On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (the “IRA”) into law, which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. It is unclear how other healthcare reform measures of the Trump administration or other efforts, if any, to challenge, repeal or replace the ACA, will impact our business.
All entries for: Psychiatry
November 6, 2025
Collegium Pharmaceutical, Inc.
Negative Outlook
Stoughton, MA
201-500 employees
We expect that additional changes to the Affordable Care Act, the Medicare and Medicaid programs, changes in the Inflation Reduction Act of 2022 that allow the federal government to directly negotiate drug prices, and changes stemming from other healthcare reform measures, including any new regulatory measures proposed or implemented by the Trump Administration, especially with regard to healthcare access and cost, as well as other legislation in individual states, could have a material adverse effect on the healthcare industry.
Disease Area: Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
November 4, 2025
Compass Pathways Plc
Neutral Outlook
London, England
51-200 employees
The Inflation Reduction Act of 2022, or the IRA, for example, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries to $2,000 starting in 2025, eliminating the prescription drug coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 1, 2032 the implementation of an HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge
Disease Area: Neurological Diseases, Psychiatry
Drug Type: Small Molecule
October 30, 2025
Vanda Pharmaceuticals
Neutral Outlook
Washington DC
201-500 employees
Prior to January 1, 2025, the Medicare Part D prescription drug benefit required manufacturers to fund approximately 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients for applicable drugs. We account for the Medicare Part D coverage gap using a point of sale model. Estimates for expected Medicare Part D rebates are based, in part, on historical activity and, where available, actual and pending prescriptions when we have validated the insurance benefits.
Disease Area: Dermatology, Gastrointestinal, Multiple, Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
October 28, 2025
Neurocrine Biosciences Inc
Negative Outlook
San Diego, CA
1,001-5,000 employees
Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the Inflation Reduction Act of 2022 (IRA), could adversely affect our business.
Disease Area: Endocrinology, Multiple, Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
September 11, 2025
Lundbeck
Layoffs
Copenhagen, Denmark
5,001-10,000 employees
As Lundbeck enacts a major business overhaul across its European and international operations, more than 600 employees of the Danish company will be left without jobs. Lundbeck has around 5,700 employees total worldwide, meaning that the restructuring could represent a more than 10% reduction in headcount.
Disease Area: Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
August 28, 2025
Indivior
Layoffs
North Chesterfield, VA
1,001-5,000 employees
Indivior is letting go of an undisclosed number of employees as it sets in motion its “Indivior Action Agenda,” a sweeping and multi-year strategic initiative to “maximize the potential” of its business. The layoffs are expected to cost Indivior some $16 million to $19 million in one-time severance payments. Aside from the workforce reduction, Indivior will also consolidate and reduce its real estate assets, for which it expects to incur $15 million to $22 million in one-time costs. The company is also looking for “strategic alternatives” for its opioid use disorder therapy Opvee, though it did not specify what options it is currently exploring.
Disease Area: Chronic Disease, Psychiatry
Drug Type: Small Molecule
August 14, 2025
Spruce Biosciences
Neutral Outlook
South San Francisco, CA
1-50 employees
The Inflation Reduction Act of 2022 (“IRA”) was signed 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 and amendments in the future. It is unclear how any such challenges and the healthcare reform measures of the second Trump administration will impact the Affordable Care Act and our business.
Disease Area: Endocrinology, Multiple, Psychiatry, Rare Diseases
Drug Type: Biologic, Small Molecule
July 30, 2025
Neurocrine Biosciences Inc
Neutral Outlook
San Diego, CA
1,001-5,000 employees
AUSTEDO and AUSTEDO XR, marketed by Teva Pharmaceuticals Industries, have been selected for the Medicare drug negotiation program in 2025 (for initial price applicability year 2027). If the negotiation program results in a decrease in the price of AUSTEDO or AUSTEDO XR, it may result in increased competitive pressure on INGREZZA. We were notified in January 2025 that INGREZZA qualifies for the small biotech exception, which provides an exemption from selection until 2027 (for initial price applicability year 2029, pursuant to which negotiated pricing would go into effect, if selected). If negotiated for initial price applicability year 2029, we expect that the negotiated price for INGREZZA would be constrained by the “short monopoly” price ceiling and temporary price floor for small biotech drugs.
Disease Area: Endocrinology, Multiple, Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
July 30, 2025
Sage Therapeutics - Cambridge
Negative Outlook
Cambridge, MA
1-50 employees
We expect that litigation involving these and other provisions of the IRA will continue, with unpredictable and uncertain results. We further cannot predict with certainty what impact the IRA or any other federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition. There may be additional Congressional and administrative efforts to address drug pricing.
Disease Area: Multiple, Neurological Diseases, Psychiatry
Drug Type: Small Molecule