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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 9361. 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
RXRX
Recursion Pharmaceuticals, Inc.
3.83 -4.96 %
$2.85$4.03
41.4%
-4.96%
2.1B
Phase 1b/2 data readout
REC-4881 (MEK1/2 inh

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Fast TrackOrphan
28%

REC-4881 is an oral, non-ATP-competitive allosteric MEK1/2 inhibitor being developed by Recursion Pharmaceuticals (RXRX) for familial adenomatous polyposis (FAP), a rare inherited syndrome that predisposes individuals to colorectal cancer. This program is particularly significant given that FAP currently lacks any FDA-approved disease-modifying drug therapies. Management of this condition primarily relies on surgical interventions, endoscopic procedures, and often prophylactic colectomy, highlighting a substantial unmet medical need for a non-surgical treatment option that effectively reduces polyp burden and delays the need for surgery. In this context, REC-4881 is classified as first-in-class, as there are no approved MEK inhibitors available for this indication. As of the latest public disclosures, REC-4881 is in Phase 1b/2 of the TUPELO study (NCT05552755). This multicenter, two-part trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the drug in patients with FAP who have undergone colectomy or proctocolectomy. The trial is currently in an open-label Phase 2 portion, although earlier company communications indicated intentions to conduct a randomized, double-blind, placebo-controlled Phase 2 study. Notably, the primary efficacy readouts thus far have focused on total polyp burden rather than traditional oncology endpoints such as overall response rate (ORR), progression-free survival (PFS), or overall survival (OS). In an update from April 2025, five efficacy-evaluable patients demonstrated a greater than 30% median reduction in total polyp burden after 12 weeks of treatment. By December 2025, further data suggested a durable benefit, with 82% of evaluable patients maintaining a reduction in polyp burden after 12 weeks off therapy, resulting in a 53% median reduction from baseline. However, treatment-related adverse events were reported in most patients, primarily manifesting as rash/dermatitis and CPK elevations, with the majority classified as grade 1 or 2, and a smaller proportion as grade 3. Regulatory designations for REC-4881 in the context of FAP are supportive but limited. The drug has received U.S. Orphan Drug designation and FDA Fast Track designation, as well as EU Orphan Drug designation. However, there is no public evidence of Breakthrough Therapy, Priority Review, or Accelerated Approval for this indication. While these designations provide some regulatory momentum, they do not offer the near-term de-risking advantages associated with breakthrough designations or accelerated pathways. The competitive landscape for REC-4881 is characterized by a small, specialized market with varying standards of surgical and endoscopic care. Consequently, the commercial success of REC-4881 hinges on demonstrating a clear and durable reduction in polyp burden that can effectively delay surgical interventions and enhance long-term management of FAP. Given the limited size of the clinical dataset and its largely non-randomized nature, the Probability of Approval (PoA) is assessed at 28.0%. This figure reflects a meaningful mechanistic rationale, along with orphan and Fast Track support, and encouraging early efficacy data, but is tempered by the necessity for more robust randomized evidence and ongoing monitoring of MEK-class toxicities. In terms of comparable precedents, the outcomes for targeted rare-disease approvals in small populations have been mixed. Success is often contingent on clear clinical benefits and manageable safety profiles, while programs that depend on small, open-label datasets may struggle if subsequent randomized data fail to confirm a strong effect. For REC-4881, the critical question remains whether the observed reductions in polyp burden can translate into durable, clinically meaningful benefits with acceptable tolerability.

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Phase 1b/2
20%

Familial Adenomatous Polyposis

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1
OCS
Oculis Holding AG
7.71 -6.66 %
$7.17$8.26
15.2%
-6.66%
474.8M
Phase 2 data presentation
Privosegtor
BreakthroughOrphan
32%

Privosegtor, also known as OCS-05, is under development by Oculis Holding AG for the treatment of acute optic neuritis. This drug is classified as a first-in-class peptoid small molecule with neuroprotective properties, aiming to preserve retinal ganglion cells and optic nerve axons rather than merely accelerating recovery from inflammation. The existing evidence supports its classification as first-in-class, as no approved therapies for acute optic neuritis with a similar neuroprotective mechanism have been identified. The commercial potential for privosegtor is challenging to quantify accurately. Acute optic neuritis represents a specialized segment of the disease landscape rather than a large standalone pharmaceutical market, and no reliable public source currently provides a specific global dollar estimate for this indication. However, the opportunity could still be significant if privosegtor secures a broad label that encompasses patients with both multiple sclerosis-associated and idiopathic optic neuritis. The unmet need in this area is substantial, as current management primarily relies on corticosteroids, which can help reduce or accelerate inflammatory recovery but do not provide an established neuroprotective treatment to prevent retinal ganglion cell and axonal loss. The completed ACUITY study was a multicenter, randomized, double-masked, placebo-controlled Phase 2 trial. In this trial, patients with acute optic neuritis received intravenous privosegtor at doses of 2 or 3 mg/kg daily for five days, in conjunction with intravenous methylprednisolone. The study specifically excluded AQP4-positive patients and enrolled individuals with symptom duration of less than 12 days. Public disclosures from the trial indicate improvements in visual function, preservation of retinal structures—including the ganglion cell-inner plexiform and retinal nerve fiber layers—and reductions in plasma neurofilament light chain and GFAP levels. However, the public record does not provide the trial's NCT number, enrollment count, complete definitions of primary and secondary endpoints, odds ratios, hazard ratios, confidence intervals, or fully detailed p-values. Notably, traditional endpoints such as overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) are not applicable to this program and have not been reported. Oculis has advanced the program into the PIONEER-1 trial, a registrational study enrolling patients with acute-onset optic neuritis from a broader population, including those with and without multiple sclerosis. While the available evidence does not confirm whether the program has formally progressed beyond Phase 2 in every regulatory classification, the registrational program indicates movement toward pivotal development. Regarding regulatory designations, privosegtor has received orphan-drug designations from both the FDA and EMA, and the FDA has also granted Breakthrough Therapy designation for this indication. However, Fast Track, Priority Review, and Accelerated Approval statuses remain unconfirmed. Although the program has been described as well tolerated, no detailed adverse-event table or discontinuation rates are available, which raises concerns about potential safety risks in later-stage development. The competitive landscape for acute optic neuritis primarily consists of corticosteroid-based standard care and investigational neuroprotective approaches, rather than approved disease-modifying therapies. The closest precedents are mechanism- and development-stage comparators rather than recently approved drugs for acute optic neuritis. A key lesson from these precedents is that biomarker preservation must support reproducible, clinically meaningful visual outcomes. The estimated probability of approval (PoA) for privosegtor stands at 32.0%, reflecting encouraging signals from the randomized Phase 2 trial, regulatory designations, and progression into registrational testing. This estimate is tempered by the incomplete numerical disclosure, uncertain endpoint validation, the small and heterogeneous target population, and execution risks associated with the PIONEER-1 trial.

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Phase 2
40%

acute optic neuritis

2
TLSA
Tiziana Life Sciences Ltd
0.67 -16.25 %
$0.77$0.80
3.88%
-16.25%
85.3M
Phase 2a data readout
20%

Foralumab, an intranasal fully human anti-CD3 monoclonal antibody developed by Tiziana Life Sciences (TLSA), is currently undergoing a Phase 2a clinical trial (NCT06292923, INFORM-MS) for non-active secondary progressive multiple sclerosis (na-SPMS). Enrollment is ongoing as of March 2025, with 17 out of 54 patients enrolled and top-line data anticipated in the first half of 2026. Preliminary open-label data from a cohort of 10 na-SPMS patients, who were experiencing progression despite prior B-cell therapies, indicate positive results. All patients demonstrated stabilization in their Expanded Disability Status Scale (EDSS) scores, and 3 out of 4 showed improvement over a 12-month period. Additionally, 6 out of 10 patients reported reduced fatigue according to the Modified Fatigue Impact Scale, and no new T2 MRI lesions were detected. Significant reductions in microglial activation were observed via TSPO-PET imaging (p<0.05 at 3 and 6 months), with no serious treatment-related adverse events reported. Similar positive trends were noted in an Expanded Access program involving 14 patients. Historical success rates for biologics in neurology indications, particularly for multiple sclerosis, are approximately 15-25%. This low probability is compounded by the challenges associated with na-SPMS, which is characterized by progression independent of relapse and has limited approved therapies available, alongside high placebo response risks in smaller trials. Additionally, there is a lack of prior Phase 3 data, PDUFA dates, Complete Response Letters, or a history of approvals in the MS space by the sponsor. Foralumab's approach of intranasal immunomodulation targeting microglial inflammation sets it apart from existing B-cell depletors like ocrelizumab used for primary progressive MS. However, the absence of direct comparator trials or validated endpoints such as progression-free survival (PFS), overall survival (OS), or overall response rate (ORR) remains a concern. The estimated probability of approval is 20%, reflecting promising preliminary biomarker and safety signals that support advancement to Phase 2. This estimate is moderated by the early-stage nature of the trial, the modest sample size, the absence of pivotal efficacy readouts, and the typical attrition rates associated with monoclonal antibodies in the progressive MS landscape.

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Phase 2a
40%

Non-Active Secondary Progressi

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N/A
DARE
Dare Bioscience, Inc.
0.655 -6.38 %
$0.64$0.70
8.67%
-3.89%
12.9M
Pre-clinical data presentation
8%

DARE-IDDS represents Daré Bioscience’s investigational, programmable implantable drug-delivery platform, with its primary application focused on contraception through the DARE-LARC1 initiative. This product aims to deliver levonorgestrel, a well-established contraceptive hormone utilized in various FDA-approved methods, via an implanted device over an extended duration. The platform is designed to support wireless control, potentially allowing users to activate, deactivate, or tailor the delivery of the hormone without the need for daily adherence or frequent replacement procedures. The global market for injectable and implantable contraceptives is estimated to be approximately $1.5 billion. However, this figure is somewhat imprecise, as public sources typically report broader categories encompassing hormonal contraception or long-acting reversible contraception rather than specifically isolating the chronic injection and implant segment. DARE-IDDS is not first-in-class due to its use of levonorgestrel; however, its potential differentiation lies in its delivery duration, programmability, wireless control, and reduced necessity for repeat procedures. The unmet need in this market is significant. While existing long-acting contraceptives are effective, users often encounter challenges such as the need for insertion or removal procedures, irregular bleeding, limited reversibility control, adherence barriers, and access constraints. Currently, DARE-IDDS is in the preclinical development stage and has not yet received any regulatory designations or FDA approval pathways that would facilitate its progression. The available public information indicates that no indication-specific designation has been identified, and the device remains investigational, with no clearance for human clinical investigation reported. The estimated probability of approval (PoA) for DARE-IDDS stands at 8.0%. This figure represents the likelihood of eventual U.S. marketing approval from the current preclinical stage, rather than the probability of entering clinical trials. A reasonable uncertainty range for this estimate is approximately 3% to 15%. Key risks associated with the program include the absence of human clinical trial data, which means no efficacy, safety, pharmacokinetic, or device-performance data have been reported. Additionally, concerns regarding implant reliability, dose accuracy, battery or wireless-control performance, infection risk, migration, tissue reaction, explantation, and unintended prolonged hormone exposure could pose significant regulatory challenges. The product may also necessitate a complex drug-device regulatory pathway, which could involve demanding combination-product manufacturing and human-factors requirements. Upcoming catalysts for DARE-IDDS include the completion of nonclinical and IND-enabling development, although specific timelines have not been disclosed. Furthermore, the FDA authorization or submission for a first-in-human clinical trial is anticipated, with no disclosed timing. Additional grant installments supporting the program are expected, with a reported installment due in October 2025 and a disclosure in October 2026. In summary, while DARE-IDDS has the potential to be classified as best-in-class if successful, it is important to note that it is not first-in-class due to its established hormone component. The competitive landscape includes established levonorgestrel implants and depot medroxyprogesterone injections, which have set high standards for efficacy, safety, and user experience. The 8.0% PoA reflects the considerable attrition associated with preclinical combination products and the lack of human data. Positive factors include the established active ingredient, a focused contraception use case, substantial grant support, and plausible user-convenience advantages. However, the absence of clinical trials, regulatory designations, and outstanding technical and clinical validation underscore the challenges ahead. The most critical catalysts for success will be the completion of IND-enabling studies, obtaining FDA clearance for a first-in-human trial, and demonstrating reliable long-term delivery with acceptable safety profiles.

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Pre-clinical
10%

Contraception, chronic injecti

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N/A
NRSN
NeuroSense Therapeutics Ltd.
1.43 -28.14 %
$2.13$2.13
0%
-32.86%
2.7M
Phase 2b data presentation
PrimeC (extended-rel

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Orphan
24%

PrimeC is an investigational extended-release oral combination therapy developed by NeuroSense Therapeutics for the treatment of amyotrophic lateral sclerosis (ALS). This innovative formulation combines ciprofloxacin and celecoxib, targeting multiple disease processes associated with ALS, including neuroinflammation, excitotoxicity, mitochondrial dysfunction, and the pathological biology of TDP-43. As a first-in-class therapy, PrimeC stands out in the ALS treatment landscape, although its components are established drugs rather than novel entities. The primary clinical evidence for PrimeC is derived from the PARADIGM study, a multinational, randomized, double-blind, placebo-controlled Phase 2b trial (NCT05357950). In this study, approximately 68–69 patients were enrolled and randomized in a 2:1 ratio to receive either PrimeC or placebo for six months, followed by a 12-month open-label extension. Initial results from the six-month analysis indicated a 29% treatment difference in the decline of the ALS Functional Rating Scale-Revised (ALSFRS-R), although this result did not reach statistical significance (p=0.12). Additionally, a 13% improvement in slow vital capacity was observed favoring PrimeC (p=0.5). Subsequent analyses reported by the company indicated a 33% reduction in functional decline over 18 months, with statistically significant ALSFRS-R differences of 36.5% at 12 months (p=0.008) and 32.8% at 18 months (p=0.007). A median survival benefit of approximately 15 months was also reported, with a hazard ratio of 0.35 (p=0.004). Furthermore, reductions in TDP-43 levels were noted at Day 180 (p=0.0421) and sustained at Day 540 (p<0.001). While these findings are promising, the small sample size raises concerns regarding the reliability of effect size, survival outcomes, and subgroup consistency, as independent peer-reviewed validation and complete confidence intervals are not yet available. The safety profile of PrimeC appears favorable, with adverse events generally classified as mild to moderate and transient, and no new safety signals reported through 18 months. However, the small sample size limits the ability to exclude rare but significant toxicities associated with ciprofloxacin and celecoxib, including risks related to QT effects, tendon injury, gastrointestinal bleeding, renal injury, cardiovascular concerns, and potential drug interactions. The global market for ALS treatments is projected to reach $819.7 million by 2025. This market opportunity is underscored by the severe burden of the disease, the limited options for extending survival, and a significant unmet need. Current approved therapies, such as riluzole, edaravone, and tofersen (for genetically defined SOD1-ALS), offer only modest benefits. Thus, a tolerable oral therapy capable of reproducibly modifying disease progression could differentiate PrimeC in the marketplace. Regulatory designations for PrimeC include Orphan Drug Designation, while Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval designations have not been confirmed. The program has progressed beyond the Phase 2b setting, with NeuroSense announcing FDA clearance in November 2025 to initiate the PARAGON Phase 3 trial. However, specific details regarding the NCT number, enrollment targets, and complete protocol for PARAGON have not been disclosed. In conclusion, while the available evidence suggests a strong potential for PrimeC, the path to approval necessitates robust, clinically meaningful data. Historical precedents in ALS indicate that approval requires substantial evidence despite the high unmet need. The modest survival benefits established by riluzole, the functional decline data supporting edaravone, and the biomarker reduction leading to tofersen's accelerated approval highlight the rigorous standards for ALS therapies. Given the small Phase 2b dataset and the absence of definitive pivotal evidence, the estimated probability of approval for PrimeC is currently set at 24.0%. The key catalysts for investment will be the successful initiation and execution of the PARAGON trial, while the primary risk lies in the inability to replicate the significant survival and functional effects observed in the Phase 2b study.

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Phase 2b
40%

Amyotrophic lateral sclerosis

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N/A
NRXP
NRX Pharmaceuticals, Inc.
2.17 -4.41 %
$2.40$2.66
10.83%
-18.42%
94.0M
PDUFA Date
-
PDUFA
100%

suicidal ideation in patients

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N/A

• 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.