Eton Pharmaceuticals Inc

Eton Pharmaceuticals, Inc. engages in the development, acquisition, and commercialization of prescription drug products. Its products include Biorphen, Alaway Preservative Free, zonisamide oral suspension, topiramate oral suspension, lamotrigine for oral suspension, cysteine injection, and ephedrine ready-to-use injection. The company was founded in April 2017 and is headquartered in Deer Park, IL.

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Eton Pharmaceuticals reports robust Q4 earnings, eyes accelerated growth

Eton Pharmaceuticals reported strong financial performance in Q4 2022, with a focus on accelerating growth, expanding product portfolio, and doubling sales and royalty revenue in 2023. The strategic transition to an in-house sales force for key products reflects proactive sales strategy control and market expansion efforts. While facing challenges in managing increased R&D expenses, Eton is well-positioned to capitalize on growth opportunities and achieve its long-term goal of commercializing rare disease products.

Eton Pharmaceuticals Reports Record Sales in Q1 2023, Eyes Growth

Eton Pharmaceuticals delivered impressive Q1 results with record sales and revenue growth, driven by successful product launches and strategic marketing initiatives. While facing challenges in managing expenses and legal matters, the company remains optimistic about its growth prospects and product development plans.

Eton Pharmaceuticals excels in Q2, eyes rare disease expansion

Eton Pharmaceuticals demonstrated strong financial performance and strategic growth initiatives in Q2 2023.
While facing regulatory challenges and timeline risks, the company's focus on rare diseases and acquisitions positions it for future growth.
With a solid cash position, successful product launches, and revenue projections, Eton is poised for continued success and value creation.
Navigating challenges and capitalizing on opportunities will be crucial for Eton to sustain its growth trajectory and maximize shareholder value.

Eton Pharmaceuticals excels in Q3, eyes rare disease market growth

Eton Pharmaceuticals demonstrated strong financial performance in Q3 2023, driven by revenue growth and operational efficiency.
While facing challenges in expense management and short-term profitability, the company remains focused on expanding its product portfolio and market presence.
With a solid cash position, strategic acquisitions, and a clear growth strategy, Eton is poised for continued success and revenue expansion in the coming quarters.

Eton Pharmaceuticals excels in Q4, eyes positive net income in 2024

Eton Pharmaceuticals delivered strong financial performance in Q4 2023, with revenue growth, positive cash flow, and a path to positive GAAP net income in 2024. The company's well-capitalized position, promising pipeline, and strategic growth initiatives position it for continued success. However, managing increasing operating expenses and ensuring the accretive nature of future acquisitions are key challenges.

Eton Pharmaceuticals reports robust Q1 revenue growth and strategic expansions

Eton Pharmaceuticals' Q1 performance reflects consistent revenue growth and strategic advancements.
While facing competition and M&A caution, the company is poised for growth with new products.
Opportunities lie in upcoming NDA approvals, product developments, and maintaining financial discipline.
Overall, Eton's prudent financial management and growth strategies position it for future success.

Eton Pharmaceuticals reports record Q3 earnings, eyes transformative acquisition

Eton Pharmaceuticals delivered strong financial performance in Q3 2024, with robust revenue growth, positive net income, and a strategic acquisition on the horizon. While facing challenges in sales force realignment and increased expenses, the company is poised to capitalize on opportunities with Increlex and ET-400.

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Shares of Eton Pharmaceuticals Inc. tumbled 20.0% in premarket trading on Friday after the company said the Food and Drug Administration issued a complete response letter, saying it cannot approve Eton's application for its methanol poisoning treatment in his current form. Eton said it can address most of the questions raised by the FDA "in the coming months.

Eton's stock falls after FDA questions application for methanol poisoning therapy

Eton Pharmaceuticals Inc (NASDAQ: ETON) has received a Complete Response Letter (CRL) from the FDA related to a marketing application for its dehydrated alcohol injection to treat methanol poisoning. The CRL indicated that the FDA has completed its review of the application and has determined that the application cannot be approved in its present form.

Eton Pharmaceuticals Stock Tumbles After FDA Rejects its Dehydrated Alcohol Injection Application For Methanol Poisoning

DEER PARK, Ill., May 28, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), today announced that the company has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) in response to the submission of its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning. The CRL indicated that the FDA has completed its review of the application and has determined that the application cannot be approved in its present form. A Pre-Approval Inspection (PAI) of the product's European contract manufacturer is pending due to what the company believes are COVID-related travel restrictions. The company believes all other FDA questions raised in the letter can be fully addressed in a response in the coming months.

Eton Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Dehydrated Alcohol Injection

Investors need to pay close attention to Eton Pharmaceuticals (ETON) stock based on the movements in the options market lately.

Do Options Traders Know Something About Eton Pharmaceuticals (ETON) Stock We Don't?

Eton Pharmaceuticals, Inc. (ETON) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

Eton Pharmaceuticals, Inc. (ETON) Surges 6.7%: Indication of Further Gains?

Eton Pharmaceuticals, Inc. (ETON) CEO Sean Brynjelsen on Q1 2021 Results - Earnings Call Transcript

Eton Pharmaceuticals, Inc. (ETON) delivered earnings and revenue surprises of 0.00% and -1.29%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?

Eton Pharmaceuticals, Inc. (ETON) Q1 Earnings Meet Estimates

Shares of Eton Pharmaceuticals (NASDAQ:ETON) moved higher in after-market trading after the company reported Q1 results. Quarterly Results Earnings per share increased 138.00% year over year to $0.19, which were in line with the estimate of $0.19.

Eton Pharmaceuticals: Q1 Earnings Insights

Eton Pharmaceuticals, Inc. (ETON) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Eton Pharmaceuticals, Inc. (ETON) Reports Next Week: Wall Street Expects Earnings Growth

DEER PARK, Ill., May 04, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report first quarter 2021 financial and operating results on Thursday, May 13, 2021. Management will host a conference call and live audio webcast to discuss these results and provide a business update at 4:30 p.m. ET (3:30 p.m. CT).

Eton Pharmaceuticals to Report First Quarter 2021 Financial Results on Thursday, May 13, 2021

Eton Pharmaceuticals, Inc. (ETON) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might help the stock continue moving higher in the near term.

Strength Seen in Eton Pharmaceuticals, Inc. (ETON): Can Its 13.1% Jump Turn into More Strength?

DEER PARK, Ill., March 17, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has appointed Jenn Adams to its board of directors effective March 17, 2021. Ms. Adams brings extensive commercial, operational, and leadership experience in the pharmaceutical industry.

Eton Pharmaceuticals Announces Appointment of Jenn Adams to its Board of Directors

Eton Pharmaceuticals, Inc. (ETON) CEO Sean Brynjelsen on Q4 2020 Results - Earnings Call Transcript

DEER PARK, Ill., March 16, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on business progress.

Eton Pharmaceuticals Announces Fourth Quarter and Full Year 2020 Financial Results

DEER PARK, Ill., March 04, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that it will report fourth quarter and full year 2020 financial and operating results on Tuesday, March 16, 2021. Management will host a conference call and live audio webcast to discuss these results and provide a business update at 4:30 p.m. ET (3:30 p.m. CT).

Eton Pharmaceuticals to Report Fourth Quarter and Full Year 2020 Financial Results on Tuesday, March 16, 2021

DEER PARK, Ill., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that company management will be participating in the 10th Annual SVB Leerink Global Healthcare Conference from February 24th through February 26th.

Eton Pharmaceuticals to Participate in 10th Annual SVB Leerink Global Healthcare Conference

Eton Pharmaceuticals Inc (NASDAQ: ETON) has sold its neurology portfolio that includes lamotrigine (ET-105), zonisamide (ET-104), and topiramate (ET-101) product candidates, to Azurity Pharmaceuticals. The marketing applications for all three candidates are currently under review with the FDA.

Eton Pharmaceuticals Offloads Neurology Portfolio To Azurity Pharmaceuticals For $45M

DEER PARK, Ill., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that it has sold its neurology portfolio to Azurity Pharmaceuticals. The portfolio includes Eton's lamotrigine (ET-105), zonisamide (ET-104), and topiramate (ET-101) product candidates, which have all been submitted to the U.S. Food and Drug Administration as new drug applications and are currently under review by the agency.

Eton Pharmaceuticals Announces Sale of Neurology Portfolio

DEER PARK, Ill., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that it has acquired Canadian rights to ALKINDI® SPRINKLE from Diurnal Group plc (LSE AIM: DNL). Eton Pharmaceuticals currently commercializes ALKINDI® SPRINKLE in the United States as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.

Eton Pharmaceuticals Announces Acquisition of Canadian Rights for ALKINDI® SPRINKLE

Application Assigned a PDUFA Date of August 6, 2021 Application Assigned a PDUFA Date of August 6, 2021

Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution

DEER PARK, Ill., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the full availability of ALKINDI® SPRINKLE for sale and distribution in the United States. The U.S. Food and Drug Administration (FDA) has approved ALKINDI® SPRINKLE (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age. ALKINDI® SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children.

Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) in the United States

Eton Pharmaceuticals, Inc. (ETON) CEO Sean Brynjelsen on Q3 2020 Results - Earnings Call Transcript

DEER PARK, Ill., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the closing of its previously announced offering of 3,220,000 shares of common stock at a public offering price of $7.00 per share. The total offering included 420,000 shares sold as a result of the underwriter's exercise of its overallotment option in full.

Eton Pharmaceuticals Announces Closing of Public Offering

- Application Assigned a PDUFA Date of May 29, 2021 - Application Assigned a PDUFA Date of May 29, 2021

Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Zonisamide Oral Suspension

DEER PARK, Ill., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the pricing of an underwritten public offering of 2,800,000 shares of its common stock at a price to the public of $7.00 per share, for gross proceeds of $19.6 million. The Company has also granted the underwriters a 45-day option to purchase, at the same price per share as the underwriters paid for the initial shares, an additional 420,000 shares to cover over-allotments in connection with the offering, which if exercised in full would increase the gross proceeds to $22.5 million.

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