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Friday, December 29, 2017 10:12:42 AM
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%
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Recent LPCN News
- Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024 • PR Newswire (US) • 05/09/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 10:06:19 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 10:03:08 AM
- Lipocine Announces Late Breaking Oral Presentation of Data from the Phase 2 Study of LPCN 1148 at EASL Congress 2024 • PR Newswire (US) • 05/08/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 10:15:30 AM
- Lipocine Announces Completion of Dosing in Pivotal Study of Postpartum Depression Candidate, LPCN 1154 • PR Newswire (US) • 05/01/2024 12:00:00 PM
- Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity • PR Newswire (US) • 04/11/2024 11:00:00 AM
- Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis • PR Newswire (US) • 03/28/2024 12:00:00 PM
- Lipocine Announces First Cohort Dosed in Pivotal Study of LPCN 1154 • PR Newswire (US) • 03/25/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 10:31:06 PM
- Lipocine Announces Financial Results for the Full Year Ended December 31, 2023 • PR Newswire (US) • 03/07/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:08:06 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/07/2024 11:07:26 AM
- Lipocine to Present at 36th Annual Roth Conference • PR Newswire (US) • 03/06/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 11:01:31 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/12/2024 09:10:26 PM
- Lipocine Announces Confirmation of Dosing Regimen for Pivotal Study of LPCN 1154 • PR Newswire (US) • 02/06/2024 01:00:00 PM
- Lipocine Announces Continued Commercialization of TLANDO® through Verity Pharmaceuticals • PR Newswire (US) • 02/02/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/18/2024 01:20:46 PM
- Lipocine and Verity Pharma Enter into License Agreement for TLANDO® Franchise in the U.S. and Canada • PR Newswire (US) • 01/18/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/19/2023 03:00:12 PM
- Lipocine to Present at Biotech Showcase 2024 • PR Newswire (US) • 12/19/2023 01:00:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 11/22/2023 09:15:57 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/13/2023 07:45:33 PM
- Lipocine Releases Late Breaking Presentation on LPCN 1148 Phase 2 Results at The Liver Meeting® 2023 • PR Newswire (US) • 11/13/2023 07:45:00 PM
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