The imposition of a “maximum fair price” under the IRA could limit the amounts that federal and state governments will pay for our products and prevent us from being able to generate revenue sufficient to cover our costs or attain profitability.
All entries for: Oncology
March 19, 2026
Galera Therapeutics, Inc.
Neutral Outlook
Malvern, PA
1-50 employees
Biden signed into law the Inflation Reduction Act (IRA), which implements substantial changes to the Medicare program, including drug pricing reforms and changes to the Medicare Part D benefit design. Among other reforms, the IRA imposes inflation rebates on drug and biological product manufacturers for products reimbursed under Medicare Parts B and D if the prices of those products increase faster than inflation; implements changes to the Medicare Part D benefit that cap benefit annual out-of-pocket spending at $2,000 (adjusted annually for inflation), with new discount obligations for pharmaceutical manufacturers; and establishes a “maximum fair price” for a fixed number of pharmaceutical and biological products covered under Medicare Parts B and D following a price negotiation process with the Centers for Medicare and Medicaid Services (CMS).
Disease Area: Oncology
Drug Type: Small Molecule
March 18, 2026
Moleculin Biotech
Neutral Outlook
Houston, TX
1-50 employees
Further, the Inflation Reduction Act (IRA), among other things, (1) directs HHS to negotiate the price of certain high-cost, single-source drugs and biologics covered under Medicare and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. Under the IRA, certain categories of drugs are excluded from price negotiations, including drugs that receive orphan drug designation as the only FDA-approved indication.
Disease Area: Hematology, Oncology
Drug Type: Small Molecule
March 18, 2026
Estrella Immunopharma
Neutral Outlook
Emeryville, CA
1-50 employees
Since its enactment, there have been judicial, congressional and executive branch challenges and amendments to certain aspects of the ACA. For example, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of pocket cost and through a newly established manufacturer discount program.
Disease Area: Immune Diseases, Oncology
Drug Type: Biologic
March 18, 2026
Processa Pharmaceuticals
Neutral Outlook
Vero Beach, FL
1-50 employees
Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (“IRA”) into law, which among other things, extended enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.
Disease Area: Gastrointestinal, Oncology
Drug Type: Small Molecule
March 18, 2026
Marker Therapeutics
Neutral Outlook
Houston, TX
1-50 employees
Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.
Disease Area: Hematology, Oncology
Drug Type: Biologic
March 17, 2026
Indaptus Therapeutics
Neutral Outlook
New York, NY
1-50 employees
Most recently, the Inflation Reduction Act of 2022, or IRA, included a number of significant drug pricing reforms, which include the establishment of a drug price negotiation program within the U.S. Department of Health and Human Services, or HHS (beginning in 2026) that requires manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers under Medicare Parts B and D to penalize price increases that outpace inflation (first due in 2023), and a redesign of the Part D benefit, as part of which manufacturers are required to provide discounts on Part D drugs (beginning in 2025).
Disease Area: Immune Diseases, Oncology
Drug Type: Biologic
March 17, 2026
Silexion Therapeutics Corp
Negative Outlook
Jerusalem, Israel
1-50 employees
We expect to experience pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative changes like the Inflation Reduction Act.
Disease Area: Oncology
Drug Type: Biologic
March 16, 2026
Kyntra Bio
Negative Outlook
San Francisco, CA
1-50 employees
Among other things, the Inflation Reduction Act established Medicare drug price negotiation for selected products, inflation-based rebate obligations, and a redesign of the Medicare Part D benefit, including a manufacturer discount program that became effective January 1, 2025. In addition, the first negotiated Medicare prices became effective on January 1, 2026. These and other current or future healthcare reform measures may reduce the commercial opportunity for our products, increase our compliance burdens, or otherwise adversely affect our business, financial condition and results of operations.
Disease Area: Hematology, Oncology, Rare Diseases
Drug Type: Small Molecule