ETON PHARMACEUTIC WKN: A2N38G ISIN: US29772L1089 Forum: Aktien Thema: Hauptdiskussion

Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105 -ET-105 assigned Prescription Drug User Fee Act (PDUFA) target action date of March 17, 2020 http://www.globenewswire.com/news-release/2019/08/01/1895523/0/en/Eton-Pharmaceuticals-Announces-FDA-Acceptance-of-New-Drug-Application-for-ET-105.html

Eton Pharmaceuticals: Short-Term Setback, Proven Business Model Jul. 18, 2019 6:24 PM ETEton Pharmaceuticals, Inc.(ETON)1 Comment Summary Even after the recent sell-off, shares have risen by 15% since IPO pricing. I provide an overview of the company, its background and advantages of its proven business model. Regulatory setback with EM-100 appears addressable in the near term. Market opportunity for ET-202 (ready-to-use injectable formulation of phenylephrine) should come into focus as it nears potential regulatory approval in October. Current risk factors include challenge to IP for certain programs, dilution in the near term, and significant competition for most indications targeted. https://seekingalpha.com/article/4275878-eton-pharmaceuticals-short-term-setback-proven-business-model?source=quotemedia_readmore

Eton Pharmaceuticals Announces Licensing of Lamotrigine New Drug Application and Provides Pipeline Update Unique patent-pending formulation of lamotrigine addresses significant unmet need in pediatric epilepsy patients NDA was submitted in May 2019; product launch anticipated in 1H 2020 Lamotrigine market currently exceeds $700 million annually The addition of ET-105 brings Eton’s emerging neurology franchise to a total of four high-value product candidates, two of which are now expected to launch in 2020. Eton plans to establish its neurology-focused sales force in early 2020 to support the anticipated launches of ET-105 in the first half of 2020, ET-104 in the second half of 2020, and ET-101 and ET-102 in 2021. https://www.globenewswire.com/news-release/2019/06/13/1868691/0/en/Eton-Pharmaceuticals-Announces-Licensing-of-Lamotrigine-New-Drug-Application-and-Provides-Pipeline-Update.html

Willkommen Weedie👋 Endlich bin ich hier nicht mehr allein🍻

Ja,wat'n Zufall. Wollte nur mal gucken,was hier so los ist,aber hat tatsächlich sonst keiner auf dem Schirm? Hört sich doch recht gut an. Danke Schorsch!

Provides Update on EM-100 Program DEER PARK, Ill., July 12, 2019 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc(Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that the U.S Food and Drug Administration (FDA) provided Eton’s partner with a Complete Response Letter relating to the application for EM-100. No concerns were raised about the clinical data in the application, so it is not anticipated that any additional clinical work will be required. A response to this letter is expected shortly, and the Company remains confident in the approvability of the product. “We believe the issues cited in the CRL can be addressed in the coming months, and we remain confident that EM-100 will be available to patients as quickly as possible,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-provides-update-em-100-program