As an example, of changes enacted by a new administration, the Inflation Reduction Act, or the IRA, was signed into law in August 2022 by President Biden, which makes 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, and government price-setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028.
All entries for: Biologic
November 6, 2025
Neumora Therapeutics, Inc.
Neutral Outlook
Waltham, Massachusetts,
51-200 employees
On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (the “IRA”) into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. It is unclear how other healthcare reform measures of the Trump administration or other efforts, if any, to challenge, repeal or replace the ACA, will impact our business.
Disease Area: Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
November 6, 2025
SUTRO BIOPHARMA, INC.
Neutral Outlook
South San Francisco, CA
201-500 employees
For example, the Inflation Reduction Act, or IRA, passed by Congress authorizes the Secretary of the U.S. Department of Health and Human Services, or HHS, to negotiate prices directly with participating manufacturers for selected medicines reimbursed by Medicare Part B or Part D even if these medicines are protected by an existing patent. In addition, we may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
Disease Area: Oncology, Rare Diseases
Drug Type: Biologic, Small Molecule
November 6, 2025
Janux Therapeutics, Inc
Neutral Outlook
San Diego, CA
51-200 employees
For example, on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law, which 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. It is also unclear how any additional healthcare reform measures of the second Trump administration will impact the Affordable Care Act or our business.
Disease Area: Oncology
Drug Type: Biologic
November 6, 2025
Sana Biotechnology, Inc.
Neutral Outlook
Seattle, Washington
51-200 employees
For example, the Inflation Reduction Act (IRA) authorizes the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for selected medicines covered by Medicare even if these medicines are protected by an existing patent. 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 and to what extent it will affect our longer-term patent strategy or our business.
Disease Area: Multiple
Drug Type: Biologic
November 6, 2025
Immunome Inc.
Negative Outlook
Bothell, WA
201-500 employees
the Inflation Reduction Act of 2022, or the 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. The uncertainty around the future of the ACA and other health reform measures, and in particular the impact to reimbursement levels, may lead to uncertainty or delay in the purchasing decisions of our customers, which may in turn negatively impact our product sales.
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 6, 2025
Collegium Pharmaceutical, Inc.
Negative Outlook
Stoughton, MA
201-500 employees
We expect that additional changes to the Affordable Care Act, the Medicare and Medicaid programs, changes in the Inflation Reduction Act of 2022 that allow the federal government to directly negotiate drug prices, and changes stemming from other healthcare reform measures, including any new regulatory measures proposed or implemented by the Trump Administration, especially with regard to healthcare access and cost, as well as other legislation in individual states, could have a material adverse effect on the healthcare industry.
Disease Area: Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
November 6, 2025
Entrada Therapeutics
Neutral Outlook
Boston, MA
51-200 employees
The Inflation Reduction Act of 2022 (the “IRA”) includes several provisions that may impact our business to varying degrees, including provisions that create a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on all drugs in 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, require companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay the rebate rule that would limit the fees that pharmacy benefit managers can charge.
Disease Area: Metabolic Diseases, Multiple, Neurological Diseases, Rare Diseases
Drug Type: Biologic
November 6, 2025
Cidara Therapeutics, Inc.
Neutral Outlook
San Diego, CA
1-50 employees
For example, on August 16, 2022, 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 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: Infectious Diseases, Oncology, Respiratory Diseases
Drug Type: Biologic
November 6, 2025
Whitehawk Therapeutics
Neutral Outlook
Morristown, NJ
1-50 employees
In August 2022, Congress passed the Inflation Reduction Act of 2022 (the “Inflation Reduction Act”), which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs
Disease Area: Oncology
Drug Type: Biologic