Lipocine Announced Results From A Phase 2 Trial Of LPCN 2401 Showing Significant Improvement In Body Composition Through Decreased Fat Mass And Increased Lean Mass Or Fat-free Mass In Obese Patients With At Least One Weight-related Comorbidity

4/11/24 7:04:37 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

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Recent Analyst Ratings for
$LPCN

Date	Price Target	Rating	Analyst
8/26/2021	$2.50 → $3.50	Buy	HC Wainwright & Co.
6/24/2021	$3.00	Overweight	Cantor Fitzgerald

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$LPCN
Press Releases

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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. Following the meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of
2/6/25 8:00:00 AM ET
$LPCN
Biotechnology: Pharmaceutical Preparations
Health Care
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. Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes. LPCN 1148 is targeted to be a "First in Class"
12/17/24 8:00:00 AM ET
$LPCN
Biotechnology: Pharmaceutical Preparations
Health Care
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 i
11/18/24 8:00:00 AM ET
$LPCN
Biotechnology: Pharmaceutical Preparations
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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). It is targeted to be a highly effective, oral, fast-acting and short duration treatment option.The Company has completed labeling
11/7/24 8:00:00 AM ET
$LPCN
Biotechnology: Pharmaceutical Preparations
Health Care
Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2024
SALT LAKE CITY, Aug. 8, 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 second quarter ended June 30, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression (PPD) In June 2024, Lipocine announced positive topline study results from the NDA enabling study of LPCN 1154. LPCN 1154 treatment was well tolerated with no sedation nor somnolence events observedThe Company is targeting NDA subm
8/8/24 8:00:00 AM ET
$LPCN
Biotechnology: Pharmaceutical Preparations
Health Care
Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024
SALT LAKE CITY, May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression In May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depressionThe FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 through
5/9/24 8:00:00 AM ET
$LPCN
Biotechnology: Pharmaceutical Preparations
Health Care

Lipocine Announced Results From A Phase 2 Trial Of LPCN 2401 Showing Significant Improvement In Body Composition Through Decreased Fat Mass And Increased Lean Mass Or Fat-free Mass In Obese Patients With At Least One Weight-related Comorbidity

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$LPCN

$LPCN
Press Releases

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Lipocine Receives Updated Regulatory Guidance on LPCN 1154

FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis

Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session

$LPCN
Insider Trading

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Amendment: SEC Form 4 filed by Chief Executive Officer Patel Mahesh V.

SEC Form 4 filed by Chief Executive Officer Patel Mahesh V.

SEC Form 4 filed by Chief Executive Officer Patel Mahesh V.

$LPCN
Leadership Updates

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LIPOCINE ANNOUNCES BOARD of DIRECTOR APPOINTMENTS

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$LPCN
SEC Filings

HC Wainwright & Co. reiterated coverage on Lipocine with a new price target

Cantor Fitzgerald initiated coverage on Lipocine with a new price target

HC Wainwright & Co. reiterated coverage on Lipocine with a new price target

SEC Form 8-K filed by Lipocine Inc.

SEC Form 8-K filed by Lipocine Inc.

SEC Form 8-K filed by Lipocine Inc.

$LPCN
Financials

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Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2024

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024

$LPCN
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FDA Approval for TESTOSTERONE UNDECANOATE issued to LIPOCINE INC

FDA Tentative Approval for TESTOSTERONE UNDECANOATE

SEC Form SC 13G/A filed by Lipocine Inc. (Amendment)

SEC Form SC 13G/A filed

SEC Form SC 13G filed

Lipocine Announced Results From A Phase 2 Trial Of LPCN 2401 Showing Significant Improvement In Body Composition Through Decreased Fat Mass And Increased Lean Mass Or Fat-free Mass In Obese Patients With At Least One Weight-related Comorbidity

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Recent Analyst Ratings for $LPCN

$LPCN Press Releases

Fastest customizable press release news feed in the world

Lipocine Receives Updated Regulatory Guidance on LPCN 1154

FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis

Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session

$LPCN Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

Amendment: SEC Form 4 filed by Chief Executive Officer Patel Mahesh V.

SEC Form 4 filed by Chief Executive Officer Patel Mahesh V.

SEC Form 4 filed by Chief Executive Officer Patel Mahesh V.

$LPCN Leadership Updates

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LIPOCINE ANNOUNCES BOARD of DIRECTOR APPOINTMENTS

$LPCN Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

$LPCN SEC Filings

HC Wainwright & Co. reiterated coverage on Lipocine with a new price target

Cantor Fitzgerald initiated coverage on Lipocine with a new price target

HC Wainwright & Co. reiterated coverage on Lipocine with a new price target

SEC Form 8-K filed by Lipocine Inc.

SEC Form 8-K filed by Lipocine Inc.

SEC Form 8-K filed by Lipocine Inc.

$LPCN Financials

Live finance-specific insights

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2024

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024

$LPCN FDA approvals

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$LPCN Large Ownership Changes

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FDA Approval for TESTOSTERONE UNDECANOATE issued to LIPOCINE INC

FDA Tentative Approval for TESTOSTERONE UNDECANOATE

SEC Form SC 13G/A filed by Lipocine Inc. (Amendment)

SEC Form SC 13G/A filed

SEC Form SC 13G filed

Recent Analyst Ratings for
$LPCN

$LPCN
Press Releases

$LPCN
Insider Trading

$LPCN
Leadership Updates

$LPCN
Analyst Ratings

$LPCN
SEC Filings

$LPCN
Financials

$LPCN
FDA approvals

$LPCN
Large Ownership Changes