Moleculin Biotech, Inc., a clinical-stage pharmaceutical company, focuses on the development of oncology drug candidates for the treatment of highly resistant tumors and viruses in the United States. Its lead drug candidate is Annamycin that is in Phase 1/2 studies for the treatment of relapsed or refractory acute myeloid leukemia (AML) and cancers metastasized to the lungs. The company's flagship immune/transcription modulator is WP1066, which is in Phase I clinical trial for the treatment of brain tumors and pediatric brain tumors, as well as pancreatic cancer and hematologic malignancies. It also develops WP1220, an analog of WP1066, which has completed Phase 1 clinical trial for the topical treatment of cutaneous T-cell lymphoma in Poland; WP1234 for the treatment of pancreatic cancer; and WP1732, an analog of WP1066 for the treatment of topical treatment of cutaneous T-cell lymphoma. The company's lead metabolism/glycosylation inhibitor compound is WP1122 to treat cancers and viruses. In addition, it engages in the preclinical development of other drug candidates, including other immune/transcription modulators and antimetabolites, targeting glycolysis and glycosylation. The company has partnerships and collaboration agreement with MD Anderson, DERMIN Sp. z o. o., Animal Life Sciences, LLC, and WPD Pharmaceuticals Sp z.o.o for the development of various drug candidates. Moleculin Biotech, Inc. was incorporated in 2015 and is headquartered in Houston, Texas.
IPO Year: 2016
Exchange: NASDAQ
Website: moleculin.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 6/9/2025 | $4.00 | Buy | H.C. Wainwright |
| 2/12/2025 | Buy → Hold | Maxim Group | |
| 7/18/2022 | $14.00 | Outperform | Oppenheimer |
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4 - Moleculin Biotech, Inc. (0001659617) (Issuer)
4 - Moleculin Biotech, Inc. (0001659617) (Issuer)
4 - Moleculin Biotech, Inc. (0001659617) (Issuer)
4 - Moleculin Biotech, Inc. (0001659617) (Issuer)
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4 - Moleculin Biotech, Inc. (0001659617) (Issuer)
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Independent Cleveland Clinic Cardiac Review Supports Potential Best-in-Class Safety Profile as MIRACLE Phase 2b/3 Trial Advances HOUSTON, May 29, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today announced new data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting further reinforcing the differentiated cardiac safety profile of its lead drug candidate, Annamycin (also known as "L-Annamycin" or "naxtarubicin"). The poster presentation, titled "Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis," highlighted findings from a pooled analysis across five completed clinical
HOUSTON, May 21, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today announced that an abstract featuring pooled cardiac safety data for its lead drug candidate Annamycin (also known as "L-Annamycin" or "naxtarubicin"), has been accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois. Access the abstract here. The abstract, titled "Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis," will be presented in a poster session focused on Symptom Science and Palliative Care. Presentation Details: Sessi
Early blinded results show 40% composite complete remission rate across difficult-to-treat AML patient population in MIRACLE Trial First interim unblinding expected in June 2026 following 45 subject enrollment milestone achieved in MIRACLE trial Enrollment in MIRACLE trial continues to advance on pace with 90th subject expected in Q3 2026 HOUSTON, May 15, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. "With enrollment now surpassing the first interim analysis threshold in the MIRACLE trial, we are just weeks away from beginning wh
Preliminary blinded CR rate for the first 45 subjects in the trial approximates 30% and represents ~67% improvement vs. standard of careFirst 45-subject data unblinding expected before June 30, 2026Program targets high-unmet-need AML population, including R/R Venetoclax subjects Recruitment of Part A continues to the target 90 subjects in Q3 2026 with 56 or 62% subjects recruited and randomizedContinued absence of cardiotoxicity and high efficacy expected to position Annamycin as a "significant advancement" in AML treatment HOUSTON, May 13, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today announced that it is approaching the first unb
Pooled analysis of 90 subjects across 5 trials shows stable mean ejection fraction and no clinically significant left ventricular dysfunction Data demonstrates Annamycin addresses the principal barrier to anthracycline use in heavily pretreated R/R AML HOUSTON, May 12, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today announced the publication of an abstract at the European Hematology Association (EHA) 2026 Congress highlighting the cardiac safety profile of Annamycin (or as known in scientific journals "L-Annamycin"), the Company's next-generation anthracycline currently in late-stage development for the treatment of relapsed/refractor
Solid Intellectual Property Protection Across Four Continents Ahead of Pending Phase 3 Data Release HOUSTON, May 08, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today announced a significant advancement in its intellectual property portfolio with the issuance of a Hong Kong patent covering its proprietary method of reconstituting liposomal Annamycin. The newly granted patent (No. 40073244), titled "Method of Reconstituting Liposomal Annamycin," extends protection through June 25, 2040, further reinforcing Moleculin's long-term global exclusivity strategy. The invention is jointly owned with The University of Texas System. This patent r
Non-cardiotoxic anthracycline demonstrates activity where traditional chemotherapies have historically failed, supporting potential expansion of Annamycin into a major unmet-need indication Significant tumor volume reduction across multiple PDAC models, including orthotopic human and syngeneic systems (p<0.001) Significantly higher tumor and pancreatic tissue accumulation than doxorubicin (p<0.0001), providing a mechanistic basis for Annamycin's activity where traditional anthracyclines have historically failed Induced infiltration of CD8+ and CD4+ T cells, suggesting potential to convert immunologically "cold" pancreatic tumors into responders and supporting future combinations with chec
HOUSTON, April 21, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today announced that an abstract highlighting data on its lead drug candidate, annamycin, has been accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois. The abstract, titled "Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis," will be presented in a poster session focused on Symptom Science and Palliative Care. Presentation Details: Session Type: Poster Session - Symptom Science and Palliative CarePresentation Date and Time: Ma
Access the Moleculin CEO Corner here HOUSTON, April 07, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today announced it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer. In this segment, Mr. Klemp highlights the differentiated safety profile of Annamycin, emphasizing its lack of cardiotoxicity which is a significant limitation associated with traditional anthracyclines such as doxorubicin. Annamycin was specifically designed to avoid cardiac damage, and has demonstrated this advantage across preclinical and clinical studies. This non-cardiotoxic profile could expand treatment opt
First Interim Unblinding of Pivotal AML Trial Now Imminent — Potentially the Most Important Data Moment in Company HistoryEarly Blinded Results Show 40% Remission Rate Across Difficult-to-Treat Patient PopulationEnrollment Accelerating Toward 90 Subject Threshold as Phase 3 Pathway Takes Shape HOUSTON, March 23, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today announced that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adult subjects with relapsed or refractory acute myeloid leukemia (R/R AML). This milestone triggers the fin
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H.C. Wainwright resumed coverage of Moleculin Biotech with a rating of Buy and set a new price target of $4.00
Maxim Group downgraded Moleculin Biotech from Buy to Hold
Oppenheimer resumed coverage of Moleculin Biotech with a rating of Outperform and set a new price target of $14.00
Roth Capital resumed coverage of Moleculin Biotech with a rating of Buy
Roth Capital resumed coverage of Moleculin Biotech with a rating of Buy and set a new price target of $29.00 from $5.00 previously
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Live Leadership Updates
40+ year career at Roche founded on dedication to bringing new innovative medicines to patients and making them accessible HOUSTON, July 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced the appointment of Adriano Treve as a Strategic Advisor for partnerships. With over four decades of experience at Roche, Mr. Treve brings exceptional leadership and a deep understanding of global healthcare markets. He has held senior executive roles across diverse regions, including overseeing U.S. supply c
Strong preclinical evidence of Annamycin's potential for treating pancreatic cancer presented at AACR expands collaboration HOUSTON, Nov. 4, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) (Moleculin or the Company), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the appointment of Daniel D. Von Hoff, M.D., F.A.C.P., FASCO, FAACR to its Annamycin Scientific Advisory Board. Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, "We are very pleased to welco
Live video webcast roundtable with members from the Moleculin Management Team and Dr. Tallman to discuss the unmet medical needs in the treatment of acute myeloid leukemia (AML), Annamycin and the Company's AML clinical development program as well as data demonstrated to dateOngoing development progress of Annamycin toward pivotal AML study in 2024 with potential qualification for an accelerated approval pathwayHOUSTON, May 2, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it will host a virtual AML Clinica
– Company appoints internationally renowned clinician, Martin S. Tallman, MD as inaugural clinician member HOUSTON, May 1, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the formation of its Annamycin Scientific Advisory Board and inaugural appointment of Dr. Martin Tallman. Dr. Tallman is an internationally renowned clinical investigator whose discoveries have fueled the progress of leukemia-
- Company urges shareholders of record date, March 27, 2023, to vote your shares immediately if you have not already done so HOUSTON, May 30, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that its annual meeting of stockholders (the "Annual Meeting") scheduled for and convened on Thursday, May 25, 2023 has been partially adjourned to Thursday, June 15, 2023 at 10:30 a.m. Eastern Time.
HOUSTON, March 1, 2022 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced the appointment of Joy Yan, M.D., Ph.D. to its Board of Directors. "We are incredibly pleased to welcome Dr. Yan to our Board of Directors. Her leadership and expertise in building, executing, and advancing clinical programs with major players in the pharma industry will be a valuable perspective as we work to progress our po
Live finance-specific insights
Early blinded results show 40% composite complete remission rate across difficult-to-treat AML patient population in MIRACLE Trial First interim unblinding expected in June 2026 following 45 subject enrollment milestone achieved in MIRACLE trial Enrollment in MIRACLE trial continues to advance on pace with 90th subject expected in Q3 2026 HOUSTON, May 15, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. "With enrollment now surpassing the first interim analysis threshold in the MIRACLE trial, we are just weeks away from beginning wh
Miracle Trial Preliminary Blinded CRc Rate of 40% in First 30 Patients Suggests Encouraging Early Results in Relapsed/Refractory AML HOUSTON, March 19, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), today reported financial results for the year ended December 31, 2025 and provided a clinical update highlighting rapid progress toward a major upcoming milestone in its pivotal MIRACLE trial of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). "With the MIRACLE trial rapidly progressing and the first MIRACLE i
Enrollment and dosing underway in Phase 3 clinical trial (the "MIRACLE" trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML Regulatory and site selection progress to date supports interim data readout expected in the second half of 2025 Recently received European Medicines Agency (EMA) approval adds nine additional countries to the Company's ongoing MIRACLE trial; Authorization granted in all EU countries requested Company to host conference call and webcast today, May 14th at 8:30 AM ET HOUSTON, May 14, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug
HOUSTON, May 07, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced that it will report its financial results for the first quarter ended March 31, 2025 on Tuesday afternoon, May 13, 2025. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results on Wednesday morning, May 14, 2025 at 8:30 AM ET. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referenci
– Continued progress in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) toward first subject treated, on track to take place in the first quarter of 2025 – Multiple subjects currently being screened in first MIRACLE site activated – Initial data readout of the Phase 3 MIRACLE trial expected in the second half of 2025 – Company to host conference call and webcast today, Monday, March 24th at 8:30 AM ET HOUSTON, March 24, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today reported its financial results
HOUSTON, March 19, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it will report its financial results for the year ended December 31, 2024, on Friday afternoon, March 21, 2025. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results on Monday morning, March 24, 2025 at 8:30 AM ET. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing t
- On track to start dosing in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 - Median durability of CRc in MB-106 Annamycin+ Cytarabine AML clinical trial continues to climb - now past 8 months - Recent virtual AML KOL event underscores how Annamycin could significantly change the AML treatment landscape; Replay available here - Company to host conference call and webcast today, Monday, November 11th at 8:30 AM ET HOUSTON, Nov. 11, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical
HOUSTON, Nov. 5, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it will report its financial results for the quarter ended September 30, 2024, on Friday, November 8, 2024. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, November 11, 2024. Interested participants and investors may access the confe
Live webcast discussion featuring internationally renowned Acute Myeloid Leukemia (AML) Key Opinion Leaders Ongoing progress of pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML HOUSTON, Oct. 7, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it will host a Virtual Acute Myeloid Leukemia KOL event on Monday, October 14th from 11:00 AM – 1:00 PM ET.
HOUSTON, Aug. 5, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it will host a corporate update webcast presentation on Tuesday, August 6, 2024 at 8:30 AM ET to discuss its recently announced plans to advance Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE"