The outcome of this litigation as well as the effects of the IRA on our business and the healthcare industry in general are not yet known.
All entries for: Oncology
March 30, 2026
Auro Biosciences, Inc
Neutral Outlook
Boston, MA
1-50 employees
Disease Area: Oncology
Drug Type: Biologic
March 30, 2026
RenovoRx, Inc
Neutral Outlook
Mountain View, CA
1-50 employees
On August 2022, Congress passed the Inflation Reduction Act of 2022, 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, imposing penalties and excise tax 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, among other changes.
Disease Area: Oncology
Drug Type: Biologic
March 30, 2026
Bicara Therapeutics Inc.
Neutral Outlook
Boston, MA
1-50 employees
The implementation of the IRA is currently subject to ongoing litigation that challenges the constitutionality of the IRA’s Medicare drug price negotiation program. The full impact of the IRA on our business and the pharmaceutical and healthcare industry in general is not yet known.
Disease Area: Oncology
Drug Type: Biologic
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 27, 2026
Werewolf Therapeutics, Inc.
Neutral Outlook
Watertown, MA
11-50 employees
For example, in August 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law by President Biden. The legislation requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), 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, and replaces the Part D coverage gap discount program with a new discounting program. The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.
Disease Area: Oncology
Drug Type: Biologic
March 27, 2026
Hoth Therapeutics/NJ
Neutral Outlook
Hoboken, NJ
1-50 employees
In August 2022, the Inflation Reduction Act of 2022 was signed into law by President Biden. The new legislation has implications for Medicare Part D, which is a program available to individuals who are entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of paying a monthly premium for outpatient prescription drug coverage. Among other things, the Inflation Reduction Act of 2022 requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), 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); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
Disease Area: Oncology
Drug Type: Small Molecule
March 27, 2026
Autolus Therapeutics plc/uk
Neutral Outlook
London, UK
201-500 employees
For example, the IRA, 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.
Disease Area: Hematology, Oncology
Drug Type: Biologic
March 26, 2026
Intensity Therapeutics, Inc
Neutral Outlook
Shelton, CT
1-50 employees
However, the IRA’s impact on the pharmaceutical industry in the United States remains uncertain, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S. Chamber of Commerce) have initiated federal lawsuits against CMS arguing the program is unconstitutional for a variety of reasons, among other complaints. Those lawsuits are currently ongoing.
Disease Area: Oncology
Drug Type: Small Molecule
March 26, 2026
Biodexa Pharmaceuticals Plc
Negative Outlook
Cardiff, UK
1-50 employees
In August 2022, the Inflation Reduction Act, or IRA, was signed into the law the IRA. The IRA includes multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. For example, 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 product’s price increases faster than the rate of inflation. This calculation is made on a product-by-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. Additionally, CMS will negotiate drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.
Disease Area: Neurological Diseases, Oncology
Drug Type: Small Molecule