In the recent article from our Beyond Neurology team, we traced the journey of BTK inhibitors (BTKi) in Multiple Sclerosis (MS), a story marked by scientific promise, high expectations, and a few sharp turns along the way. The delayed FDA decision on tolebrutinib adds another twist to that ride, dimming the fairground lights for now but not closing the gates.
For pharma, this moment is more than a pause in progress. It’s a test of strategic readiness. How companies navigate this delay, sustain momentum, and prepare for renewed competition will determine who takes the lead when the gates reopen. Read on for Beyond Blue Strategy’s take on how to turn delay into an advantage.
1. Keep the anticipation alive
The unmet need in progressive MS hasn’t changed. Patients and clinicians are still waiting for therapies that can address disease progression, not just relapses. For companies with BTKi assets in development, the goal now is to maintain momentum without overpromising.
That means keeping conversations warm across all key stakeholders, from neurologists and advocacy groups to payers and trial investigators. Continuing to communicate emerging data, unmet needs, and long-term class potential will be key to sustaining engagement and credibility.
Beyond Blue tip: Staying visible during a delay ensures that, when the decision comes, awareness and confidence are already in place.
2. Manage the narrative, don’t lose it
Regulatory delays have a way of amplifying uncertainty. Questions about safety, trial design, or class viability can resurface quickly, especially in a space like MS, where clinicians are hungry for new options but cautious after past disappointments. In this moment, perception management is as critical as regulatory progress.
Companies that stay silent risk letting the conversation drift toward speculation. Instead, this is the time to lead with transparency: reinforce the strength of the underlying data, clarify what’s known about safety monitoring, and communicate confidence in the long-term vision for the class. Targeted engagement can help sustain belief in the mechanism and the molecule.
Beyond Blue tip: Owning the narrative now won’t just steady sentiment, it will also set the tone for launch.
3. Use the pause to fine-tune your playbook
This delay offers breathing space, not downtime. It’s an opportunity to refine launch sequencing, pressure-test demand assumptions, and validate adoption models across MS centre types. Teams can use this window to pilot messaging with key stakeholders and strengthen cross-functional alignment, ensuring readiness when approval comes through.
Beyond Blue tip: Utilise the additional time to bolster confidence in your core claims and the value you offer stakeholders.
4. Watch the competitive track
The delay doesn’t stop the race. It just changes the order of the cars. Fenebrutinib’s upcoming readouts could shift perceptions of class safety and efficacy, particularly if the data continue to show consistency across a broader relapsing MS population. A cleaner safety profile and wider eligible patient base would not only build real-world confidence but could also reshape market expectations for the entire BTKi class.
Scenario planning should therefore explore both “first-to-file” and “best-in-class” outcomes, as well as how a broader treatment window might alter share dynamics, positioning, and sequencing strategies. With multiple contenders lining up, the competitive map for BTKis could look very different by early next year.
Beyond Blue tip: Ensure you have a firm grasp of what a delay can mean for your brand, including the need to tweak launch tactics as a result.
Looking ahead
The gates may be closed for now, but the fairground isn’t empty. The coming months will separate the companies that simply wait for news from those that shape what happens next.
Now is the time to:
- Pressure-test your launch assumptions and market scenarios, ensuring readiness for both first-to-file and best-in-class outcomes.
- Reinforce stakeholder engagement, maintaining visibility with neurologists, payers, and advocacy groups while sentiment is fluid.
- Refine your brand and access strategy, so when approvals resume, your teams are aligned, messaging is clear, and you can move fast.
The BTKi class still holds the promise to reshape MS care; the winners will be those preparing now for the moment the fairground lights come back on.
Think you will be impacted? Does this situation feel familiar to a different therapy area you’re working in? Then let the Beyond Blue Strategy team help you translate regulatory uncertainty into strategic advantage – identifying where to focus, how to sustain momentum, and what will matter most when the gates finally open.