Celcuity Inc. unveils new data on gedatolisib for advanced breast cancer in investor presentation

Reuters

11/14

<a href="https://laohu8.com/S/CELC">Celcuity Inc</a>. unveils new data on gedatolisib for advanced breast cancer in investor presentation

Celcuity Inc. has released new data from its Phase 3 VIKTORIA-1 clinical study evaluating gedatolisib in patients with HR+/HER2-, PIK3CA wild-type advanced breast cancer. The study showed that gedatolisib combinations met both primary endpoints by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant. Specifically, the triplet combination of gedatolisib, fulvestrant, and palbociclib achieved a median progression-free survival (mPFS) of 9.3 months versus 2.0 months for fulvestrant alone, reflecting a 7.3-month improvement. The company plans to submit a New Drug Application for the PIK3CA wild-type cohort in the fourth quarter of 2025. Celcuity is also advancing clinical trials of gedatolisib in other cancer types, including metastatic castration-resistant prostate cancer. As of the third quarter of 2025, the company reported cash and investments of $455 million, projected to fund operations through 2027. You can access the full presentation through the link below.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief on November 13, 2025, and is solely responsible for the information contained therein.

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The study showed that gedatolisib combinations met both primary endpoints by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant. Specifically, the triplet combination of gedatolisib, fulvestrant, and palbociclib achieved a median progression-free survival (mPFS) of 9.3 months versus 2.0 months for fulvestrant alone, reflecting a 7.3-month improvement. The company plans to submit a New Drug Application for the PIK3CA wild-type cohort in the fourth quarter of 2025. Celcuity is also advancing clinical trials of gedatolisib in other cancer types, including metastatic castration-resistant prostate cancer. As of the third quarter of 2025, the company reported cash and investments of $455 million, projected to fund operations through 2027. You can access the full presentation through the link below.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief on November 13, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"CELC","symbol_name":"Celcuity Inc","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251113:nNDL5jqR2n:1","article_id":"2583263548","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2583263548","pubTimestamp":1763074248,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Celcuity Inc. has released new data from its Phase 3 VIKTORIA-1 clinical study evaluating gedatolisib in patients with HR+/HER2-, PIK3CA wild-type advanced breast cancer. The study showed that gedatolisib combinations met both primary endpoints by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant. Specifically, the triplet combination of gedatolisib, fulvestrant, and palbociclib achieved a median progression-free survival  of 9.3 months versus 2.0 months for fulvestrant alone, reflecting a 7.3-month improvement. The company plans to submit a New Drug Application for the PIK3CA wild-type cohort in the fourth quarter of 2025. Celcuity is also advancing clinical trials of gedatolisib in other cancer types, including metastatic castration-resistant prostate cancer. As of the third quarter of 2025, the company reported cash and investments of $455 million, projected to fund operations through 2027. 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