Moleculin Announces Notice of Allowance for Japanese Patent Covering Annamycin
Rhea-AI Summary
Moleculin (Nasdaq: MBRX) announced a Japan Patent Office notice of allowance for Patent Application No. 2021-577862 covering methods to reconstitute liposomal Annamycin for intravenous use. A patent is expected to issue in the coming months.
The allowed claims focus on controlled-temperature reconstitution to ensure dosing consistency, stability, and handling. This allowance complements U.S. and European patent coverage and supports ongoing Phase 3 development for relapsed or refractory acute myeloid leukemia. Annamycin holds multiple orphan and Fast Track designations.
Positive
- Japan patent allowance for methods of reconstituting liposomal Annamycin
- Allowance complements existing U.S. and European Annamycin patent coverage
- Method patents protect clinical preparation, dosing consistency, and stability
Negative
- Notice of allowance; patent not yet issued and expected in coming months
- Regulatory approval still required—drug remains in pivotal Phase 3 development
News Market Reaction – MBRX
On the day this news was published, MBRX gained 5.07%, reflecting a notable positive market reaction. Argus tracked a peak move of +16.5% during that session. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $688K to the company's valuation, bringing the market cap to $14M at that time. Trading volume was very high at 4.3x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
MBRX gained 2.94% while peers showed mixed moves: LPTX up 238.84%, KZIA and INTS down (-2.53%, -10.64%), MBIO and SNGX modestly positive. Momentum scanner also flagged MBIO down 5.43%, ERNA up 15.17%, MRKR up 4.90%. The mixed directions indicate today’s reaction is stock-specific rather than a coordinated biotech sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 13 | Investor outreach | Positive | +2.9% | Launch of CEO Corner platform to share strategic and clinical updates. |
| Feb 05 | Conference/webinar | Neutral | -6.5% | Announcement of participation in Webull Corporate Connect webinar series. |
| Jan 13 | Safety data update | Positive | +5.9% | Independent assessment found no cardiotoxicity in 90 Annamycin-treated subjects. |
| Jan 12 | Pipeline/milestones | Positive | +1.8% | Detailed 2026–2028 milestones and MIRACLE pivotal trial expansion and timelines. |
Recent Moleculin news has generally seen moves that align with the perceived tone: safety and pipeline updates have coincided with positive reactions, while routine event participation produced a negative response.
Over the past months, Moleculin highlighted progress around Annamycin and corporate communications. On Jan 12, 2026, it outlined 2026–2028 milestones and pivotal MIRACLE trial plans, followed by Jan 13 safety data showing no cardiotoxicity in 90 subjects, both met with positive price moves. Later, a Feb 5 webinar notice saw a negative reaction, while the Feb 13 launch of a CEO Corner engagement platform coincided with a gain. Today’s Japanese patent allowance builds on this narrative of strengthening Annamycin’s profile and positioning.
Regulatory & Risk Context
The company has an active Form S-3 shelf registration dated 2025-09-19 that remains effective through 2028-09-19, with no recorded usage to date. Specific dollar capacity was not provided in the current context.
Market Pulse Summary
The stock moved +5.1% in the session following this news. A strong positive reaction aligns with the company’s ongoing effort to de-risk Annamycin while widening its strategic moat. The newly allowed Japanese patent supports proprietary methods for liposomal Annamycin preparation, complementing existing U.S. and European coverage. Recent news on cardiotoxicity-free data in 90 subjects and clear 2026–2028 trial milestones adds to the fundamental story, though historical volatility and capital-raising capacity under the existing shelf remain important considerations.
Key Terms
liposomal medical
lyophilizate medical
intravenous administration medical
anthracycline medical
acute myeloid leukemia medical
hematologic malignancies medical
orphan drug designation regulatory
fast track status regulatory
AI-generated analysis. Not financial advice.
HOUSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that the Japan Patent Office (JPO) has issued a notice of allowance for Patent Application No. 2021-577862 titled, “METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN.” A patent from the application is expected to be issued in the coming months.
The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under controlled temperature conditions to achieve precise concentrations suitable for intravenous administration. These methods are designed to ensure consistent dosing, stability, and handling during preparation and delivery, including maintaining the formulation at physiologic temperatures throughout reconstitution and dilution. Annamycin, Moleculin’s novel, lipid-based anthracycline drug candidate, is being developed for the treatment of acute myeloid leukemia (AML) and other hematologic malignancies and is positioned to potentially become the first non-cardiotoxic anthracycline approved for clinical use. Additional preclinical studies conducted at leading cancer centers suggest Annamycin may have broader applicability across multiple cancer types. This Japanese patent allowance complements Moleculin’s existing U.S. and European patent coverage, with additional Annamycin-related patent applications pending in major jurisdictions worldwide.
“Securing strong patent protection across key global markets remains a core strategic priority as we advance our non-cardiotoxic therapy for relapsed or refractory acute myeloid leukemia through pivotal Phase 3 development,” commented Walter Klemp, Chairman and CEO of Moleculin. “This newly allowed Japanese patent further strengthens our international intellectual property position by protecting critical methods supporting the preparation and clinical use of our therapy, reinforcing our confidence in its long-term value as we work toward potential regulatory approval and commercialization in key territories worldwide.”
Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.
Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.
For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding the timing and the outcomes of the patent issuance, and the potential for Annamycin to achieve regulatory approval or commercialization. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com
FAQ
What did Moleculin announce on February 17, 2026 about Annamycin (MBRX)?
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