RedHill Biopharma Nasdaq compliance has been formally restored, marking an important step for the specialty biopharmaceutical company as it executes its 2025 strategic plan in the U.S. market.
Key Points
The company confirmed that on November 26, 2025, it received a notice from the Nasdaq Stock Market stating that RedHill is once again in compliance with the stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1). The update removes a key overhang for investors and reinforces the impact of the firm’s recent corporate actions.
This positive development comes alongside RedHill’s continued push to expand its gastrointestinal and infectious disease portfolio, highlighted by its Talicia® partnership and an active late‑stage clinical pipeline.
Nasdaq confirms RedHill Biopharma Nasdaq compliance on equity rule
Headquartered in Tel Aviv, Israel, with U.S. operations in Raleigh, North Carolina, RedHill Biopharma Ltd. (Nasdaq: RDHL) disclosed that Nasdaq has determined the company now satisfies the stockholders’ equity threshold required for continued listing on the Capital Market tier.
The exchange’s confirmation means RedHill Biopharma Nasdaq compliance issues tied to Listing Rule 5550(b)(1) have been resolved following a period of monitoring. That rule focuses specifically on stockholders’ equity as a measure of a company’s financial foundation.
By regaining compliance, RedHill maintains uninterrupted access to the Nasdaq platform, which is critical for visibility among U.S. investors, liquidity in its shares and long‑term capital‑raising flexibility. The company noted that this outcome aligns with the financial and operational steps it has been taking throughout 2025.
Strategic moves that supported RedHill Biopharma Nasdaq compliance
RedHill pointed to its ongoing strategic initiatives as an important backdrop to the restoration of RedHill Biopharma Nasdaq compliance.
A central element has been its work around Talicia®, an FDA‑approved treatment for Helicobacter pylori (H. pylori) infection in adults. In 2025, RedHill entered into a co‑commercialization agreement with Cumberland Pharmaceuticals in the United States, designed to expand Talicia’s reach while sharing promotional responsibilities.
Alongside this partnership, RedHill has emphasized operational efficiency across its business. While specific cost measures were not detailed in the announcement, the company linked these efforts to its ability to strengthen its balance sheet and meet Nasdaq’s stockholders’ equity requirement.
Together, the Talicia collaboration and internal efficiency focus helped create the conditions for RedHill Biopharma Nasdaq compliance to be restored, while also supporting the broader strategy of concentrating resources on core therapeutic areas.
RedHill’s specialty focus: GI, infectious disease and oncology
RedHill describes itself as a specialty biopharmaceutical company primarily focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases and oncology, with a strong emphasis on the U.S. market.
Talicia remains a cornerstone of its commercial portfolio. The prescription therapy targets H. pylori infection in adults, a gastrointestinal condition that can lead to serious complications if untreated. The co‑commercialization deal with Cumberland aims to enhance U.S. market penetration by leveraging both companies’ commercial infrastructures.
Beyond Talicia, RedHill’s pipeline includes several late‑stage development programs that the company believes can add value over time if they progress successfully through clinical and regulatory milestones. These programs form a key part of the narrative around RedHill Biopharma Nasdaq compliance, as future revenue potential is closely tied to their outcomes.
Opaganib (ABC294640)
Opaganib is described as a first‑in‑class, orally administered, sphingosine kinase‑2 (SPHK2) selective inhibitor with anti‑inflammatory, antiviral and anticancer activity. RedHill is targeting multiple indications for this candidate, including:
- Development for radiation and chemical exposure conditions such as gastrointestinal acute radiation syndrome (GI‑ARS), in collaboration with U.S. government and academic partners.
- A Phase 2/3 program in hospitalized COVID‑19 patients.
- A Phase 2 study in prostate cancer in combination with darolutamide.
These varied programs underscore RedHill’s intention to position opaganib across several high‑need areas, though all remain subject to clinical and regulatory risk.
RHB‑204
RHB‑204 is a next‑generation optimized formulation of RHB‑104. The company plans a Phase 2 study in Crohn’s disease, drawing on positive Phase 3 results previously reported for RHB‑104 in that indication. RHB‑204 is also at a Phase 3 stage for pulmonary nontuberculous mycobacteria (NTM) disease.
Success in either or both areas could expand RedHill’s footprint in chronic gastrointestinal and infectious conditions. These development efforts are part of the foundation that supports longer‑term value behind RedHill Biopharma Nasdaq compliance.
RHB‑102
RHB‑102 has shown positive results in several settings, including:
- A U.S. Phase 3 study for acute gastroenteritis and gastritis.
- A U.S. Phase 2 study for irritable bowel syndrome with diarrhea (IBS‑D).
The candidate also has potential for a United Kingdom submission in chemotherapy‑ and radiotherapy‑induced nausea and vomiting. Outside North America, RHB‑102 is partnered with Hyloris Pharma for worldwide development and commercialization.
RHB‑107 (upamostat)
RHB‑107 (upamostat) is an oral, broad‑acting, host‑directed serine protease inhibitor that RedHill positions as having potential relevance for pandemic preparedness.
The program is in late‑stage development as a treatment for non‑hospitalized symptomatic COVID‑19, and is also being explored for multiple other cancer and inflammatory gastrointestinal diseases.
Collectively, these late‑stage assets help explain why maintaining RedHill Biopharma Nasdaq compliance is strategically important: the exchange listing offers a platform from which to support ongoing development and eventual commercialization if the candidates succeed.
Advisory support during the compliance process
RedHill noted that it was advised by Donohoe Advisory during the process of addressing Nasdaq’s stockholders’ equity requirement.
Engaging specialized advisory support is common practice for companies navigating exchange listing standards, as it can help align corporate actions, disclosure and timing with regulatory expectations. For RedHill, that guidance contributed to the successful outcome that saw RedHill Biopharma Nasdaq compliance restored in late November.
Forward‑looking risks around RedHill Biopharma Nasdaq compliance
While the confirmation of RedHill Biopharma Nasdaq compliance is a positive milestone, the company emphasized in its forward‑looking statements that significant risks remain.
RedHill highlighted the possibility that it may not be able to maintain ongoing compliance with Nasdaq listing requirements, including the minimum stockholders’ equity standard. It also cautioned that the strategic transaction with Cumberland may not deliver the expected benefits to the Talicia business, the company’s financial position or its broader objectives.
The company noted that new revenue‑generating products or out‑licensing deals may not materialize, and that U.S. government funding for research and development — including support for programs such as opaganib — is both uncertain and subject to change. Acceptance into government or non‑government product development pipelines does not guarantee continued development or success.
Regulatory risks are another key element. RedHill acknowledged that the U.S. Food and Drug Administration may not agree with its proposed development plans. Clinical and pre‑clinical studies may fail or produce results insufficient for regulatory submissions, including emergency or marketing applications, and additional trials may be required.
On the commercial side, the company faces uncertainty over its ability to successfully launch, promote and gain market acceptance for Talicia and any future approved products. It must also secure and manage corporate collaborations, acquire additional marketed products that achieve commercial success, and build out its marketing and commercialization capabilities.
Other risks mentioned include the scope and strength of intellectual property protection, potential defaults by licensing partners, the need for additional financing, competitive pressures across therapeutic areas, and the ability to recruit and retain executive leadership.
RedHill directed investors to its filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 20‑F, for a more complete discussion of these and other risks that could affect forward‑looking statements.
Outlook after restoring RedHill Biopharma Nasdaq compliance
With RedHill Biopharma Nasdaq compliance restored, the company enters the next phase of its 2025 strategy with its U.S. listing intact and a clearer path to pursue its commercial and clinical priorities.
Maintaining compliance will depend on how effectively RedHill executes its Talicia co‑commercialization with Cumberland, manages operational efficiency, and advances its late‑stage pipeline in gastrointestinal, infectious and oncology indications.
For investors and partners, the Nasdaq confirmation underscores that the company has met a key financial benchmark, even as its future remains tied to the performance of its assets and its ability to navigate regulatory, commercial and funding challenges.
As RedHill continues to develop and commercialize its portfolio, RedHill Biopharma Nasdaq compliance serves as both a validation of recent efforts and a reminder of the ongoing work required to sustain its position on a major U.S. exchange.
