ETON (MC $133 M) 4x FDA decision soon first one on July 11 = Multibagger Gem

Discussion in 'Stock picks and trading strategies' started by DollarChamp, Jun 24, 2019.

  1. DollarChamp

    DollarChamp Member

    (ETON)..Market Cap $133 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: $130,7 Million
    Cash: $19,5 Million
    Price: $7,42

    Shares Out: 17,6 Million

    Presentation May 2019
    https://ir.etonpharma.com/static-files/202baa89-020a-44ab-8a73-d12ad27288d1[tag]insert-text-here[/tag]


    •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....ETON-Eton-Pharmaceuticals-analyst-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.

    [​IMG]
     
  2. DollarChamp

    DollarChamp Member

    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
     
  3. DollarChamp

    DollarChamp Member

    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.
     
  4. DollarChamp

    DollarChamp Member

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