SCIENTURE Provides Update on the Commercial Launch of REZENOPY®, the Highest Strength Naloxone HCl Life-Saving Opioid Overdose Emergency Treatment Approved by the FDA
Rhea-AI Summary
SCIENTURE (NASDAQ: SCNX) provided an update on the commercial launch of REZENOPY® (naloxone HCl) Nasal Spray 10 mg, the highest-strength FDA-approved naloxone product. Scienture acquired exclusive U.S. commercialization rights in March 2025 and notes FDA approval occurred on April 19, 2024. IQVIA data (MAT September 2025) shows the U.S. naloxone market at approximately $154 million in annual sales and 9.3 million units annually.
Manufacturing is reported to be on track with product readiness expected in Q1 2026, wholesale loading in Q1 2026, and commercial availability beginning in early Q2 2026.
Positive
- Exclusive U.S. rights secured in March 2025
- FDA approval dated April 19, 2024
- Highest-strength naloxone at 10 mg
- U.S. naloxone market: $154M annual sales (MAT Sep 2025)
- U.S. naloxone unit volume: 9.3M units annually (MAT Sep 2025)
- Targeted commercial availability in Q2 2026
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus 1 Down
SCNX gained 14.47% while peers were mixed: SSY up 9.31%, WGRX roughly flat, others modestly down. This points to a stock-specific reaction rather than a broad sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 10 | Access partnership | Positive | -2.9% | Strategic BlinkRx collaboration to expand national access to Arbli™. |
| Dec 02 | Conference participation | Neutral | +0.1% | Participation in virtual investment conference and investor meetings. |
| Nov 13 | Earnings and update | Positive | -5.5% | Q3 2025 results showing revenue growth and Arbli™ launch progress. |
| Nov 04 | Formulary expansion | Positive | +15.3% | Arbli™ added to major national health plan formularies, expanding coverage. |
| Oct 23 | Commercial launch | Positive | +354.9% | Start of commercial sales and initial orders for Arbli™ oral suspension. |
Positive commercial and access updates have often aligned with strong gains, while partnership and earnings news have at times seen negative reactions.
Over the past few months, SCIENTURE has focused on commercializing novel formulations like Arbli™ and expanding access via PBM and payor channels. Key milestones included starting Arbli™ sales on Oct 23, 2025 with a large institutional market opportunity, followed by formulary additions covering over 100 million lives. Q3 2025 results on Nov 13, 2025 showed net revenue rising to $590K. A BlinkRx collaboration was announced on Dec 10, 2025. Today’s REZENOPY® launch update extends this commercialization narrative into the naloxone market.
Regulatory & Risk Context
The company has an active S-3 shelf filed on 2025-08-01 with multiple 424B5 prospectus supplements, indicating ongoing use of an at-the-market equity program. The shelf is noted as not yet effective, but prior supplements show active capital-raising through Maxim Group LLC.
Market Pulse Summary
This announcement details progress toward the commercial launch of REZENOPY®, a 10 mg naloxone HCl nasal spray targeting a U.S. market of $154 million and 9.3 million units annually. It follows recent Arbli™ commercialization and access wins and Q3 2025 revenue of $590,050. At the same time, filings report an operating loss of $4,361,206 and an at-the-market equity program of up to $150,000,000. Monitoring launch execution, financing activity, and progress toward profitability remains important.
Key Terms
naloxone hcl medical
opioid overdose medical
nasal spray medical
fda regulatory
AI-generated analysis. Not financial advice.
U.S. Naloxone Market: ~
COMMACK, NY, Dec. 22, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, today provided an update on the commercial launch of REZENOPY®.
As previously disclosed, Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc. entered into a definitive agreement with Summit Biosciences Inc. (a Kindeva subsidiary) in March 2025, for the exclusive U.S. commercialization rights to REZENOPY® (naloxone HCl) Nasal Spray 10 mg, which received FDA approval on April 19, 2024.
REZENOPY® is a high-strength naloxone HCl nasal spray approved by the FDA. The product leverages the proven use of the naloxone hydrochloride and form factor, with increased effectiveness against potent opioids. IQVIA data (MAT September 2025) indicates a total annual sales of
“REZENOPY® represents a significant advancement in overdose response as the highest-strength naloxone available on the market at 10 mg. It is specifically designed for patients who often require multiple doses of lower-strength naloxone for stabilization in emergency situations,” commented Narasimhan Mani, President and co-CEO of Scienture. “By delivering a higher dose of naloxone, REZENOPY® is intended to support opioid receptor antagonism and may help address overdose situations where multiple or potent opioids are involved.”
“Our manufacturing efforts are firmly on track, and we expect product to be ready as planned in the first quarter of 2026. We anticipate loading REZENOPY® into the wholesale channel during Q1 2026, with commercial availability beginning in early Q2 2026,” stated Shankar Hariharan, Executive Chairman and co-CEO of Scienture. “We are excited about this upcoming launch and confident that bringing the highest-strength 10 mg naloxone product to market will address a critical and growing unmet need.”
About REZENOPY™
REZENOPY™ (naloxone HCl) Nasal Spray 10mg, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present.
REZENOPY™ nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device.
IMPORTANT SAFETY INFORMATION
- Administration: REZENOPY™ nasal spray is for intranasal use only. Seek emergency medical care immediately after use. Administer a single spray into one nostril. If the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression, an additional dose may be given into the other nostril with a new device. Do not administer more than 2 sprays per day. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
- Contraindications: REZENOPY™ nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
- Warnings and Precautions:
- Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer additional doses as necessary while awaiting emergency medical assistance.
- Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
- Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
- Risk of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular effects. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.
- Adverse Reactions: The following adverse reactions were observed in a REZENOPY™ nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia.
- Storage and Handling: Store REZENOPY™ nasal spray in the blister and cartons provided. Store between 2°C to 25°C (36°F to 77°F). Excursions permitted up to 40°C (104°F). Do not freeze or expose to excessive heat above 40°C (104°F). Protect from light. REZENOPY™ nasal spray may freeze at cold temperatures. If this happens, the device will not spray. If REZENOPY™ nasal spray is frozen and is needed in an emergency, do NOT wait for it to thaw; get emergency medical help right away.
For more detailed information, please refer to the full prescribing information provided by the FDA.
About Scienture Holdings, Inc.
SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: www.scientureholdings.com and www.scienture.com.
Cautionary Statements Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, such as REZENOPY™, the success those products may have in the marketplace, and our strategies related to those products. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.
Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
Contact:
SCIENTURE HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
Phone: (866) 468-6535
Email: IR@Scienture.com
FAQ
What is REZENOPY® (SCNX) and what strength is it?
When did SCIENTURE (SCNX) obtain FDA approval for REZENOPY®?
What U.S. market size does SCIENTURE cite for naloxone (SCNX)?
When will REZENOPY® be commercially available in the U.S. (SCNX)?
How did SCIENTURE acquire U.S. commercialization rights for REZENOPY® (SCNX)?
Why does SCIENTURE describe REZENOPY® as significant for overdose response (SCNX)?
