Yeji

$ETON

Eton Pharmaceuticals, Inc.

Runway:cash-flow +
NasdaqMarket cap: —CIK 0001710340

Upcoming catalysts

6 surfaced
NDA/BLA filedDate TBD~ low confidence
$ETONEton Pharmaceuticals, Inc.
et-400
“On April 30, 2024, Eton Pharmaceuticals, Inc. (the "Company") issued a press release announcing the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400, the Company's proprietary patented formulation of hydrocortisone oral solution.”
NDA/BLA filedDate TBD
$ETONEton Pharmaceuticals, Inc.
et-400
“On July 15, 2024, Eton Pharmaceuticals, Inc. (the "Company") issued a press release announcing the acceptance of a New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA) for its submission of ET-400, the Company's proprietary patented formulation of hydrocortisone oral solution.”
CRLDate TBD
$ETONEton Pharmaceuticals, Inc.
lamotrigine
“Eton was notified that its partner, Azurity Pharmaceuticals, received a Complete Response Letter from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application for the lamotrigine product candidate.”
NDA/BLA filedDate TBD~ low confidence
$ETONEton Pharmaceuticals, Inc.
et-600
“the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-600, Eton's proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.”
FDA approvalDate TBD
$ETONEton Pharmaceuticals, Inc.
zonisade
“Eton announced that the U.S. Food and Drug Administration (FDA) has approved ZONISADE™ (zonisamide oral suspension).”
FDA approvalDate TBD~ low confidence
$ETONEton Pharmaceuticals, Inc.
“Eton Pharmaceuticals, Inc. (the "Company") issued a press release announcing that it has launched HEMANGEOL® (propranolol) Oral Solution. HEMANGEOL is the only FDA-approved treatment for infantile hemangioma”

Drug pipeline

betaine anhydrous
khindivi
desmoda
nitisinone
desmoda (desmopressin acetate)
Central diabetes insipidus (arginine vasopressin deficiency / AVP-D) as antidiuretic replacement therapy for patients of all ages
et-600
et-400
dehydrated alcohol
methanol poisoning
zonisade
lamotrigine
cysteine hydrochloride
zonisamide
eprontia (topiramate)
topiramate
rezipres
clinically important hypotension occurring in the setting of anesthesia

Recent catalysts

FDA approvalFeb 25, 2026· 101d ago· success
$ETONEton Pharmaceuticals, Inc.
desmoda
“openFDA ORIG (TYPE 3) approval of DESMODA — application NDA219873”
PDUFAFeb 25, 2026· 101d ago
$ETONEton Pharmaceuticals, Inc.
et-600
“the Company's New Drug Application for ET-600, a proprietary patented formulation of desmopressin oral solution, was accepted for review by the Food and Drug Administration (FDA) and assigned a Prescription Drug User Fee Administration target action date of February 25, 2026.”
NDA/BLA filedJul 8, 2025· 333d ago· unknown
$ETONEton Pharmaceuticals, Inc.
et-600
“the Company's New Drug Application for ET-600, a proprietary patented formulation of desmopressin oral solution, was accepted for review by the Food and Drug Administration (FDA) and assigned a Prescription Drug User Fee Administration target action date of February 25, 2026.”
FDA approvalMay 28, 2025· 374d ago· success
$ETONEton Pharmaceuticals, Inc.
khindivi
“openFDA ORIG (TYPE 3) approval of KHINDIVI — application NDA218980”
PDUFAMay 28, 2025· 374d ago· unknown
$ETONEton Pharmaceuticals, Inc.
et-400
“the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for ET-400. The new PDUFA goal date is May 28, 2025.”
CRLJun 28, 2023· 1074d ago
$ETONEton Pharmaceuticals, Inc.
dehydrated alcohol · methanol poisoning
“On June 28, 2023, Eton Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.”
PDUFAJun 27, 2023· 1075d ago· failure
$ETONEton Pharmaceuticals, Inc.
dehydrated alcohol · methanol poisoning
“The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2023.”
FDA approvalMay 25, 2023· 1108d ago· success
$ETONEton Pharmaceuticals, Inc.
nitisinone
“openFDA ORIG (UNKNOWN) approval of NITISINONE — application ANDA216201”
NDA/BLA filedJan 11, 2023· 1242d ago· unknown
$ETONEton Pharmaceuticals, Inc.
dehydrated alcohol · methanol poisoning
“the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) response for dehydrated alcohol injection for the proposed indication of methanol poisoning.”
FDA approvalApr 11, 2022· 1517d ago
$ETONEton Pharmaceuticals, Inc.
cysteine hydrochloride
“Eton Pharmaceuticals, Inc. announced that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its cysteine hydrochloride abbreviated new drug application ("ANDA").”
PDUFAJan 29, 2022· 1589d ago· unknown
$ETONEton Pharmaceuticals, Inc.
zonisamide
“The New Drug Application ("NDA") for the zonisamide product was previously assigned a target action date of January 29, 2022.”
FDA approvalJan 28, 2022· 1590d ago· success
$ETONEton Pharmaceuticals, Inc.
betaine anhydrous
“openFDA ORIG (UNKNOWN) approval of BETAINE ANHYDROUS — application ANDA210508”
FDA approvalNov 8, 2021· 1671d ago
$ETONEton Pharmaceuticals, Inc.
eprontia (topiramate)
“On November 8, 2021, Eton Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration has approved EPRONTIA™ (topiramate) oral solution, 25mg/mL.”
PDUFANov 6, 2021· 1673d ago· unknown
$ETONEton Pharmaceuticals, Inc.
topiramate
“The new PDUFA user fee goal date is November 6, 2021. Eton expects the FDA to announce a decision on or before this new PDUFA date.”
FDA approvalJun 15, 2021· 1817d ago
$ETONEton Pharmaceuticals, Inc.
rezipres · clinically important hypotension occurring in the setting of anesthesia
“On June 15, 2021, Eton Pharmaceuticals, Inc. issued a press release announcing the U.S. Food and Drug Administration has approved Rezipres® (ephedrine hydrochloride injection) for the treatment of clinically important hypotension occurring in the setting of anesthesia.”
CRLMay 28, 2021· 1835d ago
$ETONEton Pharmaceuticals, Inc.
zonisamide
“Eton was notified that its partner received a Complete Response Letter("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application for zonisamide oral suspension.”