ETON Eton Pharmaceuticals Inc.

6.29
-0.56  -8%
Previous Close 6.85
Open 6.07
52 Week Low 2.5
52 Week High 8.74
Market Cap $131,813,448
Shares 20,956,033
Float 11,877,600
Enterprise Value $156,320,738
Volume 681,443
Av. Daily Volume 304,366
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Upcoming Catalysts

Drug Stage Catalyst Date
EM-100
Allergic conjunctivitis
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Alkindi Sprinkle
Pediatric adrenal insufficiency (AI)
PDUFA
PDUFA
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DS-300
Nutritional deficiencies
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
ET-101
Oral solution of topiramate
NDA Filing
NDA Filing
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
ET-203
Injectable hospital product
NDA Filing
NDA Filing
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
ET-104
Neurological indication
NDA Filing
NDA Filing
NDA filing announced July 30, 2020.
DS-100
Methanol poisoning
NDA Filing
NDA Filing
NDA filing announced July 27, 2020.
EM-105
Lennox-Gastaut syndrome, epilepsy
CRL
CRL
CRL issued March 17, 2020. Additional trial required.
ET-202
Injectable hospital product
Approved
Approved
FDA Approval announced October 22, 2019.
DS-200
Nutritional deficiencies
NDA Filing
NDA Filing
Rolling NDA filing announced March 14, 2019. However, third-party has been granted five years of market exclusivity.

Latest News

  1. DEER PARK, Ill., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today reported financial results for the second quarter ended June 30, 2020 and provided an update on business progress.

    "Recent weeks have been the most productive in our company's history. We submitted two NDAs, including one with orphan designation, and we made significant progress preparing for our expected launch of Alkindi Sprinkle," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "In the coming months, we expect to complete two more NDA submissions and continue working towards building an industry leading multi-product commercial organization…

    DEER PARK, Ill., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today reported financial results for the second quarter ended June 30, 2020 and provided an update on business progress.



    "Recent weeks have been the most productive in our company's history. We submitted two NDAs, including one with orphan designation, and we made significant progress preparing for our expected launch of Alkindi Sprinkle," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "In the coming months, we expect to complete two more NDA submissions and continue working towards building an industry leading multi-product commercial organization. With our pipeline, we expect to launch as many as six branded products before the end of 2021, which I believe is unrivaled by any pharmaceutical company of our size," Brynjelsen added.



    Recent Milestones

    • Submission of Orphan Drug DS-100 (Dehydrated Alcohol Injection). In July, Eton submitted an NDA for DS-100. The product has been granted orphan drug designation for the treatment of methanol poisoning. The incidence of methanol poisoning has increased significantly in 2020 due to COVID-19, as unprecedented demand for hand sanitizers has led some manufacturers to improperly use methanol in their products. The U.S. Food and Drug Administration (FDA) has in fact recommended manufacturers recall more than 100 different hand sanitizers that were found to contain methanol despite being labeled as ethanol.

       
    • Submission of ET-104 (Zonisamide Oral Suspension). Eton's patent-pending liquid formulation of zonisamide was submitted to the FDA for the treatment or partial seizures. ET-104 is one of three neurology-focused liquid products that Eton expects to launch in 2021



    • Increased Credit Facility. Eton was able to amend and increase its existing credit facility with SWK Holdings. Under the new terms, the facility will increase from $10 million to $15 million upon FDA approval of Alkindi Sprinkle, and the interest rate will decrease when Eton achieves certain performance metrics in the future.

    EM-100 Update

    Eton was notified by its partner that due to a proprietary name change submission, the FDA has extended EM-100's goal date to September 15th. The company is not aware of any deficiencies besides this labeling-related item and remains confident that the product will be approved shortly.

    Alkindi® Sprinkle Update

    Alkindi Sprinkle's NDA is under review by the FDA for use as a replacement therapy for pediatric adrenal insufficiency. Eton and its development partner have been engaged in regular communication with the FDA, and Eton expects the FDA to meet the existing September 29, 2020 Prescription Drug User Fee Act (PDUFA) date without any disruption from COVID-19. Based on the communications received during the application's ongoing review, Eton remains confident that the Alkindi Sprinkle application is approvable and is working aggressively on launch preparation activities. Eton has purchased initial commercial inventory and expects to be in position to launch the product shortly after the PDUFA date, if approved.



    Biorphen Commercial Update

    Biorphen sales continue to be impacted by COVID-19. While surgical procedure volumes have rebounded from March and April lows, hospital policies continue to restrict sales representatives from visiting with pharmacy directors and hospital staff. Eton plans to implement new targeting strategies and promotional campaigns in the third quarter that are expected to drive stronger sales in the second half of 2020.

    Eton remains confident that there is strong demand for Biorphen in a vial presentation based on significant customer feedback. The company is on pace to submit a Prior Approval Supplement (PAS) for the vial conversion later this year, which should allow for a commercial launch of the vial in early 2021. Eton expects the vial product launch to significantly accelerate Biorphen adoption and help the company achieve its long-term goal of capturing 4 million of the estimated more than 20-million-unit market for ready-to-use phenylephrine injection.

    Credit Agreement.

    On August 11th, the company's existing credit facility with SWK Holdings was amended to provide Eton with the option to access additional capital and reduce the facility's interest rate. The facility will increase by $5 million to $15 million upon the FDA approval of Alkindi Sprinkle. Upon execution of the amendment, Eton agreed to draw an additional $2 million. In addition, the facility's interest rate will be reduced in the future when certain performance metrics are achieved. The facility reductions will be: 75 basis points when Eton receives approval for its next product and achieves quarterly revenue of $2.0 million; 150 basis points when Eton receives approval for two additional products and achieves quarterly revenue of $2.5 million; and a 225 basis point reduction when the company is EBITDA positive.



    Pipeline Update



    Eton now has six product candidates submitted to the FDA, and two additional product candidates that are expected to be submitted before the end of 2020.

    ProductFDA Application StatusDetails
    Biorphen®ApprovedCommercial
    EM-100 (Ketotifen Ophthalmic Soln.)SubmittedT.A.D Sept 15, 2020
    Alkindi® SprinkleSubmittedPDUFA Date: Sept 29, 2020
    DS-100 (Dehydrated Alcohol Inj.)SubmittedPDUFA date not yet assigned
    ET-105 (Lamotrigine Oral Susp.)SubmittedCRL response ongoing
    ET-104 (Zonisamide Oral Susp.)SubmittedPDUFA date not yet assigned
    DS-300 (Cysteine Inj.)SubmittedGDUFA Date: Oct 2020*
    ET-101 (Topiramate Oral Soln.)Submission Expected in 2020 
    ET-203 (Ephedrine Inj.)Submission Expected in 2020 
    *Potential tentative approval. Final approval expected to be delayed due to ongoing Paragraph IV litigation



    ET-105 (Lamotrigine for Oral Suspension). Eton and its development partner, Aucta Pharmaceuticals, are working to resolve the Complete Response Letter received in March 2020. During the second quarter, the FDA agreed to the protocol for the required human factors study. Study participant enrollment has been impacted by COVID-19, however, the company still believes the study results can submitted to the FDA before the end of 2020.



    ET-101 (Topiramate Oral Solution). Eton remains on track to submit the product's NDA before year end.



    ET-203 (Ephedrine Injection). Eton's partner expects to file the product's NDA before year end.



    Financial Update



    Revenue:
    Revenue was approximately $20,000 in the second quarter of 2020, which was from sales of Biorphen. As previously discussed, Eton's second quarter Biorphen sales were adversely impacted by the COVID-19 pandemic. Eton records sales for Biorphen when the product is shipped to wholesalers and distributors. As a result, reported revenue is not always aligned with end-user demand within a given period due to changes in inventory in this distribution channel. End-user demand for Biorphen exceeded Eton's reported sales in the second quarter of 2020 due to large stocking orders placed by wholesalers in the fourth quarter of 2019. Eton did not have any revenue in the second quarter of 2019.

    Research and Development (R&D) Expenses: R&D expenses were $1.6 million for the second quarter of 2020 compared to $1.4 million for the same period in 2019.

    General& Administrative (G&A) Expenses: G&A expenses were $2.9 million for the second quarter of 2020 compared to $1.9 million for the same period in 2019. The increase was primarily driven by legal expenses related to Eton's first-to-file paragraph IV patent challenge for its DS-300 product candidate and higher marketing and distribution expenses.

    Net Loss: Eton reported a net loss for the second quarter of 2020 of $4.7 million compared to a net loss of $3.2 million for the same period of 2019.

    Cash Position: As of June 30, 2020, Eton reported cash and cash equivalents of $10.3 million. On August 11, 2020 Eton executed an amendment to its credit facility with SWK Holdings which will add $5.0 million of additional capacity upon FDA approval of Alkindi Sprinkle. Upon closing of the amendment, Eton drew down $2.0 million and will have $8.0 million of available undrawn capacity after the approval of Alkindi Sprinkle.



    Conference Call and Webcast Information:

    Eton Pharmaceuticals will host a conference call and webcast today at 4:30 p.m. ET (3:30 p.m. CT). To access the conference call, please dial 1-866-795-8473 (domestic) or 1-470-495-9161 (international) and refer to conference ID 2083737. The webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at https://ir.etonpharma.com. The webcast will be archived and made available for replay on the company's website approximately two hours after the call and will be available for 30 days.



    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company's first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The company's lead pediatric product is the orphan drug Alkindi® Sprinkle, which is currently under review with the FDA. The company has an additional seven products under development, including five that are under review with the FDA.



    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 which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Eton Pharmaceuticals, Inc.

    Condensed Statements of Operations

    (In thousands, except per share amounts)

    (Unaudited)

      For the three months ended  For the six months ended 
      June 30,   June 30,  June 30,  June 30, 
      2020    2019  2020  2019 
    Revenues:             
    Product sales$20  $  $119  $ 
    Licensing revenue          500 
    Total revenues 20      119   500 
                    
    Cost of product sales 28      130    
                    
    Gross (loss) profit (8)     (11)  500 
                    
    Operating expenses:               
    Research and development 1,609   1,439   7,877   7,904 
    General and administrative 2,921   1,910   5,531   3,499 
    Total operating expenses 4,530   3,349   13,408   11,403 
                    
    Loss from operations (4,538)  (3,349)  (13,419)  (10,903)
                    
    Other (expense) income:               
    Interest and other (expense) income, net (192)  100   (360)  244 
                    
    Loss before income tax expense (4,730)  (3,249)  (13,779)  (10,659)
                    
    Income tax expense           
                    
    Net Loss$(4,730) $(3,249) $(13,779) $(10,659)
    Net loss per share, basic and diluted$(0.23) $(0.18) $(0.70) $(0.61)
    Weighted average number of common shares outstanding, basic and diluted 21,005   17,733   19,574   17,618 



    Eton Pharmaceuticals, Inc.

    Condensed Balance Sheets

    (in thousands, except share and per share amounts)

      June 30, 2020  December 31, 2019 
      (Unaudited)    
    Assets        
    Current assets:        
    Cash and cash equivalents $10,270  $12,066 
    Accounts receivable, net     473 
    Inventory  1,709   380 
    Prepaid expenses and other current assets  844   2,090 
    Total current assets  12,823   15,009 
             
    Property and equipment, net  938   1,117 
    Intangible assets, net  650   725 
    Operating lease right-of-use assets, net  96   160 
    Other long-term assets, net  52   61 
    Total assets $14,559  $17,072 
             
    Liabilities and stockholders' equity        
    Current liabilities:        
    Accounts payable $1,953  $575 
    PPP loan, current portion  159    
    Accrued liabilities  627   1,388 
    Total current liabilities  2,739   1,963 
             
    Long-term debt, net of discount and including accrued fees  4,587   4,540 
    Long-term portion of PPP loan  202    
    Operating lease liabilities, net of current portion     19 
             
    Total liabilities  7,528   6,522 
             
    Commitments and contingencies (Note 11)        
             
    Stockholders' equity        
    Common stock, $0.001 par value; 50,000,000 shares authorized as of June 30,

    2020 and December 31, 2019; 20,956,033 and 17,877,486 shares issued and

    outstanding at June 30, 2020 and December 31, 2019, respectively
      21   18 
    Additional paid-in capital  84,977   74,720 
    Accumulated deficit  (77,967)  (64,188)
    Total stockholders' equity  7,031   10,550 
             
    Total liabilities and stockholders' equity $14,559  $17,072 



    Eton Pharmaceuticals, Inc.

    Condensed Statements of Cash Flows

    (In thousands)

    (Unaudited)

      Six months ended

    June 30, 2020
      Six months ended

    June 30, 2019
     
    Cash flows from operating activities        
    Net loss $(13,779) $(10,659)
             
    Adjustments to reconcile net loss to net cash used in operating activities:        
    Stock-based compensation  1,079   850 
    Common stock issued for product candidate licensing rights  1,264    
    Depreciation and amortization  326   178 
    Debt discount amortization  50    
    Changes in operating assets and liabilities:        
    Accounts receivable  473    
    Inventory  (1,329)   
    Prepaid expenses and other assets  1,251   (1,052)
    Accounts payable  1,378   (69)
    Accrued liabilities  (783)  (211)
    Net cash used in operating activities  (10,070)  (10,963)
             
    Cash used in investing activities        
    Purchases of property and equipment  (4)  (1,030)
             
    Cash flows from financing activities        
    Proceeds from sales of common stock, net of offering costs  7,756    
    Proceeds from PPP loan  361    
    Proceeds from employee stock purchase plan and stock option exercises  161   205 
    Net cash provided by financing activities  8,278   205 
             
    Change in cash and cash equivalents  (1,796  (11,788)
    Cash and cash equivalents at beginning of period  12,066   26,735 
    Cash and cash equivalents at end of period $10,270  $14,947 
             
    Supplemental disclosures of cash flow information        
    Cash paid for interest $358  $ 
    Cash paid for income taxes $  $ 



    Investor Contact:

    David Krempa



    612-387-3740

    Primary Logo

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  2. DEER PARK, Ill., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, reported that its partner has not yet received a communication from the U.S. Food and Drug Administration (FDA) regarding its decision on the review of EM-100. EM-100's Generic Drug User Fee Act (GDUFA) target action date was August 10th. The company is not aware of any information requests outstanding and expects the FDA to communicate a decision in the coming days.

    About Eton Pharmaceuticals
    Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily…

    DEER PARK, Ill., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, reported that its partner has not yet received a communication from the U.S. Food and Drug Administration (FDA) regarding its decision on the review of EM-100. EM-100's Generic Drug User Fee Act (GDUFA) target action date was August 10th. The company is not aware of any information requests outstanding and expects the FDA to communicate a decision in the coming days.

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company's first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The company's lead pediatric product is the orphan drug Alkindi® Sprinkle, which is currently under review with the FDA. The company has an additional seven products under development, including five that are under review with the FDA.



    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 which they were made.  Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Company Contact:

    David Krempa

     

    612-387-3740

    Primary Logo

    View Full Article Hide Full Article
  3. DEER PARK, Ill., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that it will report second quarter 2020 financial and operating results on Wednesday, August 12, 2020. 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). 


    The live webcast can be accessed on the investors section of Eton's website at https://ir.etonpharma.com/. The conference call can be accessed by dialing 1-866-795-8473 (domestic) or 1-470-495-9161 (international) and refer to conference ID 2083737. An archived webcast will be available…

    DEER PARK, Ill., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that it will report second quarter 2020 financial and operating results on Wednesday, August 12, 2020. 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). 



    The live webcast can be accessed on the investors section of Eton's website at https://ir.etonpharma.com/. The conference call can be accessed by dialing 1-866-795-8473 (domestic) or 1-470-495-9161 (international) and refer to conference ID 2083737. An archived webcast will be available on Eton's website approximately two hours after the completion of the event and for 30 days thereafter.

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company's first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The company's lead pediatric product is the orphan drug Alkindi® Sprinkle, which is currently under review with the FDA. The company has an additional seven products under development, including five that are under review with the FDA.

    Investor Contact:

    David Krempa



    612-387-3740

    Primary Logo

    View Full Article Hide Full Article
  4. - Application Submitted for the Treatment of Partial Seizures in Epilepsy Patients

    - Eton's Patent-Pending Product Addresses Significant Unmet Need for a Liquid Formulation of Zonisamide

    - Application is Eton's Sixth Drug Application Under FDA Review

    DEER PARK, Ill., July 30, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced it has submitted a new drug application (NDA) for zonisamide oral suspension, previously known as the company's ET-104 product candidate, to the U.S. Food & Drug Administration (FDA) for the treatment of partial seizures in patients with epilepsy.

    "We know there is strong demand…

    - Application Submitted for the Treatment of Partial Seizures in Epilepsy Patients

    - Eton's Patent-Pending Product Addresses Significant Unmet Need for a Liquid Formulation of Zonisamide

    - Application is Eton's Sixth Drug Application Under FDA Review

    DEER PARK, Ill., July 30, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced it has submitted a new drug application (NDA) for zonisamide oral suspension, previously known as the company's ET-104 product candidate, to the U.S. Food & Drug Administration (FDA) for the treatment of partial seizures in patients with epilepsy.

    "We know there is strong demand for liquid zonisamide from neurologist and patients, and we look forward to working with the FDA to get the product approved and available to patients as soon as possible," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

    Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA approved in liquid form. Eton's patent-pending liquid formulation addresses the significant unmet need for patients with dysphagia and patients that require the precision dosing that a liquid product offers. Based on IQVIA data, more than 150,000 prescriptions of zonisamide are written annually for the treatment of epilepsy.

    ET-104 is one of Eton's three neurology-focused liquid product candidates, along with ET-105 (lamotrigine oral suspension) and ET-101 (topiramate oral solution). The company expects all three product candidates to be approved and launched in 2021.

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company's first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The company's lead pediatric product is the orphan drug Alkindi® Sprinkle, which is currently under review with the FDA. The company has an additional seven products under development, including five that are under review with the FDA.



    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 which they were made.  Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Company Contact:

    David Krempa



    612-387-3740

    Primary Logo

    View Full Article Hide Full Article
  5. -Granted Orphan Drug Designation by the FDA for the Treatment of Methanol Poisoning

    -Since the Start of COVID-19, the FDA has Recalled More Than 75 Contaminated Hand Sanitizers Due to Risk of Methanol Poisoning

    -DS-100 is Eton's Fifth Drug Application Under FDA Review and Second Orphan Application

    DEER PARK, Ill., July 27, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced it has submitted a new drug application (NDA) for dehydrated alcohol injection, previously known as the company's DS-100 product candidate, to the U.S. Food & Drug Administration (FDA) for the treatment of methanol poisoning.

    "We are very…

    -Granted Orphan Drug Designation by the FDA for the Treatment of Methanol Poisoning

    -Since the Start of COVID-19, the FDA has Recalled More Than 75 Contaminated Hand Sanitizers Due to Risk of Methanol Poisoning

    -DS-100 is Eton's Fifth Drug Application Under FDA Review and Second Orphan Application

    DEER PARK, Ill., July 27, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced it has submitted a new drug application (NDA) for dehydrated alcohol injection, previously known as the company's DS-100 product candidate, to the U.S. Food & Drug Administration (FDA) for the treatment of methanol poisoning.



    "We are very excited to add another orphan drug NDA submission to our late-stage pipeline. Our team and our partners have worked tirelessly to complete DS-100's extensive clinical and development activities, which has allowed us to submit this application ahead of schedule," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "If approved by the FDA, we look forward to launching the product in the near future."



    Eton's product has been granted orphan drug designation for the treatment of methanol poisoning, and as a result, the product is expected to receive seven years of market exclusivity upon its approval. The incidence of methanol poisoning has increased significantly in 2020 due to COVID-19, as unprecedented demand for hand sanitizers has led some manufacturers to improperly use methanol in their products. Earlier this month, the FDA recommended manufacturers recall more than 75 different hand sanitizers that were found to contain methanol despite being labeled as ethanol. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested. The FDA has reported cases of adults and children suffering from adverse events including blindness, hospitalization and death, due to methanol poisoning caused by methanol-based sanitizers.1



    The DS-100 NDA represents Eton's second orphan drug candidate and fifth total drug candidate under review with the FDA. Alkindi® Sprinkle, the company's other orphan drug product, is currently under FDA review as a replacement therapy for pediatric adrenal insufficiency (AI) and has been assigned a Prescription Drug User Fee Act date of September 29, 2020. Eton's EM-100 (preservative-free ketotifen ophthalmic solution) product candidate has an August 10, 2020 target action date.

    1 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-methanol

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company's first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The company's lead pediatric product is the orphan drug Alkindi® Sprinkle, which is currently under review with the FDA. The company has an additional seven products under development, including four that are under review with the FDA.



    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 which they were made.  Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Company Contact:

    David Krempa



    612-387-3740

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