Will lipocine get FDA approval?
About Lipocine TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males.
Is TLANDO approved by FDA?
As Healio previously reported, the FDA approved Clarus Therapeutics’ testosterone capsule to treat men with certain forms of hypogonadism, in March 2019. That approval marked the first new oral testosterone replacement product in more than 60 years. The FDA issued a complete response letter for Tlando in November 2019.
What is Tlando?
TLANDO™ is an oral testosterone replacement therapy product candidate containing Testosterone Undecanoate (TU) that is designed to help restore normal testosterone levels in males for conditions associated with a deficiency or absence of endogenous testosterone.
Is lipocine a good buy?
Lipocine has received a consensus rating of Buy. The company’s average rating score is 3.00, and is based on 3 buy ratings, no hold ratings, and no sell ratings.
Is LPCN a good buy?
Out of 3 analysts, 2 (66.67%) are recommending LPCN as a Strong Buy, 1 (33.33%) are recommending LPCN as a Buy, 0 (0%) are recommending LPCN as a Hold, 0 (0%) are recommending LPCN as a Sell, and 0 (0%) are recommending LPCN as a Strong Sell. What is LPCN’s earnings growth forecast for 2021-2023?
Does Tlando get approved?
The approval for Tlando is tentative and it will be eligible for final approval and marketing in the U.S. only when the exclusivity period previously granted to rival product Jatenzo, developed by Clarus Therapeutics, expires on March 27, 2022.
Is LPCN a buy or sell?
Will lipocine stock go up?
Stock Price Forecast The 4 analysts offering 12-month price forecasts for Lipocine Inc have a median target of 2.75, with a high estimate of 10.00 and a low estimate of 2.50. The median estimate represents a +96.43% increase from the last price of 1.40.
Is TNXP a good buy?
Tonix Pharmaceuticals (NASDAQ:TNXP) stands out as a good example of these under-the-radar stocks. With the small biotech recently making it onto the most popular list, Robinhood investors are clearly buying the company’s stock.
Is TNXP a buy or sell?
Out of 1 analysts, 0 (0%) are recommending TNXP as a Strong Buy, 0 (0%) are recommending TNXP as a Buy, 1 (100%) are recommending TNXP as a Hold, 0 (0%) are recommending TNXP as a Sell, and 0 (0%) are recommending TNXP as a Strong Sell. What is TNXP’s earnings growth forecast for 2021-2023?
Is Biolase stock a buy?
BIOLASE has received a consensus rating of Buy. The company’s average rating score is 3.00, and is based on 3 buy ratings, no hold ratings, and no sell ratings.
Is CTXR a good buy?
Out of 2 analysts, 2 (100%) are recommending CTXR as a Strong Buy, 0 (0%) are recommending CTXR as a Buy, 0 (0%) are recommending CTXR as a Hold, 0 (0%) are recommending CTXR as a Sell, and 0 (0%) are recommending CTXR as a Strong Sell.
When is the PDUFA date for Lipocine TLANDO?
After the end of the quarter, Lipocine announced the PDUFA date for Tlando as November 9th, 2019. We have increased our optimism on the likelihood of approval for Tlando given the favorable outcomes for other TRT approvals and the successful assignment of a PDUFA date, and we raise our target price accordingly.
When does the Food and Drug Administration reauthorize PDUFA?
On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of PDUFA through September 2022. PDUFA VI will provide for the continued timely review of new drug and biologic license applications. Regulations and Federal Register Documents
What are the highlights of 1q : 19 for Lipocine?
The most important highlights for 1Q:19 and include the grant of priority motion to Lipocine in the Clarus case, favorable results for and clinical advancement of LPCN 1144 in the Liver Fat Study, participation in several NASH conferences and completion of several requirements for Tlando resubmission.
What kind of disease does home Lipocine treat?
We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. We improve compliance, absorption, and more with our proprietary drug delivery technologies. Developed as a treatment of non-alcoholic steatohepatitis (“NASH”).