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  • Lipocine Inc. (LPCN) stock Collapses After Hours. Any Reasons?

    Lipocine Inc. (LPCN) stock Collapses After Hours. Any Reasons?

    On January 14, Lipocine Inc. (LPCN) stock collapsed in the after-hours to lose 9.49% at 29.36K shares. No news from the company seems to be responsible for the downtrend in the stock.

    During the regular session, LPCN stock added 1.59% at its close of $0.9956 on Friday. Soon the stock saw a reversal as it entered the after-hours session. LPCN stock lost $0.09 in the after-hours to reach $0.9011.

    More about LPCN and its Movement

    The clinical-stage biopharmaceutical company, Lipocine Inc. was founded in 2011. Currently, the company’s 88.29 million outstanding shares trade at a market capitalization of $87.9 million. Moreover, the stock has subtracted 3.34% in the past five days and 8.66% last month. Currently, the stock stands at a year-to-date gain of a minuscule 0.45% while it lost 38.54% last year.

    On Friday, the stock traded in the green during the regular session. While there was no news from the company, LPCN entered the red in the after-hours. Hence, the stock suffered a loss of 9.49% in the after-market session on Friday.

    Phase 2 Study of LPCN 1148

    Recently, the company initiated the Phase 2 proof-of-concept clinical study of LPCN 1148 for the management of liver cirrhosis. Further, it is a multi-center, randomized, placebo-controlled 52-week study in sarcopenic cirrhotic patients who are on the liver transplant list.

    Currently, decompensated liver cirrhosis has only one cure of liver transplant, which is a very expensive and time-consuming process.

    The study’s endpoints include the following:  Firstly, the primary endpoint of the study changes in Skeletal Muscle Index (SMI) from baseline through computed tomography against placebo at week 24. Secondly, measures of frailty, change in waitlist events, myoteatosis, rate of hospital admissions, all-cause mortality, and decompensation events are some of the key secondary endpoints.

    On December 22, 2021, LPCN announced the dosing of the first patient in the Phase 2 study. The company expects to provide the primary endpoint topline results from the study in the second half of 2022.

    LPCN 1148 is the company’s novel prodrug with the potential of improving liver and muscle function.

    Financial Highlights

    The company declared its financial results for the third quarter of 2021, on November 10.

    In the third quarter of 2021, LPCN had a net loss of $3.1 million ($0.03/share) against $4.3 million ($0.07/share) in Q3 of 2020.

    Furthermore, the company ended the quarter with unrestricted cash, cash equivalents, and marketable securities of $38.7 million. As part of licensing agreement with Antares Pharma, the company also received an $11.0 million upfront license fee after the end of the quarter.

  • Lipocine Inc. (LPCN) stock surged in the after-hours on Wednesday after a recent announcement

    Lipocine Inc. (LPCN) shares surged 11.63% in after-hours on Wednesday, July 14, 2021, and closed the trading at $1.44 per share. Earlier in the morning session on Wednesday, LPCN’s stock lost 2.27% to close Wednesday’s session at $1.29. LPCN shares have risen 4.88% over the last 12 months, and they have moved down 4.44% in the past week. Over the past three months, the stock has lost 12.24%, while over the past six months, it has shed 20.86%.

    Let’s have a brief look at its recent developments.

    Settlement With Clarus Therapeutics

    On July 14, 2021, Lipocine Inc entered into a global settlement and license agreement with Clarus Therapeutics Inc (Clarus) to resolve all outstanding claims in the ongoing intellectual property battle between the two companies as well as the ongoing interference proceeding between the two companies.

    Both companies agreed to dismiss the Lipocine Inc. v Clarus Therapeutics, Inc., No 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware and interference proceedings captioned Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 presently pending in the U.S. Patent and Trademark. The terms of the settlement remain confidential.

    Participation in the recent health and investor conferences

    Lipocine Inc recently participated virtually at Ladenburg Thalmann Healthcare Conference, which held on July 13-14, 2021.

    Earlier, the company took part in The International Liver Congress™ in 2021, the annual meeting of the European Association for the Study of the Liver (EASL), Digital Event, which held on June 23-26, 2021.

    Lipocine was present at Raymond James Human Health Innovation Conference which held on June 21-23, 2021, and at Lytham Partners Summer 2021 Investor Conference which held on June 14-16, 2021.

    LPCN 1154 IND application cleared by FDA

    On June 14, 2021, the U.S. Food and Drug Administration (FDA) cleared Lipocine’s Investigational New Drug Application to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression in adults.

    Clarus Therapeutics won Patent Infringement Case against Lipocine

     

    On May 25, 2021, The U.S. District Court for the District of Delaware granted Clarus Therapeutics’ motion for summary judgment against remaining patents in a patent infringement case brought by Lipocine Inc regarding Clarus’s oral testosterone replacement product, Jatenzo.

    The statement gave Clarus an unequivocal win, Judge Bryson found all of the asserted Lipocine patents claims invalid.

    Conclusion

    The latest settlement with Clarus Therapeutics was the reason behind its gains in the after-hours on Wednesday because investors always take such news as a positive development. We can see LPCN to surge in the coming days.

  • Lipocine Inc. [LPCN] is a stock which investors cannot afford to ignore

    Lipocine Inc. (Nasdaq: LPCN), shares have changed -12.80% in price in a 5-day period, and -10.63% in the past three months. Shares of LPCN are up 5.15% YTD, with their twelve-month performance up 162.48%. In the last year, the lowest price was $53.15 and the highest was $138.79.

    Lipocine Inc. (Nasdaq: LPCN), is a clinical-stage biopharmaceutical company developing novel drug delivery technologies for metabolic and endocrine disorders. TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107 are in Lipocine’s clinical development pipeline. The FDA has tentatively approved TLANDO, an oral prodrug of testosterone containing testosterone undecanoate, for the treatment of men who have deficiency of endogenous testosterone, also called hypogonadism.

    WHAT HAPPENED RECENTLY

    It was announced March 3, 2021 that Lipocine Inc. (Nasdaq: LPCN), the developer of TLANDO, will present their clinical data at the ENDO 2021 Conference, which is scheduled for March 20-23, 2021. For adult males with conditions associated with a lack of endogenous testosterone, called hypogonadism, TLANDO is an oral testosterone replacement therapy product candidate.

    Meanwhile,

    An analysis of the pharmaceutical industry shows that only a small percentage of Phase I products ever make it to the market. Typically, the percentage rises to 40% in Phase II and 70% in Phase III. Thus, a drug at Phase I is clearly a riskier investment than at Phase III. Market potentials can be determined using publicly available data on patient populations and current prices per patient/year. An analysis of competitor activity will demonstrate the number of companies conducting research on the same disease, and the level of their progress. The analysts claim that as a result, all major risks in a product development are quantifiable, such as clinical and competitor risk. It is possible to calculate the net present value or its net value to the company by adding up the risks.

  • Is this the news why Lipocine Inc. (NASDAQ: LPCN) shares took a hike in the After-hours?

    Is this the news why Lipocine Inc. (NASDAQ: LPCN) shares took a hike in the After-hours?

    Lipocine Inc. (NASDAQ: LPCN), shares jumped 22.62% in the after-hours after the announcement by the clinical-stage biotech firm focusing on metabolic and endocrine diseases, recently confirmed that the U.S. TLANDO, the oral testosterone medication for testosterone replacement therapy in adult males, has been tentatively approved by the Food and Drug Administration for disorders associated with lack or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

    In granting preliminary approval, the FDA determined that TLANDO meets all the consistency, protection, and effectiveness requirements needed for approval, but that TLANDO did not obtain final approval and that it is not available for final approval and marketing in the United States until the expiry of the exclusivity term previously given to Clarus Therapeutics, Inc. in respect of Jatenzo, which expires in March.

    Lipocine is actively evaluating the preliminary approval of TLANDO by the FDA and remains committed to taking adequate steps to gain full approval to allow TLANDO to be released. The FDA has also required Lipocine to perform some post-marketing trials to assess patient awareness of the critical risks associated with TLANDO and (ii) evaluate adrenal insufficiency production with chronic TLANDO treatment.