Lipocine Inc. (LPCN) is a specialty pharmaceutical company. The Company is focused on applying its oral drug delivery technology for the development of pharmaceutical products in the area of men's and women's health. Its primary development programs are based on oral delivery solutions for bioavailable drugs. Its lead product candidate, LPCN 1021, is an oral testosterone replacement therapy (TRT), designed for twice-a-day dosing and is in Phase III testing. The Company's additional pipeline candidates include LPCN 1111, an oral testosterone therapy product targeted for once daily dosing, which is in Phase II testing, and LPCN 1107, an oral therapy for the prevention of preterm birth, which is in Phase I testing. These products are based on its Lip'ral promicellar drug delivery technology platform. Lip'ral promicellar technology is a technology based on lipidic compositions, which form an optimal dispersed phase in the gastrointestinal environment for improved absorption of insoluble drugs.
H.C. Wainwright analyst Corey Davis came out today with an extremely bullish call on Lipocine Inc (NASDAQ:LPCN), sending shares up nearly 24% to $5.29 in early trading Friday. The analyst initiated coverage on the stock with a Buy rating and price target of $25, which implies an upside of 364% from current levels. http://www.smarteranalyst.com/2016/10/07/heres-lipocine-inc-lpcn-shares-jumped-24-today/
HIGH RISK Bio Stock but with significant upside potential if everything goes well . ADCOM meeting on January 10 for Lipocine´s Tlando the potential FIRST Oral product for the treatment of hypogonadism , if outcome is positive the stock will likely jump close or above $10 easily especially because of its low float more infos below and good luck . Lipocine (LPCN) Market Cap: $74 Million Cash: $25.7 Million Price: $3.50 Shares Out: 21.2 Million Latest Presentation files.shareholder.com/downloads/AMDA-2BVSIV/5783990236x0x958103/2EB5BE41-D62A-4270-9634-2DAE6A0E1438/LPCN_11.08.17_long_FINAL__002_.pdf 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 finance.yahoo.com/news/lpcn-third-quarter-operational-financial-180000459.html Summary 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%
