Most recently, the Inflation Reduction Act of 2022, or IRA, included a number of significant drug pricing reforms, which include the establishment of a drug price negotiation program within the U.S. Department of Health and Human Services, or HHS (beginning in 2026) that requires manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers under Medicare Parts B and D to penalize price increases that outpace inflation (first due in 2023), and a redesign of the Part D benefit, as part of which manufacturers are required to provide discounts on Part D drugs (beginning in 2025).
All entries for: Immune Diseases
March 16, 2026
Coya Therapeutics
Neutral Outlook
Houston, TX
1-50 employees
Most significantly, in August 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law. This statute marks the most significant action by Congress with respect to the pharmaceutical industry since adoption of the ACA in 2010. 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; redesigns the Medicare Part D benefit and replaces the Part D coverage gap discount program with a new manufacturer discount program. Under an annual process, CMS has negotiated prices for ten drugs whose new prices began in 2026 and for another 15 drugs whose new prices will be effective in 2027.
Disease Area: Immune Diseases, Neurological Diseases
Drug Type: Biologic
March 16, 2026
Atara Biotherapeutics
Neutral Outlook
Thousand Oaks, CA
201-500 employees
While it remains to be seen how the drug pricing provisions imposed by the IRA will affect the broader pharmaceutical industry, several pharmaceutical manufacturers and other industry stakeholders have challenged the law, including through lawsuits brought against the U.S. Department of Health and Human Services (HHS), the Secretary of HHS, CMS, and the CMS Administrator challenging the constitutionality and administrative implementation of the IRA’s drug price negotiation provisions.
Disease Area: Immune Diseases, Oncology
Drug Type: Biologic
March 13, 2026
Nektar Therapeutics
Neutral Outlook
San Francisco, CA
51-200 employees
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.
Disease Area: Dermatology, Endocrinology, Immune Diseases, Neurological Diseases, Oncology
Drug Type: Biologic
March 12, 2026
Corvus Pharmaceuticals, Inc.
Neutral Outlook
South San Francisco, CA
51-200 employees
For that and other reasons, it is currently unclear how the IRA will be effectuated.
Disease Area: Dermatology, Hematology, Immune Diseases, Oncology
Drug Type: Biologic, Small Molecule
March 12, 2026
Adicet Bio, Inc.
Neutral Outlook
Boston, MA
51-200 employees
Although the effects of the IRA on our business and the healthcare industry in general is not yet known, we are taking into consideration the potential impact of the IRA on our development and commercialization activities.
Disease Area: Hematology, Immune Diseases, Oncology
Drug Type: Biologic
March 12, 2026
Tonix Pharmaceuticals Holding Corp.
Neutral Outlook
Berkeley, CA
51-200 employees
There is no assurance that federal or state health care reform will not adversely affect our future business and financial results, and we cannot predict how future federal or state legislative, judicial or administrative changes relating to healthcare policy will affect our business.
Disease Area: Immune Diseases, Infectious Diseases, Neurological Diseases, Oncology, Psychiatry, Rare Diseases
Drug Type: Biologic, Small Molecule