In addition, the Inflation Reduction Act of 2022 (“IRA”) which among other things, extended enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminated 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. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have an adverse effect on customers for ZELSUVMI and our product candidates, if approved, and, accordingly, our financial operations.
All entries for: Infectious Diseases
March 17, 2026
AN2 Therapeutics
Neutral Outlook
Menlo Park, CA
1-50 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.
Disease Area: Infectious Diseases, Rare Diseases
Drug Type: Small Molecule
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
March 12, 2026
Acurx Pharmaceuticals, Inc./NY
Neutral Outlook
Staten Island, NY
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.
Disease Area: Dermatology, Infectious Diseases
Drug Type: Small Molecule
March 12, 2026
Precision Biosciences Inc
Neutral Outlook
Durham, NC
51-200 employees
While the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.
Disease Area: Antiviral, Hematology, Immune Diseases, Infectious Diseases, Neurological Diseases, Rare Diseases
Drug Type: Biologic
March 12, 2026
Theriva Biologics, Inc.
Negative Outlook
Rockville, MD
1-50 employees
Although full economic effect of the IRA on our business and the pharmaceutical industry in general is unknown at this time, it will likely have a significant impact on the pharmaceutical industry and the pricing of our products and product candidates.
Disease Area: Infectious Diseases, Oncology, Rare Diseases
Drug Type: Biologic
March 11, 2026
Verrica Pharmaceuticals Inc.
Neutral Outlook
West Chester, PA
51-200 employees
It is unclear how such challenges and the healthcare reform measures of the current administration will impact the ACA and our business.
Disease Area: Dermatology, Infectious Diseases, Oncology
Drug Type: Biologic, Small Molecule
March 5, 2026
GSK plc
Negative Outlook
London, England
10,000+ employees
In ovarian cancer, Zejula saw a decrease in sales, driven by ongoing volume reductions, including impacts of an FDA labelling update restricting use to certain patient populations, and the impacts of IRA Medicare Part D redesign in the US
Disease Area: Antiviral, Chronic Disease, Gastrointestinal, Hematology, Immune Diseases, Infectious Diseases, Metabolic Diseases, Oncology, Respiratory Diseases
Drug Type: Biologic, Small Molecule
March 5, 2026
CorMedix Inc
Negative Outlook
Parsippany, NJ
1-50 employees
“In particular, there have been several recent U.S. Congressional inquiries, hearings and proposed and enacted federal legislation and rules, as well as executive orders and sub-regulatory guidance that may impact pricing for pharmaceutical products. These initiatives include, among others… implementation of the inflation Reduction Act of 2022 (Inflation Reduction Act), including provisions that generally require manufacturers of Medicare Part B and Part D drugs to pay inflation rebates to the Medicare program if pricing metrics associated with their products increase faster than the rate of inflation;”
Disease Area: Cardiology, Hematology, Infectious Diseases
Drug Type: Biologic, Small Molecule