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Lipocine Inc.

LPCNFDA catalysts, PDUFA dates & pipeline intelligence
$1.42
▼ -0.02 · -1.39%

Financials

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R&D Expenses
Operating CF
Total Assets
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52W LOW $1.4052W HIGH $12.37
Volume
73.33 K
Value Traded
90.00 K
Short % Float
1.25%
Days to Cover
2.3
-7.84%Week
-32.54%1 Month
-34.11%3 Month
-40.51%6 Month
-90.51%5 Year
-99.34%All Time

Cash Data

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  • Monthly Burn
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  • SEC Filing

Key Stats

Market Cap
11.62 M
EPS (TTM)
-1.44
P/E Ratio
-
Ent. Value
-11.72 M
Total Shares
8.25 M
Float Shares
7.83 M
Insiders
4.98%
Institutions
36.15%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
NDA Submission
LPCN 1154
Postpartum Depression (PPD)
NDASmall MoleculesPsychiatric Disorders
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

LPCN Catalyst Timeline

Dated clinical, regulatory and corporate events for Lipocine Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Lipocine Inc.

910Total events
14Upcoming
268Tier-1 (high impact)
2013 to 2026Coverage

Upcoming catalysts 2

T2First Patient Dosed
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TBD
T2Oral Presentation
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Event history 50

▲FDA ApprovalTLANDOApprovedFDA Decision
Health Canada approves TLANDO for testosterone replacement therapy
testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism)source ↗
●Trial InitiationTrial
Lipocine initiates BLOOM Phase 3 study of LPCN 1154 in postpartum depression
postpartum depressionsource ↗
●Quarterly UpdateCorporate
Q2 2026 financial results announced
▲Other Regulator MilestoneTLANDOApprovedEx-US Regulatory
Pharmalink received marketing authorization approval for TESTYRA (TLANDO) in UAE
hypogonadismsource ↗
▲FDA ApprovalTESTYRAApprovedFDA Decision
Pharmalink received marketing authorization approval for TESTYRA (TLANDO) in UAE
testosterone replacement therapysource ↗
▲Other Regulator MilestoneTESTYRAApprovedEx-US Regulatory
Pharmalink received marketing authorization approval for TESTYRA (TLANDO) in UAE
hypogonadismsource ↗
◆Oral PresentationPresentation
Virtual KOL event highlighting unmet needs in PPD and clinical profile of LPCN 1154
postpartum depressionsource ↗
●R&D DayPresentation
Virtual KOL event for investment community
postpartum depressionsource ↗
●Timing GuidancePresentation
505(b)(2) NDA submission for LPCN 1154 expected in mid-2026
postpartum depressionsource ↗
◆Poster PresentationPresentation
Phase 3 data for LPCN 1154 selected for poster presentation at 2026 ASCP Annual Meeting
postpartum depressionsource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How LPCN actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-06-30LPCN 1154 Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Valuation Signal
3
Drugs Scored
rNPV / MCap
Top Drug
Top 34%
Micro Cap
(rank 224 of 657)
Percentile Rank
Showing 5 of 6 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
LPCN 1148 Small moleculeCompletedNCT04874350Liver CirrhosisPhase 2 COMPLETED 30Dec 18, 2023
LPCN 1154A Small moleculeNCT06979544Depression, PostpartumPhase 3 COMPLETED 210Feb 17, 2026
LPCN 1144 Small moleculeCompletedNCT04685993NASH - Nonalcoholic SteatohepatitisPhase 2 COMPLETED 25Mar 1, 2022
LPCN 1021 Small moleculeMarketedNCT03242408Hypogonadism, MalePhase 3 COMPLETED 333Jul 1, 2017
testosterone undecanoate, LPCN 1021 Small moleculeMarketedNCT02081300Male HypogonadismPhase 3 COMPLETED 315May 1, 2015
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PTRS, rNPV, enrollment velocity, trial design quality and ML risk signals for every asset above.
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Clinical Trial Results

Readouts, endpoints and source filings for every LPCN program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
LPCN 1154
Fast Track
Postpartum DepressionPhase 32026-05-07N=90; no treatment-related serious adverse events; no cases of excessive sedation or loss of consciousness; no treatment-related discontinuations; n=54Read MoreLipocine Announces Financial Results for the First Quarter Ended March 31, 2026Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Higuchi John W.DirectorBuy 15,970 241,365 held$2.23 09/30/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
Ikarian Capital, LLC 0.1 % (-66.7 %) 1.30 M 508.56 K
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

LPCN Institutional Ownership Trends

LPCN Short Interest

Shares sold short, counted twice a month.

1.25%
Short % of Float
of tradable shares sold short
97.8K
Shares Sold Short
-1.6% vs prior count
2.3 Moderate
Days to Cover
trading days of normal volume to buy every short share back
43.3K
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

CallsPutsLog scale
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Competitive positioning

How LPCN ranks across every disease it competes in

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See how LPCN ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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LPCN News

LPCN
Oct 7, 2026
LPCNFDA Updates

Lipocine Announces Health Canada Approval of TLANDO® for Testosterone Replacement Therapy

Lipocine Inc. announced that Health Canada has approved TLANDO® (testosterone undecanoate) capsules for testosterone replacement therapy in adult males with male hypogonadism. This approval, facilitated through Lipocine's partner Verity Pharmaceuticals, allows for a new oral treatment option that simplifies dosing. Verity Pharma is set to launch TLANDO in Canada by the end of 2026, aiming to capture a significant share of the TRT market.

Read more →
LPCN
Sep 14, 2026
LPCNPhases

Lipocine Announces Initiation of BLOOM Phase 3 Study of LPCN 1154 for Postpartum Depression

Lipocine Inc. has initiated the BLOOM Phase 3 study for LPCN 1154, targeting postpartum depression. The study aims to evaluate the drug's efficacy and safety based on previous findings and FDA feedback. Approximately 120 participants will be enrolled, with dosing expected to start in early Q4 2026. The company is optimistic about the treatment's potential to provide rapid relief.

Read more →
LPCN
Sep 10, 2026
LPCNConferences/Events

Lipocine to Present at the H.C. Wainwright 28th Annual Global Investment Conference

Lipocine Inc. will present at the H.C. Wainwright 28th Annual Global Investment Conference from September 14-16, 2026. The presentation is scheduled for September 16 at 10am ET in New York. Investors can register for the conference and access a live webcast of the presentation on Lipocine's website.

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LPCN
Aug 4, 2026
LPCNGeneral

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2026

Lipocine Inc. reported its financial results for Q2 2026, highlighting a net loss of $2.6 million. The company faced challenges with LPCN 1154 for postpartum depression, failing to meet primary trial endpoints, though post hoc analyses indicated potential efficacy. Lipocine plans to conduct further trials and has scheduled a meeting with the FDA for guidance.

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LPCN
Aug 3, 2026
LPCNGeneral

Lipocine Appoints Michael J. Grissinger to Board of Directors

Lipocine Inc. has appointed Michael J. Grissinger to its Board of Directors, effective August 3, 2026. Grissinger brings over two decades of experience from Johnson & Johnson, where he held senior management roles in pharmaceutical licensing and corporate development. His expertise is expected to aid Lipocine in advancing its pipeline and forming strategic partnerships.

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LPCN
Jun 4, 2026
LPCNConferences/Events

Lipocine to Host Virtual KOL Event Highlighting Unmet Needs in Postpartum Depression and the Clinical Profile of LPCN 1154

Lipocine Inc. is hosting a virtual Key Opinion Leader event on June 12, 2026, to discuss ongoing unmet needs in postpartum depression (PPD) and the clinical profile of LPCN 1154, an investigational oral formulation of brexanolone. The webinar will bring together leading physicians to review the current treatment landscape, persistent gaps in care, and present Phase 3 trial results for LPCN 1154. Attendees will explore the potential impact of LPCN 1154 within the PPD treatment paradigm. Advance registration for the event is required and a replay will be available afterward.

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LPCN
Jun 4, 2026
LPCNConferences/Events

Lipocine Inc. to Host Virtual KOL Event Highlighting Unmet Needs in Postpartum Depression and the Clinical Profile of LPCN 1154

Lipocine Inc. announced a virtual Key Opinion Leader (KOL) event focusing on postpartum depression (PPD) and its investigational oral treatment, LPCN 1154. Scheduled for June 12, 2026, the webinar will feature expert discussions on PPD's unmet clinical needs and the latest results from Phase 3 trials of LPCN 1154, which aims to provide convenient at-home treatment. The event aims to engage leading physicians and will include a Q&A session for attendees.

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LPCN
May 19, 2026
LPCNGeneral

Anaveon Strengthens Leadership Team with Appointments of Eric Zanelli as Chief Scientific Officer and Jill Jene as Chief Business Officer

Anaveon has appointed Eric Zanelli as Chief Scientific Officer and Jill Jene as Chief Business Officer. These appointments aim to enhance the company's leadership and accelerate its clinical development and pipeline expansion in the field of autoimmune and inflammatory diseases. Both executives bring extensive experience in their respective fields, which is expected to drive Anaveon's growth and impact.

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LPCN
May 19, 2026
LPCNConferences/Events

Lipocine Announces LPCN 1154 Phase 3 Data Accepted for Oral Presentation at 2026 ASCP Annual Meeting

Lipocine Inc. announced that its Phase 3 clinical data for LPCN 1154 has been accepted for an oral presentation at the 2026 ASCP Annual Meeting. The presentation will focus on LPCN 1154's efficacy in treating postpartum depression. The company highlights the potential of LPCN 1154 to provide rapid symptom relief with minimal side effects.

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LPCN
May 18, 2026
LPCNConferences/Events

Lipocine to Present at A.G.P.'s Annual Virtual Healthcare Company Showcase

Lipocine Inc. will participate in A.G.P.'s Annual Healthcare Company Showcase on May 20, 2026. The event will feature a fireside chat with management, highlighting Lipocine's innovative oral delivery technology and its drug development pipeline. The company aims to address significant unmet medical needs with its diverse range of drug candidates.

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LPCN
May 7, 2026
LPCNGeneral

Lipocine Announces Financial Results for the Quarter Ended March 31, 2026

Lipocine Inc. announced its financial results for the first quarter ended March 31, 2026, reporting a net loss of $3.7 million, an increase from the previous year's loss. The company disclosed that LPCN 1154, under investigation for treating postpartum depression, failed to meet its primary endpoint in a Phase 3 study, despite showing some positive results in a subgroup analysis. Lipocine is currently contemplating its development strategy for LPCN 1154 and has applied for breakthrough therapy and fast track designations with the FDA. The company's cash reserves have grown significantly, providing a stronger financial foundation for future development efforts.

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LPCN
May 7, 2026
LPCNGeneral

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2026

Lipocine Inc. reported its financial results for Q1 2026, highlighting the Phase 3 trial results for LPCN 1154, which did not meet its primary endpoint for treating postpartum depression. However, the drug was well tolerated, and significant improvements were noted in a subset of patients. The company is exploring further development options and has applied for breakthrough therapy designation.

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LPCN
Apr 2, 2026
LPCNPhases
▼ -77.8%on this newsshared move

Lipocine Reports Topline Safety and Efficacy Results for LPCN 1154 in Patients with Postpartum Depression

Lipocine Inc. announced topline results from its Phase 3 trial of LPCN 1154 for postpartum depression. The trial did not meet its primary endpoint, showing no significant reduction in HAM-D scores compared to placebo. However, LPCN 1154 was well tolerated, with no serious adverse events reported. The company is exploring further development options and has applied for breakthrough therapy designation.

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LPCN
Mar 10, 2026
LPCNGeneral

Lipocine Announces Financial Results for the Full Year Ended December 31, 2025

Lipocine Inc. announced its financial results for the full year ended December 31, 2025, highlighting a pivotal year for the company. Their revenue fell significantly to $2.0 million from $11.2 million in the previous year, leading to a net loss of $9.6 million. Despite these challenges, Lipocine remains optimistic about its drug developments, particularly its LPCN 1154 therapy for postpartum depression. Furthermore, the company's cash reserves increased to approximately $24.7 million as of March 2026.

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LPCN
Feb 18, 2026
LPCNPhases

Lipocine Announces Last Patient Last Visit in Pivotal Phase 3 Trial of LPCN 1154 for Postpartum Depression (PPD)

Lipocine Inc. has announced that the last patient completed their final visit in the pivotal Phase 3 trial of LPCN 1154, designed to treat postpartum depression. The trial involved 90 patients and reported a positive safety profile, with no serious side effects noted. The drug's oral formulation aims to provide rapid relief for new mothers suffering from severe postpartum depression, addressing significant existing gaps in treatment options. Data from this trial will support a 505(b)(2) NDA submission expected in 2026.

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LPCN
Jan 20, 2026
LPCNPhases
▼ -10.9%on this news

Lipocine Announces Completion of Enrollment and Dosing in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

Lipocine Inc. has completed enrollment and dosing in its Phase 3 trial for LPCN 1154, an oral treatment for postpartum depression (PPD). The trial involved 90 patients and has shown a favorable safety profile with no serious adverse events reported. Results are anticipated in early Q2 2026, which may support a future NDA submission.

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LPCN
Jan 12, 2026
LPCNPhases
▲ +12.7%on this news· ran to +41% by day 3

Lipocine Reports Encouraging Progress Post Second Interim Safety Review in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

Lipocine Inc. announced positive updates from the second interim safety review of its Phase 3 trial for LPCN 1154, an oral formulation aimed at treating postpartum depression (PPD). The independent Data Safety Monitoring Board (DSMB) recommended the trial continue without modifications, reporting no serious adverse events among the participants. With ongoing enrollment and a successful safety profile, Lipocine is set to release topline results in the second quarter of 2026, potentially paving the way for a new treatment option in PPD. The company aims to file a New Drug Application based on the trial data in 2026.

Read more →
LPCN
Dec 16, 2025
LPCNPhases

Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone

Lipocine Inc. has announced that its Phase 3 clinical trial for LPCN 1154, aimed at treating postpartum depression (PPD), has reached 80% enrollment. The trial, which has received positive feedback from the FDA, is being conducted entirely in an outpatient setting. The results are expected to support a 505(b)(2) NDA submission in 2026.

Read more →
LPCN
Nov 18, 2025
LPCNPhases
▲ +12.7%on this news

Lipocine Highlights Promising Interim Safety Profile in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

Lipocine Inc. has reported positive interim results from its Phase 3 trial of LPCN 1154 for postpartum depression. An independent Data Safety Monitoring Board review confirmed no serious adverse events and recommended the trial continue as planned. The trial aims to evaluate LPCN 1154's safety and efficacy in women diagnosed with severe postpartum depression, with results expected in 2026.

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LPCN
Nov 6, 2025
LPCNGeneral

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2025

Lipocine reported a net loss of $3.2 million for the third quarter ended September 30, 2025. The company held $15.1 million in unrestricted cash and marketable investment securities at the end of the period. Royalty revenue from TLANDO sales reached $115,000 during the quarter. Research and development expenses increased to $2.7 million compared to the prior year period.

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About Lipocine Inc.

Salt Lake City, X1 14 employees lipocine.com
Headquarters675 ARAPEEN DRIVE, SUITE 202, SALT LAKE CITY, X1, 84108
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