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Lipocine Inc (LPCN.OQ)

LPCN.OQ on NASDAQ Stock Exchange Capital Market

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Latest Key Developments (Source: Significant Developments)

Lipocine Announces Settlement Of Securities Class Action Lawsuit
Friday, 16 Feb 2018 08:00am EST 

Feb 16 (Reuters) - Lipocine Inc ::LIPOCINE ANNOUNCES SETTLEMENT OF SECURITIES CLASS ACTION LAWSUIT.LIPOCINE INC - CO AND OTHER DEFENDANTS ENTERED INTO A MEMORANDUM OF UNDERSTANDING TO SETTLE PURPORTED SECURITIES CLASS ACTION LITIGATION​.  Full Article

Lipocine Says FDA's BRUDAC Voted 6 In Favor & 13 Against Benefit/Risk Profile Of Tlando
Wednesday, 10 Jan 2018 04:33pm EST 

Jan 10 (Reuters) - Lipocine Inc ::LIPOCINE - FDA'S BRUDAC VOTED 6 IN FAVOR & 13 AGAINST BENEFIT/RISK PROFILE OF CO'S ORAL TESTOSTERONE PRODUCT CANDIDATE FOR TRT IN ADULT MALES, TLANDO.LIPOCINE INC SAYS ‍FDA DECISION ON TLANDO NDA IS ANTICIPATED BY ASSIGNED PDUFA GOAL DATE OF MAY 8, 2018 - SEC FILING ​.LIPOCINE INC - CONTINUE TO BELIEVE EFFICACY AND SAFETY RESULTS FROM CLINICAL STUDIES WITH TLANDO CONSISTENT WITH OTHER FDA APPROVED TRT PRODUCTS.  Full Article

Lipocine Says On Jan 5, Co, Unit, Silicon Valley Bank Entered Into Loan, Security Agreement
Tuesday, 9 Jan 2018 08:19am EST 

Jan 9 (Reuters) - Lipocine Inc ::LIPOCINE INC SAYS ON JAN 5, CO, UNIT, SILICON VALLEY BANK ("SVB") ENTERED INTO A LOAN AND SECURITY AGREEMENT -SEC FILING.LIPOCINE SAYS PURSUANT TO AGREEMENT SVB HAS AGREED TO LEND CO $10.0 MILLION; LOAN MATURES ON DEC 1, 2021.  Full Article

Lipocine says ‍FDA assigned a new prescription drug user fee act goal date of May 8, 2018 for Tlando​
Friday, 17 Nov 2017 08:00am EST 

Nov 17 (Reuters) - Lipocine Inc :U.S. FDA extends review for Tlando™; advisory committee meeting date of January 10, 2018 remains unchanged.Lipocine Inc - ‍FDA has assigned a new prescription drug user fee act goal date of May 8, 2018 for Tlando​.  Full Article

Lipocine Inc Q3 loss per share $0.22
Wednesday, 8 Nov 2017 08:00am EST 

Nov 8 (Reuters) - Lipocine Inc :Lipocine announces financial and operational results for the third quarter and nine months ended September 30, 2017.Q3 loss per share $0.22.Q3 earnings per share view $-0.21 -- Thomson Reuters I/B/E/S.  Full Article

Lipocine Inc files for mixed shelf of up to $150 million
Friday, 13 Oct 2017 04:07pm EDT 

Oct 13 (Reuters) - Lipocine Inc :Lipocine Inc files for mixed shelf of up to $150 million - SEC filing‍​.  Full Article

Lipocine announces FDA acknowledgement of Tlando NDA resubmission
Monday, 14 Aug 2017 08:00am EDT 

Aug 14 (Reuters) - Lipocine Inc :Lipocine announces FDA acknowledgement of Tlando (LPCN 1021) NDA resubmission; PDUFA goal date, February 8, 2018.FDA deemed resubmission a complete response to June 2016 CRL that requested additional information related to dosing algorithm for proposed label.  Full Article

Lipocine posts Q2 loss per share $0.31
Monday, 7 Aug 2017 08:00am EDT 

Aug 7 (Reuters) - Lipocine Inc :Lipocine announces financial and operational results for the second quarter and six months ended June 30, 2017.Q2 loss per share $0.31.Q2 earnings per share view $-0.31 -- Thomson Reuters I/B/E/S.Lipocine Inc - ‍on track to resubmit a new drug application to FDA in August 2017 for LPCN 1021 DV study​.  Full Article

Lipocine announces submission of special protocol assessment request to FDA on LPCN 1107, an oral alternative for prevention of preterm birth
Monday, 26 Jun 2017 08:00am EDT 

June 26 (Reuters) - Lipocine Inc :Lipocine Inc - Announces submission of special protocol assessment request to FDA on LPCN 1107, an oral alternative for prevention of preterm birth.  Full Article

Lipocine validates “no titration” dosing regimen with positive topline efficacy results for LPCN 1021
Monday, 19 Jun 2017 04:00pm EDT 

June 19 (Reuters) - Lipocine Inc : :Lipocine validates “no titration” dosing regimen with positive topline efficacy results for lpcn 1021, oral testosterone candidate.Lipocine Inc- LPCN 1021 achieved primary endpoints confirming efficacy of twice daily oral administration.Lipocine Inc- LPCN 1021 generally met pre-specified per dose secondary endpoints for twice daily oral administration.Lipocine Inc- new drug application resubmission planned in Q3 of 2017.Lipocine Inc - all drug related adverse events ("AES") were either mild or moderate in intensity and none were severe.  Full Article

BRIEF-Lipocine Receives Complete Response Letter For Tlando From U.S. FDA

* LIPOCINE RECEIVES COMPLETE RESPONSE LETTER FOR TLANDO FROM U.S. FOOD AND DRUG ADMINISTRATION