As a result, if we were to have one or more of our small molecule drugs approved by the FDA, under the IRA, we could be forced to sell our products at a lower price for CMS programs for several years earlier than would otherwise be the case. In addition, because this could result in lower future cash flows in those years, the valuation of the company could be negatively impacted.
All entries for: Oncology
November 4, 2025
Corvus Pharmaceuticals
Neutral Outlook
Burlingame, CA
51-200 employees
While the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.
Disease Area: Dermatology, Immune Diseases, Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 4, 2025
Werewolf Therapeutics
Negative Outlook
Watertown, MA
1-50 employees
Moreover, given the risk that could be the case, these provisions of the IRA may also further heighten the risk that we would not be able to achieve the expected return on our drug products or full value of our patents protecting our products if prices are set after such products have been on the market for nine years.
Disease Area: Oncology
Drug Type: Biologic
November 4, 2025
Rigel Pharmaceuticals Inc
Neutral Outlook
South San Francisco, CA
51-200 employees
While it remains to be seen how the drug pricing provisions imposed by the IRA will affect the broader pharmaceutical industry, several pharmaceutical manufacturers and other industry stakeholders have challenged the law, including through lawsuits brought against the DHHS, the Secretary of the DHHS, CMS, and the CMS Administrator challenging the constitutionality and administrative implementation of the IRA’s drug price negotiation provisions.
Disease Area: Hematology, Oncology
Drug Type: Small Molecule
November 3, 2025
Karyopharm Therapeutics
Neutral Outlook
Newton, MA
201-500 employees
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
Disease Area: Hematology, Multiple, Oncology
Drug Type: Small Molecule
November 3, 2025
Nuvation Bio Inc
Neutral Outlook
New York, NY
51-200 employees
For example, the Inflation Reduction Act of 2022 (“IRA”), among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act 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: Oncology
Drug Type: Small Molecule
October 31, 2025
Merus N.V.
Neutral Outlook
Utrecht
201-500 employees
Most recently, in August 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (which began in 2025).
Disease Area: Oncology
Drug Type: Biologic
October 30, 2025
Nuvalent Inc
Neutral Outlook
Cambridge, MA
51-200 employees
Further, with passage of the Inflation Reduction Act of 2022 (IRA) in August 2022, Congress authorized Medicare beginning in 2026 to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars. This provision is limited in terms of the number of pharmaceuticals whose prices can be negotiated in any given year and it only applies to drug products that have been approved for at least 9 years and biologics that have been licensed for 13 years.
Disease Area: Oncology
Drug Type: Small Molecule
October 30, 2025
Bicycle Therapeutics
Negative Outlook
Cambridge, MA
201-500 employees
Our results of operations could be adversely affected by the Patent Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, the Inflation Reduction Act of 2022, or the IRA, and by other healthcare legislative reforms that may be enacted or adopted in the future, particularly in light of the recent U.S. Presidential and Congressional elections. 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. The downward pressure on healthcare costs in general, particularly prescription drugs and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.
Disease Area: Cardiology, Multiple, Neurological Diseases, Oncology
Drug Type: Small Molecule
October 30, 2025
Bristol Myers Squibb Princeton
Negative Outlook
Princeton, NJ
10,001-50,000 employees
It is possible that more of our products could be selected in future years based upon the selection criteria currently utilized by the HHS or potentially expanded future criteria. This could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections. We continue to evaluate the impact of the IRA on our results of operations, and it is possible that these changes may result in a material impact on our business and results of operations.
Disease Area: Cardiology, Hematology, Immune Diseases, Multiple, Oncology
Drug Type: Biologic, Small Molecule