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.
All entries for: Psychiatry
Neurocrine Biosciences Inc
Neutral Outlook
San Diego, CA
1,001-5,000 employees
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.
Sage Therapeutics - Cambridge
Layoffs
Cambridge, MA
201-500 employees
Not two weeks after being acquired, Sage Therapeutics has let go of all of its remaining workforce—338 employees in Cambridge, Massachusetts, according to a Worker Adjustment and Retraining Notification notice. The Cambridge-based biotech’s layoffs will take effect Aug. 22. As of April 22, the company had 338 full-time employees, including 98 members focused on research and development, according to its most recent quarterly report. The workforce reduction comes a few weeks after Sage agreed to be acquired by Supernus Pharmaceuticals. The Maryland-based company offered to buy Sage for $591 million, with a contingent value right that could swell the overall deal value to $795 million based on certain milestones. Sage and Supernus expect to close the transaction in the third quarter.
SciSparc
Neutral Outlook
Tel Aviv, Israel
1-50 employees
The passage of the Inflation Reduction Act, or the IRA, of 2022 further affects Medicare reimbursement. The IRA has three key elements reforming Medicare drug-pricing policy. The implementation of certain elements of the IRA are still forthcoming, as outlined below, so the specific implications for biopharmaceutical pricing and reimbursement are yet to be determined. Likewise, SciSparc is unable to predict potential modification, amendment, or repeal of the IRA, though some predict that challenges may be made as different provisions are enacted.
Vanda Pharmaceuticals
Negative Outlook
Washington DC
201-500 employees
We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, including our and our partners’ ability to continue to successfully commercialize our products, including activities related to Fanapt® for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults which was approved in April 2024 and acquired rights to PONVORY® in the U.S. and Canada in December 2023, the impact of the Medicare Part D benefit redesign effective January 1, 2025 under the Inflation Reduction Act of 2022, any possible payments made or received pursuant to license agreements, progress of our research and development efforts, the timing and outcome of clinical trials and related possible regulatory approvals and the status of existing and future potential litigation involving our products and intellectual property.
Rapport Therapeutics
Negative Outlook
Boston, MA
1-50 employees
For instance, the Inflation Reduction Act of 2022 (the “IRA”) includes several provisions that will impact our business to varying degrees, including provisions that 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, among others. All of our disclosed product candidates are small molecule drugs and certain of them are being developed in indications that may rely heavily on Medicare reimbursement, such as peripheral neuropathic pain. Accordingly, these new price-negotiation provisions may have a negative impact on our future revenue and profits. Further, the IRA 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. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our revenue generated from the sale of any approved products.
Spruce Biosciences
South San Francisco, CA
1-50 employees
For example, the Inflation Reduction Act (“IRA”) passed by the U.S. Congress authorizes the Secretary of the Department of Health and Human Services (“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 that it will not affect our patent strategy in the long term.
Contineum Therapeutics
Negative Outlook
San Diego, CA
1-50 employees
While it remains to be seen how the drug pricing provisions imposed by the IRA will affect the broader pharmaceutical industry (including orphan drug development), several pharmaceutical manufacturers and other industry stakeholders have challenged the law, including through lawsuits brought against federal agencies challenging the constitutionality and administrative implementation of the IRA’s drug price negotiation provisions. The IRA and any other similar laws introduced in the future may result in additional reductions in Medicare and other healthcare funding, which could negatively affect our future revenues and results of operations.
Sage Therapeutics - Cambridge
Negative Outlook
Cambridge, MA
1-50 employees
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.
Spruce Biosciences
Layoffs
South San Francisco, CA
1-50 employees
A little over a year after cutting 21% of its workforce, Spruce Biosciences has disclosed it’s axing 55% of its employees, according to an April 25 SEC filing. The San Francisco–based late-stage biopharma had 21 employees as of Dec. 31, 2024, according to an April 15 SEC filing, meaning that the layoffs could leave the business with around 10 employees.