On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (the IRA) into law. This statute marks the most significant action by Congress with respect to the pharmaceutical industry since adoption of the ACA in 2010. Among other things, the IRA (i) directs the Department of Health and Human Services (HHS) to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare; (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation; (iii) reduces the out-of-pocket cap for Medicare Part D beneficiaries to $2,000 starting in 2025.
All entries for: Biologic
November 12, 2025
TScan Therapeutics, Inc.
Neutral Outlook
Cambridge, Massachusetts
51-200 employees
…the Inflation Reduction Act that creates a distinction between small molecule and large molecule products for purposes of determining when a drug may be eligible for drug price negotiation.
Disease Area: Oncology
Drug Type: Biologic
November 12, 2025
Artiva Biotherapeutics, Inc.
Neutral Outlook
San Diego, California,
51-200 employees
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.
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
Acurx Pharmaceuticals, Inc.
Neutral Outlook
Waltham, MA
201-500 employees
In August 2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law. The IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. Starting in 2023, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the drug product’s price increases faster than the rate of inflation.
Disease Area: Multiple, Neurological Diseases, Rare Diseases
Drug Type: Biologic
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 12, 2025
Kalaris Therapeutics
Negative Outlook
Palo Alto, CA
1-50 employees
Further, with the passage of the Inflation Reduction Act (the “IRA”) in August 2022, Congress extended the expansion of ACA premium tax credits through 2025. These and other laws may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our products or product candidates for which we may obtain regulatory approval or the frequency with which any such product is prescribed or used.
Disease Area: Chronic Disease, Multiple, Neurological Diseases, Rare Diseases
Drug Type: Biologic
November 10, 2025
Bicara Therapeutics Inc. Bridgewater
Negative Outlook
" Bridgewater, NJ"
1,001-5,000 employees
For example, the Inflation Reduction Act of 2022 (the “IRA”) includes several provisions that will impact our business to varying degrees, including provisions that allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic or biosimilar competition, among others. Our lead candidate ficerafusp alfa is being developed in indications that may rely heavily on Medicare reimbursement.
Disease Area: Oncology
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 10, 2025
uniQure N.V.
Neutral Outlook
Amsterdam, Netherlands
51-200 employees
Most recently, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”), was signed into law. Among other things, the IRA requires manufacturers of certain high-Medicare spend drugs to engage in price negotiations with Medicare (with the maximum fair prices for the first year of the negotiation program being initially applicable in 2026), with prices that can be negotiated subject to a cap; imposes rebates for certain drugs 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: Rare Diseases
Drug Type: Biologic