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Old 06-25-2019, 09:27 AM   Nav to Top  #1
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Default ETON --3x FDA Decisions: July & October 2019 , May 2020

(ETON)..Market Cap $130 M / 2 FDA decisions imminent for attractive products first one on July 11 and next one on October 21 / HUGE late stage pipeline with multiple milestones in near-term milestones (read below) /undiscovered Ultra low float stock with multi bagger potential here : GLTA

Eton Pharma (ETON)

Market-cap: $130 Million
Cash: $19,5 Million
Price: $7,10

Shares Out: 17,6 Million


Presentation May 2019
https://ir.etonpharma.com/static-fil...3-d12ad27288d1


•Diversified pipeline of 11 products under development. Four products submitted to the FDA,three additional NDA’s expected to be submitted in 2019

•Expect to become commercial revenue company in 2019



Products:

EM-100. EM-100, Eton’s preservative-free ophthalmic solution for allergic conjunctivitis has been assigned a target action date of July 11, 2019. Bausch Health will be responsible for all remaining regulatory and commercial activities surrounding the product. Eton is entitled to a milestone payment upon product launch and a royalty on commercial sales.


ET-202. Eton has initiated launch preparations for ET-202, Eton’s ready-to-use injectable formulation of phenylephrine. If approved on its PDUFA date of October 21, 2019, Eton anticipates launching the product in the fourth quarter of 2019. Eton believes the addressable phenylephrine market for ET-202 is more than 10 million units annually.


ET-105 is an innovative patent-pending formulation of lamotrigine that will be delivered to patients as an oral liquid. Aucta submitted the product’s New Drug Application (NDA) to the FDA in May 2019 and is seeking approval as an epilepsy treatment to be used as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older.


ET-203. The NDA for ET-203, a ready-to-use formulation of a high-volume injectable product, is expected to be submitted by Eton’s partner by the end of the third quarter of 2019.


ET-104. The bioequivalence study for ET-104, a patent-pending oral suspension pursuing a neurological indication, is ongoing. Eton expects study results in September and, if successful, plans to submit the NDA in the fourth quarter of 2019.


DS-300. Due to a third-party approval of another NDA product containing DS-300’s active ingredient, the FDA has notified Eton’s development partner that DS-300 no longer qualifies for the NDA regulatory pathway and will be required to follow the ANDA regulatory pathway. Eton is pursuing the FDA’s process to appeal the decision. If the appeal is unsuccessful, Eton plans to re-submit DS-300 as an ANDA later this year.


ET-103. The bioequivalence study for ET-103, a liquid formulation of levothyroxine, is ongoing. Eton expects study results in September and, if successful, plans to submit the NDA in the fourth quarter of 2019.

DS-100. Eton has an FDA meeting scheduled for August 2019 to discuss DS-100’s clinical pathway. If successful, Eton anticipates submitting the product’s NDA in 2020.

ET-101
. Development activities are ongoing for ET-101, an innovative oral liquid neurology product. Eton currently expects to submit the product’s NDA in 2020

ET-102
. Development activities are ongoing for ET-102, an innovative oral liquid neurology product. Eton currently expects to submit the product’s NDA in 2020

ET-201. Development activities are ongoing for ET-201, an injectable product currently approved in Europe. Eton expects to submit the product’s NDA in 2020.



Largest Shareholders

Harrow Health, Inc...3,500,000
Peter A. Appel...1,249,329 ´
Sean Brynjelsen, MBA...1,034,940
Mark L. Baum...794,745
Charles J. Casamento, MBA...60,420
Paul V. Maier, MBA...59,745
Norbert G. Riedel, PhD ...59,745
Wilson W. Troutman, CPA...5,000



https://thefly.com/landingPageNews.p...st-commentary-

Eton Pharmaceuticals price target raised to $18 from $15 at H.C. Wainwright H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Eton Pharmaceuticals to $18 from $15 after the company in-licensed ET-105, a patent-pending formulation of lamotrigine designed to be delivered to patients as an oral liquid, from the privately-held Aucta Pharmaceuticals. The analyst believes the in-licensing of ET-105 meaningfully expands Eton's "stable" of neurology-focused product candidates. He reiterates a Buy rating on the shares.


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Old 06-25-2019, 09:30 AM   Nav to Top  #2
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Bausch Health acquires U.S. rights for Eton's eye drop ..2019-02-19
https://www.stockwatch.com/News/Item...%3aBHC-2719331


Eton Pharmaceuticals Announces Licensing of Lamotrigine New Drug Application and Provides Pipeline Update
https://ir.etonpharma.com/news-relea...igine-new-drug

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


Eton Pharmaceuticals Enters Into License Agreement for Two Branded Hospital Product Candidates
https://ir.etonpharma.com/news-relea...nt-two-branded


Eton Pharmaceuticals Announces Licensing of Oral Liquid Product Candidate ET-104
https://ir.etonpharma.com/news-relea...liquid-product
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Old 07-01-2019, 09:53 AM   Nav to Top  #3
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First FDA Decision in 10 Days if approved stock likely to jump above $11+ especially of its very low float .GL

EM-100. EM-100, Eton’s preservative-free ophthalmic solution for allergic conjunctivitis has been assigned a target action date of July 11, 2019.

EM-100 Ophthalmic Solution

•Innovative over-the-counter ophthalmic solution for treatment of allergic conjunctivitis

•If approved, EM-100 would be the first preservative-free ophthalmic product indicated for allergic conjunctivitis

•Product has been filed with the FDA and is expected to be approved in 2019

•U.S. allergic conjunctivitis ophthalmic market is >$600 million annually

•Eton partnered with Bausch Health for commercialization

•Eton receives additional milestone payment upon approval and a royalty on net sales
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Old 07-08-2019, 09:44 AM   Nav to Top  #4
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First FDA Decision this Thursday ............

"EM-100. EM-100, Eton’s preservative-free ophthalmic solution for allergic conjunctivitis has been assigned a target action date of July 11, 2019. Bausch Health will be responsible for all remaining regulatory and commercial activities surrounding the product. Eton is entitled to a milestone payment upon product launch and a royalty on commercial sales."


Eton Pharmaceuticals (NASDAQ:ETON) Given New $18.00 Price Target at HC Wainwright

“We have valued Eton based on a discounted cash flow (DCF) assessment, driven by our projection of future sales and royalty-based revenue from three candidates in the company’s pipeline, namely EM-100, ET-202 and CT-100. Our valuation approach utilizes a 12% discount rate and 2% terminal growth rate, along with a 28% effective tax rate applied to future cash flows. We assign a 90% probability of regulatory approval to EM-100, an 85% probability of approval to ET-202, which have already been filed with the 80% probability of approval to ET-103.”,” the firm’s analyst commented.
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Old 07-10-2019, 09:40 AM   Nav to Top  #5
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Opaleye bought 5% stake or 881K shares of Eton .Now over 8 million shares of the 17.6 Million O/S held by insiders and institutional alone ..With potential FDA approval tomorrow this low float stock could fly like a bullet
Track insider buy and sell
B 2019-05-24 17:20:10.0 Eton Pharmaceuticals ETON Opaleye Management Inc 5.0%
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Old 07-15-2019, 11:07 AM   Nav to Top  #6
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great buying opportunity , lots of big news around the corner . And EM-100 still likely to be approved in Q1-Q2 2020 its a light CRL by FDA.

ET-202. Eton has initiated launch preparations for ET-202, Eton’s ready-to-use injectable formulation of phenylephrine. If approved on its PDUFA date of October 21, 2019, Eton anticipates launching the product in the fourth quarter of 2019. Eton believes the addressable phenylephrine market for ET-202 is more than 10 million units annually.

ET-103. The bioequivalence study for ET-103, a liquid formulation of levothyroxine, is ongoing. Eton expects study results in September and, if successful, plans to submit the NDA in the fourth quarter of 2019.

ET-203. The NDA for ET-203, a ready-to-use formulation of a high-volume injectable product, is expected to be submitted by Eton’s partner by the end of the third quarter of 2019.


ET-104. The bioequivalence study for ET-104, a patent-pending oral suspension pursuing a neurological indication, is ongoing. Eton expects study results in September and, if successful, plans to submit the NDA in the fourth quarter of 2019.
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Old 08-19-2019, 02:19 PM   Nav to Top  #7
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Mega opportunity to add or for new entry , lots of news on the way ...

ETON ( $99 M) 4 Drugs awaiting FDA approval/ first FDA decision on October 21 / 3 NDA submission in Q4 2019 (more infos below) / Low float and undiscovered Stock = Potential 10 Bagger Gem


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)


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