Although the effects of the IRA on our business and the healthcare industry in general are not yet known, we are taking into consideration the potential impact of the IRA on our development and commercialization activities.
All entries for: Biologic
March 10, 2026
ADC Therapeutics SA-Switzerland
Neutral Outlook
Switzerland
51-200 employees
Thus, while it is unclear how some provisions of the IRA will be implemented, we are liable for Part B inflation rebates for ZYNLONTA under the IRA, which has and will continue to negatively impact our gross-to-net adjustment for ZYNLONTA sales.
Disease Area: Hematology, Oncology
Drug Type: Biologic
March 9, 2026
Macrogenics Inc
Neutral Outlook
Rockville, MD
201-500 employees
For example, on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law, which among other things, (i) extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025, (ii) authorizes HHS to negotiate the price of certain high-expenditure, single-source drugs covered under Medicare that have been on the market for at least 7 years, and (iii) 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: Endocrinology, Hematology, Oncology
Drug Type: Biologic
March 9, 2026
Editas Medicine
Neutral Outlook
Cambridge, MA
201-500 employees
On August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) 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 IRA 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). The IRA permits the Secretary of the HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years
Disease Area: Cardiology, Hematology, Immune Diseases, Metabolic Diseases, Oncology, Rare Diseases
Drug Type: Biologic
March 9, 2026
Dianthus Therapeutics, Inc
Neutral Outlook
New York, NY
1-50 employees
Notwithstanding these provisions, the IRA’s impact on commercialization and competition remains largely uncertain.
Disease Area: Dermatology, Immune Diseases, Neurological Diseases, Rare Diseases
Drug Type: Biologic
March 9, 2026
Coherus Oncology
Negative Outlook
Redwood City, CA
201-500 employees
While the impact of the IRA on our business and the pharmaceutical industry cannot yet be fully determined, it is likely to be significant. In particular, if a product becomes subject to the IRA negotiation provision and related price cap, that may significantly alter the economic rationale for developing and commercializing a biosimilar.
Disease Area: Oncology
Drug Type: Biologic
March 9, 2026
Corbus Pharmaceuticals Holding, Inc
Negative Outlook
Norwood, MA
51-200 employees
Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain…For example, the Inflation Reduction Act of 2022 included, among other things, a provision that authorizes CMS to negotiate a “maximum fair price” for a limited number of high-cost, single-source drugs every year, and another provision that requires drug companies to pay rebates to Medicare if prices rise faster than inflation.
Disease Area: Metabolic Diseases, Oncology
Drug Type: Biologic, Small Molecule
March 9, 2026
ALX Oncology Holdings Inc
Negative Outlook
South San Francisco, CA
51-200 employees
In 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….The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.
Disease Area: Hematology, Oncology
Drug Type: Biologic