FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis [Yahoo! Finance]
Lipocine Inc. (LPCN)
Last lipocine inc. earnings: 11/12 04:00 pm
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Source: Yahoo! Finance
leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept (POC) Phase 2 study in patients with decompensated cirrhosis. Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for management of cirrhosis. (PRNewsfoto/Lipocine Inc.) "We are excited the FDA has recognized that sarcopenia in patients with cirrhosis is a serious condition and that LPCN 1148 has the potential to provide clinical benefits for these patients where no therapy currently exists," said Dr. Mahesh Patel, President and Chief Executive Officer of Li
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LPCN
News
- Lipocine Inc. (NASDAQ: LPCN) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Lipocine Inc. (NASDAQ: LPCN) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated CirrhosisPR Newswire
- Lipocine Inc. (NASDAQ: LPCN) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Lipocine Inc. (NASDAQ: LPCN) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
LPCN
Sec Filings
- 1/2/25 - Form 4/A
- 1/2/25 - Form 4
- 12/30/24 - Form 4
- LPCN's page on the SEC website