The biopharma community is divided over the FDA’s new policy to publish Complete Response Letters (CRLs), which are now available here in the AlphaSense platform.
In a move to increase transparency, the U.S. Food and Drug Administration has instituted real-time public disclosure for CRLs. The FDA announced in September that it will publish CRLs in real time and released 89 CRLs for non-approved drug candidates. This was a step beyond the FDA’s first publication of 200 CRLs on July 10, which covered only already-approved drugs.
These CRLs are an important signal for biopharmas, industry watchers, and investors as they detail why a new drug or biologics license application cannot be approved in its current form. The shift toward publicizing this previously private correspondence fundamentally reshapes the biopharmaceutical regulatory landscape, creating new risks and strategic opportunities across the entire healthcare ecosystem.
With the help of Tegus Expert Insights and other tools available in AlphaSense, let’s dive into the FDA’s CRL decision and the market implications.
About CRLs
The FDA has used CRLs for decades to signal that a marketing application is not yet ready for approval. A CRL is issued instead of an approval when the FDA has outstanding questions on safety, efficacy, manufacturing, bio-equivalence, or labeling. CRLs are not unusual: Roughly 30% of new drug and biologic applications submitted between 2018 and 2023 received a CRL rather than a first-cycle approval.
However, the decision to make CRLs publicly available marks a departure from the historical precedent of confidential regulator–sponsor correspondence. Previously, drug sponsors often issued high-level press releases instead of publishing the CRL, leaving investors and clinicians reliant on company summaries. Yet the FDA said that, with this practice, sponsors “often misrepresent” the rationale behind the FDA’s decisions.
The FDA’s initial move to address the issue in July was a retrospective release of more than 200 historic CRLs covering approved drug and biologic applications filed between 2020 and 2024. Then in a second, more controversial move, the FDA released 89 additional letters covering nonapproved drugs and announced that all future CRLs will be released upon issuance.
While July communications generally reflected early-warning deficiency notices, the second tranche crystallized these deficiencies into formal rejections demanding additional studies or controls before approval. Prior to the September release, one former FDA deputy director outlined the difficulties and potential opportunities tied to releasing CRLs for nonapproved drugs:
“It would be more interesting, more controversial, and more cutting-edge to pivot to publishing complete response letters for drugs that are still not approved because [with] those, you also have to start navigating confidentiality issues and all that. That is a much stickier road to go down.”
– Former Deputy Director at the FDA, July 2025 Call
Real-Time Disclosure: Opportunities and Risks
The FDA’s policy progression on CRLs transforms the documents from a confidential regulatory signal into an immediate public event. This shift carries material implications across life sciences, with distinct implications for different players.
Clinicians, Patients, and Wall Street Welcome the Move
For clinicians and patients, the added transparency can potentially help with treatment planning and risk assessment whereas before, FDA conclusions such as the need for new trials or specific safety and efficacy concerns were largely kept under wraps.
Investors and analysts largely welcome the FDA’s transparency push, broker research in AlphaSense shows. Analysts say direct visibility into regulatory decision-making enhances the speed and quality of price discovery, plus the CRLs can be used to draw inferences about regulatory outcomes for other biopharma companies.
“We see several takeaways from the CRLs for our coverage, both regarding potential paths forward for the rejected drugs and in elucidating potential FDA approaches to upcoming approval decisions.”
– RBC Capital Markets, September 4, 2025
Experts agree that for the investment community, this wealth of newly accessible information can translate into a powerful competitive advantage: more data at their fingertips than ever before.
“Since this is so new, it is hard to speculate on exactly what investors will extrapolate out of these letters and how they will respond…but I can tell you that there is a context [now for] the [drug application’s] deficiencies…and it should matter to [investors].”
– Consultant at Biomedix, October 9, 2025
Transparency a Double-Edged Sword for Biopharmas
The impact on biopharma companies is highly differentiated by company type, but by and large, they have generally opposed publishing of CRLs, according to trade journals. Biopharma companies, particularly small- and mid-sized ones, see CRL releases as creating unnecessary reputational and litigation risk, as well as jeopardizing trade secrets.
“If we are unable to prevent unauthorized material disclosure of our trade secrets to third parties, we may not be able to establish or maintain a competitive advantage in our market, which could harm our business, operating results, and financial condition.”
– Urogen Pharma Annual Report, July 15, 2025
Although privacy and confidentiality remain sticking points for biopharma sponsors, one industry expert said the FDA takes stringent measures to quell privacy concerns.
“[The FDA is] very good at [redactions] across the board. …They have an internal team review the whole document, they decide what they are going to redact, and then it goes through a system of redactions. They do a keyword search so that clinical data isn't left in there, something that might breach privacy concerns that the company has.”
– Consultant at Biomedix, October 2025 Call
Meanwhile, rapid stock market repricing can coincide with public postings of CRLs, especially if a posting comes without advance notice to the sponsor. The recent class-action lawsuit against Capricor Therapeutics highlights a central tension: When a company’s stock drops after negative regulatory news (in this case by nearly 33%), is the cause the disclosure itself or the company’s prior lack of transparency? The plaintiffs argue that Capricor’s failure to fully communicate FDA feedback misled investors, implying that earlier disclosure could have mitigated the stock decline.
Yet some biotechs have a positive view on the FDA’s transparency push, particularly those developing new drugs. These companies say they can now benchmark against real-world clinical trial design, manufacturing, and bioequivalence pitfalls, which can help strengthen FDA submissions and reduce the chance of costly rejections. Firms are already using this intelligence to their advantage.
“One of the benefits of being second is you get to see what the…company that was ahead of you went through [in the FDA approval process]. …Our read of [our competitor’s] CRL is [that] there was a study that was not completely done the way that the FDA wanted it to be done. …So one of the things we really focused on is making sure we did everything that the FDA asked for.”
– Aquestive Therapeutics Q2 Earnings Call, Aug. 12, 2025
Similarly, developers of generic drugs and biosimilars say they can apply lessons from branded-drug CRLs. Biopharmas that have received CRLs can review other CRLs to prepare for resubmission. Even big pharma companies potentially benefit as they can use insights from CRLs to evaluate potential M&A targets. Experts say biopharma companies, regardless of their vantage point, will be forced to sharpen their regulatory strategies, not just to meet FDA requirements, but also to enhance their competitive position.
“If there is a competitor that is coming out soon, they can start learning from your CRL and mitigate it accordingly. …If you're a big pharma, even if you're a small pharma…you should have someone who is putting together an assessment of what kinds of CRLs are coming out from the FDA, that are not approved, and the ones that are approved.”
– Drug Development Consultant at Honda Scientific, October 2025 Call
At AlphaSense, we offer immediate access to FDA CRLs within our platform. Our AI features — including Generative Search, Generative Grid, and Deep Research — enable a thorough, nuanced understanding by automatically connecting CRLs to relevant clinical trial data, company filings, and historical precedents. This integrated analysis helps industry players and investors quickly identify regulatory patterns, key deficiency factors, and the risks and rewards accompanying each decision.
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