Legislative, administrative, and private payor efforts to control drug costs span a range of proposals, including drug price negotiation, Medicare Part D redesign, drug price inflation rebates, international mechanisms, generic drug promotion and anticompetitive behavior, manufacturer reporting, and reforms that could impact therapies utilizing the accelerated approval pathway. We cannot predict the ultimate content, timing or effect of any changes to the ACA, the Inflation Reduction Act, or other federal and state healthcare policy reform efforts including those aimed at drug pricing.
All entries for: Infectious Diseases
March 31, 2026
Tevogen Bio Holdings Inc
Neutral Outlook
Warren, NJ
51-200 employees
For example, the Inflation Reduction Act introduces several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs and a change in manufacturer liability under the program which could negatively affect the profitability of our product candidates. The IRA sunsets the current Part D coverage gap discount program starting in 2025 and replaces it with a new manufacturer discount program. Failure to pay a discount under this new program will be subject to a civil monetary penalty. In addition, the IRA established a Medicare Part B inflation rebate scheme effective January 2023 and a Medicare Part D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe rebates if the price of a Part B or Part D drug increases faster than the pace of inflation.
Disease Area: Infectious Diseases, Oncology
Drug Type: Multiple
March 30, 2026
60 Degrees Pharmaceuticals, Inc
Neutral Outlook
Washington, DC
1-50 employees
Future indications for Arakoda may justify higher pricing in principle, but cumulative health-care reforms inclusive of the IRA limit price increases and/or indication-based pricing without financial penalties if manufacturers’ products have Medicare coverage. The impact of these reforms on the pharmaceutical industry generally is in its infancy, and will depend on how or if they are implemented by regulators. We will monitor this issue to determine the effects of this legislation on our business – full implementation of the reforms may have a negative impact on maximizing the profitability, but the actual impact at this juncture is uncertain.
Disease Area: Infectious Diseases
Drug Type: Small Molecule
March 30, 2026
PDS Biotechnology Corp/NJ
Neutral Outlook
Princeton, NJ
51-200 employees
For that and other reasons, it is currently unclear how the IRA will be effectuated, and the impact of the IRA on the pharmaceutical industry cannot yet be fully determined.
Disease Area: Infectious Diseases, Oncology
Drug Type: Biologic
March 26, 2026
Spero Therapeutics
Neutral Outlook
Cambridge, MA
1-50 employees
Further, in August 2022, President Biden signed into the law the Inflation Reduction Act (“IRA”). Among other things, 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. A manufacturer of drugs covered by Medicare Parts B or D must now pay a rebate to the federal government if their drug product’s price increases faster than the rate of inflation. This calculation is made on a drug product by drug product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D.
Disease Area: Infectious Diseases, Rare Diseases
Drug Type: Biologic
March 23, 2026
Arbutus Biopharma Corp/PA
Negative Outlook
Warminster, PA
51-200 employees
The IRA also created a drug price negotiation program under which the prices for certain Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar competition are capped by reference to, among other things, a specified non-federal average manufacturer price starting in 2026. Failure to comply with requirements under the drug price negotiation program is subject to an excise tax and/or a civil monetary penalty. This or any other legislative change could impact the market conditions for our product candidates.
Disease Area: Antiviral, Infectious Diseases
Drug Type: Biologic
March 20, 2026
InflaRx N.V.
Neutral Outlook
Jena, Germany
51-200 employees
In 2022, the Inflation Reduction Act, or the IRA, was enacted, which, among other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms. Specifically, the IRA authorizes and directs the U.S. Department of Health and Human Services or the DHHS to set drug price caps for certain high-cost Medicare qualified drugs and the first year of maximum price applicability to begin in 2026. The IRA further authorizes the DHHS to penalize pharmaceutical manufacturers that increase the price of certain Medicare drugs faster than the rate of inflation. Finally, the IRA creates significant changes to certain Medicare benefits by capping certain beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025.
Disease Area: Chronic Disease, Immune Diseases, Infectious Diseases
Drug Type: Biologic, Small Molecule
March 19, 2026
XORTX Therapeutics
Neutral Outlook
Calgary, Canada
1-50 employees
The effect of Inflation Reduction Act of 2022 on our business and the pharmaceutical industry in general is not yet known.
Disease Area: Cardiovascular, Infectious Diseases, Rare Diseases
Drug Type: Small Molecule
March 19, 2026
Assembly Biosciences
Neutral Outlook
South San Francisco, CA
51-200 employees
For example, the Inflation Reduction Act of 2022 (IRA) enacted on August 16, 2022, seeks to reduce prescription drug costs by, among other provisions, allowing Medicare to negotiate prices for certain high-cost prescription drugs in Medicare Parts B and D, imposing an excise tax on pharmaceutical manufacturers that refuse to negotiate pricing with Medicare, and requiring inflation rebates to limit annual drug price increases in Medicare. These provisions began taking effect progressively starting in 2023, and, in January 2026, CMS announced the 15 drugs selected for the third cycle of Medicare drug price negotiations. Beginning in 2025, the IRA also eliminated the coverage gap under Medicare Part D by significantly lowering the enrollee maximum out-of-pocket cost and imposing a new manufacturer discount program. However, various industry stakeholders, including certain pharmaceutical companies and industry trade organizations have initiated lawsuits against the federal government asserting that the price negotiation provisions of the IRA are unconstitutional.
Disease Area: Antiviral, Infectious Diseases
Drug Type: Small Molecule