Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA") denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2, 2019. Specifically, the FDA declined to issue product-specific guidance on oral T-ester drug products and denied without comment Clarus' request regarding how the FDA should review and make approval decisions on any pending or future oral T-ester products.
Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the results of a pre-clinical study of LPCN 1144. LPCN 1144 is an oral prodrug of bioidentical testosterone ("testosterone undecanoate" or "TU"). The pharmacological effect of LPCN 1144 was investigated in a non-genomic, five arm, 12-week high fat diet ("HFD")-induced, rabbit animal model of NASH and hepatic fibrosis.
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 American Urological Association ("AUA") Virtual Experience, to take place May 15-17, 2020. 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.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that Judge William C. Bryson of the United States District Court of Delaware has issued a Claim Construction Order post the claim construction hearing (commonly referred to as a "Markman Hearing") related to Lipocine's patent infringement lawsuit against Clarus Therapeutics, Inc. ("Clarus"). The purpose of a Markman Hearing is to determine the precise meaning of words from patent claims that are in dispute in a patent infringement lawsuit. No ultimate determination of infringement or validity of the patents has been determined at this point.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced today that the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office ("USPTO") under Rule 36. Previously the PTAB granted Lipocine's Priority Motion in the interference case, Patent Interference No. 106,045, between Clarus Therapeutics, Inc. ("Clarus") U.S. Patent No. 8,828,428 (the "Clarus '428 Patent") and Lipocine Inc. ("Lipocine"), U.S. Patent Application No. 14/713,692 (the "Lipocine '692 Application"), and entered adverse judgment against Clarus.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update.
Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food & Drug Administration ("FDA") has accepted the Company's Investigational New Drug application ("IND") to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for the treatment of liver cirrhosis in adult male cirrhotic patients. The planned Phase 2 clinical study is a prospective, multi-center, randomized, placebo-controlled 52-week study in male cirrhotic patients that are on the liver transplant list. Contingent upon available funding, Lipocine projects study initiation in the fourth quarter of 2020 or the first quarter of 2021.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced today that in an effort to streamline the issues and associated costs for dispute in its infringement lawsuit against Clarus Therapeutics, Inc. ("Clarus") in the United States District Court ("Delaware") related to the infringement of six Lipocine U.S. Patents by Clarus's JATENZO® product, Lipocine has voluntarily dismissed its allegations of patent infringement for expired U.S. Patent Nos. 6,569,463 and 6,923,988. Lipocine continues to vigorously defend its patent rights and maintains its allegations for patent infringement of four U.S. patents – U.S. patent nos. 9,034,858; 9,205,057; 9,480,690; and 9,757,390 – by Clarus's JATENZO® product, which has yet to launch.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, today announced financial results for the year ended December 31, 2019, and provided a corporate update.
NEW YORK, Jan. 14, 2020 -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Lipocine Inc. (NASDAQ: LPCN) between March 27, 2019 and.
By John Vandermosten, CFA NASDAQ:LPCN READ THE LATEST LPCN RESEARCH REPORT Lipocine (NASDAQ:LPCN) held its post action meeting with the FDA’s Division of Bone, Reproductive and Urologic Products in mid-January and recently received the minutes of the meeting. On February 24th the company announced that, according to FDA feedback, it will be able to address the remaining outstanding deficiency
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of the resubmission of TLANDO New Drug Application ("NDA"), the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. TLANDO is part of Lipocine's TRT franchise of development candidates. The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") goal date of August 28, 2020. The NDA incorporates the reanalysis of existing data based on written feedback to address the single remaining deficiency discussed in the Post Action Meeting with the FDA.
It's nice to see the Lipocine Inc. (NASDAQ:LPCN) share price up 13% in a week. But spare a thought for the long term...
Bragar Eagel & Squire, P.C., a nationally recognized shareholder law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the District of Utah on behalf of investors that purchased Lipocine, Inc. (LPCN) securities between March 27, 2019 and November 8, 2019 (the “Class Period”). Lipocine’s lead product candidate is TLANDO (LPCN 1021), an oral testosterone replacement therapy. The Company has previously submitted New Drug Applications (“NDA”) for TLANDO twice and, both times, received Complete Response Letters (“CRL”) from the U.S. Food and Drug Administration (“FDA”) rejecting the NDAs.
By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT 2019 Operational and Financial Results On March 13, 2020 Lipocine (NASDAQ:LPCN) filed its fiscal year 2019 10-K and posted its earnings release for the twelve-month period ending December 31, 2019. The company reported $165,000 in revenues and a net loss per share of ($0.50) compared to prior year revenues of $428,000 and
In 1997 Mahesh Patel was appointed CEO of Lipocine Inc. (NASDAQ:LPCN). First, this article will compare CEO...
LOS ANGELES, CA / ACCESSWIRE / January 14, 2020 / The Schall Law Firm , a national shareholder rights litigation firm, announces the filing of a class action lawsuit against Lipocine Inc. ("Lipocine" ...
Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the results of its Post Action meeting with the U.S. Food and Drug Administration ("FDA') regarding its New Drug Application ("NDA") for TLANDO™, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. Based on the Post Action meeting and written feedback, the FDA indicated Lipocine's approach to addressing the single remaining deficiency through the reanalysis of existing data in accordance with FDA feedback appears to be a reasonable path forward. The FDA requested that the information generated by the reanalysis be submitted as part of an NDA resubmission with a six-month Prescription Drug User Fee Act ("PDUFA") clock.
Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has entered into securities purchase agreements with certain institutional investors providing for the purchase and sale of 10,084,034 Class A Units at an offering price of $0.595 per unit, with each Class A Unit consisting of one share of its common stock and one-half of a common warrant to purchase one share of common stock at an exercise price of $0.53 per share of common stock, in a registered direct offering priced at-the-market. Gross proceeds to the Company are expected to be approximately $6 million, before deducting placement agent fees and other estimated offering expenses. The closing of the sale of the securities is expected to take place on or about February 27, 2020, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.