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Business Wire
6 days ago
- Health
- Business Wire
Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elinzanetant. Elinzanetant is the first neurokinin 1 and neurokinin 3 receptor antagonist in late-stage clinical development for the hormone-free treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. The FDA has determined additional time is needed for a full review of the NDA submission, including information provided to support the application. The extension to the Prescription Drug User Fee Act (PDUFA) review period is up to 90 days. The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence. 'We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,' said Yesmean Wahdan, M.D., Senior Vice President and Head of Medical Affairs, North America, Pharmaceuticals. 'We continue to work with the FDA to make this treatment available for women in menopause with moderate to severe hot flashes. Despite the universal experience of menopause, social stigma and misinformation persist, leaving many women to suffer without treatment and support. It's critical we advance innovation and education in menopause so women can work with their healthcare provider to determine the best option for them.' The NDA is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Results from OASIS 1 and 2 were published in August 2024 in The Journal of the American Medical Association (JAMA). Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024. In the last 30 days, elinzanetant was approved under the brand name Lynkuet™ in the United Kingdom and Canada. Submissions for marketing authorizations for elinzanetant are also ongoing in the EU and other markets around the world. About Women's Healthcare at Bayer Women's Health is in Bayer's DNA. As a global leader in women's healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low- and middle- income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Business Wire
14-07-2025
- Business
- Business Wire
Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer. Corcept's filing is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms. Relacorilant did not increase the safety burden of the patients who received it. 'This submission is an important milestone for Corcept as we now have two New Drug Applications before the FDA: Relacorilant in combination with nab-paclitaxel as a treatment for people with platinum-resistant ovarian cancer and relacorilant as a treatment for patients with hypercortisolism,' said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. 'Better treatment options are needed for the many patients living with these diseases. Our oncology and endocrinology business units are already working to make sure relacorilant is available immediately following regulatory approval.' About Relacorilant Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism. About Cortisol's Role in Oncology Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body's immune response, which weakens its ability to fight all diseases, including cancer. About Platinum-Resistant Ovarian Cancer Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have 'platinum-resistant' disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements concerning: relacorilant's potential to receive regulatory approval from the FDA as a treatment for patients with platinum-resistant ovarian cancer and for patients with hypercortisolism; relacorilant's ability to provide important benefits to patients living with these diseases; relacorilant's availability following potential regulatory approval; the scope and protective power of relacorilant's orphan drug designation and our intellectual property; and the potential of cortisol modulation to treat patients with a wide variety of serious disorders. We disclaim any intention or duty to update forward-looking statements made in this press release.
Yahoo
14-07-2025
- Business
- Yahoo
Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer
REDWOOD CITY, Calif., July 14, 2025--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer. Corcept's filing is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms. Relacorilant did not increase the safety burden of the patients who received it. "This submission is an important milestone for Corcept as we now have two New Drug Applications before the FDA: Relacorilant in combination with nab-paclitaxel as a treatment for people with platinum-resistant ovarian cancer and relacorilant as a treatment for patients with hypercortisolism," said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. "Better treatment options are needed for the many patients living with these diseases. Our oncology and endocrinology business units are already working to make sure relacorilant is available immediately following regulatory approval." About Relacorilant Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism. About Cortisol's Role in Oncology Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body's immune response, which weakens its ability to fight all diseases, including cancer. About Platinum-Resistant Ovarian Cancer Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements concerning: relacorilant's potential to receive regulatory approval from the FDA as a treatment for patients with platinum-resistant ovarian cancer and for patients with hypercortisolism; relacorilant's ability to provide important benefits to patients living with these diseases; relacorilant's availability following potential regulatory approval; the scope and protective power of relacorilant's orphan drug designation and our intellectual property; and the potential of cortisol modulation to treat patients with a wide variety of serious disorders. We disclaim any intention or duty to update forward-looking statements made in this press release. View source version on Contacts Investor inquiries:ir@ Media inquiries:communications@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Malaysian Reserve
09-07-2025
- Business
- Malaysian Reserve
U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer
Orphan drug designation highlights the potential for ADRX-0405 to address the high unmet need in gastric cancer SAN DIEGO, July 8, 2025 /PRNewswire/ — Adcentrx Therapeutics ('Adcentrx'), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ADRX-0405, for the treatment of patients with gastric cancer. ADRX-0405 is a STEAP1 ADC being evaluated in the Phase 1a portion of an ongoing Phase 1a/b clinical trial (NCT06710379) for the treatment of select advanced solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. While STEAP1 is primarily associated with prostate cancer, there is a meaningful amount of target expression in gastric cancer, making this a potential indication of interest for future clinical development. 'Receiving orphan drug designation from FDA is a notable milestone for Adcentrx and reinforces the potential for ADRX-0405 to improve the lives of patients with gastric cancer,' said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. 'We are encouraged by the progress of our Phase 1a trial and look forward to further evaluating the safety, tolerability and anti-tumor activity of ADRX-0405 in gastric and other cancers.' Gastric cancer, or stomach cancer, is a serious malignancy that develops in the stomach lining and is often diagnosed at advanced stages. The American Cancer Society estimates there will be 30,300 new cases of gastric cancer in the U.S. in 2025, meeting FDA's criteria for a rare disease. The orphan drug designation is a program designed to stimulate the development of treatments for rare diseases, defined as conditions affecting fewer than 200,000 people in the U.S. Benefits of this designation include access to grant funding and scientific assistance, tax credits for qualified clinical trials, waiver of Prescription Drug User Fee Act (PDUFA) application fees, and the potential for seven years of market exclusivity following regulatory approval. About ADRX-0405ADRX-0405 is a clinical-stage next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers with limited expression in normal healthy tissue. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx's innovative i-Conjugation® technology platform – a core component in the design of the company's ADCs. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial. For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on About Adcentrx TherapeuticsAdcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit Contact Information:Investor Relationsir@
Yahoo
12-06-2025
- Business
- Yahoo
Capricor says FDA inspection brought Form 483 with several observations
Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration's pre-license inspection of its San Diego manufacturing facility for Deramiocel, the company's lead cell therapy candidate with a biologics license application under FDA review for potential approval in the treatment of Duchenne muscular dystrophy. The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or facility. 'The observations were primarily related to routine quality systems and documentation practices. The Company is confident that the facility will meet the necessary requirements to support product licensure and, pending approval, commercial launch,' Capricor added. The FDA informed Capricor of its intent to hold the Advisory Committee meeting on July 30, although that date is pending confirmation by the FDA. 'At the time of the mid-cycle review, no significant issues or major deficiencies were noted. A late-cycle meeting is planned for mid-July 2025,' the company added. The BLA for Deramiocel remains under priority review with a Prescription Drug User Fee Act action date of August 31. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on CAPR: Disclaimer & DisclosureReport an Issue Largest borrow rate increases among liquid names Capricor Therapeutics participates in a conference call with Maxim Capricor Therapeutics Approves 2025 Equity Incentive Plan MongoDB and Asana downgraded: Wall Street's top analyst calls Capricor Therapeutics initiated with a Buy at Roth Capital
