Latest news with #drugapproval
Yahoo
26 minutes ago
- Business
- Yahoo
Corcept Advances Cancer Drug as Analysts Back Strong Growth Prospects
Corcept Therapeutics Incorporated (NASDAQ:CORT) is one of the . Analysts are reiterating their Buy rating for the stock amid advancements in ovarian cancer treatment. A biologist in a lab coat studying a culture of cells to find a cure for metabolic disorders. Corcept Therapeutics Incorporated (NASDAQ:CORT) is a pharmaceutical company specializing in cortisol modulation by developing compounds that antagonize the glucocorticoid receptor. Based in California, the company treats Cushing's syndrome with its commercial drug Korlym. The company advances a pipeline of over 30 clinical-stage molecules for endocrinology, oncology, metabolism, and neurology. On July 14, 2025, the company announced that it had filed for a new drug application to the U.S. FDA for relacorilant. Relacorilant is a selective cortisol modulator for treating platinum-resistant ovarian cancer. The submission follows the positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. The trials indicated that relacorilant combined with nab-paclitaxel offers improved progression-free and overall survival, without increasing the safety burden of the patients. Since platinum-resistant ovarian cancer currently has limited therapies, the FDA approval for relacorilant has high expectations. Amid this advancement in Corcept Therapeutics Incorporated (NASDAQ:CORT)'s relacorilant, Piper Sandler and H.C. Wainwright reiterated their Buy rating on the stock. Piper Sandler maintains a price target of $131 while H.C. Wainwright has set the price target at $145. With an impressive projected 5-year EPS growth of 69.48% and a low beta of 0.21, Corcept Therapeutics Incorporated (NASDAQ:CORT) promises an attractive investment for those seeking high growth at low risk. While we acknowledge the potential of CORT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Metal Stocks with Insider Buying in 2025 and 10 Energy Stocks with Insider Buying in 2025 Disclosure. None. 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
Daily Mail
5 days ago
- Business
- Daily Mail
Cancer drug snub wipes £3bn off GSK value
Shares in GSK tumbled after a key blood cancer drug failed to win over US regulators – wiping more than £3billion off its value. In a setback for chief executive Emma Walmsley, a Food and Drug Administration (FDA) committee recommended against approving Blenrep amid concerns over side effects. GSK was trying to revive a product pulled from US markets in 2022. Its shares fell 4.6 per cent, or 65p, to 1348p yesterday. The pharma firm hoped two trials showed Blenrep helped reduce the risk of death and delayed cancer progression as it seeks newer drug approvals to offset declining sales from top medicines and vaccines. GSK is also bracing for HIV patents to expire from 2028. The FDA is due to give its formal decision next week, but bank analysts say that gaining approval is unlikely. Side effects cited by the FDA advisory panel included blurred vision and dry eyes.
Bloomberg
6 days ago
- Health
- Bloomberg
GSK's Blood Cancer Drug Blenrep Fails to Win FDA Panel Support
GSK Plc's blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt. The US Food and Drug Administration 's Oncologic Drugs Advisory Committee voted that the risks from the drug, called Blenrep, outweighed its benefits. Panelists voted 5-to-3 against a combination of Blenrep and the generic cancer drug Velcade and 7-to-1 against the drug in tandem with Pomalyst, marketed by Bristol Myers Squibb Co.
Reuters
6 days ago
- Health
- Reuters
FDA advisers vote against combination therapies of GSK's blood cancer drug
July 17 (Reuters) - The U.S. Food and Drug Administration's panel of independent advisers voted on Thursday against approval of GSK's (GSK.L), opens new tab blood cancer drug Blenrep for use in combination with other treatments.
South China Morning Post
14-07-2025
- Health
- South China Morning Post
How Hong Kong's new drug regulator can give the city a competitive edge
Feel strongly about these letters, or any other aspects of the news? Share your views by emailing us your Letter to the Editor at letters@ or filling in this Google form . Submissions should not exceed 400 words, and must include your full name and address, plus a phone number for verification Last month, the Department of Health announced the timetable for establishing the Centre for Medical Products Regulation (CMPR). In line with recommendations from the chief executive's 2023 policy address, and with the adoption of primary evaluation of clinical data, this new regulator is a major step forward in the city's ambition to become a global hub for health and medical innovation. To attract investment and talent to Hong Kong, the CMPR needs to offer value on top of existing initiatives. One Greater Bay Area scheme, in particular, allows drugs and devices adopted in Hong Kong or Macau to gain expedited access to mainland China through Guangdong province. As of April, 51 drugs and 63 devices have been approved under the scheme. Between April 2023 and September 2024, 18 of the drugs were approved in four batches. For context, Hong Kong registered around 400 new medicines in the past year alone. According to our analysis, most of the 18 drugs were first approved in the United States through priority or orphan drug pathways to treat serious conditions. Eight drugs obtained Hong Kong approval within two years of US approval. The CMPR could enable Hong Kong to launch more new drugs within an earlier global window. By September 2024, the median time for approval under the Greater Bay Area measure had fallen to around six months. After Guangdong adopted provincial legislation, this timeline has been compressed to 10 days. Macau, meanwhile, has emerged as a competitive entry point, with five drugs approved there before Hong Kong. Eight of the 18 drugs subsequently obtained national approval, on average within 21 months of their initial approval in Hong Kong or Macau. As pharmaceutical companies increasingly prioritise early launches in mainland China, fewer drugs will have sufficient lead time to make effective use of the Greater Bay Area measure.
