RedHill Biopharma (RDHL) Company Report

RedHill Biopharma Ltd. announced development progress for RHB-102 (Bekinda®), a proprietary, once-daily, extended-release oral tablet formulation of ondansetron, targeting multiple gastrointestinal (GI) indications.
The company is advancing RHB-102 via the accelerated FDA 505(b)(2) route for GLP-1/GIP receptor agonist therapy-associated GI side effects, with a Phase 2 Proof-of-Concept study planned to commence as early as possible in 2026.
RHB-102 is also being pursued for potential U.S. FDA approval for oncology support, and if approved, could be the first oral 24-hour extended-release ondansetron antiemetic drug for chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV).
The development of RHB-102 is supported by prior positive U.S. Phase 3 results in gastroenteritis/gastritis and positive U.S. Phase 2 results for IBS-D.
GI side effects are a key contributor to the discontinuation of GLP-1 receptor agonist drugs, potentially reducing forecasted market valuations by an estimated $35 billion by 2030.

Jan 5, 2026, 12:02 PM

6-K

RedHill Biopharma Completes Strategic Transaction for Talicia® with Cumberland Pharmaceuticals

RDHL

M&A

New Projects/Investments

Accounting Changes

RedHill Biopharma Ltd. completed a strategic transaction on October 17, 2025, regarding its proprietary drug, Talicia®, through the sale of a portion of its holdings in Talicia Holdings Inc. (THI) to Cumberland Pharmaceuticals Inc..
Cumberland Pharmaceuticals Inc. invested $4.0 million to acquire a 30% equity interest and joint control in THI.
RedHill Biopharma Ltd. retains a 70% ownership interest in THI but has deconsolidated THI, now recognizing its retained interest as an investment in a Joint Venture under the equity method.
The Talicia® activity is now classified as discontinued operations in RedHill's pro forma financial statements.

Dec 31, 2025, 9:58 PM

6-K

RedHill Biopharma Enters $25 Million Standby Equity Purchase Agreement

RDHL

RedHill Biopharma Ltd. has entered into a Standby Equity Purchase Agreement (SEPA) with YA II PN, LTD., allowing the company to sell up to $25 million of its American Depositary Shares (ADSs) to the investor.
As part of the agreement, RedHill Biopharma will pay a 2.00% Commitment Fee on the total amount, payable in four installments, and a $25,000 structuring fee to the Investor.
The Company has already issued 122,130 ADSs to the Investor in connection with the first tranche of the Commitment Fee.
As of December 22, 2025, RedHill Biopharma had 5,092,326 ADSs outstanding.
RedHill Biopharma is required to file a Registration Statement within 21 days of the agreement date to cover the resale of these securities by the Investor, aiming for effectiveness within 45 calendar days of filing.

Dec 23, 2025, 12:00 PM

6-K

RedHill Biopharma Announces Positive Opaganib Results for Venetoclax-Resistant CLL

RDHL

New Projects/Investments

RedHill Biopharma Ltd. announced positive in vivo results for its drug opaganib, showing a 50% reduction in Chronic Lymphocytic Leukemia (CLL) cells when combined with venetoclax compared to controls.
These findings indicate opaganib's potential as an add-on therapy for venetoclax-resistant CLL, addressing a significant challenge in current treatment strategies.
Opaganib, which has demonstrated a favorable safety and tolerability profile in over 470 clinical trials and expanded access participants, is also currently undergoing a Phase 2 clinical trial for advanced prostate cancer in combination with darolutamide.

Dec 15, 2025, 12:03 PM

6-K

RedHill Biopharma Regains Nasdaq Stockholders’ Equity Compliance

RDHL

Delisting/Listing Issues

RedHill Biopharma Ltd. regained compliance with the Nasdaq Stockholders’ Equity Requirement on November 26, 2025.
The company met the Nasdaq Listing Rule 5550(b)(1) by demonstrating its stockholders’ equity exceeded the minimum $2.5 million threshold.
This achievement aligns with RedHill's 2025 strategic initiatives, which include the Talicia® partnership with Cumberland Pharmaceuticals and a focus on operational efficiency.

Dec 1, 2025, 12:02 PM

6-K

RedHill Biopharma Announces Final $10.5 Million New York Supreme Court Judgment Win

RDHL

Legal Proceedings

RedHill Biopharma Ltd. announced that its $10.5 million New York Supreme Court summary judgment win against Kukbo Co. Ltd is now final and eligible for enforcement.
The total award includes a main judgment of approximately $8.6 million and an award for legal fees and expenses of approximately $1.9 million, with 9% annual statutory interest continuing to accrue on both.
The $8.6 million main judgment is final, while the $1.9 million award for legal fees and expenses remains subject to appeal until March 13, 2026.
RedHill has also secured a Korean court attachment grant against Kukbo aimed at preventing asset disposal prior to judgment enforcement.

Nov 4, 2025, 2:33 PM

6-K

RedHill Biopharma Announces Final Judgment Win in New York Supreme Court

RDHL

Legal Proceedings

RedHill Biopharma announced that the New York Supreme Court's summary judgment in its favor against Kukbo Co. Ltd is now final and eligible for enforcement.
The Court awarded RedHill more than $10.5 million in total, which includes a main judgment of approximately $8.6 million (now final) and an award for legal fees and expenses of approximately $1.9 million.
The $1.9 million award for legal fees and expenses remains subject to appeal until March 13, 2026, and 9% annual statutory interest continues to accrue on both awards.
RedHill has also secured a Korean court attachment grant against Kukbo to prevent the disposal of assets prior to judgment enforcement.

Nov 4, 2025, 2:30 PM

Press Release

RedHill Biopharma Signs New Middle East Deal for Talicia

RDHL

New Projects/Investments

Product Launch

Revenue Acceleration/Inflection

RedHill Biopharma Ltd. has signed a new Middle East licensing deal for its drug Talicia®, with a potential value of $1.8 million plus sales royalty payments.
The agreement includes $500,000 in guaranteed payments, consisting of a $250,000 upfront payment and $250,000 in fixed payments due within 18 months.
RedHill may also receive a minimum of $1.3 million in near-term potential milestone payments and tiered royalties up to mid-teens percent on Talicia net sales.
This deal is intended to accelerate Talicia’s entry into new Middle East markets.

Oct 6, 2025, 12:04 PM

6-K

RedHill Biopharma Wins New York Supreme Court Appeal, Upholding $10 Million Judgment

RDHL

Legal Proceedings

The New York Supreme Court has upheld its original summary judgment ruling in favor of RedHill Biopharma Ltd. against Kukbo Co. Ltd., unequivocally dismissing Kukbo's defense and confirming RedHill's fulfillment of agreement obligations.
RedHill Biopharma has been granted approximately $10 million in total awards, which includes an $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses, along with 9% statutory interest accrual.
Kukbo Co. Ltd. retains the right to further appeal the Court's ruling.
In addition to the New York Supreme Court case, RedHill Biopharma recently secured an attachment grant against Kukbo from Korea's Incheon District Court, allowing for a court-ordered seizure of Kukbo's assets.