|Bid||0.00 x 0|
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|Day's Range||1.49 - 1.58|
|52 Week Range||1.15 - 5.33|
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Lipocine Inc. (LPCN) filed its 2017 10-K and posted its earnings release on March 12, summarizing an volatile year which included new dosing studies for Tlando and a resubmission of the drug to the FDA. Several key events have taken place year to date with additional financing secured and an advisory committee meeting that sought additional information for the company’s testosterone replacement therapy product. Progress was also made on patent rights and class action lawsuits, placing Lipocine in a stronger position overall with respect to Clarus’ patent.
For investors with a long-term horizon, assessing earnings trend over time and against industry benchmarks is more valuable than looking at a single earnings announcement in one point in time.Read More...
Lipocine Inc (NASDAQ: LPCN ) is still down 57 percent since the U.S. Food and Drug Administration’s Bone, Reproductive and Urologic Drugs Advisory Committee voted 6-13 on Tlando’s benefit-risk profile. ...
On January 10, 2018 the 19 member Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 13 to 6 against the benefit / risk profile for Lipocine Incorporated’s (LPCN) Tlando (Testosterone undecanoate). The panel’s main focus was related to blood pressure concerns. While Lipocine did measure blood pressure during each visit for each study, this was insufficient to provide the data the panel sought. The lack of data prompted the BRUDAC to vote against the benefit / risk profile as they felt they had insufficient information to cast a positive vote. Other items raised during the meeting related to breakdown of testosterone undecanoate (TU) into testosterone in the collection tubes, and the data leading to the stopping of TRT.
Lipocine Inc (NASDAQ: LPCN ), a pharma company focusing on men's and women's health, announced Wednesday the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, voted against the benefit/risk ...
Investors are fleeing from testosterone drugmaker Lipocine, but its FDA woes portend bigger challenges for companies developing new versions of the embattled hormone.
Lipocine Inc (NASDAQ:LPCN) just announced an update relating to its lead development program and the company has taken a real hit on the back of the news. The update details the outcome of a Bone, Reproductive and Urologic Drugs Advisory Committee, which was set up to discuss the company’s New Drug Application (NDA) for an […] The post What’s Next For Lipocine After A Disappointing Panel Review? appeared first on Market Exclusive.
Lipocine Inc (NASDAQ:LPCN) failed to convince the Food and Drug Administration advisory committee that its phase 3 data testing TLANDO in hypogonadal male patients was good enough to award the drug an approval. Lipocine shares reacted accordingly, crashing nearly 56%. The final vote came in at 6 to 13 recommending the FDA not approve the drug. The FDA doesn't have to follow the panel's advice, but given the negative tone, it seems highly unlikely the agency would go against the negative recommendation.
Below is a list of notable corporate events for the week beginning January 8th. Note, this list is not comprehensive and all dates are subject to change. Monday Conferences CES 2018 Jan. 8 thru Jan. 11 ...
Lipocine (LPCN) made progress addressing its CRL for Tlando in the third quarter and resubmitted its NDA for the product receiving a February 8, 2018 PDUFA date, which was later changed to May 8, 2018 following the submission of additional information. The FDA also scheduled an advisory committee meeting for Tlando on January 10, 2018. The other highlight of 3Q:17 related to the USPTO motion for Lipocine’s and Clarus’ initial priority dates regarding Tlando. This change shifted the focus to Lipocine’s 2009 patent, which the company believes contains sufficient evidence to support their claim of priority and is dated prior to the earliest priority that will be accorded Clarus. The Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review the submission. The AdCom has been scheduled for January 10, 2018 and the PDUFA date has been extended to May 8, 2018. The reason for the three month extension of the PDUFA date was a result of Lipocine submitting additional information that was considered a major amendment to the NDA. Lipocine expects to spend an additional $2.5 million of research and development costs for Tlando as of November 2017.
The Salt Lake City-based company said it had a loss of 22 cents per share. The company's shares closed at $3.55. A year ago, they were trading at $3.07. _____ This story was generated by Automated Insights ...
On September 20, Lipocine, Inc. (LPCN) announced that an Advisory Committee (AdCom) will be convened to review Tlando following the August submission of data in the Dosing Validation and the Dosing Flexibility studies which evaluated the efficacy and tolerability of Tlando. Prior to the PTAB motions decision, Clarus was using a patent filed in 2006 and Lipocine was using evidence from 2002 and 2003 to support their claim. The PTAB responded that there was no embodiment of all the elements asserted in the earlier dates that both Lipocine and Clarus were citing. As a result, the PTAB did not allow either of their earlier asserted priority dates.
The highlight of the second quarter was the announcement of topline results from the dosing validation (DV) and dosing flexibility (DF) studies for Lipocine’s testosterone therapy, LPCN 1021. The studies supported the Phase 3 design providing LPCN 1021 as a fixed dose with twice daily administration. Results met FDA guidelines for average testosterone levels with 81% of subjects achieving the normal range. Providing LPCN 1021 as a fixed dose with no titration is an important factor for simplicity in administration and monitoring for physicians and their patients. The DV study will be the pivotal study for the resubmission and is expected to be presented to the FDA later this month. On August 8th Lipocine Inc. (LPCN) filed its first quarter 2017 10-Q in conjunction with a press release highlighting recent achievements. The company reported 2Q:17 net loss of ($6.1) million which equates to ($0.31) on a per share basis. This compares to our estimates of ($6.3) million and ($0.33) per share. Actual R&D expenditures for the dosing validation (DV) and dosing flexibility (DF) study were lower than our estimates, but did rise by 60% over the same period in the prior year.
On a per-share basis, the Salt Lake City-based company said it had a loss of 31 cents. The results surpassed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment ...
By John Vandermosten, CFA NASDAQ:LPCN 1Q:17 Operational and Financial Results On May 9th Lipocine Inc. (NASDAQ:LPCN) filed its first quarter 2017 10-Q in conjunction with a press release highlighting recent ...
The Salt Lake City-based company said it had a loss of 26 cents per share. The company's shares closed at $4.15. A year ago, they were trading at $8.91. _____ This story was generated by Automated Insights ...