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.
All entries for: Biologic
March 3, 2026
Sana Biotechnology/WA
Neutral Outlook
Seattle, WA
201-500 employees
Most significantly, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (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, beginning in 2026, that manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap; imposes rebates, first due in 2023, under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation; and, beginning in 2025, replaces the Part D coverage gap discount program with a new discounting program.
Disease Area: Endocrinology, Hematology, Immune Diseases, Oncology
Drug Type: Biologic
March 3, 2026
Anaptysbio/CA
Neutral Outlook
San Diego, CA
1-50 employees
Healthcare reform initiatives include the enactment of the Inflation Reduction Act (“IRA”), which, among other things, allows the HHS to negotiate the selling price of certain drugs and biologics that CMS reimburses under Medicare Part B and Part D, although only high-expenditure single-source drugs that have been approved for at least seven years (11 years for biologics) can be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced.
Disease Area: Dermatology, Gastrointestinal, Immune Diseases
Drug Type: Biologic
March 3, 2026
Amylyx Pharmaceuticals
Neutral Outlook
Cambridge, MA
51-200 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 effects of the IRA on our business and the healthcare industry in general is not yet known.
Disease Area: Endocrinology, Neurological Diseases, Rare Diseases
Drug Type: Biologic, Small Molecule
March 3, 2026
BioAtla
Layoffs
San Diego, CA
51-200 employees
San Diego-based BioAtla is cutting approximately 70% of its workforce as it explores strategic options including asset sales, licensing transactions, and strategic partnerships for its pipeline of antibody therapeutics targeting solid tumors.
Disease Area: Oncology
Drug Type: Biologic
March 2, 2026
Scholar Rock Holding Corp
Neutral Outlook
Cambridge, MA
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: Metabolic Diseases, Neurological Diseases, Rare Diseases
Drug Type: Biologic
March 2, 2026
Geron Corp/CA
Negative Outlook
Foster City, CA
201-500 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, Oncology
Drug Type: Biologic
March 2, 2026
Apogee Therapeutics
Neutral Outlook
Waltham, MA
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: Gastrointestinal, Immune Diseases, Respiratory Diseases
Drug Type: Biologic
March 2, 2026
Sarepta Therapeutics/MA
Neutral Outlook
Cambridge, MA
501-1,000 employees
Beyond the Healthcare Reform Act, there have been ongoing healthcare reform efforts, including efforts focused on drug pricing and payment. For example, the Inflation Reduction Act (“IRA”) of 2022 includes a number of changes intended to address rising prescription drug prices in Medicare Parts B and D, with varying implementation dates. These changes include caps on Medicare Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer discount drug program (replacing the ACA Medicare Part D coverage gap discount program) and a drug price negotiation program for certain high spend Medicare Part B and D drugs (with negotiated prices for the first set of drugs taking effect in 2026). The IRA has had and will likely continue to have a significant impact on the pharmaceutical industry. Additionally, changes to Medicaid effective in 2024 eliminated the Medicaid rebate cap. And changes to certain Medicare price reporting requirements for drugs beginning in2026 will likely increase the administrative and compliance burden for manufacturers.
Disease Area: Neurological Diseases, Rare Diseases
Drug Type: Biologic
March 2, 2026
Biohaven Ltd
Neutral Outlook
New Haven, CT
201-500 employees
In August 2022, Congress passed the Inflation Reduction Act of 2022 (the “IRA”), which, among other things, 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: Immune Diseases, Metabolic Diseases, Neurological Diseases, Oncology, Rare Diseases
Drug Type: Biologic, Small Molecule