Thus, while it is unclear how the IRA will be implemented, it will likely have a significant impact on the pharmaceutical industry.
All entries for: Biologic
November 4, 2025
Biocryst Pharmaceuticals
Negative Outlook
Durham, NC
501-1,000 employees
The full effect of the IRA on our business and the healthcare industry in general is not yet known. The IRA or other government efforts to reduce the price of prescription drugs or to limit the amount that governments pay for healthcare products and services could result in additional pricing pressure and have a significant impact on our business.
Disease Area: Rare Diseases
Drug Type: Biologic, Small Molecule
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
Vertex Pharmaceuticals
Neutral Outlook
Providence, RI
5,001-10,000 employees
We cannot, however, predict how changes in the law, including through the Inflation Reduction Act of 2022 and passage of state laws (e.g., transparency laws and prescription drug affordability boards), will affect our ability to negotiate successfully with third-party payors and distribute our products.
Disease Area: Endocrinology, Hematology, Multiple, Rare Diseases, Respiratory Diseases
Drug Type: Biologic, Small Molecule
November 3, 2025
Solid Biosciences Inc.
Negative Outlook
Boston, MA
51-200 employees
Accordingly, while it is currently unclear how the IRA will be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition.
Disease Area: Cardiology, Multiple, Neurological Diseases, Rare Diseases
Drug Type: Biologic
November 3, 2025
Precision BioSciences
Neutral Outlook
Durham, NC
51-200 employees
Most recently, on August 16, 2022, the Inflation Reduction Act of 2022 (the “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: Chronic Disease, Immune Diseases, Rare Diseases
Drug Type: Biologic
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
Bristol Myers Squibb Princeton
Negative Outlook
Princeton, NJ
10,000+ 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
October 30, 2025
Vanda Pharmaceuticals
Neutral Outlook
Washington DC
201-500 employees
Prior to January 1, 2025, the Medicare Part D prescription drug benefit required manufacturers to fund approximately 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients for applicable drugs. We account for the Medicare Part D coverage gap using a point of sale model. Estimates for expected Medicare Part D rebates are based, in part, on historical activity and, where available, actual and pending prescriptions when we have validated the insurance benefits.
Disease Area: Dermatology, Gastrointestinal, Multiple, Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule