Eton Pharmaceuticals Inc (ETON) ニュース

ETON, near a 52+week high

ETON under $5

8k out great news

ETON new 52 week high

$ETON - 👆Up 30% Pre-Market/Current Price $3.38
Q2 &Recent Business Highlights
👉Total Q2 revenue of $12m &net income of $4.6m
👉Tenth straight quarter of sequential growth in product sales and royalty revenue

Eton Pharmaceuticals Announces FDA Approval of ZONISADE™ (Zonisamide Oral Suspension)
July 18, 2022 07:05 ET | Source: Eton Pharmaceuticals




...
DEER PARK, Ill., July 18, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved ZONISADE™ (zonisamide oral suspension).

“We are proud to have another product approval from our team’s development efforts. This is now the eighth product approval that our team has contributed to, and we are excited for Azurity to bring the product to patients. The proceeds from the launch milestone will be used to further grow our rare disease portfolio,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

ZONISADE™ was included in Eton’s multi-product neurology oral solution partnership with Azurity Pharmaceuticals announced in February of 2021. Under the agreement, Eton is entitled to receive an additional $5 million payment upon the launch of ZONISADE™, royalty on net sales, and up to $15 million of commercial milestones tied to the combined sales of all three products in the partnership. Azurity Pharmaceuticals will be responsible for the commercialization of ZONISADE™, and no marketing expenses will be incurred by Eton.

About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The product currently commercializes ALKINDI SPRINKLE® and Carglumic Acid tablets and has two additional rare disease products under development, dehydrated alcohol injection and the ZENEO® hydrocortisone autoinjector. In addition, the company’s royalty segment is entitled to receive milestone payments or royalties on six different products.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on

Upgraded Buy Target
Nice catch here

https://www.google.com/amp/s/news.yahoo.com/amphtml/eton-pharmaceuticals-following-fda-approval-225718935.html

And more in the pipeline

Eton Pharmaceuticals Announces FDA Approval of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) as Replacement Therapy in Pedi...

Needs daily dose and impacts 5000-11000 children in US.

It is a rare disease so will have high pricing.

Tomorrow is the day!

Next one is next week 29th Sept

Finally first of the 2 approval

$138k buy at $8.12 3pm central time.

Today is the new PDUFA date for one of the drugs. So there are 2 PDUFA dates in 2 weeks


2020-09-15
ETON EM-100 $7.93

PDUFA date August 10, 2020 extended to September 15, 2020.


2020-09-29
ETON Alkindi Sprinkle $7.93

PDUFA date September 29, 2020.

Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates

Eton's In-licensed Pediatric Adrenal Insufficiency Drug Awaits FDA Clearance

Company: Eton Pharma
Type of Application: NDA
Candidate: Alkindi Sprinkle
Indication: pediatric adrenal insufficiency
Date: Sept. 29
Eton acquired U.S. marketing rights to Alkindi Sprinkle from AIM-listed Diurnal Group plc in late March. Alkindi Sprinkle, a taste neutral sprinkle or granule formulation of hydrocortisone, is being evaluated as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age.

The product, which is approved in Europe, is to be available strengths 0.5mg, 1mg, 2mg, and 5mg to provide pediatric atients with optimal precision and flexibility.

Eton estimates the market opportunity of Alkindi Sprinkle to be $100 million annually.

Maybe today then

This gets approved today!!! 50-100% spike?

https://etonpharma.com/eton-pharma-business-model/

MAJOR Breakout imminent guys

ETON =MC $96 M--3x FDA DECISIONS in this year (link below) ,LOW FLOAT =CHEAPEST and MOST attractive FDA Gem in 2020 a potential 10 Bagger here RALLYYYYYYYYYYYYYYY

It's a month out from the fda decision. Out of curiosity, when did you expect the volume to pick up? I would expect the runup to start asap. I'm not sure of how much volume will change but anticipation should start to induce buying....

I have no position yet but potentially soon.. Et105 with potential 500+ million market from quick reading should really help the share price as well as revenue reports upcoming(which I dont expect too much since biorphen is new).

I'm showing Earnings around March 5th. If anyone has a better date please let me know. Any negatives about the company feel free to lambaste me with them(appreciate all knowledge). Institutional ownership isnt horrible and appears to be growing slowly....

There’s more meat on this bone. Took some profit as volume didn’t pick up as anticipated.

What a joke. This is truly pathetic!

* * $ETON Video Chart 10-22-2019 * *

Link to Video - click here to watch the technical chart video

I'm out -- broke even. Good luck if you stay in.

For having great news --- this trading doesn't look good.

rallyyyyyyyyyyyyyyyyy

APPROVEEEEEEEED

Eton Pharmaceuticals Announces U.S. FDA Approval of Biorphen® (phenylephrine HCI) Injection
https://finance.yahoo.com/news/eton-pharmaceuticals-announces-u-fda-110005067.html

FDA DECISION TODAY ...could jump to $9-10

may be last chance to get some before close ...News likely will come in pre-mkt on monday

major breakout coming

FDA DECISION THIS MONDAY...LOAD UP

Lead product candidate ET-202, a ready-to-use phenylephrine injection with an October 21, 2019 PDUFA date

Is there a particular reason this stock plummeted this week?

clinical results should be released any day now

clinical results of ET 103 trial imminent and next FDA decision in 60 days ..

Presentation
https://seekingalpha.com/article/4282869-eton-pharmaceuticals-eton-investor-presentation-slideshow#

insider buying ,, time to load up ahead to the clinical results expected this quarter and the FDA decision in october ...

https://fintel.io/n/us/eton

Massive opportunity to add or for new entry , lots of big 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 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)

great buying opportunity indeed , lots of big news around the corner . And EM-100 still likely to be approved in Q1-Q2 2020 its a light crl .

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.

CRL IT IS! Not Manufacturing but application. but still CRL.
Looks like OCTOBER PDFUA is the big one anyway right?
Maybe ILL get in Monday. I like the longer term pic of this co

someone got 08:09:35 $ 9.65 High 7,778 premkt.

Ah ok - well then if that is the case it looks like it would be a lock approval as it shows clear benefit.
This company has some good assets under its belt huh!

Up 10% looks like good news from FDA coming

RALLYYYYYYYYYYYYYYYY ...FDA Decision tomorrow

looks like the fda did already inspect their manufacturing site if there were an issue the company would get a CRL not a new pdufa date of july 11 we will see what happens tomorrow .


this new pipeline update is from last month
https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-licensing-lamotrigine-new-drug

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.


this is from early may

https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-reports-first-quarter-2019-financial

EM-100. EM-100 is Eton’s preservative-free ophthalmic solution for the treatment of allergic conjunctivitis. The product is currently under review with the FDA and has been assigned a target action date of May 2019 or July 2019 depending on whether the FDA chooses to inspect EM-100’s manufacturing site. Bausch Health is responsible for all commercialization activities for the product.

What about the inspection? The reason the month delay was due to inspection. No care about that?

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
http://www.insidercow.com/institution/subject.jsp;jsessionid=B54DEE86A6DD2C22783F1ABDA5F8B1A6?subject=0001710340&company=ETON
B 2019-05-24 17:20:10.0 Eton Pharmaceuticals ETON Opaleye Management Inc 5.0%

2 Days untill FDA Decision ....

$9+ before FDA Decision on Thursday is possible then jump to $11-13 on approval

Deals which just closed in last 6 months :

Bausch Health acquires U.S. rights for Eton's eye drop ..2019-02-19
https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aBHC-2719331


"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


Eton Pharmaceuticals Announces Licensing of Lamotrigine New Drug Application and Provides Pipeline Update
https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-licensing-lamotrigine-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-releases/news-release-details/eton-pharmaceuticals-enters-license-agreement-two-branded



Eton Pharmaceuticals Announces Licensing of Oral Liquid Product Candidate ET-104
https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-licensing-oral-liquid-product

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.