…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.
All entries for: Oncology
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
November 7, 2025
GERON CORP
Negative Outlook
Foster City, CA
51-200 employees
The Inflation Reduction Act of 2022 includes several provisions to lower prescription drug costs for people with Medicare and reduce drug spending by the federal government, including the Medicare Drug Price Negotiation Program, which may ultimately have a negative effect on the pricing for RYTELO.
Disease Area: Hematology, Multiple, Oncology
Drug Type: Small Molecule
November 6, 2025
IOVANCE BIOTHERAPEUTICS, INC
Neutral Outlook
San Carlos, California
501-1,000 employees
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.
Disease Area: Oncology
Drug Type: Biologic
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
OnKure Therapeutics, Inc.
Neutral Outlook
Boulder, CO
1-50 employees
In August 2022, Congress passed the Inflation Reduction Act of 2022 (the “IRA”), which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including among other changes allowing the federal government to negotiate a maximum fair price for certain high-priced single-source Medicare drugs, imposing penalties and excise taxes for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries.
Disease Area: Oncology
Drug Type: Small Molecule
November 6, 2025
Immunome Inc.
Negative Outlook
Bothell, WA
51-200 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
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