Pipeline Developments - Corcept submitted a new drug application (NDA) to the FDA for its lead pipeline candidate, relacorilant, in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer [9] - The NDA submission was based on data from the pivotal phase III ROSELLA study, which met its primary endpoint of improved progression-free survival [10] - The company is also evaluating relacorilant in combination with nab-paclitaxel and Avastin in the phase II BELLA study for the same indication [11][12] - Additional studies are ongoing for relacorilant in early-stage prostate cancer and for other pipeline candidates targeting various conditions [13] Market Performance - Year-to-date, Corcept's shares have increased by 33.3%, significantly outperforming the industry average rise of 4.5% [2]
Corcept Seeks FDA Approval for Relacorilant in Ovarian Cancer
ZACKS· 2025-07-15 15:21
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]
TPST to Evaluate Strategic Options for Pipeline Studies, Stock Up
ZACKS· 2025-04-10 16:05
Core Viewpoint - Tempest Therapeutics, Inc. is exploring strategic options to enhance stockholder value, which may include mergers, acquisitions, partnerships, or licensing arrangements [1] Company Development Plans - Tempest is developing amezalpat (TPST-1120), a PPAR-alpha antagonist, for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) [2] - The company is also working on TPST-1495, a selective EP2-EP4 dual antagonist, for treating familial adenomatous polyposis (FAP) [2] - Tempest has partnered with Roche to evaluate amezalpat in combination with Roche's Tecentriq and Avastin for HCC treatment [5] - The FDA has cleared Tempest to begin a pivotal phase III study for amezalpat in combination with Roche's therapy for HCC [6] - Ongoing studies have shown that amezalpat combined with Roche's therapy resulted in a six-month improvement in median overall survival compared to the standard therapy alone [7] - The FDA has granted Fast Track and Orphan Drug designations to amezalpat for HCC treatment [7] - Tempest has received a "Study May Proceed" letter from the FDA for a phase II study on TPST-1495, expected to start in 2025 [9] - The FDA has also granted Orphan Drug designation to TPST-1495 for FAP treatment [9] - Management believes that amezalpat has blockbuster potential in HCC, while TPST-1495 also shows promise [10] Stock Performance - Following the announcement of strategic options, Tempest's shares rose by 6.3% in after-hours trading on April 9 [2] - Year-to-date, Tempest's shares have decreased by 34.1%, compared to a 14.6% decline in the industry [3]