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Historical FDA Catalyst Database & Approval Archive

Analyze historical FDA approval trends with a searchable archive of past PDUFA decisions, Complete Response Letters (CRLs), and key regulatory outcomes across biotech and pharma.
Showing 6 Drugs Out Of 6723. Click On The Tickers For More Details
Ticker Name Price Reaction Best Trade Event Move Market Capital Event Type Drug Name Catalyst Date Poa % Poa Summary Stage Treatment Hedge Funds Description Source
SILO
Silo Pharma, Inc.
4.32 3.10 %
$4.22
47.46%
Pending
6.4M
IND Submission
8%

SPC-15, developed by Silo Pharma (NASDAQ: SILO), is a novel intranasal serotonin 5-HT4 receptor agonist aimed at preventing post-traumatic stress disorder (PTSD). Currently in the IND-enabling preclinical phase, the company plans to submit an Investigational New Drug (IND) application by late 2025. To date, SPC-15 has completed animal studies, showing no local or systemic toxicity and favorable pharmacokinetics, comparable to oral formulations, which is a prerequisite for clinical testing. However, there is currently no human data available, nor any objective response rates or statistical efficacy outcomes, leaving its efficacy and long-term safety in humans entirely unproven. The program is being prepared for the FDA's 505(b)(2) pathway, potentially allowing for an expedited review process based on existing safety or efficacy data from reference drugs. SPC-15’s mechanism of action is unique in the context of PTSD, as it differs from the two currently approved PTSD medications, which are both SSRIs, and from various historical candidates that have failed in this area. CNS small molecules, particularly those aimed at PTSD, have historically shown low Phase 1-to-approval probabilities, with average approval chances estimated at 5–8%, reflecting high attrition rates due to efficacy and safety concerns. Regulatory authorities have not approved a new therapy for PTSD in over two decades, indicating significant challenges in this indication. Currently, there are no Fast Track, Orphan Drug, or Breakthrough Therapy designations for SPC-15, and no PDUFA date has been set, as the drug has not yet entered clinical trials. Ongoing device studies are focused on the proprietary microchip-based nasal spray system, but no human pharmacodynamic or comparative studies against standard care have been reported. Silo Pharma retains global commercialization rights and is collaborating with Columbia University; however, the company has not previously brought a drug through FDA or EMA approval, introducing additional execution risk. Considering the early development stage, lack of human data, specific challenges in CNS and PTSD drug development, and absence of regulatory acceleration, the estimated probability of approval for SPC-15 remains at 5–8%, in line with historical trends in CNS small molecule development.

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IND
20%

Post-traumatic stress disorder

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N/A
SXTP
60 Degrees Pharmaceuticals, Inc.
1.16 -0.85 %
$1.36
23.53%
Pending
3.9M
NDA Filing
30%

ARAKODA® (tafenoquine), developed by 60 Degrees Pharmaceuticals (SXTP), is a small molecule 8-aminoquinoline antimalarial approved by the FDA in 2018 for malaria prophylaxis and currently under investigation for treating babesiosis, a tick-borne parasitic infection with no FDA-approved therapies. The company is running three clinical trials for babesiosis: an open-label expanded access study for relapsing babesiosis (NCT06478641), a Phase 2 double-blind randomized placebo-controlled trial in hospitalized patients (NCT06207370) targeting 33 patients, and a Phase 2 open-label study for chronic babesiosis with severe fatigue (NCT06656351, B-FREE study) aiming for 100 patients. As of October 15, 2025, the first patient in the relapsing babesiosis study tested negative for Babesia infection using highly sensitive tests, marking a positive initial result. On October 3, 2025, the company submitted a Breakthrough Therapy designation request to the FDA and plans to have a Type B meeting in early 2026 to discuss the supplemental New Drug Application (sNDA) requirements. Trial data from ongoing studies is expected in the second half of 2026, with the sNDA submission projected for 2027, although the company remains in late Phase 2 without completed pivotal Phase 3 trials. While the incidence of babesiosis is rising (9% annually from 2015 to 2022), the clinical evidence for tafenoquine's efficacy is still in its infancy, comprising limited case series and a single patient report. The established safety profile from its malaria indication includes risks such as hemolytic anemia in G6PD deficient patients, and common adverse effects like headaches and gastrointestinal disturbances. Historical data suggests that the transition from Phase 2 to approval occurs in about 30% of drug development programs, with orphan and rare disease designations possibly boosting this to 40-50% under certain conditions. While the absence of approved therapies for babesiosis and the increasing public health burden suggest a favorable environment for potential approval, significant challenges remain, including the need for robust efficacy data and the limitations of small and non-randomized trial designs. The estimated probability of approval is 30%, reflecting a balance of unmet medical needs, the drug's safety profile, and the challenges of early-stage development and regulatory scrutiny.

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NDA
100%

babesiosis

N/A
CAMP
CAMP4 Therapeutics Corporation
4.21 22.03 %
$3.44
24.42%
Pending
234.2M
Phase 1/2 data readout
15%

CMP-SYNGAP-01, an investigational therapy by CAMP4 Therapeutics (NASDAQ: CAMP), targets SYNGAP1-related disorders and is currently in Phase 1/2 clinical development. Translational and preclinical studies have shown that CMP-SYNGAP-01 can restore SYNGAP1 protein levels and reduce disease-relevant phenotypes in haploinsufficient mice, as well as enhance protein expression in relevant brain regions of non-human primates. This RNA-targeting therapy employs antisense technology to upregulate gene expression, which has had moderate historical success in treating rare neurological disorders, though there is limited precedent for disease-modifying therapies in monogenic CNS conditions. As of now, there are no publicly available efficacy or safety results from human trials involving SYNGAP1 patients; all existing data is derived from preclinical or animal studies, leaving critical efficacy metrics such as overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and statistical significance undisclosed. The company has reported favorable safety and pharmacokinetic data for a related candidate tested in healthy volunteers, with no serious adverse events (SAEs) or dose-limiting toxicities reported for CMP-SYNGAP-01 thus far, which raises questions regarding human tolerability. No details are available from ClinicalTrials.gov or SEC filings concerning the design of clinical trials, including randomized, placebo-controlled, or blinded designs, comparator arms, or sample sizes. SYNGAP1-related disorders are ultra-rare pediatric neurological conditions with significant unmet needs, and while regulatory agencies typically support innovation in this area with Orphan Drug and Fast Track designations, there has been no confirmation of regulatory status, PDUFA date, or prior interactions with the FDA for CMP-SYNGAP-01. Historically, Phase 1/2 programs in neurology have a low-to-moderate advancement rate, with RNA-targeted therapies achieving overall Phase 1-to-approval probabilities of approximately 10%-25%, according to independent analyses of FDA data for rare CNS and genetic disorders. Existing therapies for haploinsufficiency targeting single-gene pediatric CNS conditions are limited and primarily in early development stages, with failures in similar programs often attributed to insufficient translational efficacy in humans or challenges in CNS delivery. Despite a recent $100 million private placement that reflects strong investor confidence, CAMP4 Therapeutics has no prior approvals or regulatory history for comparable products, nor any experience with Complete Response Letters (CRLs) or resubmissions. In conclusion, while CMP-SYNGAP-01 represents a promising mechanism addressing an urgent need in SYNGAP1-related disorders, the absence of human clinical efficacy and safety data results in an estimated Probability of Approval between 15% and 25%, consistent with historical trends for first-in-class, RNA-targeted therapies for rare CNS monogenic disorders at this stage.

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Phase 1/2
20%

SYNGAP1-related disorders

2
ABEO
Abeona Therapeutics Inc.
6.39 -0.47 %
$4.23
49.17%
Pending
324.3M
IND Filing
9%

ABO-503 is a gene therapy candidate developed by Abeona Therapeutics, targeting X-linked retinoschisis (XLRS) and is currently in the Investigational New Drug (IND) stage. As of now, there are no ongoing or completed clinical trials for ABO-503 listed on ClinicalTrials.gov or mentioned in peer-reviewed literature, SEC filings, or company press releases. Historical data indicates that gene therapies for rare, monogenic ophthalmologic diseases in the U.S. have an average approval likelihood of 7–12% from the IND stage, highlighting the difficult development landscape for these innovative therapies. XLRS presents additional challenges; despite a strong biological rationale for RS1 gene augmentation, previous trials using intravitreal AAV vectors have not shown robust and lasting efficacy. Recent data from Atsena Therapeutics suggests early functional and anatomical improvements from their Phase I/II trial using ATSN-201, but these findings are based on a small cohort and should be viewed with caution until further validated. Currently, there are no approved gene therapies for XLRS globally, and the challenges associated with ocular AAV gene therapies, such as inflammation and delivery precision, are significant. Abeona Therapeutics has not disclosed any FDA regulatory designations for ABO-503, nor has there been any announced PDUFA date or late-stage readouts. The company has a mixed track record with regulatory agencies, having advanced gene therapies in other indications without achieving approval, which contributes to the uncertainty surrounding ABO-503. The estimated probability of approval for ABO-503 in XLRS stands at 9%, reflecting the uncertain efficacy signals, low historical success rates for similar gene therapies, and a lack of disclosed clinical and regulatory milestones.

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IND
20%

X-linked retinoschisis (XLRS)

3
BOLT
Bolt Biotherapeutics, Inc.
3.98 -0.25 %
$3.85
4.16%
Pending
9.5M
phase 1 data readout
7%

BDC-4182, developed by Bolt Biotherapeutics, is a next-generation Boltbody™ ISAC targeting claudin 18.2, set to enter a first-in-human Phase 1 clinical trial for gastric and gastroesophageal cancers in Q2 2025. This immune-stimulating antibody conjugate (ISAC), featuring a TLR7/8 agonist payload, represents a novel biologic approach, with historical Phase 1-to-approval success rates for solid tumors estimated at around 7-8%, based on comprehensive datasets from BioMedtracker and Citeline. The Phase 1 trial is designed as a non-randomized, single-arm, open-label, dose-escalation study involving approximately 122 participants to assess safety and determine the recommended Phase 2 dose. Currently, there are no disclosed human efficacy or safety data for BDC-4182, nor any regulatory designations such as Fast Track or Orphan Drug status. Preclinical studies indicate anti-tumor activity and favorable tolerability in non-human primates at the highest tested dose of 12mg/kg; however, the translation of these preclinical results to human clinical benefit, particularly in complex solid tumors, remains uncertain. Claudin 18.2 is a validated target in gastric and gastroesophageal cancers, supported by previous approvals of agents like zolbetuximab; however, no clinical data is available to confirm that BDC-4182 can match or surpass these outcomes. The trial design lacks comparative or randomized elements, and Bolt has not disclosed prior regulatory outcomes or a PDUFA date. As Bolt's only comparable clinical-stage asset, BDC-3042, is also in early testing without completed pivotal trials, the company lacks historical precedents for regulatory approval. Given the current stage of development and absence of safety, dose-finding, or preliminary efficacy data, the estimated probability of approval (PoA) of 7% is consistent with historical benchmarks for Phase 1 biologics in high-risk oncology indications.

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Phase 1
20%

gastric cancer, gastroesophage

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1
AARD
Aardvark Therapeutics, Inc.
7.08 7.27 %
$3.48
72.13%
Pending
99.0M
phase 3 data readout
30%

ARD-101 is an oral pan-agonist of bitter taste receptors (TAS2R) developed by Aardvark Therapeutics for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS), currently in Phase 3 development. This small molecule aims to regulate hunger by stimulating enteroendocrine cells and modulating gut-brain signaling, with the potential to trigger the release of endogenous satiety hormones such as GLP-1 and CCK, representing a novel therapeutic approach. The FDA has granted ARD-101 Orphan Drug and Fast Track designations, indicating recognition of the unmet need and the potential for expedited development and review processes. However, key details regarding the Phase 3 trial—such as randomization, blinding, sample size, comparator arms, and endpoints—have not been disclosed, and there is currently no public data from Phase 2 or interim Phase 3 trials for ARD-101 in PWS. Historically, the probability of approval from Phase 3 for rare disease CNS/metabolic indications with small molecule oral drugs is estimated at 40-60%, but this figure decreases for first-in-class agents and recent regulatory precedents. The competitive landscape has changed with the FDA's approval of VYKAT XR (diazoxide choline) in April 2025 as the first treatment for hyperphagia in PWS, which demonstrated statistically significant efficacy and a favorable safety profile in a robust Phase 3 trial. In contrast, ARD-101 lacks a PDUFA date and has not announced any recent regulatory milestones, with no published head-to-head efficacy data against VYKAT XR. Aardvark Therapeutics has limited regulatory experience, with no approved products in the US market, contributing to a lower probability of approval for ARD-101. Given the absence of disclosed efficacy and safety outcomes and the emergence of a competitive market, the estimated probability of approval for ARD-101 in this indication is set at 30%, accounting for both the baseline Phase 3 probability and factors that negatively impact its competitiveness.

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Phase 3
60%

hyperphagia associated with Pr

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1

• FAQs

Frequently asked questions about historical FDA data

The approval archive above lists past FDA approvals and Complete Response Letters by date, so you can pull up the decisions from any given week or month and see the company, drug, and indication for each. It captures both clearances and rejections, which matters because a withheld approval (a CRL) is often as informative as a positive outcome. To browse the dataset, sort or filter the archive by the period you care about. For decisions that have not happened yet, switch to the upcoming calendar rather than this historical record.

It is a searchable record of past FDA decision dates and the outcomes attached to them: which drugs were approved, which received a Complete Response Letter, and when each decision landed. Unlike a forward calendar of pending events, the archive above lets you study completed catalysts and trace how specific approvals played out over time. You can review outcomes across biotech and pharma in one dated view, then jump to the live calendar for decisions still ahead.

A Complete Response Letter means the FDA declined to approve an application in its then-current form and asked the company to fix specific deficiencies, which can span manufacturing, labeling, safety, or efficacy. Browsing past CRLs in the archive above shows how a given type of problem tended to be resolved on resubmission and roughly how long the second review cycle ran. Because a CRL starts a new review clock and a new decision deadline, the record often shows a later approval for the same drug once the issues were addressed. This is general information, not investment advice.

Looking back at completed decisions in the archive above helps you see how frequently drugs in a given phase, disease area, or review type were approved, and how the underlying stocks tended to react. That retrospective context is the foundation for gauging the probability and risk of similar events still to come. Pair the archive with the live calendar so you can move from studying what already happened to tracking what is coming next. This is general information, not investment advice.

The review deadline (the PDUFA date) is the FDA's target to act on an application, while the approval date is the day the agency actually clears the drug, which can fall on, before, or after that target. In the archive above both can appear, and the gap between them shows whether a decision came early, on time, or after an extension to assess new information. Not every listed deadline ends in an approval: some past entries resolve as a Complete Response Letter rather than a clearance.

A New Drug Application (NDA) is the submission used to clear small-molecule, chemically synthesized drugs, while a Biologics License Application (BLA) covers biologics such as antibodies, vaccines, and cell and gene therapies. Both are reviewed under the same decision timelines and both resolve as either an approval or a Complete Response Letter, so both appear throughout the approval archive above. The distinction is worth noting when comparing historical approvals, because biologics follow a separate regulatory pathway with different exclusivity rules.

The archive above is compiled from primary disclosures: FDA approval announcements, company press releases, and SEC filings, then consolidated into one dated view of decisions and outcomes. Past entries are retained after a decision is issued, so the timeline stays auditable and you can reconstruct what was known and when. For decisions still pending, the upcoming calendar is the place to look rather than this archive.