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RedHill Announces Transformational Acquisition of Commercialization Rights to Ferring’s Rebyota® and Clenpiq®

(Very High)
(Very Positive)

RedHill Biopharma (Nasdaq: RDHL) announced a transformational deal with Ferring Pharmaceuticals, acquiring exclusive global commercialization rights to Rebyota and exclusive U.S. rights to Clenpiq. According to RedHill, the products generated approximately $37.5 million in U.S. net sales in 2025 ($16.9 million Rebyota, $20.6 million Clenpiq).

Under the agreement, RedHill pays Ferring a $12 million upfront fee, fully funded from the previously announced $18 million Talicia divestiture, plus potential milestones and tiered royalties. Ferring retains Rebyota manufacturing and will supply product for the agreement term. Rebyota, FDA-approved in 2022 and Health Canada-approved in 2025, has Breakthrough Therapy and Orphan Drug designations with protections that could run to 2036. Clenpiq is a ready-to-drink, low‑volume bowel preparation with 2025 U.S. net sales of $20.6 million and broad payer coverage. The transaction is positioned by RedHill as completing a major strategic repositioning of its commercial gastrointestinal business.

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Positive

  • $12 million upfront secures exclusive global Rebyota and U.S. Clenpiq rights
  • Acquired products generated about $37.5 million U.S. net sales in 2025
  • Upfront payment fully funded from prior $18 million Talicia divestiture
  • Rebyota benefits from regulatory and patent protections potentially through 2036

Negative

  • Agreement includes ongoing tiered royalties and potential milestone payments to Ferring

Market reaction after GI commercialization rights acquisition: RDHL -3.32%

-3.32% $0.87
15m delay
-3.32% Vs previous close
$0.87 Last Price
$0.75 $0.99 Day Range
$5.29M Market Cap
0.1x Rel. Volume

Following this news, RDHL has declined 3.32%, reflecting a moderate negative market reaction. Our momentum scanner has triggered 21 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $0.87.

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Market Context

The stock is dropping -15.5% following this news. 21.56% was RDHL’s 24-hour decline after its June 9...
Analysis

The stock is dropping -15.5% following this news. 21.56% was RDHL’s 24-hour decline after its June 9 designation announcement, showing that positive corporate news had not always aligned with trading outcomes. The active F-3 is a resale registration, and insider data showed Net Selling.

Key Figures

Combined 2025 net sales: $37.5 million Upfront rights payment: $12 million Talicia divestment: $18 million +5 more
8 metrics
Combined 2025 net sales $37.5 million Rebyota and Clenpiq combined
Upfront rights payment $12 million Paid to Ferring under the commercialization agreement
Talicia divestment $18 million Cash upfront from previously announced divestiture
Potential divestiture milestones $35 million Potential worldwide net sales milestone payments
Rebyota 2025 net sales $16.9 million U.S. net sales
Clenpiq 2025 net sales $20.6 million U.S. net sales
rCDI prevention success rate More than 70% Rebyota prevention of recurrent C. diff infection
U.S. payer coverage 93% of lives Rebyota coverage including 43% after first recurrence

Historical Context

5 past events · Latest: Aug 31 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Aug 31 Talicia divestiture Positive +36.2% Divestiture generated upfront cash and potential milestones to fund commercial expansion.
Jul 28 Ebola development update Positive +4.3% Opaganib development update accompanied by Ebola outbreak and clinical data disclosures.
Jun 22 Private placement closing Negative +10.2% Private placement provided liquidity but introduced potential warrant-related dilution.
Jun 18 Private placement announcement Negative +3.7% Proposed equity and warrant financing was intended to support acquisition and working capital.
Jun 09 FDA designation Positive -21.6% FDA granted rare pediatric disease designation to opaganib for neuroblastoma.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

RDHL aligned with positive strategic and operational news in two recent events but diverged from positive news in three others.

Key Terms

fecal microbiota transplant, breakthrough therapy, orphan drug designation, tiered royalties
4 terms
fecal microbiota transplant medical
"FDA-approved Fecal Microbiota Transplant (FMT for prevention of recurrent C. diff"
A fecal microbiota transplant is a medical procedure that transfers processed stool from a healthy donor into a patient’s gut to restore a balanced community of microorganisms. It matters to investors because it is an emerging therapeutic approach with clinical and regulatory implications, manufacturing and safety considerations, and potential commercial markets tied to specific indications and approved delivery methods.
breakthrough therapy regulatory
"Rebyota, was granted a Breakthrough Therapy and received Orphan Drug designations"
A breakthrough therapy is a regulatory designation granted to an experimental drug or treatment when early clinical evidence indicates it could offer a substantial improvement over existing options for a serious or life‑threatening condition. For investors it matters because the label brings faster, more intensive interaction with regulators and can shorten development and review time—like a VIP fast‑track toward potential approval, reducing time and risk before a product can reach the market.
orphan drug designation regulatory
"received Orphan Drug designations and generated approximately $16.9 million"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
tiered royalties financial
"plus tiered royalties on net sales and potential milestones"
Tiered royalties are a payment structure where the percentage of earnings paid as royalties changes based on different levels of sales or production. For example, a company might pay a smaller percentage on initial sales and a higher percentage as sales increase beyond certain points. This system encourages higher sales by adjusting payments, making it important for investors to understand how revenue sharing may vary as a product or project grows.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Redhill Biopharma Ltd.

Together with the previously announced Talicia strategic divestiture, the acquisition from Ferring of commercialization rights to two larger, proprietary, established gastrointestinal (GI) FDA-approved drugs that together generated approximately $37.5 million in 2025 net sales, completes a major strategic repositioning of RedHill’s commercial GI business

The divestiture of Talicia and the acquisition of the new GI products from Ferring create a catalyst for commercial growth through a materially larger GI business under RedHill’s control, with a significantly stronger liquidity position and provides additional growth and expansion opportunities

Under the terms of the agreement, RedHill obtained the exclusive commercialization rights for an upfront payment to Ferring of $12 million plus potential future milestones and tiered royalties

The $12 million upfront payment is fully funded through the previously announced $18 million Talicia divestment, with RedHill securing exclusive global and U.S. commercialization rights to Ferring’s Rebyota and Clenpiq, respectively - two synergistic, revenue-generating, FDA-approved GI drugs

Rebyota is a proprietary, first and only single-dose FDA-approved Fecal Microbiota Transplant (FMT for prevention of recurrent C. diff infection (rCDI). FDA-approved in 2022 and Health Canada-approved in 2025, Rebyota, was granted a Breakthrough Therapy and received Orphan Drug designations and generated approximately $16.9 million in 2025 U.S. net sales

Proprietary Clenpiq, a ready-to-use (no mixing required) low-volume bowel preparation on the U.S. market, generated $20.6 million in U.S. 2025 net sales with minimal promotion

RALEIGH, N.C., Sept. 01, 2026 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced the transformational acquisition of exclusive global and U.S. commercialization rights to Rebyota and Clenpiq, from Ferring Pharmaceuticals (“Ferring”), as part of Ferring’s ongoing strategic refocusing.

Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “We have executed a clear strategic sequence. We have monetized Talicia for $18 million cash upfront, plus $35 million in potential upside, used $12 million to secure commercialization rights to two established, proprietary, FDA-approved gastrointestinal drugs, that collectively generated approximately $37.5 million in U.S. net sales in 2025, and emerged with a materially larger, fully controlled commercial business and a stronger liquidity position. Rebyota and Clenpiq are expected to generate a positive cash contribution to RedHill. This, combined with RedHill’s experienced and lean commercial team and proven development capabilities, creates a scalable foundation for further growth, including additional acquisition of complementary revenue-generating products.”

Mr. Ben-Asher added: “We thank Ferring for a smooth process to date and look forward to a successful collaboration.”

Under the terms of the agreement, RedHill obtained an exclusive global commercialization license of Rebyota and an exclusive U.S. commercialization license of Clenpiq, for an upfront payment to Ferring of $12 million, plus tiered royalties on net sales and potential milestones. Ferring retains its Rebyota manufacturing facilities, and Ferring will continue to supply Rebyota through the term of the agreement.

“Rebyota is a first-in-class microbiota-based therapy for prevention of recurrent Clostridioides difficile (C. diff) infection (rCDI) in individuals 18 years of age and older following antibiotic treatment for rCDI. FDA-approved in 2022, it generated approximately $16.9 million in U.S. net sales in 2025 through its clinical profile, broad coverage and an established customer base of approximately 600 active accounts,” said Rick Scruggs, RedHill’s Chief Commercial Officer. “Clenpiq, a ready-to-drink low-volume bowel preparation on the U.S. market, delivered $20.6 million in net sales in 2025, with minimal promotion. Together the two assets give RedHill a significantly stronger commercial growth engine in both the U.S. and other new territories.”

C. diff (CDI) infection is a distressing and life-threatening condition – in developed countries it is the most common cause of healthcare-associated (HA) diarrhea. An estimated 3.6 million cases of CDI occur globally each year, including approximately half a million cases in the U.S. 30,000 Americans die every year due to CDI, with a global mortality rate of 1-in-10, rising to almost 1-in-3 in high-risk settings1. In the U.S., up to approximately 165,000 CDI cases result in one or more recurrences, indicating the need for use of prevention strategies.

Rebyota’s one-time administration, which requires no fasting, bowel prep or extended treatment timeframe, has demonstrated more than a 70% success rate at preventing rCDI. An aging population and accompanying increasing hospital-acquired vulnerabilities will likely increase this need. A streamlined ordering and reimbursement process is already in place for physicians, and broad and improving U.S. payer coverage means that 93% of lives have coverage including 43% with coverage after 1st recurrence.

Rebyota, which was granted, Breakthrough Therapy and Orphan Drug designations - with exclusivities and other patent protections that could run to 2036, provides multiple growth opportunities, including recent approval in Canada. The existing approvals also provide the potential for additional approvals in other territories.

Colonoscopy is the cornerstone of GI practice, with more than 15 million colonoscopies performed in the U.S. annually. This number is rising, with follow-up needed after noninvasive screening tests that yield a positive result, an aging population, and guidelines that recommend testing at age 45 instead of age 50, contributing to an increased need for colonoscopy. Bowel preparation is not a pleasant process and is often poorly performed.

Clenpiq is a ready-to-drink low-volume bowel prep. Clenpiq is readily available to patients and has broad commercial and government payer coverage: More than 108 million lives (63%) with unrestricted (no prior approval) have commercial coverage, including 57 million (33%) with preferred position. 23m lives (41%) of Medicare Part D lives have unrestricted access to Clenpiq, including 12m (21%) lives with preferred position5.

RedHill was advised by Morningstar Law Group and Greenberg Traurig LLP on this transaction.

About RedHill Biopharma  
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal therapies Rebyota, for the prevention of recurrent C. diff infection (rCDI), and the bowel preparation treatment, Clenpiq. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with a track record of U.S. government and academic collaborations intended for medical countermeasure development including for EVD, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-102 (Bekinda), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.

More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.

Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the divestment of Talicia and the potential use of the proceeds of such sale; the expected benefits of the acquisition of commercialization rights to Rebyota and Clenpiq, the anticipated commercial growth and cash contribution from these products, expectations regarding market share growth, anticipated payer coverage, the Company’s strategic repositioning and path to operational profitability, potential use of milestone and royalty payments, and the Company’s ability to successfully commercialize Rebyota and Clenpiq. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements

[i] Akorful RAA, Odoom A, Awere-Duodu A, Donkor ES. The Global Burden of Clostridioides difficile Infections, 2016-2024: A Systematic Review and Meta-Analysis. Infect Dis Rep. 2025 Apr 14;17(2):31. doi: 10.3390/idr17020031. PMID: 40277958; PMCID: PMC12026862.
[ii] Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, Farley MM, Holzbauer SM, Meek JI, Phipps EC, Wilson LE, Winston LG, Cohen JA, Limbago BM, Fridkin SK, Gerding DN, McDonald LC. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Feb 26;372(9):825-34. doi: 10.1056/NEJMoa1408913. PMID: 25714160; PMCID: PMC10966662.
[iii] Feuerstadt P, Theriault N, Tillotson G. The burden of CDI in the United States: a multifactorial challenge. BMC Infect Dis. 2023 Mar 7;23(1):132. doi: 10.1186/s12879-023-08096-0. PMID: 36882700; PMCID: PMC9990004.
[iv] Khanna S, Assi M, Lee C, et al. Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrent Clostridioides difficile infection. Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x.
[v] Data on file. Ferring Pharmaceuticals
[vi] MarketScan Commercial Claims and Encounters and Medicare Supplemental database

Contact

Chief Corporate and BD Officer
Adi Frish
RedHill Biopharma
adi@redhillbio.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b4f73c57-9f49-4c60-8d50-4abafd908297


FAQ

What did RedHill Biopharma (NASDAQ: RDHL) acquire from Ferring in September 2026?

RedHill acquired exclusive global commercialization rights to Rebyota and exclusive U.S. commercialization rights to Clenpiq from Ferring. According to RedHill, the deal supports a strategic repositioning of its gastrointestinal portfolio and expands its control over two FDA-approved, revenue-generating GI therapies.

How much 2025 net sales did Rebyota and Clenpiq generate before RedHill’s acquisition (RDHL)?

According to RedHill, Rebyota and Clenpiq together generated approximately $37.5 million in U.S. net sales in 2025. Rebyota contributed about $16.9 million, while Clenpiq delivered about $20.6 million, providing an established commercial base for RedHill’s expanded GI business.

How is RedHill funding the $12 million upfront payment for Rebyota and Clenpiq rights (RDHL)?

RedHill is funding the $12 million upfront payment entirely from its previously announced $18 million Talicia divestiture. According to RedHill, this redeploys proceeds from Talicia into acquiring two larger, established GI products without requiring additional external financing for the upfront cost.

What are the main terms of RedHill’s commercialization agreement with Ferring for Rebyota and Clenpiq?

RedHill obtained an exclusive global commercialization license for Rebyota and exclusive U.S. rights for Clenpiq. According to RedHill, the agreement includes a $12 million upfront payment, tiered royalties on net sales, potential milestone payments, while Ferring retains Rebyota manufacturing and supplies product for the agreement term.

What is Rebyota and what exclusivity does it have according to RedHill Biopharma (RDHL)?

Rebyota is a single-dose fecal microbiota therapy approved to prevent recurrent C. diff infection in adults. According to RedHill, it holds Breakthrough Therapy and Orphan Drug designations, with regulatory and patent protections that could extend to 2036, alongside approvals in the U.S. and Canada.

What is Clenpiq and how does it support RedHill’s GI portfolio (RDHL)?

Clenpiq is a ready-to-drink, low-volume bowel preparation used before colonoscopy procedures. According to RedHill, Clenpiq generated $20.6 million in U.S. net sales in 2025 with minimal promotion and has broad commercial and government payer coverage, strengthening RedHill’s commercial GI franchise.