For example, in 2022, 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 PPACA 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 PPACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and additional reform measures of the second Trump administration will impact the PPACA. Additional legislative proposals to reform healthcare and government insurance programs, along with the trend toward managed healthcare in the United States, could influence the purchase of medicines and reduce reimbursement and/or coverage of GlycoMimetics’ product candidates, if approved. Current and future healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the price that GlycoMimetics receives for any approved drug. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors.
All entries for: Chronic Disease
IGM Biosciences - Mountainview
Layoffs
Mountain View, CA
51-200 employees
Sanofi has turned its back on its partner IGM Biosciences, forcing the small California biotech to enact drastic strategic measures, including an 80% reduction in force. The company disclosed the layoffs—and the closure of most of its remaining lab and office facilities—in an SEC filing May 8. It noted that the moves would preserve cash. According to its annual report, IGM had 149 full-time employees at the end of 2024. In January, the biotech reduced its workforce by 100 people, corresponding to 73% of its headcount, leaving it with 37 full-time staff. The new cuts leave IGM with around seven employees.
HCW Biologics
Neutral Outlook
Miramar, FL
1-50 employees
For example, the provisions related to the negotiation of selling prices of high- expenditure single-source drugs and biologics have been challenged in multiple lawsuits brought by pharmaceutical manufacturers. Thus, while it is unclear how the IRA will be implemented, it will likely have a significant impact on the pharmaceutical industry.
Edgewise Therapeutics
Negative Outlook
Boulder, CO
51-200 employees
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.
Akebia Therapeutics
Negative Outlook
Cambridge, MA
201-500 employees
On August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law by President Biden. The legislation has implications for Medicare Part D, which is a program available to individuals who are entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of paying a monthly premium for outpatient prescription drug coverage. Among other things, the IRA imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025). The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. We consider many factors when we implement a price increase for a product, including historical and potential future inflation rates. However, there are many variables that are outside of our control and if we increase the price of Auryxia or Vafseo faster than the pace of inflation, we would be subject to additional rebates under Medicare, which could have a material adverse effect on our product revenues
Pliant Therapeutics
Negative Outlook
South San Francisco, CA
51-200 employees
The IRA explicitly excludes from price negotiation orphan drugs designated for only one rare disease or condition and for which the only active approved indication is for such disease or condition. Those drugs with multiple orphan designations are not excluded from drug price negotiation. As we are developing bexotegrast in multiple orphan indications and may seek obtain orphan drug designation for other product candidates, this aspect of the IRA could have a negative impact on our ability to rely on the orphan drug exclusion to the “maximum fair price”.
Gilead Sciences
Negative Outlook
Foster City, CA
10,000+ employees
While the full impact of the IRA on our business and the pharmaceutical industry remains uncertain at this time, we anticipate that the IRA will increase our payment obligations under the redesigned Part D discount program, limit the prices we can charge for our products, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results.
Pliant Therapeutics
Layoffs
South San Francisco, CA
51-200 employees
About two months after discontinuing the Phase IIb/III BEACON-IPF study of idiopathic pulmonary fibrosis drug candidate bexotegrast, Pliant Therapeutics announced it’s cutting roughly 45% of its workforce. The move is meant to help extend the San Francisco–based biotech’s cash runway to support execution of late-stage clinical trials. The company, which develops oral integrin inhibitors for fibrotic diseases, did not say how long that runway will last.
Medera
Negative Outlook
Boston, MA
51-200 employees
It is currently unclear how these judicial challenges as well as other legislative, executive, and administrative actions, including how the IRA will be implemented, will impact the pharmaceutical industry. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.
Ardelyx
Neutral Outlook
Waltham, MA
201-500 employees
While the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant