Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 62

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 62
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 so. Furthermore, if we decide to submit an application for accelerated approval or under another expedited regulatory designation (e.g., breakthrough therapy designation), there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The FDA or other comparable foreign regulatory authorities could also require us to conduct further studies prior to considering our application or granting approval of any type. A failure to obtain accelerated approval or any other form of expedited development, review or approval for our product candidate would result in a longer time period to commercialization of such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.

We may face difficulties from changes to current healthcare regulations and future legislation.

We may face significant challenges due to changes in existing healthcare regulations or the introduction of new legislation. Shifts in regulatory policies or the enactment of additional government regulations could prevent, limit, or delay the approval of our product candidates. Actions by current or future administrations may impact regulatory agencies such as the FDA, potentially delaying or complicating the approval process for our products Our ability to adapt to evolving requirements is critical; failure to do so could result in the loss of marketing approvals and hinder our ability to achieve or maintain profitability.

Healthcare reform measures, such as the Affordable Care Act (ACA) and subsequent legislative changes, have substantially altered healthcare financing and continue to impact the pharmaceutical industry. Ongoing legal challenges and executive orders create further uncertainty regarding the implementation and future of these reforms. Additional laws, including reductions in Medicare payments and expanded government authority to recover overpayments, may further affect our financial operations and the market for our products.

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Moreover, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing or