If “most favored nation” pricing is implemented under the law, payment for our products and our business results could be adversely affected, although the full impact of any such actions cannot be predicted. We expect to experience pricing pressures in connection with products due to the increasing trend toward managed healthcare, including the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs, has increased and is expected to continue to increase in the future. As a result, profitability of our products, if any, may be more difficult to achieve even if they receive regulatory approval. If we are unable to successfully further develop and maintain internal commercialization capabilities, sales of our future products may be negatively impacted.
All entries for: Negative Outlook
Aligos Therapeutics, Inc.
Negative Outlook
South San Francisco, CA
51-200 employees
Imposing a rebate in the U.S. that is based on drug prices outside the U.S. would mark a drastic and unprecedented shift in the U.S. pharmaceutical market, and while the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant.
PepGen Inc
Negative Outlook
Boston, MA
51-200 employees
It is unclear whether and to what extent these proposals will be implemented or survive legal challenge, and a similar MFN model finalized during the first Trump Administration was halted by federal courts and subsequently rescinded for procedural reasons; however, MFN pricing policy represents a significant and evolving uncertainty that could materially adversely affect our pricing strategy, revenue, and ability to commercialize our product candidates, if approved.
Iovance Biotherapeutics
Negative Outlook
San Carlos, CA
501-1,000 employees
If such Most Favored Nation policies are implemented, changes to drug pricing are expected to affect the profitability of pharmaceutical and biotech companies in the U.S. as well as in other countries, as a price referencing policy to the U.S. market could make it commercially unviable to commercialize a drug product in a price constrained market. The details of the proposed policies are unclear, and the final terms and impact remain uncertain and may pose long-term risks to our business and our future commercialization plans of our products and product candidates.
Edgewise Therapeutics, Inc
Negative Outlook
Boulder, CO
51-200 employees
We cannot predict the full impact of the OBBB Act, executive orders, and new laws focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. The impact of ongoing and future judicial challenges as well as future legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the current administration on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.
Immuneering Corporation
Negative Outlook
Cambridge, MA
1-50 employees
In addition, pharmaceutical pricing and marketing has long been the subject of considerable discussion among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry generally and our business specifically.
Akebia Therapetuics, Inc
Negative Outlook
Cambridge, MA
201-500 employees
The implications and consequences of these actions and subsequent actions by the Trump Administration to compel an MFN regulatory pricing requirement in the U.S. continue to remain unclear and uncertain and could ultimately result in litigation. However, if an MFN regulatory pricing requirement is implemented in the U.S., it could have an adverse effect on our business.
TG Therapeutics, Inc
Negative Outlook
Morrisville, NC
201-500 employees
In addition, legislative and regulatory proposals in the United States have included “most favored nation” (MFN) or international reference pricing models that would tie reimbursement or net prices for certain drugs to the lowest price available in other countries. Adoption or expansion of MFN or similar reference pricing policies could result in downward pressure on U.S. pricing if BRIUMVI or any of our future products are sold at lower net prices in ex-U.S. markets. Because we have partnered the rights to commercialize BRIUMVI in territories outside of the U.S. and do not control pricing, reimbursement negotiations or commercial strategy in those territories, we may have limited ability to influence ex-U.S. pricing decisions that could be used as reference points under MFN or similar frameworks. As a result, pricing determinations made by our collaboration partner in Europe, including in response to local market access dynamics or governmental requirements, could adversely affect the reimbursement or net price realized for BRIUMVI in the U.S. or other markets, which could have a material adverse effect on our revenues and results of operations.
Enliven Therapeutics
Negative Outlook
Burlingame, CA
1-50 employees
Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets for prescription drugs or that increase generic and biosimilar drug entry sooner than expected can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future, or the pricing of our approved product in the U.S. and in foreign countries.
Revolution Medicines, Inc.
Negative Outlook
Redwood City, CA
1000-5000 employees
A rebate in the United States tied to drug prices outside the United States would represent a significant departure from historical U.S. pharmaceutical pricing practices and could reduce the revenues we receive for any products that we commercialize. Even if these initiatives are modified, delayed, not finalized or successfully challenged, the uncertainty surrounding them could adversely affect our ability to forecast revenues determine commercial launch timing and sequencing, and make investments in manufacturing capacity and commercialization infrastructure.