ETON Eton Pharmaceuticals Inc.

4.97
+0.15  (+3%)
Previous Close 4.82
Open 4.86
52 Week Low 4.03
52 Week High 10.3
Market Cap $122,196,449
Shares 24,600,175
Float 19,712,577
Enterprise Value $100,813,852
Volume 94,506
Av. Daily Volume 425,095
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Upcoming Catalysts

Drug Stage Catalyst Date
Topiramate Oral Solution
Seizures/migraine
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
REZIPRES (ephedrine hydrochloride injection)
Injectable hospital product
Approved
Approved
FDA approval announced June 15, 2021.
Cysteine Inj (DS-300)
Nutritional deficiencies
CRL
CRL
CRL received October 2020 (announced November 12, 2020). Expects to respond in December 2020.
Biorphen (ET-202)
Injectable hospital product
Approved
Approved
FDA Approval announced October 22, 2019.
ET-105 (Lamotrigine for Oral Suspension)
Lennox-Gastaut syndrome, epilepsy
CRL
CRL
CRL issued March 17, 2020. Additional trial to be completed in the coming months.
Novothyrox (EM-100)
Allergic conjunctivitis
Approved
Approved
FDA approval announced September 25, 2020.
Zonisamide oral suspension - (ET-104)
Neurological indication
CRL
CRL
CRL announced May 28, 2021. Inspection of the third-party manufacturing facility was unable to occur due to travel restrictions.
Dehydrated alcohol injection (DS-100)
Methanol poisoning
CRL
CRL
CRL announced May 28, 2021.
Alkindi Sprinkle
Pediatric adrenal insufficiency (AI)
Approved
Approved
FDA approval announced September 29, 2020.

Latest News

  1. DEER PARK, Ill., Aug. 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 second quarter ended June 30, 2021.

    "During the second quarter we received FDA-approval for Rezipres®, which is now the fourth FDA-approved product in our portfolio," said Sean Brynjelsen CEO of Eton Pharmaceuticals. "We look forward to launching Rezipres® in the coming months. We also expanded our pediatric endocrinology portfolio with the acquisition of U.S. and Canadian rights to the ZENEO® Hydrocortisone autoinjector. ZENEO Hydrocortisone is a terrific strategic fit with ALKINDI SPRINKLE, and we look…

    DEER PARK, Ill., Aug. 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 second quarter ended June 30, 2021.

    "During the second quarter we received FDA-approval for Rezipres®, which is now the fourth FDA-approved product in our portfolio," said Sean Brynjelsen CEO of Eton Pharmaceuticals. "We look forward to launching Rezipres® in the coming months. We also expanded our pediatric endocrinology portfolio with the acquisition of U.S. and Canadian rights to the ZENEO® Hydrocortisone autoinjector. ZENEO Hydrocortisone is a terrific strategic fit with ALKINDI SPRINKLE, and we look forward to working with Crossject to bring it to market as quickly as possible."

    Second Quarter Business Highlights

    • Received U.S. Food and Drug Administration (FDA) approval of Rezipres®, a ready-to-use formulation of ephedrine injection. Eton expects the product to be commercially available in the coming months.



    • Acquired U.S. and Canadian rights to ZENEO® Hydrocortisone autoinjector. The product candidate is expected to be the first needle-free autoinjector for the treatment of adrenal crisis. Eton expects the product to be submitted to the FDA in 2023.



    • Progressed ALKINDI SPRINKLE commercial launch. ALKINDI SPRINKE launch activities expanded in the quarter as the company was able to shift from virtual meetings to in-person meetings with physicians and industry leaders. The product continues to receive a favorable reception from physicians, patients, and payers.

    Commercial Update

    The second quarter of 2021 was ALKINDI SPRINKLE's second full quarter of commercial launch. Eton continues to see increasing adoption of the product, and the number of patients on treatment has grown month over month. As a result of fewer COVID-19 restrictions during the quarter, the ALKINDI SPRINKLE sales force was able to prioritize in-person meetings for the first time since the product's launch. In-person meetings are now the primary method of engagement, surpassing telephone and video calls in the quarter. As a result of favorable feedback from the in-person meetings, Eton expects to expand its sales force to drive more frequent engagement with physicians and potentially faster patient conversion.

    ALKINDI SPRINKLE has received favorable support from payers that recognize the importance of precision dosing in the treatment of adrenal insufficiency. The company has seen a very high rate of new patients converting from initial quick starts to commercial reimbursement. Currently more than 90% of patients on treatment are being reimbursed.

    During the quarter Eton expanded its active engagement with the adrenal insufficiency community. The company sponsored continuing medical education programs for healthcare professionals to raise awareness of the significant risks and lifelong side effects associated with over or under-dosing when treating adrenal insufficiency in pediatric patients. Eton continues to work with key advocacy partners to help raise awareness of adrenal insufficiency and is hosting an advisory panel with key opinion leaders in the adrenal insufficiency community in late August.

    Pipeline Update

    Current Product Portfolio & Pipeline
    ProductStatus
    ALKINDI SPRINKLE®Commercial
    Alaway® Preservative FreeCommercial
    Biorphen®Commercial
    Rezipres®Approved
    Topiramate Oral SolutionFiled
    Dehydrated Alcohol InjectionFiled
    Zonisamide Oral SolutionFiled
    Lamotrigine for SuspensionFiled
    Cysteine InjectionFiled
    ALKINDI® (Canada)Under Development
    ZENEO® Hydrocortisone AutoinjectorUnder Development

    Topiramate Oral Solution. The topiramate product candidate was sold to Azurity Pharmaceuticals in February 2021. Azurity is now responsible for all regulatory activities. During the quarter, Azurity submitted responses to the FDA's review questions which the FDA deemed to be an amendment to the application and resulted in the FDA extending the application's PDUFA date to November 6, 2021. Eton believes all FDA requests have been responded to and expects the application to be approved on or before the new PDUFA date. The product's U.S. manufacturing site was successfully inspected by the FDA in August 2020, so Eton does not expect a pre-approval inspection to be required for the application review.

    Dehydrated Alcohol Injection. Eton expects to submit an application amendment to the FDA in the coming months that fully addresses the agency's complete response letter and could allow for FDA approval in early 2022.

    Zonisamide Oral Solution. The zonisamide product candidate was sold to Azurity Pharmaceuticals in February 2021. Azurity is now responsible for all regulatory activities. Azurity has submitted a formal response to the FDA's complete response letter; however, the potential timing of an inspection of the product's foreign manufacturing site remains unknown.

    Lamotrigine for Suspension. The lamotrigine product candidate was sold to Azurity Pharmaceuticals in February 2021. Azurity is now responsible for all regulatory activities. The third and final arm of the human factor study has now been enrolled. The study is expected to be completed and submitted to the FDA before the end of 2021.

    Cysteine Injection. The product's paragraph IV litigation remains ongoing and the company remains confident in a successful outcome.

    Financial Results

    Revenue: Eton reported revenue of $3.1 million for the second quarter of 2021. Revenue included $2.5 million of licensing revenue related to the company's previously announced transaction with Azurity. In the prior-year period, the company did not have any material revenue.

    General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2021 were $3.3 million compared to $2.9 million in the prior-year period. The increase was largely due to increased costs related to the commercialization of ALKINDI SPRINKLE. G&A expenses for the second quarter of 2021 included $0.7 million of non-cash expenses.

    Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2021 were $2.0 million compared to $1.6 million in the prior-year period. R&D expenses included $0.5 million related to the acquisition of U.S. and Canadian rights to ZENEO® Hydrocortisone in the quarter.

    Net Income: Eton reported a net loss of $2.0 million for the second quarter of 2021, compared to a net loss of $4.7 million in the prior-year period. Eton reported diluted earnings per share (EPS) of ($0.08) in the second quarter of 2021, compared to ($0.23) in the prior year period.

    Cash Position: Cash and cash equivalents were $25.8 million as of June 30, 2021.

    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 2454465. 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 an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from four FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, Alaway® Preservative Free, and Rezipres® and has five additional products that have been submitted to 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, 
      2021  2020  2021  2020 
    Revenues:                
    Licensing revenue $2,500  $  $14,000  $ 
    Product sales and royalties  567   20   964   119 
    Total net revenues  3,067   20   14,964   119 
                     
    Cost of sales:                
    Licensing revenue        1,500    
    Product sales and royalties  136   28   226   130 
    Total cost of sales  136   28   1,726   130 
                     
    Gross profit (loss)  2,931   (8  13,238   (11)
                     
    Operating expenses:                
    Research and development  1,990   1,609   2,876   7,877 
    General and administrative  3,266   2,921   7,324   5,531 
    Total operating expenses  5,256   4,530   10,200   13,408 
                     
    (Loss) income from operations  (2,325)  (4,538)  3,038   (13,419)
                     
    Other (expense) income:                
    Interest and other expense, net  (237)  (192)  (484)  (360)
    Gain on PPP loan forgiveness  365      365    
    Gain on equipment sale  181      181    
                     
    (Loss) income before income tax expense  (2,016)  (4,730)  3,100   (13,779)
                     
    Income tax expense            
                     
    Net (loss) income  $(2,016) $(4,730) $3,100  $(13,779)
    Net loss (income) per share, basic  $(0.08) $(0.23) $0.12  $(0.70)
    Net loss (income) per share, diluted $(0.08) $(0.23) $0.12  $(0.70)
    Weighted average number of common shares outstanding, basic  25,211   21,005   25,133   19,574 
    Weighted average number of common shares outstanding, diluted  25,211   21,005   26,486   19,574 



    Eton Pharmaceuticals, Inc.

    Condensed Balance Sheets

    (in thousands, except share and per share amounts)

      June 30, 2021  December 31, 2020 
      (Unaudited)    
    Assets        
    Current assets:        
    Cash and cash equivalents $25,802  $21,295 
    Accounts receivable, net  303   48 
    Inventories  1,242   1,242 
    Prepaid expenses and other current assets  1,728   2,116 
    Total current assets  29,075   24,701 
             
    Property and equipment, net  156   811 
    Intangible assets, net  500   575 
    Operating lease right-of-use assets, net  143   192 
    Other long-term assets, net  32   40 
    Total assets $29,906  $26,319 
             
    Liabilities and stockholders' equity        
    Current liabilities:        
    Accounts payable $1,522  $2,344 
    Current portion of long-term debt  749    
    PPP loan, current portion     280 
    Accrued liabilities  835   1,170 
    Total current liabilities  3,106   3,794 
             
    Long-term debt, net of discount and including accrued fees  5,856   6,532 
    Long-term portion of PPP and EIDL loans  150   231 
    Operating lease liabilities, net of current portion  58   99 
             
    Total liabilities  9,170   10,656 
             
    Commitments and contingencies         
             
    Stockholders' equity        
    Common stock, $0.001 par value; 50,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 24,600,175 and 24,312,808 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively  25   24 
    Additional paid-in capital  109,769   107,797 
    Accumulated deficit  (89,058)  (92,158)
    Total stockholders' equity  20,736   15,663 
             
    Total liabilities and stockholders' equity $29,906  $26,319 



    Eton Pharmaceuticals, Inc.

    Condensed Statements of Cash Flows

    (In thousands)

    (Unaudited)

      Six months ended

    June 30, 2021
      Six months ended

    June 30, 2020
     
    Cash flows from operating activities        
    Net income (loss) $3,100  $(13,779)
             
    Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:        
    Stock-based compensation  1,509   1,079 
    Common stock issued for product candidate licensing rights     1,264 
    Depreciation and amortization  240   326 
    Debt discount amortization  73   50 
    Gain on forgiveness of debt  (365)   
    Gain on sale of equipment  (181)   
    Changes in operating assets and liabilities:        
    Accounts receivable  (255  473 
    Inventories     (1,329
    Prepaid expenses and other assets  419   1,251 
    Accounts payable  (822  1,378 
    Accrued liabilities  (372)  (783)
    Net cash provided by (used in) operating activities  3,346   (10,070)
             
    Cash provided by (used in) investing activities        
    Proceeds from sale of equipment  700    
    Purchases of property and equipment  (3)  (4)
    Net cash provided by (used in) financing activities  697   (4)
             
    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  464   161 
    Net cash provided by financing activities  464   8,278 
             
    Change in cash and cash equivalents  4,507   (1,796)
    Cash and cash equivalents at beginning of period  21,295   12,066 
    Cash and cash equivalents at end of period $25,802  $10,270 
             
    Supplemental disclosures of cash flow information        
    Cash paid for interest $424  $358 
    Cash paid for income taxes $  $ 

    Investor Contact:

    David Krempa

    dkrempa@etonpharma.com

    612-387-3740



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  2. DEER PARK, Ill., Aug. 03, 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 second quarter 2021 financial and operating results on Monday, August 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).

    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 2454465. An archived webcast will be available…

    DEER PARK, Ill., Aug. 03, 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 second quarter 2021 financial and operating results on Monday, August 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).

    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 2454465. 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 an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from four FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, Alaway® Preservative Free, and Rezipres® and has five additional products that have been submitted to the FDA.

    Investor Contact:

    David Krempa

    dkrempa@etonpharma.com

    612-387-3740



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    • Expands Eton's Adrenal Insufficiency Orphan Drug Portfolio
    • ZENEO® Hydrocortisone is Expected to be the First and Only Hydrocortisone Autoinjector for Patients Requiring Emergency Hydrocortisone
    • Proprietary ZENEO® Needleless Device is Covered by 24 U.S. Patents Extending as Far as 2037

    DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), the U.S. marketer of ALKINDI SPRINKLE®, a treatment for adrenocortical insufficiency in pediatric patients, today announced that it has acquired U.S. and Canadian rights to Crossject's ZENEO® hydrocortisone needleless autoinjector, which is under development as a rescue treatment for adrenal crisis.

    "The ZENEO autoinjector is a revolutionary delivery system, and this product…

    • Expands Eton's Adrenal Insufficiency Orphan Drug Portfolio
    • ZENEO® Hydrocortisone is Expected to be the First and Only Hydrocortisone Autoinjector for Patients Requiring Emergency Hydrocortisone
    • Proprietary ZENEO® Needleless Device is Covered by 24 U.S. Patents Extending as Far as 2037

    DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), the U.S. marketer of ALKINDI SPRINKLE®, a treatment for adrenocortical insufficiency in pediatric patients, today announced that it has acquired U.S. and Canadian rights to Crossject's ZENEO® hydrocortisone needleless autoinjector, which is under development as a rescue treatment for adrenal crisis.

    "The ZENEO autoinjector is a revolutionary delivery system, and this product is a terrific strategic fit with our current adrenal insufficiency business. Patients, advocacy groups, and physicians in the adrenal insufficiency community have repeatedly expressed to us the need for a hydrocortisone autoinjector, so we are excited to be partnering with Crossject to bring this product to patients in need," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

    Patrick Alexandre, CEO of Crossject, added: ‘‘We are proud to announce a sound commercial agreement for ZENEO® Hydrocortisone in the US and Canada with an American leader in adrenal insufficiency. ETON has successfully established strong relations with the patient communities and medical specialists that are its core focus. ZENEO® Hydrocortisone answers a medical need. This strong partnership will contribute to saving lives by bringing to patients and their families a modern autoinjection possibility.''

    "We are delighted about Eton Pharmaceuticals' plans to partner with Crossject to bring this incredibly needed product to patients in the U.S.", said Dina Matos, Executive Director of CARES Foundation, a leading North American advocacy foundation for patients with congenital adrenal hyperplasia, the most common presentation of adrenal insufficiencies in children. "The challenge for patients and caregivers facing an adrenal crisis is serious; an easy-to-use needleless autoinjector of hydrocortisone will be a game changer for our patients. We welcome this advancement."

    ZENEO® is a proprietary needleless device developed and manufactured by Crossject. The pre-filled, single-use device propels medication through the skin in less than a tenth of a second. The device's compact form factor, simple two-step administration, and needle-free technology make it an ideal delivery system for emergency medications that need to be administered in stressful situations by non-healthcare professionals. Crossject holds more than 400 global patents on the device, including 24 issued in the United States that extend as far as 2037, and has successfully completed bioequivalence and human factor studies with the ZENEO device using various medications.

    Crossject has developed a proprietary, room-temperature stable liquid formulation of hydrocortisone to be delivered via the ZENEO device. ZENEO hydrocortisone is expected to be the first and only hydrocortisone autoinjector available for patients that require a rescue dose of hydrocortisone. Currently, injectable hydrocortisone is only available in the United States in a lyophilized powder formulation that must be reconstituted and manually delivered via a traditional syringe.

    Eton expects to submit a New Drug Application for the product to the U.S. Food and Drug Administration in 2023 and plans to request Orphan Drug Designation. In the United States, it is estimated that approximately 100,000 patients currently suffer from adrenocortical insufficiency and are at risk for adrenal crisis.

    Under the terms of the agreement, Crossject will receive development and regulatory milestone payments from Eton of up to $5.0 million, commercial milestones of up to $6.0 million, and a 10% royalty on net sales of the product. Crossject will be responsible for the management and expense of development, clinical, and manufacturing activities. Eton will be responsible for all regulatory and commercial activities.

    About Adrenal Crisis

    Patients with adrenal insufficiency can go into adrenal crisis if their cortisol levels are too low. Adrenal crisis is typically caused by missed doses of maintenance hydrocortisone, trauma, surgery, illness, fever, or major psychological distress. Signs of adrenal crisis include hyperpigmentation, severe weakness, nausea, abdominal pain, and confusion. It is estimated that approximately 8% of adrenal insufficiency patients will report an adrenal crisis in any given year and more than 6% of cases result in death.

    About Crossject

    Crossject (OTC:CRJTF, TICKER:ALCJ, LEI: 969500W1VTFNL2D85A65))) is developing and is soon to market a portfolio of drugs dedicated to emergency situations: epilepsy, overdose, allergic shock, severe migraine and asthma attack. The company's portfolio currently contains eight products in advanced stages of development, including 7 emergency treatments, 5 of which are intended for life-threatening situations. Thanks to its patented needle-free self-injection system, Crossject aims to become the world leader in self-administered emergency drugs. The company has been listed on the Euronext Growth market in Paris since 2014, and benefits from Bpifrance funding.

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®, and has six additional products that have been submitted to the FDA.

    Company Contact:

    David Krempa

    dkrempa@etonpharma.com

    612-387-3740



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  3. DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezipres® (ephedrine hydrochloride injection) for the treatment of clinically important hypotension occurring in the setting of anesthesia.

    "We are excited to see the approval of Rezipres, which is now our second FDA-approved ready-to-use hospital injectable product. We believe ready-to-use injectable products provide a compelling benefit to hospitals and reduce the need for hospitals to rely on unapproved compounded products," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "This innovative sulfite-free formulation has been successfully sold in Europe for years, and we…

    DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezipres® (ephedrine hydrochloride injection) for the treatment of clinically important hypotension occurring in the setting of anesthesia.

    "We are excited to see the approval of Rezipres, which is now our second FDA-approved ready-to-use hospital injectable product. We believe ready-to-use injectable products provide a compelling benefit to hospitals and reduce the need for hospitals to rely on unapproved compounded products," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "This innovative sulfite-free formulation has been successfully sold in Europe for years, and we are excited to make it available to U.S. patients shortly."

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from four FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, Rezipres®, and Alaway® Preservative Free, and has five additional products that have been submitted to 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.

    Investor Contact:

    David Krempa

    dkrempa@etonpharma.com

    612-387-3740



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  4. 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…

    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.

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®, and has six additional products that have been submitted to 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

    dkrempa@etonpharma.com

    612-387-3740

     



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