Preparing for a Pivotal Clinical Trial Readout: What Biopharmaceutical Companies Should Consider to Prepare for a Potential Transformational Moment
Late-stage clinical trial readouts are a key inflection point in the life cycle of a biopharmaceutical company. Regardless of company size or commercial experience, the aftermath of a readout can make a substantial impact on a company’s reputation, market position, and overall value.
If positive, a successful Phase 3 readout can send share prices soaring and serve as supporting or confirmatory data in future regulatory approvals. If negative or mixed, it can lead to potential setbacks, such as activist investor interest or even operational changes such as a restructuring.
The external and internal communications around a late-stage readout are crucial, as the significance of the results will need to be fully explained and appropriately conveyed to key stakeholders.
Recommended Communications Strategies
Our Healthcare & Life Sciences experts share the following key considerations to help biopharmaceutical companies prepare for and communicate around Phase 3 readouts, regardless of the outcome:
Conduct scenario planning
Clinical development can be unpredictable. However, if the appropriate teams – leadership, medical affairs, corporate and financial communications, and beyond – are in close contact around the outcome, this will enable appropriate scenario planning to occur.
By systematically identifying and evaluating potential risks, opportunities, and operational challenges, scenario planning enables organizations to build flexible strategies that can adapt to varying trial outcomes and market dynamics. Teams should identify positive, negative, and mixed scenarios, and develop proactive mitigation plans and decision frameworks both from communications and operational perspectives.
Regardless of the outcome, an organization should always create materials that position the data accurately and transparently. This structured approach not only strengthens trial execution and resource management but also enhances stakeholder confidence and positions the program for greater regulatory and commercial success.
Develop strong messaging
Conveying clear and consistent messaging for each identified scenario is essential to ensuring audiences understand the data and its implications. To the extent possible, messaging should also reflect initial next steps such as the path forward to registration or intended medical meeting participation, so stakeholders are aware of future company plans. Depending on the trial outcome, messaging should reinforce how the results advance the company towards its next stage of growth or strengthen its broader pipeline and/or platform.
Position spokespersons for maximum impact
A late-stage data readout can impact pipeline credibility, regulatory pathways, investor confidence, and ultimately, patient trust. Choosing the right spokespersons is essential to communicating trial results clearly, responsibly, and in a compelling fashion. Primary company spokespersons should have a deep scientific or clinical background, with the Chief Medical Officer (CMO) or Head of Research & Development (R&D) serving as ideal candidates. The CEO will also play an important role in communications and should speak to any broader business implications.
A physician key opinion leader (KOL) or the study’s principal investigator (PI) will be able to offer a credible third-party perspective, put the data into context, and participate in communications efforts such as the company investor call and/or media interviews. These individuals must be prepared to offer a physician’s perspective, translate complex clinical data accurately, or answer technical questions.
Keep disclosure timing on track
Developing and adhering to a timeline for disclosing the data will reaffirm an organization’s credibility with stakeholders. Providing and sticking to company guidance will also help manage investor expectations and prevent any major changes in trading behavior or perception.
Importantly, companies should consider the timing for top-line vs. full data. Traditionally, top-line data is announced in a press release, ideally with an investor call before trading hours on the day of the announcement. Full data would then be presented at a relevant, major scientific conference, offering another opportunity to reinforce key messages and create interest around the readout. An important consideration is level of detail in the top-line announcement to clearly communicate the results, while preserving the opportunity to present the full data at a medical conference.
Prepare for pricing and value discussions
Positive, late-stage data support a drug’s path to regulatory approval and subsequent commercial launch. Price will be a primary topic of conversation ahead of any commercial launch and when setting and communicating a price, the company must consider the drug’s clinical value, market access dynamics, and commercial sustainability.
Developing a strong value narrative, grounded in clinical outcomes and unmet need, is critical to gaining provider adoption, securing payer access, maintaining investor confidence, and shaping public perception. Appropriate and thoughtful early stakeholder engagement around a drug’s value and the company’s affordability and access plans reduces risk, without diluting brand equity. A disciplined, evidence-based approach rooted in peer benchmarking is essential to drive uptake, maximize patient impact, and protect long-term reputation.
Consider organizational impact
Negative or mixed late-stage data can also have a significant impact on an organization and potentially create the need for a reduction in force (RIF). While RIFs are a challenging, significant period of transition, it is important to ensure clear and consistent communications are implemented alongside a stakeholder engagement strategy to explain business plan updates. Not only will this help preserve a company’s reputation, but it will help clarify the intended go-forward strategy.
Conversely, a positive data readout can bring changes of its own. Although many of these changes are positive for a company, it can bring great uncertainty among stakeholders, especially employees. A proactive communications strategy is necessary for navigating a transition into a commercial company, scaling to integrate new commercial products into a portfolio, and adjusting an organization’s strategy as it brings new products to market.
Prepare for potential M&A activity
Having an approved, marketable medicine often increases the likelihood of external buyer interest. Conversely, having a negative late-stage readout may cause activist investors to become vocal, challenge leadership, and potentially push for a variety of changes including return of capital, board seats, or an outright sale.
An important aspect of the company’s original scenario planning is to proactively prepare for investor reactions, including mapping any vulnerabilities and potential issues, implementing a thoughtful shareholder engagement strategy, and having a ‘break the glass’ plan in place should an activist or potential buyer surface.
How We Can Help
FTI Consulting’s Healthcare & Life Sciences team has helped dozens of biopharmaceutical organizations navigate pivotal late-stage clinical data readouts, including some of the most high profile ones in the industry. Please contact one of the authors with any questions about multi-stakeholder communications considerations and strategies during these important inflection points.
The views expressed herein are those of the author(s) and not necessarily the views of FTI Consulting, Inc., its management, its subsidiaries, its affiliates, or its other professionals.
FTI Consulting, Inc., including its subsidiaries and affiliates, is a consulting firm and is not a certified public accounting firm or a law firm.
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