LipocineLPCN
LPCN
About: Lipocine Inc is a clinical-stage biopharmaceutical company, that is engaged in research and development for the delivery of drugs using its proprietary delivery technology. Its principal operation is to provide oral delivery solutions for existing drugs. Lipocine develops its drug candidates or it develops drug candidates on behalf of or in collaboration with corporate partners. The company's product TLANDO is an oral testosterone replacement therapy ("TRT"). It also has other products in the pipeline such as LPCN 1144, TLANDO, TLANDO XR, LPCN 1148, LPCN 1107, LPCN 1154, and LIP'RAL7 Technology. The Company has a single reportable segment, research, and development for the delivery of drugs using its proprietary delivery technology.
Employees: 16
0
Funds holding %
of 7,407 funds
–
Analysts bullish %
Fund manager confidence
Based on 2024 Q4 regulatory disclosures by fund managers ($100M+ AUM)
0% more repeat investments, than reductions
Existing positions increased: 4 | Existing positions reduced: 4
3% less capital invested
Capital invested by funds: $2.44M [Q3] → $2.37M (-$70K) [Q4]
1.08% less ownership
Funds ownership: 10.18% [Q3] → 9.1% (-1.08%) [Q4]
6% less funds holding
Funds holding: 18 [Q3] → 17 (-1) [Q4]
50% less first-time investments, than exits
New positions opened: 1 | Existing positions closed: 2
Research analyst outlook
We haven’t received any recent analyst ratings for LPCN.
Financial journalist opinion
Neutral
PRNewsWire
3 weeks ago
Lipocine Announces Initiation of Outpatient Phase 3 Postpartum Depression Trial of LPCN 1154
48 hour at-home dosing Patient dosing expected in Q2/2025 SALT LAKE CITY , March 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD). Based on observed comparable exposure of LPCN 1154 and the reference drug established in the pharmacokinetic (PK) bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dosed in the second quarter of 2025.
Neutral
PRNewsWire
1 month ago
Lipocine Announces Financial Results for the Full Year Ended December 31, 2024
SALT LAKE CITY , March 13, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the year ended December 31, 2024, and provided a corporate update. Oral Brexanolone LPCN 1154 is an oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the rapid treatment of postpartum depression (PPD).
Neutral
PRNewsWire
1 month ago
Lipocine Announces FDA Labeling Changes for Testosterone Products
SALT LAKE CITY , March 12, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration (FDA) has recently informed sponsors of approved testosterone products about class-wide labeling changes. This decision follows the Agency's review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required post market ambulatory blood pressure (ABPM) studies.
Neutral
PRNewsWire
2 months ago
Lipocine Receives Updated Regulatory Guidance on LPCN 1154
SALT LAKE CITY , Feb. 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced receipt of revised regulatory guidance for LPCN 1154 which the Company is developing for postpartum depression (PPD) treatment. As previously disclosed, the Company was scheduled to meet with the U.S. Food and Drug Administration (FDA or the Division) in Q1 2025 to discuss the NDA submission package of LPCN 1154.
Neutral
PRNewsWire
4 months ago
FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis
SALT LAKE CITY , Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company 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.
Neutral
PRNewsWire
5 months ago
Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session
SALT LAKE CITY , Nov. 18, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced the publication and discussion of a manuscript "Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial" in the journal Hepatology and discussion at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session held on November 16, 2024. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for overt hepatic encephalopathy and sarcopenia indications.
Neutral
PRNewsWire
5 months ago
Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024
SALT LAKE CITY , Nov. 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD).
Neutral
PRNewsWire
5 months ago
Lipocine Announces Distribution and License Agreement with SPC Korea to Commercialize TLANDO® in South Korea
SALT LAKE CITY , Oct. 31, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced a license, development and supply agreement with to SPC Korea http://spcpharm.co.kr granting exclusive rights to market TLANDO® in South Korea. Under the terms of the distribution and license agreement, Lipocine will receive an upfront payment and is also eligible to receive certain regulatory and sales milestone payments, including a payment upon regulatory approval of TLANDO in South Korea.
Neutral
PRNewsWire
6 months ago
Lipocine Announces Positive Oral Brexanolone Quantitative EEG Results
Quantitative Electroencephalogram (qEEG) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid (NAS), confirmed GABAA modulation Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders SALT LAKE CITY , Oct. 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive data from its qEEG study of its oral brexanolone, a proprietary bioidentical NAS being developed for the treatment of post-partum depression (PPD). Changes in spectral power (a quantitative measure of the strength or intensity of specific brain wave frequencies) are frequently used to characterize the effects of drug candidates and may have utility in indication and dose selection in CNS clinical trials.
Neutral
PRNewsWire
6 months ago
Lipocine Announces Supply and Distribution Agreement with Pharmalink to Commercialize TLANDO® in the Gulf Cooperation Council (GCC) Countries
SALT LAKE CITY , Oct. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced an exclusive supply and distribution agreement with Pharmalink https://pharmalink.ae/ to commercialize TLANDO®, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. Under the terms of the agreement, Lipocine received an upfront payment from Pharmalink and, upon Marketing Authorizations (MA) in individual GCC countries, Lipocine will provide TLANDO drug product to Pharmalink at an agreed transfer price.
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