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Genprex (GNPX)

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Research analysts covering Genprex.

Recent press releases and 8-K filings for GNPX.

Genprex, Inc. Announces Clinical Program Updates for GPX-002 Diabetes Gene Therapy
GNPX
New Projects/Investments
Regulatory Engagement
  • Genprex, Inc. issued a press release on January 7, 2026, detailing clinical program updates for its diabetes gene therapy drug candidate, GPX-002.
  • In 2025, the company expanded preclinical studies into Type 2 diabetic (T2D) animal models, demonstrating in vivo proof-of-concept where GPX-002 rejuvenated exhausted beta cells and normalized glucose levels.
  • Genprex also submitted a request to the FDA for a meeting in Q1 2026 to discuss Investigational New Drug (IND)-enabling studies, and successfully transferred GPX-002 manufacturing to a contract development and manufacturing organization (CDMO).
  • Future plans include initiating clinical scale production, optimizing the product, and conducting toxicology studies to support an IND filing.
Jan 7, 2026, 12:04 PM
Genprex Publishes Acclaim-1 Phase 1 Clinical Trial Data in Clinical Lung Cancer
GNPX
New Projects/Investments
  • Genprex, Inc. announced the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa® Gene Therapy in combination with Tagrisso® for advanced non-small cell lung cancer (NSCLC) in the peer-reviewed journal Clinical Lung Cancer.
  • The Phase 1 trial established a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg and reported no Dose Limiting Toxicities (DLTs), indicating a strong safety profile.
  • Early efficacy results showed that three out of 12 patients experienced prolonged time to progression, with one patient achieving a partial remission and continuing treatment for over 32 months as of April 2025 data.
Nov 24, 2025, 12:00 PM
Genprex Expands Clinical Trial Sites for Lung Cancer Therapies
GNPX
New Projects/Investments
Guidance Update
  • Genprex, Inc. has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for its Acclaim-1 and Acclaim-3 clinical trials studying Reqorsa® Gene Therapy in lung cancer, with plans to open additional sites to expedite patient enrollment.
  • The Acclaim-1 Phase 2a expansion study, which evaluates Reqorsa with Tagrisso for late-stage non-small cell lung cancer, aims to enroll approximately 33 patients and expects to complete enrollment of the first 19 patients for interim analysis in the first half of 2026.
  • The Acclaim-3 Phase 2 expansion study, which evaluates Reqorsa with Tecentriq for extensive stage small cell lung cancer maintenance therapy, plans to enroll approximately 50 patients and expects to complete enrollment of the first 25 patients for interim analysis in the first half of 2026.
  • Both Acclaim-1 and Acclaim-3 clinical trials have received U.S. Food and Drug Administration (FDA) Fast Track Designation, with Acclaim-3 also holding Orphan Drug Designation.
Nov 19, 2025, 12:13 PM
Genprex Receives Patent for Reqorsa Combination Therapy and Provides Acclaim-3 Trial Update
GNPX
New Projects/Investments
  • Genprex, Inc. announced that the United States Patent and Trademark Office has granted it a patent covering the use of its lead drug candidate, Reqorsa® Gene Therapy, in combination with PD-L1 antibodies (such as Tecentriq®), providing exclusivity through 2037.
  • This patent is directly applicable to the company's Acclaim-3 clinical trial, a Phase 1/2 study evaluating REQORSA and Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC).
  • The Phase 2 expansion portion of the Acclaim-3 trial is expected to enroll approximately 50 patients, with an interim analysis planned after the first 25 patients complete 18 weeks of follow-up.
  • Genprex anticipates completing enrollment of these first 25 patients for interim analysis in the first half of 2026.
  • The Acclaim-3 clinical trial has received U.S. Food and Drug Administration Fast Track Designation and Orphan Drug Designation.
Nov 18, 2025, 12:10 PM
Genprex Announces U.S. Patent for Reqorsa® Gene Therapy Combination
GNPX
New Projects/Investments
  • Genprex announced that the United States Patent and Trademark Office (USPTO) has granted it a patent covering the use of its lead drug candidate, Reqorsa® Gene Therapy, in combination with PD-L1 antibodies, such as Tecentriq®, providing protection through 2037.
  • This new patent strengthens the company's intellectual property portfolio and provides necessary technology protection for its Acclaim-3 clinical trial in small cell lung cancer (SCLC), securing exclusivity for this drug combination.
  • Genprex expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the Acclaim-3 study in the first half of 2026.
Nov 18, 2025, 12:00 PM
Genprex Receives European Patent Intent for Cancer Therapy
GNPX
  • The European Patent Office (EPO) has communicated its intent to grant Genprex a patent for the use of Reqorsa® Gene Therapy in combination with PD-1 antibodies for the treatment of cancer.
  • This patent will further strengthen Genprex's intellectual property portfolio and expand on previously granted patents for REQORSA in combination with PD-1 antibodies in other markets, including the U.S. and Japan.
  • REQORSA is a clinical-stage gene therapy being developed to treat lung cancer, and preclinical studies have shown it to be complementary with targeted drugs and immunotherapies.
Nov 4, 2025, 12:00 PM
Genprex Announces Registered Direct Offering and Private Placement
GNPX
  • Genprex, Inc. announced a registered direct offering of 377,780 shares of common stock at a purchase price of $9.00 per share, expected to generate approximately $3.4 million in upfront gross proceeds.
  • In a concurrent private placement, the company will issue unregistered short-term warrants to purchase up to 755,560 shares of common stock at an exercise price of $8.75 per share.
  • The full exercise of these warrants could provide an additional $6.6 million in gross proceeds, bringing the total potential aggregate gross proceeds from the offering to approximately $10.0 million.
  • The net proceeds from the offering are intended for working capital and general corporate purposes.
  • The closing of the offering is expected to occur on or about October 29, 2025.
Oct 29, 2025, 12:55 PM
Genprex announces registered direct offering and private placement
GNPX
  • Genprex, Inc. announced a registered direct offering of 377,780 shares of common stock at a purchase price of $9.00 per share, expected to generate approximately $3.4 million in gross proceeds.
  • Concurrently, the company will issue unregistered short-term warrants to purchase an aggregate of up to 755,560 shares of common stock at an exercise price of $8.75 per share in a private placement.
  • If fully exercised on a cash basis, these warrants could provide approximately $6.6 million in additional gross proceeds, bringing the total potential gross proceeds from both transactions to approximately $10.0 million.
  • The net proceeds from the offering are intended for working capital and general corporate purposes.
  • The closing of the offering is expected to occur on or about October 29, 2025.
Oct 28, 2025, 3:19 PM
Genprex Announces Registered Direct Offering and Concurrent Private Placement
GNPX
Delisting/Listing Issues
  • Genprex, Inc. announced a registered direct offering of 243,622 shares of common stock at $11.21 per share, expected to generate approximately $2.7 million in gross proceeds.
  • Concurrently, the company will issue unregistered short-term warrants to purchase up to 487,244 shares of common stock at an exercise price of $11.00 per share, which could provide an additional $5.4 million in gross proceeds if fully exercised.
  • The net proceeds from the offering, estimated at approximately $2.3 million, are intended for working capital and general corporate purposes.
  • The offering is being conducted as Genprex addresses Nasdaq listing compliance issues, including the need for additional capital to meet the Minimum Stockholders’ Equity Requirement.
Oct 24, 2025, 12:26 PM
Genprex Receives Nasdaq Listing Extension and Announces Reverse Stock Split
GNPX
Delisting/Listing Issues
New Projects/Investments
  • Genprex, Inc. (GNPX) has been granted an exception by the Nasdaq Hearings Panel until October 31, 2025, to regain compliance with the $1.00 Minimum Bid Price Requirement and the Minimum Stockholders’ Equity Requirement. The company's stockholders' equity was $1,391,195 as of June 30, 2025, which is below the required $2.5 million.
  • To aid in regaining compliance, Genprex will effect a one-for-fifty (1:50) reverse stock split of its common stock, which will be effective at 12:01 a.m. Eastern Time on October 21, 2025. Trading on a split-adjusted basis is anticipated to begin when the market opens on the same day.
  • The company is currently enrolling patients in the Phase 2 expansion portion of its Acclaim-3 clinical trial for extensive stage small cell lung cancer (ES-SCLC), with interim analysis expected in the second half of 2026.
  • Genprex plans to submit a request to the FDA to meet regarding IND-enabling studies for its GPX-002 diabetes gene therapy product by the end of 2025.
Oct 17, 2025, 1:00 PM