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

ANDA mit paragraph IV cerification für DS-300 wurde an die FDA übermittelt. Bausch health hat eine geänderte Fassung zu ihrem zurückgewiesen EM-100 Antrag an die FDA gesendet. https://ir.etonpharma.com/node/6766/html

Eton Pharmaceuticals Announces U.S. FDA Approval of Biorphen® (phenylephrine HCI) Injection https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-us-fda-approval-biorphenr

Eton Pharmaceuticals Announces Positive Results from Clinical Study Report of ET-104 Business WireAugust 19, 2019, 1:00 PM GMT+2 DEER PARK, Ill.--(BUSINESS WIRE)-- ET-104 Successfully Demonstrated Bioequivalence to Currently Approved Oral Solid Formulation New Drug Application (NDA) Submission Expected in Fourth Quarter of 2019 https://finance.yahoo.com/news/eton-pharmaceuticals-announces-positive-results-110000902.html

ton Pharmaceuticals (ETON) Investor Presentation - Slideshow https://seekingalpha.com/article/4282869-eton-pharmaceuticals-eton-investor-presentation-slideshow?source=quotemedia_readmore

Second Quarter Financial Results Revenue: Eton reported no revenue in the second quarter of 2019 and no revenue for the same period in 2018. Research and Development (R&D) Expenses: R&D expenses were $1.4 million for the second quarter of 2019 versus $1.7 million for the same period in 2018. The decline was primarily driven by reduced product-specific development costs in the period, partially offset by increased costs associated with headcount and the operation of the company’s R&D laboratory facility that was set up in late 2018. General and Administrative (G&A) Expenses: G&A expenses were $1.9 million for the second quarter of 2019 versus $1.0 million for the same period in 2018. The increase was primarily driven by higher employee-related costs from increased headcount, public company expenses, and marketing expenses associated with product launch preparation activities. Excluding non-cash expenses, G&A expenses for the quarter were $1.5 million versus $0.6 million in the prior year period. Net Loss: Eton reported a net loss for the second quarter of 2019 of $3.2 million versus $3.1 million for the same period of 2018. Cash Position: As of June 30, Eton reported cash and cash equivalents of $14.9 million compared to $26.7 million as of December 31, 2018 and $19.6 million as of March 31, 2019. Subsequent to the quarter-end, in early July, Eton received a $1.3 million refund from the FDA for an NDA filing fee which had been paid in March 2019.

5d1m3m1y5y10y Eton Announces Second Quarter Financial Results and Highlights Business Progress ET-203 NDA submitted, Three Additional Product Submissions Expected in 2019 ET-105 Acquisition Closed & Application Assigned PDUFA Date of March 17, 2020 Company to Host Conference Call and Webcast Today at 4:30p.m. ET (3:30 p.m. CT) Potential Upcoming Business Milestones: ET-104 Clinical Results (Third Quarter 2019) ET-103 Clinical Results (Third Quarter 2019) ET-202 PDUFA Date (October 21, 2019) Potential ET-103 NDA Submission (Fourth Quarter 2019) Potential ET-104 NDA Submission (Fourth Quarter 2019) Potential DS-300 ANDA Submission (Fourth Quarter 2019) EM-100 Amendment Submission (Fourth Quarter 2019) ET-105 PDUFA Date (March 17, 2020) Potential EM-100 FDA Response (First Quarter 2020) http://app.quotemedia.com/quotetools/newsItem.htm?webmasterId=102683&storyId=8156764402249823

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

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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