For example, the Inflation Reduction Act of 2022 (IRA), among other things, (i) directs the U.S. Department of Health and Human Services (HHS) to negotiate the price of certain high-expenditure, single-source biologics that have been on the market for at least 11 years covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs and biologics under the law (the Medicare Drug Price Negotiation Program), and (ii) imposes rebates with respect to certain drugs and biologics covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation.
All entries for: Immune Diseases
November 12, 2025
Artiva Biotherapeutics, Inc.
Neutral Outlook
San Diego, California,
51-200 employees
Disease Area: Immune Diseases
Drug Type: Biologic
November 12, 2025
CalciMedica, Inc.
Neutral Outlook
La Jolla, California
1-50 employees
For example, the Inflation Reduction Act (IRA) passed by Congress authorizes the Secretary of the Department of HHS to negotiate prices directly with participating manufacturers for selected medicines covered by Medicare even if these medicines are protected by an existing patent. For small molecule medicines, the process begins seven years after initial approval by the FDA. While we do not believe that the IRA or its effects will impact our ability to obtain patents in the near future, we cannot be certain whether it will affect our patent strategy in the long run.
Disease Area: Chronic Disease, Gastrointestinal, Immune Diseases, Multiple, Respiratory Diseases
Drug Type: Biologic, Small Molecule
November 12, 2025
Zenas Biopharma
Neutral Outlook
Waltham, MA
51-200 employees
Notably, the Inflation Reduction Act of 2022 (the “IRA”) includes a number of healthcare reform provisions, which have varying implementation dates. The IRA extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025
Disease Area: Chronic Disease, Immune Diseases, Neurological Diseases
Drug Type: Biologic
November 10, 2025
Nkarta, Inc.
Neutral Outlook
South San Francisco, California
51-200 employees
Most significantly, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law. The IRA includes provisions that will, among others: (i) direct CMS to negotiate the price of certain single-source prescription drugs reimbursed under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law; (ii) impose requirements on drug manufacturers to provide rebates to CMS under Medicare Part B and Medicare Part D as a penalty for price
Disease Area: Chronic Disease, Immune Diseases
Drug Type: Biologic
November 5, 2025
Vor Biopharma Inc Cambridge
Neutral Outlook
Cambridge, MA
51-200 employees
The Inflation Reduction Act of 2022, or 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 creating a new manufacturer discount program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. We cannot predict the ultimate content, timing or effect of any such challenges or changes to the ACA or other federal and state reform efforts.
Disease Area: Hematology, Immune Diseases, Multiple
Drug Type: Biologic
November 5, 2025
Merck
Neutral Outlook
Rahway, NJ
10,001-50,000 employees
In 2022, the U.S. Congress passed the Inflation Reduction Act (IRA), which made significant changes to how drugs are covered and paid for under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits (which has taken effect in 2025), and government price-setting for certain Medicare Part D drugs (starting in 2026) and Medicare Part B drugs (starting in 2028).
Disease Area: Antiviral, Cardiology, Immune Diseases, Multiple, Neurological Diseases, Oncology
Drug Type: Biologic, Small Molecule
November 5, 2025
Vir Biotechnology, Inc
Neutral Outlook
San Francisco, CA
201-500 employees
It is currently unclear how certain new measures, including the drug pricing provisions of the Inflation Reduction Act of 2022 (and subsequent rulemaking) and changes to Medicaid eligibility requirements in the OBBBA, will ultimately be effectuated. Accordingly, we cannot predict with certainty what impact these or any other federal or state health reforms will have on us, including whether finalized rules will be implemented or withstand judicial review.
Disease Area: Antiviral, Chronic Disease, Immune Diseases, Infectious Diseases, Oncology
Drug Type: Biologic
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 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 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