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Lipocine

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.

Lipocine Inc

Lipocine Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced the initiation&nbsp;of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD). &nbsp;
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. This randomized, blinded, placebo controlled study is designed to evaluate safety and efficacy of LPCN 1154 in women with PPD. This outpatient trial is expected to support a global registration package for LPCN 1154 in PPD.&nbsp;
"We are excited to initiate this registration-enabling Phase 3 trial," said Mahesh Patel, CEO of Lipocine. "Importantly, based on FDA protocol feedback, patients will self-administer LPCN 1154 at home. We believe that LPCN 1154 has the potential to be the first line option for rapid symptom relief in women with PPD."

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General

LPCN

Lipocine Announces Initiation Of A Phase 3 Trial For LPCN 1154 Which Is In Development For Treatment Of Postpartum Depression

Earnings

Earnings Beats

Lipocine FY24 Sales $11.198M Beat $10.321M Estimate

Lipocine Announces Revised FDA Guidance For LPCN 1154 Requiring Efficacy And Safety Study For Postpartum Depression NDA Submission

FDA Grants Fast Track Designation To Lipocine's LPCN 1148 For Treating Sarcopenia In Patients With Decompensated Cirrhosis, Targeting First-In-Class Status With Novel Mechanism Of Action

Lipocine Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>), 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. A copy of the publication can be accessed <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4304805-1&amp;h=1195872298&amp;u=https%3A%2F%2Fjournals.lww.com%2Fhep%2Fabstract%2F9900%2Foral_lpcn_1148_improves_sarcopenia_and_hepatic.1074.aspx&amp;a=here">here</a>.
The publication features the results from a Phase 2 proof-of-concept clinical trial (LPCN 1148-21-001) that evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation. The trial was conducted in two stages. Stage 1 was double blind, placebo-controlled with participants randomized 1:1, to receive either oral LPCN 1148 or placebo. This was followed by Stage 2, a 28-week single-arm open label extension. The publication reports the analyses from the Stage 1 readout.
The results at 24 weeks showed that LPCN 1148 therapy resulted in a significant improvement in sarcopenia when compared with placebo. Furthermore, despite most participants already on background therapies for HE, participants receiving LPCN 1148 also experienced significantly fewer episodes of overt hepatic&nbsp;encephalopathy (OHE) compared to those on placebo. Additional beneficial effects of LPCN 1148, including improved muscle quality, hemoglobin, and patient reported symptom improvement are also covered in the manuscript.
The publication was discussed at The Liver Meeting during 'The Editors Cut: Clinical Studies' session. This session critically discusses the most notable, influential, cutting edge, game changing clinical research papers published during the past year.

Lipocine Announces 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 2024 Editor's Cut

WIIM

Lipocine shares are trading lower. The company reported Q3 financial results.

Lipocine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>) reported quarterly losses of $(0.44) per share which beat the analyst consensus estimate of $(0.48) by 8.33 percent. This is a 65.35 percent increase over losses of $(1.27) per share from the same period last year.

Lipocine Q3 EPS $(0.44) Beats $(0.48) Estimate

Lipocine Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>), 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 <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4291615-1&amp;h=2176293939&amp;u=http%3A%2F%2Fspcpharm.co.kr%2F&amp;a=http%3A%2F%2Fspcpharm.co.kr">http://spcpharm.co.kr</a> granting exclusive rights to market TLANDO&#xAE; 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. Lipocine is entitled to royalties on net commercial sales. Lipocine will supply TLANDO to SPC Korea and will receive a supply price. SPC Korea will assume responsibility for obtaining regulatory approval within the territory.

Global

Lipocine Announces Distribution And License Agreement With SPC Korea To Commercialize TLANDO In South Korea

The results indicate robust central nervous system (CNS) activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG. These results confirm GABAA&nbsp;positive allosteric modulation and support future development of oral brexanolone in neuropsychiatric indications.
&quot;&ldquo;We are pleased with the qEEG results that confirm target engagement of oral bioidentical brexanolone, which suggests potential utility in treating numerous psychiatry indications, including depression and anxiety, and neurology indications such as essential tremor and epilepsy,&rdquo; said Dr. Mahesh Patel, President and CEO of Lipocine Inc.
&quot;These positive biomarker results and favorable safety profile support further development of oral brexanolone.&quot;

Lipocine Reports Data From Its qEEG Study Of Its Oral Brexanolone, A Proprietary Bioidentical NAS Being Developed For The Treatment Of Post-partum Depression - Filing

Lipocine Announced Oral Brexanolone QEEG Results; Oral Brexanolone Well-tolerated With Minimal CND Depressant Effects

Lipocine Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>), 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 <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4272507-1&amp;h=4094279648&amp;u=https%3A%2F%2Fpharmalink.ae%2F&amp;a=https%3A%2F%2Fpharmalink.ae%2F">https://pharmalink.ae/</a> to commercialize TLANDO&#xAE;, 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.&nbsp;

Lipocine Announces Supply And Distribution Agreement With Pharmalink To Commercialize TLANDO In The Gulf Cooperation Council Countries

Alliance Global Partners analyst Scott Henry initiates coverage on Lipocine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>) with a Buy rating and announces Price Target of $10.

Price Target

Initiation

Analyst Ratings

Alliance Global Partners Initiates Coverage On Lipocine with Buy Rating, Announces Price Target of $10

Study evaluated LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity
SALT LAKE CITY, Sept. 5, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that a poster featuring Phase 2 data on LPCN 2401 will be presented at the Obesity Society's Annual <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4247052-1&amp;h=3963450958&amp;u=https%3A%2F%2Fobesityweek.org%2F&amp;a=ObesityWeek%C2%AE">ObesityWeek&#xAE;</a>&nbsp;conference to be held November 3 – 6, 2024 in San Antonio, TX.

Lipocine Announces Phase 2 Data On LPCN 2401 To Be Presented At ObesityWeek November 3 – 6, 2024

Lipocine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>) reported quarterly losses of $(0.56) per share which beat the analyst consensus estimate of $(0.78) by 28.21 percent. This is a 17.65 percent increase over losses of $(0.68) per share from the same period last year. The company reported quarterly sales of $89.565 thousand which missed the analyst consensus estimate of $290.000 thousand by 69.12 percent.

Earnings Misses

Lipocine Q2 2024 GAAP EPS $(0.56) Beats $(0.78) Estimate, Sales $89.565K Miss $290.000K Estimate

<ul>
<li>Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC0-∞</li>
<li>Ctrough criterion was met</li>
<li>LPCN 1154 was well tolerated with no sedation or somnolence events observed</li>
<li>On track for NDA filing, targeted by end of Q4 2024</li>
</ul>

Lipocine Says LPCN 1154 Met standard Bioequivalence (BE) Criteria; Co Says On Track For NDA Filing, Targeting Q4 2024

<h3>Gainers</h3>
<ul>
<li>Geovax Labs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOVX#NASDAQ">GOVX</a>) stock moved upwards by 72.1% to $1.91 during Wednesday's regular session. The company's market cap stands at $4.8 million. </li>
<li>Nexalin Technology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NXL#NASDAQ">NXL</a>) shares increased by 43.06% to $1.08. The market value of their outstanding shares is at $8.0 million. </li>
<li>Vaxart (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VXRT#NASDAQ">VXRT</a>) shares rose 33.45% to $0.7. The market value of their outstanding shares is at $123.8 million. </li>
<li>Sunshine Biopharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBFM#NASDAQ">SBFM</a>) stock increased by 28.92% to $0.39. The market value of their outstanding shares is at $7.4 million. </li>
<li>Portage Biotech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTG#NASDAQ">PRTG</a>) shares increased by 25.0% to $0.3. The company's market cap stands at $5.9 million. </li>
<li>Silk Road Medical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SILK#NASDAQ">SILK</a>) shares increased by 23.78% to $26.82. The company's market cap stands at $1.0 billion. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>DermTech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DMTK#NASDAQ">DMTK</a>) shares fell 55.2% to $0.15 during Wednesday's regular session. The market value of their outstanding shares is at $5.2 million. </li>
<li>Zentalis Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZNTL#NASDAQ">ZNTL</a>) shares decreased by 49.95% to $4.2. The market value of their outstanding shares is at $298.2 million. </li>
<li>Anitra (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AZTR#AMEX">AZTR</a>) shares fell 33.51% to $0.16. The company's market cap stands at $4.4 million. </li>
<li>Lipocine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>) stock decreased by 32.93% to $7.17. The market value of their outstanding shares is at $38.3 million. </li>
<li>Taysha Gene Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSHA#NASDAQ">TSHA</a>) shares decreased by 26.56% to $2.96. The market value of their outstanding shares is at $553.5 million. </li>
<li>Virpax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRPX#NASDAQ">VRPX</a>) shares fell 24.9% to $0.57. The market value of their outstanding shares is at $1.5 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Movers

AZTR

DMTK

GOVX

PRTG

SBFM

SILK

TSHA

VRPX

VXRT

ZNTL

12 Health Care Stocks Moving In Wednesday's Intraday Session

&nbsp;Lipocine Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>), a biopharmaceutical company, today announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4186705-1&amp;h=1751763964&amp;u=https%3A%2F%2Fwww.easlcongress.eu%2F&amp;a=European+Association+for+the+Study+of+Liver+(EASL)+Congress">European Association for the Study of Liver (EASL) Congress</a>&nbsp;on Saturday, June 8, in Milan, Italy. The presentation "Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy (HE) in patients with cirrhosis: a 52-week phase 2 randomized clinical trial" was presented by Arun J. Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University. The presentation is featured in the symposium "Revolutionary Advances in Liver Disease Research Unveiled at EASL Congress 2024" (<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4186705-1&amp;h=3308810334&amp;u=https%3A%2F%2Fwww.hepmag.com%2Farticle%2Frevolutionary-advances-liver-disease-research-unveiled-easl-congress-2024&amp;a=https%3A%2F%2Fwww.hepmag.com%2Farticle%2Frevolutionary-advances-liver-disease-research-unveiled-easl-congress-2024">https://www.hepmag.com/article/revolutionary-advances-liver-disease-research-unveiled-easl-congress-2024</a>) highlighting significant advances in liver disease.

Lipocine To Present 52 Week Results From LPCN 1148 Phase 2 Study In Late Breaking Session At EASL Congress 2024

Lipocine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>) reported quarterly earnings of $0.66 per share. This is a 186.84 percent increase over losses of $(0.76) per share from the same period last year. The company reported $7.50 million in sales this quarter. This is a 13.54K percent increase over sales of $54.99 thousand the same period last year.

Lipocine Q1 EPS $0.66 Up From $(0.76) YoY, Sales $7.50M Up From $54.99K YoY

Lipocine Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPCN#NASDAQ">LPCN</a>), a biopharmaceutical company, today announced that data from the Phase 2 study of LPCN 1148 has been selected for a late breaking oral presentation at the European Association for the Study of Liver ("EASL") Congress, to take place June 5 to 8, 2024 in Milan, Italy.
Presentation Details
<figure class="table"> 
<table>
<tbody>
<tr>
<td colspan="1" rowspan="1">Title&nbsp; &nbsp;</td>
<td colspan="1" rowspan="1">Intervention with oral&nbsp;LPCN 1148 improves sarcopenia and hepatic encephalopathy ("HE") in patients with cirrhosis: a 52-week phase 2 randomized clinical trial</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Presenter:&nbsp;&nbsp;</td>
<td colspan="1" rowspan="1">Dr. Arun J. Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Session Title:&nbsp;</td>
<td colspan="1" rowspan="1">Late Breaker</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Session Date and Time:&nbsp;</td>
<td colspan="1" rowspan="1">Saturday, 8 June, 14:00 - 15:30 CEST</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Presentation Time:&nbsp;</td>
<td colspan="1" rowspan="1">15.15 CEST</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Location</td>
<td colspan="1" rowspan="1">Gold Room</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Abstract Number:</td>
<td colspan="1" rowspan="1">LP139</td>
</tr>
</tbody>
</table>
</figure>
About LPCN 1148
Lipocine is currently evaluating LPCN 1148 comprising testosterone laurate ("TL") for the management of decompensated cirrhosis. The Company believes LPCN 1148 targets unmet needs for patients with cirrhosis including improvements in sarcopenia and quality of life, prevention or reduction in the occurrence of decompensation events such as HE, and improvement in post liver transplant outcomes, survival, and costs.

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