In its May press release, HHS also advised that it will calculate the MFN price as the lowest price in a country that is part of the Organisation for Economic Co-operation and Development and that has a per capita gross domestic product (“GDP”) of at least 60% of the U.S. per capita GDP. The Company will continue to evaluate the 2025 EO and its potential impact to international opportunities for ZELSUVMI.
All entries for: Neutral Outlook
November 13, 2025
Aardvark Therapeutics
Neutral Outlook
San Diego, CA
1-50 employees
These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. These actions and proposals may, for example, include directives…directing HHS and other agencies to lower prescription drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products…
November 12, 2025
Metsera, Inc
Neutral Outlook
New York, New York
201-500 employees
On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (the 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 (i) directs the Department of Health and Human Services (HHS) to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare; (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation; (iii) reduces the out-of-pocket cap for Medicare Part D beneficiaries to $2,000 starting in 2025.
Disease Area: Metabolic Diseases
Drug Type: Biologic, Small Molecule
November 12, 2025
TScan Therapeutics, Inc.
Neutral Outlook
Cambridge, Massachusetts
51-200 employees
…the Inflation Reduction Act that creates a distinction between small molecule and large molecule products for purposes of determining when a drug may be eligible for drug price negotiation.
Disease Area: Oncology
Drug Type: Biologic
November 12, 2025
Artiva Biotherapeutics, Inc.
Neutral Outlook
San Diego, California,
51-200 employees
For example, the Inflation Reduction Act of 2022 (IRA), among other things, (i) directs the U.S. Department of Health and Human Services (HHS) to negotiate the price of certain high-expenditure, single-source biologics that have been on the market for at least 11 years covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs and biologics under the law (the Medicare Drug Price Negotiation Program), and (ii) imposes rebates with respect to certain drugs and biologics covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation.
Disease Area: Immune Diseases
Drug Type: Biologic
November 12, 2025
CalciMedica, Inc.
Neutral Outlook
La Jolla, California
1-50 employees
For example, the Inflation Reduction Act (IRA) passed by Congress authorizes the Secretary of the Department of HHS to negotiate prices directly with participating manufacturers for selected medicines covered by Medicare even if these medicines are protected by an existing patent. For small molecule medicines, the process begins seven years after initial approval by the FDA. While we do not believe that the IRA or its effects will impact our ability to obtain patents in the near future, we cannot be certain whether it will affect our patent strategy in the long run.
Disease Area: Chronic Disease, Gastrointestinal, Immune Diseases, Multiple, Respiratory Diseases
Drug Type: Biologic, Small Molecule
November 12, 2025
Theravance Biopharma, Inc.
Neutral Outlook
South San Francisco, California
201-500 employees
The Inflation Reduction Act of 2022 (the “IRA”) and was replaced with a new manufacturer discount program), rules regarding prescription drug benefits under the health insurance exchanges, changes to the Medicare Drug Rebate program, expansion of the Public Health Service Act’s 340B drug pricing program, fraud and abuse and enforcement. These changes have impacted previously existing government healthcare programs and have resulted in the development of new programs, including Medicare payment for performance initiatives and improvements to the physician quality reporting system and feedback program. However, the transition to a new US presidential administration could impact the policy priorities relating to healthcare programs and we are unable to precisely predict what actions the new administration will take.
Disease Area: Respiratory
Drug Type: Small Molecule
November 12, 2025
Acurx Pharmaceuticals, Inc.
Neutral Outlook
Waltham, MA
201-500 employees
In August 2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law. The IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. Starting in 2023, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the drug product’s price increases faster than the rate of inflation.
Disease Area: Multiple, Neurological Diseases, Rare Diseases
Drug Type: Biologic
November 12, 2025
Lyra Therapeutics, Inc.
Neutral Outlook
Watertown, Massachusetts
51-200 employees
In August 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. The IRA includes several provisions that may impact our business to varying degrees, including provisions that establish a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on many drugs reimbursed under Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic or biosimilar competition, and require companies to pay rebates to Medicare for drug prices that increase faster than inflation (first due in 2023). The IRA permits the Secretary of the Department of Health and Human Services (“HHS”) to implement many of these provisions through guidance, as opposed to regulation, for the initial years.
Disease Area: Respiratory
Drug Type: Small Molecule
November 12, 2025
Zenas Biopharma
Neutral Outlook
Waltham, MA
51-200 employees
Notably, the Inflation Reduction Act of 2022 (the “IRA”) includes a number of healthcare reform provisions, which have varying implementation dates. The IRA extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025
Disease Area: Chronic Disease, Immune Diseases, Neurological Diseases
Drug Type: Biologic