Government agreements with pharmaceutical companies and any other government measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or that increase generic drug and biosimilar entry sooner than expected, could materially harm our business, including with respect to our ability to set adequate pricing for new drugs to recover our research and development costs.
All entries for: Negative Outlook
March 31, 2026
HCW Biologics Inc.
Negative Outlook
Miramar, FL
1-50 employees
For example, on May 12, 2025, President Trump issued an Executive Order that, among other things, required HHS, within 30 days, to establish and communicate to drug manufacturers most favored nation, or MFN, price targets designed to bring drug prices for American patients in line with those in comparably developed nations. If significant progress towards MFN pricing is not achieved, the Executive Order requires HHS to propose a rulemaking to implement MFN pricing. Recently, on December 23, 2025, CMS issued proposed regulations to establish, under the Center for Medicare and Medicaid Innovation, two mandatory MFN demonstration models under Medicare Parts B and D, respectively. If these rules or other MFN pricing rules are finalized, they are likely to reduce prices of at least some drugs in the United States, if they are also sold in comparator countries. Even if we do not market drugs in such countries, we will be indirectly affected if our drugs competed with drugs whose prices were reduced as a result of MFN pricing initiatives.
March 31, 2026
Connect Biopharma Holdings Ltd
Negative Outlook
San Diego, CA
51-200 employees
The Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S. to the lowest price in a group of other countries. In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government. The Trump administration is also pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations in December 2025, referred to as Globe and Guard. If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing. While the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant.
March 31, 2026
Omeros Corp
Negative Outlook
Seattle, WA
201-500 employees
Inflation Reduction Act Deductions. If, during the Net Sales Term for an Anticipated Product in the United States, such Anticipated Product is designated as a Selected IRA Drug by the Secretary of the U.S. Department of Health and Human Services, and Novo Nordisk or its Affiliate or its or their licensee or Sublicensee is required to negotiate and is ultimately subject to a Maximum Fair Price that will apply to sales of such Anticipated Product during the Price Applicability Period (the Calendar Quarter during which such event occurred, the “Event Quarter”), then the Net Sales of such Anticipated Product in the United States[***] will be reduced by [***].
Disease Area: Immune Diseases, Neurological Diseases
Drug Type: Small Molecule
March 31, 2026
NeuoSense Therapeutics Ltd
Negative Outlook
Tel Aviv, Israel
1-50 employees
On August 16, 2022, President Biden signed into law the Inflation Reduction Act that is intended to lower certain prescription drug costs under Medicare. The law permits the Medicare program to negotiate Medicare payments for a limited number of drugs. On August 1, 2024, CMS announced an agreement reached for negotiated Medicare prices for 10 selected drugs. CMS then announced on January 17, 2025, negotiations for Medicare prices for 15 selected drugs. In addition, the law set a cap of $2,000 in 2025 on out-of-pocket drug costs for Medicare eligible individuals…If healthcare policies or reforms intended to curb healthcare costs are adopted, or if we experience negative publicity with respect to the pricing of our products or the pricing of pharmaceutical drugs generally, the prices that we charge for any approved products may be limited, our commercial opportunity may be limited and/or our revenues from sales of our products may be negatively impacted.
Disease Area: Neurological Diseases, Rare Diseases
Drug Type: Small Molecule
March 31, 2026
OSR Holdings, Inc
Negative Outlook
Bellevue, WA
1-50 employees
The Affordable Care Act and the Inflation Reduction Act, as well as other ongoing healthcare legislative and regulatory reform measures, may have a material adverse effect on our business and results of operations.
Disease Area: Oncology
Drug Type: Biologic
March 31, 2026
Nanobiotoix S.A.
Negative Outlook
Paris, France
51-200 employees
Additionally, in the United States, the Inflation Reduction Act of 2022 (IRA), enacted on August 16, 2022, includes several provisions to lower prescription drug costs for people with Medicare and reduce drug spending by the federal government. We cannot predict the ultimate content, timing or effect of any changes to the ACA, the IRA or other federal and state reform efforts, and there can be no assurance that any such health care reforms will not adversely affect our future business and financial results.
Disease Area: Oncology
Drug Type: Biologic
March 31, 2026
BioAtla Inc
Negative Outlook
San Diego, CA
51-200 employees
Thus, while it is unclear how the IRA will be implemented, it will likely have a significant impact on the biopharmaceutical industry and the pricing of prescription drug products.
Disease Area: Oncology
Drug Type: Biologic
March 31, 2026
Centessa Pharmaceuticals plc
Negative Outlook
London, UK
201-500 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: Oncology, Rare Diseases
Drug Type: Small Molecule
March 31, 2026
HCW Biologics Inc.
Negative Outlook
Miramar, FL
1-50 employees
Thus, while it is unclear how the IRA will be implemented, it will likely have a significant impact on the biopharmaceutical industry and the pricing of prescription drug products.
Disease Area: Immune Diseases, Oncology
Drug Type: Biologic