The Fast Track Paradox: Why Biotech Companies Are Leaving Millions on the Table

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An investigation into the regulatory pathway that can increase company growth and accelerate patient access yet remains underutilized. The numbers tell an interesting story.

On Aug. 26, 2025, Allarity Therapeutics announced FDA Fast Track designation for Stenoparib, an investigational treatment for patients with advanced ovarian cancer (1). This regulatory milestone was a significant step forward for women facing this devastating diagnosis. The announcement triggered a same day 100% stock price surge, a reflection of the investor confidence in the therapy’s promise to meaningfully impact patient outcomes.

For patients, the ability to access innovative treatments sooner through FDA Fast Track designation can mean earlier relief, improved outcomes, and even lifesaving options. Academic research shows biotech companies receiving Fast Track designation see stock prices surge 21% within five days, 38% within a month, and 111% over three years (4). Over and beyond investor confidence, this expedited path to market has other ample benefits as well, we’ll explore a few.

Most importantly, the FDA isn’t the bottleneck here. They approve roughly 75% of Fast Track applications that get submitted (8). The agency wants these applications to succeed; each approval could mean faster access for patients with serious conditions.

Yet the industry systematically underutilizes this pathway. The Center for Drug Evaluation and Research (CDER) approved 66% of novel drug applications using expedited pathways in 2024 (10). That same year, CDER received 1,855 Investigational New Drug (IND) applications (11) but only 312 Fast Track designation requests (9), a utilization rate of just 17%.

Why are so many eligible companies overlooking this opportunity? First, let’s examine what the Fast Track designation delivers.

Understanding the Fast Track Advantage

The FDA offers a suite of programs to speed promising therapies to patients. This article centers specifically on the Fast Track designation, but sponsors can stack incentives if eligible, pairing Fast Track with Breakthrough Therapy and Orphan Drug status.

What Fast Track delivers

Enhanced FDA communication. Sponsors gain more frequent, earlier touch point meetings and written feedback, often in weeks rather than months.

Rolling review. Sections of an NDA/BLA can be submitted as they’re finished, allowing the FDA to begin its assessment sooner.

Priority Review eligibility. Fast Track products can qualify for a shorter review clock, about six months instead of the standard ten (7), a timeline shift that can materially change a program’s trajectory. In practice, the gap in approval times is even larger, often surpassing 6 months (2).

However, key misconceptions keep companies from pursuing the Fast Track designation.

Why Companies Don’t Apply: Common Misconceptions

The Rare Disease Assumption. Companies assume Fast Track is only for ultra-rare diseases. In reality, it covers any serious condition with unmet need, including depression, diabetes, Alzheimer’s, and common cancers.

The Timing Fallacy. Companies typically take a conservative approach and wait for “more data.” Meanwhile, Fast Track can be requested with your initial IND. Earlier applications mean more benefit from enhanced FDA communication, allowing companies to tackle key issues such as safety and endpoint selection early on.

As we have seen in rare disease research, vulnerable patients and their families are often highly motivated to participate in clinical trials. Ensuring participant safety during early-stage product development is paramount. Regular and proactive communication with the FDA enables sponsors to implement comprehensive safety protocols that effectively mitigate potential risks to trial participants.

Fear of Added Scrutiny. Companies typically worry about attracting added FDA attention. This is backwards thinking, as Fast Track provides better access to reviewers, quicker responses, and more predictable pathways. Ultimately, companies should seek a collaborative relationship with the FDA, viewing the agency as a partner rather than a barrier. Their primary mission is ensuring patients have access to safe and effective therapeutic options.

The Missed Opportunity

Beyond traditional regulatory advantages, a Fast Track designation creates value for both patients and sponsors alike. Most importantly, this pathway expedites patient access to potentially lifesaving therapies, addressing unmet medical needs.

The human cost is immeasurable. A six month delay for an Alzheimer’s treatment means 180 additional days of cognitive decline for thousands of patients. For cancer therapies, it could mean the difference between remission and progression for hundreds of families.

Simultaneously, the Fast Track designation provides substantial commercial advantages. These designations move markets and deals.

Investor confidence. Fast Track announcements commonly trigger double-digit stock increases, often around 20%, with the biggest moves in smaller, pre-revenue biotechs (4).

Partnership leverage. Designation increases institutional attention and analyst coverage, providing useful currency at the negotiating table for licensing and co-development discussions.

Competitive positioning. Being earlier to market by even six months materially lifts asset value. A well cited Health Affairs analysis shows what a six month head start is worth for different sized drugs:

• Large “blockbuster” drugs (around $1 billion in fifth-year U.S. sales): ~$349 million in added value (5)
• Mid-scale drugs (around $500 million in fifth-year sales): ~$175 million in added value (5)
• Smaller programs (around $250 million in fifth-year sales): ~$87 million in added value (5)

These massive numbers come from three key factors: companies start earning revenue earlier, they capture more market share before competitors arrive, and they get more years of patent protected sales before generic competition begins.

The Resource Reality

The irony is that companies benefiting most from Fast Track are often least equipped to pursue it. While 81% of expedited designations go to smaller companies, suggesting those who do apply generally succeed (3), smaller biotechs often lack the resources and regulatory sophistication to navigate the nuances effectively.

The challenge isn’t writing difficulty, it’s knowing when to apply, what to emphasize, and how to frame medical need. Small biotechs are so laser focused on development that they rarely have the time or the internal expertise.

The Bottom Line

The FDA built a machine specifically designed to accelerate access to critical therapies for patients facing serious conditions with limited treatment options. While these programs are meant to address urgent patient needs through faster development timelines, they also offer meaningful commercial advantages for sponsors.

For biotechs developing therapies that may qualify for Fast Track designation, leveraging these pathways represents both a strategic opportunity and a responsibility to the patient communities they serve.

The regulatory pathway exists. The benefits are proven. The approval rates are favorable. The only question is whether companies will utilize the available tools fully, and complete their mission of addressing unmet medical needs.

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References

1. Allarity Therapeutics. (2025, August 26). Allarity Therapeutics granted FDA Fast Track designation for stenoparib for the treatment of advanced ovarian cancer [Press release]. allarity.com
2. Analysis of US FDA approvals, regulatory pathways, and review times, 1980–2022. (2024). Scientific Reports. nature.com
3. Ozmosi. (2025, January). Value of FDA accelerated approval in drug development. ozmosi.com
4. Review of the impact of the FDA’s Fast Track designation on biotechnology companies’ share prices. (2023). Drug Discovery Today. sciencedirect.com
5. Ridley, D. B., & Régnier, S. A. (2016). The commercial market for priority review vouchers. Health Affairs, 35(5), 776–783. doi.org
6. U.S. Food and Drug Administration. (2014, May). Expedited programs for serious conditions—Drugs and biologics: Guidance for industry. fda.gov
7. U.S. Food and Drug Administration. (2018, January 4). Priority review. fda.gov
8. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. (2025). Fast Track designation request performance. fda.gov
9. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. (2025, January 13). CDER Fast Track designation requests received: Fiscal year 1998–fiscal year 2024 [Table]. fda.gov
10. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. (2025, January 17). CDER brings many safe and effective therapies to patients and consumers in 2024 [FDA Voices]. fda.gov
11. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. (2025, February 14). CDER drug and non-biosimilar biologic IND receipts: Calendar year 2024 [Table]. fda.gov

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