Hypogonadotropic hypogonadism

Lipocine Announces Financial Results for the Year Ended December 31, 2022

Retrieved on: 
Friday, March 10, 2023
NASH, Hypogonadotropic hypogonadism, PK, Exercise, Research, Proxy, Sale, FDA, Cirrhosis, 1154, 1107, LPCN 1107, File, Testosterone, SALT, CNS, NDA, Week, Food, Central nervous system, PPD, Male, Travel, NAS, TRT, Regulation of tobacco by the U.S. Food and Drug Administration, Cryptocurrency, Pharmaceutical industry, Antares

Lipocine recognized license revenue of $500,000 during the year ended December 31, 2022, compared to $16.1 million during the year ended December 31, 2021.

Key Points: 
  • Lipocine recognized license revenue of $500,000 during the year ended December 31, 2022, compared to $16.1 million during the year ended December 31, 2021.
  • Research and development expenses were $8.6 million and $7.7 million, respectively, for the years ended December 31, 2022, and 2021.
  • General and administrative expenses were $4.1 million and $5.3 million, respectively, for the years ended December 31, 2022, and 2021.
  • As of December 31, 2022, Lipocine had $32.5 million of unrestricted cash, cash equivalents and marketable investment securities compared to $46.6 million at December 31, 2021.

Reproductive Hormones and Proteins Tests Market Research Report 2022 Featuring Danaher, Abbott Laboratories, Siemens Healthineers, Ortho-Clinical Diagnostics, F. Hoffmann-La Roche, & Tosoh - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 10, 2022
Medical Supplies, Hospitals, Baby, Maternity, Genetics, Biometrics, Other Health, Health, Consumer, General Health, Woman, Segment, Country, Industry, ASP, Hypogonadotropic hypogonadism, Hyperprolactinaemia, Man, Epidemiology, Review, COVID-19, Market access, Fertility, Chlamydia trachomatis, Cystic fibrosis, SWOT, SWOT analysis, Protein, Region, Neisseria gonorrhoeae, Hormone, Feed manufacturing, Healthcare, Milk, Retail, Neisseria, Forecast, Chlamydia

Reproductive Hormones and Proteins Tests Market Report is built to visualize quantitative market trends within In Vitro Diagnostics therapeutic area.

Key Points: 
  • Reproductive Hormones and Proteins Tests Market Report is built to visualize quantitative market trends within In Vitro Diagnostics therapeutic area.
  • The model discusses in detail the impact of COVID-19 on Reproductive Hormones and Proteins tests market for the year 2020 and beyond.
  • Annualized total Reproductive Hormones and Proteins Tests market revenue by segment and market outlooks from 2015- 2030.
  • Competitive dynamics insights and trends provided for Reproductive Hormones and Proteins Tests market.

Lipocine Announces Peer-Reviewed Publication of Phase 3 Study Results for TLANDO®

Retrieved on: 
Thursday, January 27, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NASH, Cirrhosis, DV, XR, Male, Hypogonadism, Hypogonadotropic hypogonadism, Patient, Private Securities Litigation Reform Act, Form 10-K, FDA, Hydroxyprogesterone caproate, Multimedia, SEC, Form 8-K, Adult, SALT, Man, NASDAQ, Testosterone, Food, Birth, Preterm birth, Physician, Pharmaceutical industry, Andrology

As previously disclosed, the DV study met its primary endpoint, with TLANDO restoring testosterone levels to the normal range in hypogonadal males.

Key Points: 
  • As previously disclosed, the DV study met its primary endpoint, with TLANDO restoring testosterone levels to the normal range in hypogonadal males.
  • "We are pleased by the publication of our positive Phase 3 DV study results," said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine.
  • "The primary efficacy results confirm that TLANDO administered without dose titration restores testosterone levels to the normal range in hypogonadal men.
  • Lipocine's clinical development pipeline includes: TLANDO, TLANDO XR, LPCN 1144, LPCN 1148, LPCN 1107 and oral neurosteroids.

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2021

Retrieved on: 
Wednesday, November 10, 2021
NDA, Safety, American Association, Private Securities Litigation Reform Act, Therapy, American Association for the Study of Liver Diseases, XR, Form 10-K, Antares, Cirrhosis, Hypogonadism, License, NASDAQ, Orange Book, AASLD, Trial of the century, Investment, Institute of Liver and Biliary Sciences, Exercise, Research, Testosterone, End-user license agreement, Association, Preterm birth, NASH, Company, Hypogonadotropic hypogonadism, New Drug Application, Birth, SEC, SALT, Lift, Marketing, Form 8-K, Patient, TRT, Hydroxyprogesterone caproate, FDA, Man, Adult, Pharmaceutical industry, Generic drug, Medical imaging, Aquaculture, Cryptocurrency

SALT LAKE CITY, Nov. 10, 2021 /PRNewswire/ --Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update.

Key Points: 
  • SALT LAKE CITY, Nov. 10, 2021 /PRNewswire/ --Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update.
  • Research and development expenses were $2.4 million for the third quarter ended September 30, 2021, compared with $2.5 million for the third quarter ended September 30, 2020.
  • General and administrative expenses were $1.2 million for the third quarter ended September 30, 2021, compared with $1.9 million for the third quarter ended September 30, 2020.
  • Research and development expenses were $5.4 million for the nine months ended September 30, 2021, compared with $7.3 million for the nine months ended September 30, 2020.

Lipocine And Antares Pharma Enter Into U.S. Licensing Agreement To Commercialize TLANDO®

Retrieved on: 
Monday, October 18, 2021
AMAG Pharmaceuticals, XR, Industry, Private Securities Litigation Reform Act, Cirrhosis, Contributor License Agreement, Testosterone, Trial of the century, NDA, Adult, Hypogonadism, Birth, SEC, Ferring Pharmaceuticals, License, Teva, FDA, Multimedia, TRT, NASH, Drug Price Competition and Patent Term Restoration Act, Exercise, Pfizer, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Hydroxyprogesterone caproate, AMAG, Form 10-K, Company, Preterm birth, Form 8-K, Antares, Hypogonadotropic hypogonadism, NASDAQ, Therapy, Methotrexate, Pharmaceutical industry, Generic drug

Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO.

Key Points: 
  • Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO.
  • Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S.
  • Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR.
  • Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO®

Retrieved on: 
Tuesday, September 28, 2021
Food, Therapy, Man, Compliance, XR, Hypogonadism, Preterm birth, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Hypogonadotropic hypogonadism, Private Securities Litigation Reform Act, FDA, Multimedia, Orange Book, Adult, Testosterone, Form 10-K, Marketing, NASH, Form 8-K, New Drug Application, Risk, Birth, Safety, Cirrhosis, Nasdaq, Hydroxyprogesterone caproate, SALT, SEC, Pharmaceutical industry

SALT LAKE CITY, Sept. 28, 2021 /PRNewswire/ --Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the U.S. Food and Drug Administration ("FDA") has affirmed the resubmission of its New Drug Application ("NDA") for TLANDO, its oral testosterone product, will be a Class 1 resubmission.A Class 1 NDA resubmission includes a two-month FDA review goal period.

Key Points: 
  • SALT LAKE CITY, Sept. 28, 2021 /PRNewswire/ --Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the U.S. Food and Drug Administration ("FDA") has affirmed the resubmission of its New Drug Application ("NDA") for TLANDO, its oral testosterone product, will be a Class 1 resubmission.A Class 1 NDA resubmission includes a two-month FDA review goal period.
  • Resubmission of the NDA is a necessary requirement to receive final approval from the FDA and is expected to occur on January 28, 2022, based on the FDA's Class 1 affirmation.
  • "We are pleased that the FDA has affirmed the resubmission of the NDA for TLANDO will be a Class 1 resubmission," said Dr.Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine.
  • Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107.

Clarus Therapeutics Announces Comprehensive Settlement of Patent Litigation With Lipocine

Retrieved on: 
Thursday, July 15, 2021
Hormones, Endocrine system, Organ systems, Sex hormones, Peptide hormones, Hypogonadotropic hypogonadism, Hypogonadism, Follicle-stimulating hormone, Gonadotropin, Luteinizing hormone, Isolated hypogonadotropic hypogonadism, Testosterone

These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Key Points: 
  • These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
  • Safety and efficacy of JATENZO in males less than 18 years old have not been established.
  • Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.

Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Next-Generation Oral Testosterone Replacement Therapy in Male Patients With Hypogonadism

Retrieved on: 
Tuesday, January 5, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical trials, Organ systems, Medical specialties, Steroids, Androstanes, Enones, Estrogens, GABAA receptor positive allosteric modulators, Male genital disorders, Hypogonadism, Testosterone, Androgen deficiency, Hypogonadotropic hypogonadism, Testosterone & Hypogonadism, KYZATREX®, Marius Pharmaceuticals

KYZATREX has generated strong results in both safety and efficacy studies for KYZATREX for treatment of primary and secondary hypogonadism in men.

Key Points: 
  • KYZATREX has generated strong results in both safety and efficacy studies for KYZATREX for treatment of primary and secondary hypogonadism in men.
  • Marius also intends to file a marketing authorization application (MAA) with the European Medicines Agency in the first half of 2022.
  • Hypogonadism, often referred to as testosterone deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone.
  • Marius is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, commonly referred to as testosterone deficiency.

CLARUS THERAPEUTICS ANNOUNCES FINANCING TO SUPPORT THE COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO® (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE TREATMENT OF HYPOGONADISM

Retrieved on: 
Monday, March 16, 2020
Hormones, Endocrine system, Branches of biology, Peptide hormones, Sex hormones, Progonadotropins, Glycoproteins, Recombinant proteins, Hypogonadism, Hypogonadotropic hypogonadism, Follicle-stimulating hormone, Gonadotropin

These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Key Points: 
  • These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
  • Safety and efficacy of JATENZO in males less than 18 years old have not been established.
  • Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

Teva Announces Launch of a Generic Version of AndroGel® (testosterone gel) 1.62% CIII in the United States

Retrieved on: 
Thursday, April 11, 2019
Health, Pharmaceutical, Consumer, MEN, Hormones, Endocrine system, Branches of biology, Peptide hormones, Sex hormones, Hypogonadotropic hypogonadism, Hypogonadism, Follicle-stimulating hormone, Gonadotropin-releasing hormone, Gonadotropin, Luteinizing hormone, Hypothalamus

Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Key Points: 
  • Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
  • These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
  • i AndroGel is a registered trademark of AbbVie, Inc.
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