Market Cap: $74 Million
Cash: $25.7 Million
Shares Out: 21.2 Million
The previously scheduled Bone, Reproductive and Urologic Drugs Advisory Committee (“BRUDAC”) meeting on January 10, 2018 to discuss the NDA for TLANDO remains unchanged.
The FDA has assigned a new Prescription Drug User Fee Act (“PDUFA”) goal date of May 8, 2018.
TLANDO™: Potential first oral TRT option
-Differentiated product targeting ~$2.0 billion established US TRT market
-Poised to meet and exceed unmet need
LPCN has resubmitted its NDA for Tlando and has been assigned both a PDUFA and AdCom date. We are optimistic that Lipocine can successfully navigate both of these regulatory requirements and obtain FDA approval. Following the anticipated approval, Lipocine will develop the required sales force and find an appropriate partner to commercialize the primary care segment over the following 90 days. Based on this timeline, first sales are anticipated to take place near mid-year 2018. Lipocine will then be able to launch its first product and shift its development efforts towards LPCN 1111 and 1107.
Top Shareholders :
Royce & Associates LP 843 142 3,98%
Mahesh V. Patel, PhD 713 112 3,36%
The Vanguard Group, Inc. 661 337 3,12%
Carlson Capital LP 500 000 2,36%
John W. Higuchi, MBA 475 248 2,24%
DLD Asset Management LP 401 295 1,89%
VHCP Management LLC 386 928 1,83%
BlackRock Fund Advisors 330 684 1,56%
Renaissance Technologies LLC 228 600 1,08%
Millennium Management LLC 193 269 0,91%