Lipocine Announces Presentations on TLANDO™ at ENDO 2021 Conference

Rhea-AI Summary

Lipocine Inc. (Nasdaq: LPCN) announced that clinical data on its lead candidate, TLANDO™, will be presented at the ENDO 2021 Conference from March 20-23, 2021. TLANDO is an oral testosterone replacement therapy for adult males with hypogonadism. Key presentations include assessments on liver health interventions and efficacy/safety of TLANDO. The FDA has given tentative approval for TLANDO to treat testosterone deficiency. Lipocine's pipeline also includes LPCN 1144, TLANDO XR, LPCN 1148, and LPCN 1107.

Positive

• Tentative FDA approval for TLANDO to treat testosterone deficiency in adult males.
• Presentation of clinical data at a significant conference, which may attract investor interest.

Negative

• None.

SALT LAKE CITY, March 3, 2021- /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that clinical data for lead candidate TLANDO™ will be presented at the ENDO 2021 Conference, to take place March 20-23, 2021.  TLANDO is an oral testosterone replacement therapy ("TRT") product candidate being developed for adult males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

1. Title: Low Testosterone in Males may Warrant Liver Health Assessment Intervention
   Session Type: Poster Session
   Session: P12 - Cardiovascular Endocrinology
   Date:  March 20, 2021 11:00 a.m. E.T., On-Demand
   Link:  https://www.abstractsonline.com/pp8/#!/9188/presentation/3323
   
   
2. Title: Efficacy and Safety of TLANDO, a Novel Oral Easy to Prescribe and Use TRT Option
   Session Type: Poster Session
   Session: P25 – Endocrine Disrupting Compounds: Mechanisms of Action and Clinical Implications
   Date:  March 20, 2021 11:00 a.m. E.T., On-Demand
   Link:  https://www.abstractsonline.com/pp8/#!/9188/presentation/1912
   
   
3. Title: TLANDO, a Novel Oral TRT, Improves Sexual and Mental Domain Outcomes in Hypogonadal Men
   Session Type: Poster Session
   Session: P25 – Endocrine Disrupting Compounds: Mechanisms of Action and Clinical Implications
   Date:  March 20, 2021 11:00 a.m. E.T., On-Demand
   Link: https://www.abstractsonline.com/pp8/#!/9188/presentation/1915

About Lipocine
Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.   

Forward-Looking Statements
This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risk that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov.  Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

 

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SOURCE Lipocine Inc.

FAQ

What is TLANDO and its significance for LPCN?

TLANDO is an oral testosterone replacement therapy being developed by Lipocine for adult males with hypogonadism, and it has received tentative FDA approval.

When will Lipocine present data on TLANDO?

Clinical data for TLANDO will be presented at the ENDO 2021 Conference from March 20-23, 2021.

Where can I find more information about Lipocine's clinical trials?

You can find more details on Lipocine's clinical trials and pipeline on their website or by checking their SEC filings.

What potential risks does LPCN face regarding FDA approval?

LPCN faces risks related to FDA approval processes, which may impact the commercialization and expected benefits of their products.