Legislative, administrative, and private payor efforts to control drug costs span a range of proposals, including drug price negotiation, Medicare Part D redesign, drug price inflation rebates, international mechanisms, generic drug promotion and anticompetitive behavior, manufacturer reporting, and reforms that could impact therapies utilizing the accelerated approval pathway. We cannot predict the ultimate content, timing or effect of any changes to the ACA, the Inflation Reduction Act, or other federal and state healthcare policy reform efforts including those aimed at drug pricing.
All entries for: Rare Diseases
March 31, 2026
Palvella Therapeutics, Inc.
Neutral Outlook
Wayne, PA
1-50 employees
Several healthcare reform proposals culminated in the enactment of the Inflation Reduction Act of 2022 (“IRA”) for example, contains substantial drug pricing and other reforms to Medicare’s coverage of pharmaceuticals. Among other things, the IRA eliminated, beginning in 2025, the coverage gap under Medicare Part D by significantly lowering the enrollee maximum out-of-pocket cost and requiring manufacturers to subsidize, through a newly established manufacturer discount program (replacing the former Coverage Gap Discount Program), 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket limit, and 20% once the out-of-pocket limit has been reached.
Disease Area: Dermatology, Rare 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
Belite Bio, Inc
Neutral Outlook
San Diego, CA
51-200 employees
Notably, on August 16, 2022, President Biden signed the “Inflation Reduction Act of 2022” (IRA) into law, incorporating many key provisions of the “Build Back Better Act”. Prescription drug price reform is a focal point of this landmark legislation that incorporates many proposals advanced over the last decade to overhaul drug costs under the Medicare program.
Disease Area: Other, Rare Diseases
Drug Type: Small Molecule
March 31, 2026
Belite Bio, Inc
Neutral Outlook
San Diego, CA
51-200 employees
Notably, on August 16, 2022, President Biden signed the “Inflation Reduction Act of 2022” (IRA) into law, incorporating many key provisions of the “Build Back Better Act”. Prescription drug price reform is a focal point of this landmark legislation that incorporates many proposals advanced over the last decade to overhaul drug costs under the Medicare program.
Disease Area: Other, Rare Diseases
Drug Type: Small Molecule
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 26, 2026
Spero Therapeutics
Neutral Outlook
Cambridge, MA
1-50 employees
Further, in August 2022, President Biden signed into the law the Inflation Reduction Act (“IRA”). Among other things, 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. A manufacturer of drugs covered by Medicare Parts B or D must now pay a rebate to the federal government if their drug product’s price increases faster than the rate of inflation. This calculation is made on a drug product by drug product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D.
Disease Area: Infectious Diseases, Rare Diseases
Drug Type: Biologic
March 26, 2026
Gain Therapeutics
Neutral Outlook
Bethesda, MD
1-50 employees
In 2022, President Biden signed the Inflation Reduction Act, which, among other things, contains a provision that authorizes CMS to negotiate a “maximum fair price” for a limited number of high-cost, single-source drugs each year, and another provision that requires drug companies to pay rebates to Medicare if prices rise faster than inflation. It is unclear to what extent these and other statutory, regulatory, and administrative initiatives will be enacted and implemented in future years.
Disease Area: Neurological Diseases, Rare Diseases
Drug Type: Small Molecule
March 26, 2026
Quoin Pharmaceuticals, Ltd.
Neutral Outlook
Ashburn, VA
1-50 employees
The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties. These provisions have been and may continue to be subject to legal challenges. It is unclear what policies will be advanced with respect to IRA implementation and other drug pricing proposals.
Disease Area: Dermatology, Rare Diseases
Drug Type: Biologic, Small Molecule
March 25, 2026
Nasus Pharma Ltd
Neutral Outlook
Tel Aviv, Israel
1-50 employees
On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act 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. It is possible that the Affordable Care Act will be subject to judicial or Congressional challenges in the future.
Disease Area: Neurological Diseases, Rare Diseases
Drug Type: Small Molecule