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FDA sagt "Nein"
endpts.com/...da-shows-another-testosterone-therapy-the-door/
LPCN 1144
http://ir.lipocine.com/2019-01-17-Lipocines-NASH-Therapy-Candidate-Achieves-Meaningful-Liver-Fat-Reduction-Based-on-Interim-Results
Allerdings gibt es Kritik am Studiendesign:
"I could conduct another webinar on clinical trial red flags based solely on todays LPCN liver fat study press release. Missing patients (and too few overall), no placebo control, skewed means, arbitrary data cutoffs, etc etc. "
https://twitter.com/adamfeuerstein/status/1085877664991178753
LPCN 1144
wieder Kritik von AF:
"Not that anyone trading cares, but today’s LPCN iver fat (NASH? NAFLD? Something else?) data are worse than the data previously disclosed in January. Also, wow, so many changes to endpoint definitions. Carry on…."
twitter.com/adamfeuerstein/status/1105446714276761600
FDA verweigert TLANDO zum dritten Mal die Zulassung
endpts.com/...ir-oral-testosterone-drug-snubbed-again-by-fda/
6 Mio. $ Offering
Was für schlechtes Timing vom Management. Finger weg!
ir.lipocine.com/...blic-Offering-Of-Common-Stock-And-Warrants
6 Mio. $ Offering
ir.lipocine.com/...tered-Direct-Offering-Priced-At-The-Market
FDA benötigt zusätzliche Zeit
"Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it needs additional time to complete its review of TLANDO's New Drug Application ("NDA") and is committed to taking action as expeditiously as possible. The anticipated Prescription Drug User Food Act ("PDUFA") goal date was August 28, 2020 for TLANDO. Although the FDA did not provide a timeline on a new action date, the FDA informed the Company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional data and the Company has provided the FDA with all information requested to date.
TLANDO is the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism."
ir.lipocine.com/...e-Provides-Regulatory-Update-for-TLANDO-TM
FDA erteilt die "vorläufige" Zulassung für Tlando
www.rttnews.com/3152093/...tosterone-replacement-therapy.aspx
25 Mio. $ Offering
ir.lipocine.com/...derwritten-Public-Offering-Of-Common-Stock
Lipocine verliert vor dem US-Bezirksgericht von Delaware gegen Clarus Therapeutics
"...weil keine angemessene schriftliche Beschreibung der von Lipocine geltend gemachten Patentansprüche vorgelegt wurde.
In seiner Entscheidung, die Clarus einen eindeutigen Sieg beschert, befand Richter William C. Bryson alle geltend gemachten Patentansprüche von Lipocine für ungültig."
seekingalpha.com/news/...ent-infringement-lawsuit-for-jatenzo
Vergleich mit Clarus Therapeutics
Die Details bleiben vertraulich.
www.benzinga.com/general/biotech/21/07/...clarus-therapeutics
Lizenzvereinbarung mit Antares Pharma
ir.lipocine.com/...ensing-Agreement-To-Commercialize-TLANDO-R
Zulassung für TLANDO
ir.lipocine.com/...PARTNER-RECEIVED-FDA-APPROVAL-OF-TLANDO-TM
Vorbörslich sieht es nach einer "Sell-the-News" Reaktion aus (LPCN 1,54$ / -15%). Nichtsdestotrotz konnte man hier seit Oktober 100% einfahren.
Zahlen für Q2/22
ir.lipocine.com/...for-the-Second-Quarter-Ended-June-30,-2022
Nicht selten bei Biotechs, dass die großen HF die Zulassung zum Ausstieg nutzen um die Kommerzialisierungsrisiken zu umgehen.
Zahlen für FY22
ir.lipocine.com/...sults-for-the-Year-Ended-December-31,-2022
ir.lipocine.com/...l-Candidate-for-Rapid-Relief-of-Depression
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Wertung | Antworten | Thema | Verfasser | letzter Verfasser | letzter Beitrag | |
4 | 46 | Lipocine Inc | iwanooze | Vassago | 17.05.23 10:59 | |
6 | Lipocine im Aufwind | Tiger | Tiger | 09.12.22 12:44 |