LPCN - Lipocine Inc.
| Previous Close | 0.5299 |
| Open | 0.5350 |
| Bid | 0.5230 x 34100 |
| Ask | 0.5233 x 1100 |
| Day's Range | 0.5022 - 0.5400 |
| 52 Week Range | 0.3200 - 3.4500 |
| Volume | 968,919 |
| Avg. Volume | 1,169,514 |
| Market Cap | 18.901M |
| Beta (5Y Monthly) | 0.16 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | N/A |
| Earnings Date | N/A |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | N/A |
- Insider Monkey
Is Lipocine Inc (LPCN) Going To Burn These Hedge Funds ?
Out of thousands of stocks that are currently traded on the market, it is difficult to identify those that will really generate strong returns. Hedge funds and institutional investors spend millions of dollars on analysts with MBAs and PhDs, who are industry experts and well connected to other industry and media insiders on top of that. Individual investors can piggyback […]
- Zacks Small Cap Research
LPCN: Third Quarter 2019 Operational and Financial Results
By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT On November 12, 2019 Lipocine (NASDAQ:LPCN) filed its 3Q:19 10-Q and posted its earnings release for the three month period ending September 30, 2019. The company reported $165,000 in revenues and a net loss per share of ($0.12) compared to prior year revenues of zero and loss of ($0.12) per share. Activities and results
- Benzinga
The Daily Biotech Pulse: Amarin Gets Unanimous Backing For Vascepa Expansion, BeiGene's Blood Cancer Drug Gets Approval
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Nov. 14) 10X Genomics Inc (NASDAQ: TXG )(IPOed Sept. 12) 89bio ...
- Benzinga
Lipocine's Male Hormone Therapy Stumbles With FDA For The Third Time
Lipocine said Monday the FDA said "nay" for the third time for its Tlando, an oral testosterone replacement therapy for use in adult males for treating conditions associated with hypogonadism, which is a deficiency of endogenous testosterone. The complete response letter, or CRL, issued by the FDA signaling the application cannot be approved in the present form, pointed to one deficiency — the efficacy trial not meeting the three secondary endpoints for maximal testosterone concentration. Lipocine initially submitted the NDA for Tlando back in 2015, although the FDA shot down the application the very next year on the grounds that there were deficiencies related to the dosing algorithm for the label.
- Reuters
UPDATE 1-FDA rejects Lipocine's testosterone drug for third time
The U.S. Food and Drug Administration on Monday declined to approve Lipocine Inc's oral drug to treat a condition that results in lower production of male sex hormone for the third time, sending the drug developer's shares down 34%. The company said a letter from the regulator indicated the application could not be approved in its present form as Lipocine's trial did not meet three secondary goals that were designed to assess if higher levels of testosterone in patients could raise safety concerns. The decision marks the third regulatory setback in over three years for Lipocine's Tlando, which aims to restore normal testosterone levels in men with deficiency or absence of testosterone.
- MarketWatch
Lipocine's stock plummets after receiving CRL from FDA for testosterone deficiency treatment
Shares of Lipocine Inc. plummeted 67% toward a record low, and to pace all premarket losers, after the biopharmaceutical company said the Food and Drug Administration indicated that its New Drug Application (NDA) for its testosterone deficiency treatment can't be approved in its present form. The company said it received a Complete Response Letter from the FDA, which identified a deficiency stating the efficacy trial didn't meet three secondary endpoints for maximal testosterone concentrations. "We are disappointed by the FDA's decision and intend to request a meeting with the FDA as soon as possible to discuss a potential path forward for the approval of TLANDO," said Lipocine Chief Executive Mahesh Patel. The company said it is still actively enroll in its ongoing phase 2 study for LPCN 1144 LiFT (Liver Fat intervention with oral Testosterone). The stock had more than doubled (up 110%) year to date through Friday, while the iShares Nasdaq Biotechnology ETF has gained 14.5% and the S&P 500 has rallied 23.4%.
- Benzinga
The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight
Biotech stocks extended their gains last week amid earnings news flow and the broader market strength. Large-cap pharma stocks saw particular strength. Here are the key catalytic event a biotech investor ...
- Benzinga
Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates
The FDA worked overtime in October , deciding on the fate of several therapies and treatment options. Most reviews produced positive outcomes. Three new molecular entities, or NMEs, were approved in October, ...
- Simply Wall St.
Introducing Lipocine (NASDAQ:LPCN), The Stock That Zoomed 129% In The Last Year
Unless you borrow money to invest, the potential losses are limited. But if you pick the right business to buy shares...
- Simply Wall St.
How Should Investors Feel About Lipocine Inc.'s (NASDAQ:LPCN) CEO Pay?
Mahesh Patel has been the CEO of Lipocine Inc. (NASDAQ:LPCN) since 1997. This report will, first, examine the CEO...
- Zacks Small Cap Research
LPCN: NASH Trial Launched
By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT Second Quarter 2019 Operational and Financial Results On August 7, 2019 Lipocine (NASDAQ:LPCN) filed its 2Q:19 10-Q and posted its ...
- Simply Wall St.
Is Lipocine (NASDAQ:LPCN) Using Too Much Debt?
David Iben put it well when he said, 'Volatility is not a risk we care about. What we care about is avoiding the...
- Zacks Small Cap Research
LPCN: Poster Demonstrates NASH and Free T Link
While there has been evidence of a relationship between low free testosterone (T) levels and non-alcoholic steatohepatitis (NASH) as well as between fibrosis and non-alcoholic fatty liver disease (NAFLD), until recently it had not yet been supported by a biopsy confirmed study in humans. The authors of a recent poster, Sarkar, et al. did identify this relationship between low free T and NASH and between fibrosis and biopsy confirmed NAFLD enrolling adult men with a full spectrum of biopsy confirmed NAFLD.
- Simply Wall St.
What Percentage Of Lipocine Inc. (NASDAQ:LPCN) Shares Do Insiders Own?
A look at the shareholders of Lipocine Inc. (NASDAQ:LPCN) can tell us which group is most powerful. Institutions often...
- Benzinga
18 Stocks Joining The Russell Indices
The Russell 2000 Index is a small-cap stock market index that includes the bottom 2,000 companies found in the Russell 3000 index. The Russell Microcap Index includes the 1,000 smallest securities found ...
- Simply Wall St.
Is Lipocine Inc.'s (NASDAQ:LPCN) Balance Sheet Strong Enough To Weather A Storm?
While small-cap stocks, such as Lipocine Inc. (NASDAQ:LPCN) with its market cap of US$32m, are popular for their...
- Zacks Small Cap Research
LPCN: Now We Have PDUFA Date; Target To $7
By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT HERE First Quarter 2019 Operational and Financial Results On May 8, 2019 Lipocine (NASDAQ:LPCN) filed its 1Q:19 10-Q and posted ...
- Associated Press
Lipocine: 1Q Earnings Snapshot
The Salt Lake City-based company said it had a loss of 14 cents per share. The company's shares closed at $1.86. A year ago, they were trading at $1.57. _____ This story was generated by Automated Insights ...
- Simply Wall St.
Did You Manage To Avoid Lipocine's (NASDAQ:LPCN) Devastating 81% Share Price Drop?
Want to participate in a short research study? Help shape the future of investing tools and you could win a $250 gift card! While not a mind-blowing move, it is good to see that the Lipocine Inc. (NASDAQ:LPCN) share price...
- Zacks Small Cap Research
LPCN: Turning the Tables
During the approval of these competitors, Lipocine Inc. (LPCN) has been completing its blood pressure and ex vivo conversion studies in support of a 2Q:19 resubmission of its new drug application (NDA) so it can obtain approval and launch its own oral formulation of TRT. Clarus and Lipocine have been competing for the same market and also battling it out in the courts over patent conflicts. After the recent grant of Lipocine’s Priority Motion by the Patent Trial and Appeal Board (PTAB) and the adverse judgment against Clarus regarding the interference case, we see a low likelihood of a successful appeal by Clarus.
- Zacks Small Cap Research
LPCN: ABPM Study Topline Data
Lipocine (LPCN) distributed a press release yesterday announcing the completion of the Ambulatory Blood Pressure Monitoring (ABPM) clinical study and providing topline results. Blood pressure measurements were taken at baseline and at end of study with 118 subjects providing evaluable ABPM data. Results of the ABPM demonstrated a mean change of systolic blood pressure (SBP) of +3.82 mm Hg and diastolic blood pressure (DBP) of +1.20 mm Hg over the course of the study.
- Zacks Small Cap Research
LPCN: NASH Topline
By John Vandermosten, CFA NASDAQ:LPCN READ THE LATEST LPCN RESEARCH REPORT Lipocine (NASDAQ:LPCN) announced topline results from its non-alcoholic steatohepatitis (NASH) liver fat study demonstrating relative ...
- Benzinga
Lipocine Surges On Positive 16-Week Liver Imaging Study For Its NASH Candidate
Lipocine Inc (NASDAQ: LPCN ) is seeing some momentum Tuesday morning after the company reported results of a study evaluating its non-alcoholic steatohepatitis (NASH) candidate. What Happened Lipocine ...
- Simply Wall St.
Does Lipocine Inc.’s (NASDAQ:LPCN) CEO Pay Reflect Performance?
Mahesh Patel became the CEO of Lipocine Inc. (NASDAQ:LPCN) in 1997. This analysis aims first to contrast CEO compensation with other companies that have similar market capitalization. Next, we'll considerRead More...
- Zacks Small Cap Research
LPCN: Soldiering on and Winning Some Battles
Lipocine (LPCN) published two press releases in the last two weeks signaling the advancement of LPCN 1144 towards a Phase II trial in non-alcoholic steatohepatitis (NASH) with biopsy confirmed NASH subjects. In the weeks prior, the company released other positive news regarding the grant of priority motion against Clarus and results from the phlebotomy study required to resubmit TLANDO.
