…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.
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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
Theravance Biopharma, Inc.
Neutral Outlook
South San Francisco, California
201-500 employees
The Inflation Reduction Act of 2022 (the “IRA”) and was replaced with a new manufacturer discount program), rules regarding prescription drug benefits under the health insurance exchanges, changes to the Medicare Drug Rebate program, expansion of the Public Health Service Act’s 340B drug pricing program, fraud and abuse and enforcement. These changes have impacted previously existing government healthcare programs and have resulted in the development of new programs, including Medicare payment for performance initiatives and improvements to the physician quality reporting system and feedback program. However, the transition to a new US presidential administration could impact the policy priorities relating to healthcare programs and we are unable to precisely predict what actions the new administration will take.
Disease Area: Respiratory
Drug Type: 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
Lyra Therapeutics, Inc.
Neutral Outlook
Watertown, Massachusetts
51-200 employees
In August 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. The IRA includes several provisions that may impact our business to varying degrees, including provisions that establish a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on many drugs reimbursed under Medicare Part D, 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, and require companies to pay rebates to Medicare for drug prices that increase faster than inflation (first due in 2023). The IRA permits the Secretary of the Department of Health and Human Services (“HHS”) to implement many of these provisions through guidance, as opposed to regulation, for the initial years.
Disease Area: Respiratory
Drug Type: 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 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
Zentalis Pharmaceuticals, Inc
Neutral Outlook
San Diego, CA
51-200 employees
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, 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); redesigns the Medicare Part D benefit (beginning in 2024); and replaces the Part D coverage gap discount program with a new manufacturer discount program (beginning in 2025). CMS has published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and has published the list of the subsequent 15 drugs that will be subject to negotiation
Disease Area: Oncology
Drug Type: Small Molecule