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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 9051. 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
LGVN
Longeveron Inc.
2.71 -57.78 %
$5.95$7.33
23.19%
0.45%
8.2M
Phase 2b topline data readout
laromestrocel (Lomec

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Fast TrackOrphanRare Pediatric
22.5%

Laromestrocel (Lomecel-B®), developed by Longeveron (LGVN), is a first-in-class, bone marrow-derived mesenchymal stem cell (MSC) therapy administered via intramyocardial injection as an adjunct to Stage II (BDCPA) surgery for hypoplastic left heart syndrome (HLHS). HLHS is a rare and fatal congenital cardiac defect, with an estimated global market size of $150 million. This market is driven by the high costs associated with multi-stage surgeries and long-term care. Despite this financial potential, there exists a significant unmet medical need due to the absence of curative options and the high rates of right ventricular failure and mortality among affected patients. The mechanism of laromestrocel involves the delivery of biological signals that support right ventricular (RV) function and enhance overall cardiovascular performance. This therapeutic approach aims to provide a regenerative solution rather than merely managing symptoms, setting it apart from traditional surgical interventions and positioning it within a novel therapeutic class. Currently, laromestrocel is undergoing development in a Phase 2b trial (ELPIS II), with full enrollment achieved in June 2025 and top-line results expected in August 2026. The pivotal Phase 1 trial (ELPIS I, NCT03525418) demonstrated safety, with no major adverse cardiac events reported, and promising efficacy outcomes, including a 100% survival rate free of transplant at 1 to 3.5 years. Additionally, significant quantitative improvements in tricuspid regurgitant fraction (TR RF) were observed at both 6 and 12 months (P < 0.05). The ongoing Phase 2b trial (NCT04925024) is designed to evaluate safety, tolerability, and efficacy in a larger cohort, focusing on primary endpoints related to RV function and freedom from transplant. Regulatory designations for laromestrocel in the context of HLHS include Orphan Drug and Fast Track status, both granted in November 2021, while Breakthrough Therapy and Priority Review designations have not been awarded. These regulatory recognitions underscore the FDA's acknowledgment of the disease's rarity and the therapeutic potential of laromestrocel, although they do not guarantee approval. The competitive landscape for HLHS therapies currently lacks any approved MSC treatments. Other investigational approaches, such as cardiosphere-derived cells, have demonstrated feasibility but remain unapproved. Notable precedents in the field include the 2023 accelerated approval of talimogene laherparepvec (T-VEC) for melanoma based on surrogate endpoints, contrasted with the 2022 rejection of a stem cell therapy for heart failure due to inadequate survival data. The estimated probability of approval (PoA) for laromestrocel stands at 22.5%. This figure reflects the inherent risks associated with small-sample cell therapy trials, reliance on surrogate endpoints, and the FDA's stringent requirements for therapies addressing life-threatening conditions. While early data from the trials are compelling, the limited scale of the studies and potential challenges related to manufacturing and safety present significant hurdles. Key upcoming catalysts include the anticipated top-line results from the ELPIS II trial in August 2026 and a potential Biologics License Application (BLA) submission for HLHS, which may occur in the fourth quarter of 2026 if the trial results are favorable. Investors should closely monitor FDA feedback regarding endpoint adequacy and manufacturing consistency, as these factors will be critical in determining the path to approval.

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Phase 2b
40%

hypoplastic left heart syndrom

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1
VRCA
Verrica Pharmaceuticals Inc.
4.65 2.65 %
$4.38$4.58
4.57%
-1.09%
79.9M
Phase 3 data presentation
97%

YCANTH (VP-102; cantharidin 0.7% topical solution) is a topical film-forming product developed by Verrica Pharmaceuticals for the treatment of molluscum contagiosum, a contagious viral skin infection that predominantly affects children. The program has successfully transitioned from Phase 3, with the FDA granting approval on July 21, 2023, for the topical treatment of molluscum contagiosum in adults and pediatric patients aged 2 years and older. This approval is based on the results of two identical randomized, double-blind, placebo-controlled Phase 3 trials, known as CAMP-1 and CAMP-2 (also referred to as VP-102-101 and VP-102-102; NCT03377790 and NCT03377803). In these trials, subjects received treatment every 21 days for up to four applications, with the primary endpoint being the complete clearance of all treatable lesions by Day 84. The reported efficacy was robust and statistically significant, showing complete clearance rates of 46% versus 18% in CAMP-1 and 54% versus 13% in CAMP-2, both with p<0.0001. These compelling data, along with the FDA approval, effectively de-risk the program, leading to a probability of approval (PoA) of 97.0%. The market landscape for YCANTH is characterized by a significant unmet need. Molluscum contagiosum has historically lacked an FDA-approved treatment, and the FDA has classified YCANTH as the first approved treatment for this condition. The global market size for molluscum contagiosum is projected to reach $2.53 billion by 2025, highlighting the potential for commercial success. Despite the self-limited nature of the disease, the approval of YCANTH addresses a meaningful unmet need in the market. However, several key risks must be considered. There is a commercial adoption risk due to the disease's often self-limited course and the burden of topical administration. Additionally, safety and tolerability concerns arise from local application-site reactions, which may include vesicles, pain, pruritus, erythema, and scabbing. Furthermore, reimbursement and execution risks are present, particularly for a niche dermatology product that is heavily utilized in pediatric populations. Regulatory designations for YCANTH appear limited, as the FDA did not grant any molluscum-specific Fast Track, Orphan, Breakthrough, Priority Review, or Accelerated Approval designations. Despite this, the successful approval of YCANTH represents a significant achievement for Verrica Pharmaceuticals, as it is the first FDA-approved treatment for molluscum contagiosum, which mitigates broader execution concerns regarding the sponsor's track record. In terms of competitive positioning, YCANTH stands out as the only approved treatment for molluscum contagiosum in the U.S. market. While the mechanism of action—vesicant destruction of infected lesions through cantharidin—is well-known, the product's regulatory status is novel for this indication, reinforcing its classification as first-in-class. Looking ahead, upcoming catalysts include post-approval regulatory and label-expansion updates, as well as additional postmarketing safety or utilization disclosures, although specific timelines have not been disclosed. Overall, the current approval status of YCANTH, supported by strong clinical data and a favorable benefit-risk profile, leads to a high degree of confidence in its market potential and justifies the 97.0% probability of approval.

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Phase 3
60%

molluscum contagiosum

2
VRCA
Verrica Pharmaceuticals Inc.
4.65 2.65 %
$4.38$4.58
4.57%
-1.09%
79.9M
Phase 2 data presentation
22.5%

VP-315, also known as ruxotemitide, is an innovative intratumoral oncolytic peptide program developed by Verrica Pharmaceuticals for the treatment of basal cell carcinoma (BCC). This drug aims to provide a non-surgical immunotherapeutic option for patients with locally treated primary lesions, and it may also have potential as a neoadjuvant therapy. The primary clinical study associated with this program is identified as NCT05188729, which is a Phase 2, multicenter, open-label, dose-escalation, proof-of-concept study that includes a safety run-in. The second part of the trial evaluated once-daily intratumoral dosing over 2 to 3 days, targeting up to two lesions per subject with a maximum daily dose of 8 mg. The key objectives of this trial include assessing safety, tolerability, maximum tolerated dose, pharmacokinetics, and objective antitumor activity. As of now, the study has enrolled 82 subjects across 92 lesions in Part 2, indicating that this remains an early-stage development program rather than a late-stage pivotal asset. The efficacy signals emerging from the trial are encouraging, though not yet definitive. Preliminary results indicate approximately 51% complete histologic clearance, 86% overall tumor size reduction, and a 71% reduction among tumors with residual disease. Furthermore, exploratory analyses suggest that some patients experienced reductions in untreated lesions, which may indicate potential systemic immune activity. However, these findings are derived from small subsets and open-label observations, lacking robust randomized comparisons or data on hazard ratios, progression-free survival, or overall survival. Such data is typically expected in localized dermatologic indications, leaving significant uncertainty regarding the effect size and durability of the treatment. Safety data thus far appears acceptable, with reports highlighting local skin reactions and no major systemic safety signals emerging from the available data. Nonetheless, the total population exposed to the treatment remains too small to definitively rule out uncommon adverse events or tolerability issues that could arise with broader use. From a regulatory perspective, there is currently no public evidence indicating that VP-315 has received Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations for BCC. This absence suggests that the program will need to demonstrate success based on conventional clinical and regulatory criteria. Market analysis indicates that the BCC treatment market is substantial, with projected global revenues reaching approximately $8.53 billion by 2026. While there is a genuine unmet need, particularly for patients who are difficult to treat or averse to surgery, the existing surgical options remain highly effective. Thus, any new drug must demonstrate clear advantages in terms of recurrence rates, cosmetic outcomes, convenience, or suitability for non-surgical patients. VP-315 is classified as a first-in-class therapy, as its intratumoral oncolytic peptide mechanism is distinct from currently approved BCC treatments. However, it faces significant competition from established surgical methods and hedgehog-pathway inhibitors used in advanced disease. The risks associated with VP-315 include the promising yet preliminary nature of the Phase 2 data, the absence of regulatory designations, and the lack of randomized confirmation. These factors contribute to a modest approval risk for this innovative dermatology-oncology asset, particularly given the strong existing standards of care in the field. Therefore, a probability of approval (PoA) of 22.5% is a reasonable estimate based on the current data and market conditions.

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Phase 2
40%

basal cell carcinoma (BCC)

2
BLSM
BlossomHill Therapeutics, Inc. Common Stock
26.82 2.17 %
$15.80$26.25
66.14%
20.75%
—
Phase 1/2 data presentation
BH-30643
Fast Track
23%

BH-30643 is BlossomHill Therapeutics’ lead clinical program, representing an oral, non-covalent, macrocyclic, mutant-selective OMNI-EGFR inhibitor designed to retain efficacy against EGFR resistance mutations, particularly C797S. The company positions BH-30643 as brain-active and effective across a range of classical EGFR mutations, atypical mutations, exon 20 insertions, and T790M/C797S resistance settings. The relevant development program, known as SOLARA, is a global, open-label Phase 1/2 first-in-human study (NCT06706076) targeting locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR and/or HER2 mutations. Public disclosures indicate that the study has enrolled over 40 sites across 10 countries and had progressed into expansion cohorts by August 2025. As of September 2, 2026, the program remains in Phase 1/2, with no public evidence suggesting advancement to a later phase or registration status. The specific indication under review—EGFR-mutant NSCLC with secondary EGFR resistance mutation C797S—addresses a significant unmet need. C797S is a recognized on-target resistance mechanism that arises following treatment with third-generation EGFR TKIs, such as osimertinib. Current therapeutic options are limited, often necessitating reliance on chemotherapy, antibody-based combinations, or participation in clinical trials. This scenario presents a substantial commercial opportunity; however, the addressable patient population is biomarker-defined and relatively narrow compared to the broader EGFR-mutant NSCLC landscape. BH-30643 is classified as first-in-class, as it is being developed as an OMNI-EGFR inhibitor specifically designed to overcome C797S-mediated resistance, rather than as a follow-on version of an existing EGFR inhibitor. Public company materials indicate potent preclinical activity against C797S, both with and without T790M, while sparing wild-type EGFR. Although this mechanism is differentiated, it remains unproven in clinical settings, which affects the program's probability of approval (PoA), currently estimated at 18-28%. Clinical efficacy data for the specific C797S cohort have not yet been robustly published in peer-reviewed journals or detailed public formats. While company-linked and conference-adjacent disclosures suggest that tumor regressions have been observed in C797S-positive genotypes, mature data on overall response rate (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, p-values, and confidence intervals are not yet available for a comprehensive efficacy evaluation. Safety data also remain immature; while no major safety signals have been clearly established, early-phase development in EGFR-mutant NSCLC is often associated with class toxicities, dose-limiting tolerability issues, and insufficient exposure at active doses. For this indication, the only confirmed regulatory designation is FDA Fast Track, granted on August 18, 2026, for advanced or metastatic EGFR C797S-positive NSCLC following prior treatment with third-generation EGFR TKIs. There is no verified public evidence supporting orphan drug, breakthrough therapy, priority review, or accelerated approval for this specific indication. BlossomHill Therapeutics appears to be a clinical-stage company without a history of public FDA approvals or rejections, which limits regulatory de-risking from previously marketed products. Comparable precedents in the EGFR-mutant NSCLC space indicate that the FDA rewards credible biomarker-driven benefits but still expects clinically meaningful durability of response and tolerability. Programs targeting resistant EGFR biology often face challenges related to modest response depth, short PFS, or toxicity that limits combinability and chronic use. Given these factors, a PoA in the high teens to high twenties is deemed reasonable. While BH-30643 presents differentiated biology and addresses an important unmet need, it remains in the early stages of development, with incomplete evidence of human efficacy.

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Phase 1/2
20%

EGFR-mutant non-small cell lun

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N/A
SMMT
Summit Therapeutics Inc.
17.72 1.81 %
$12.43$18.42
48.19%
-6.08%
14.1B
Phase III interim results
74%

Ivonescimab is a PD-1/VEGF bispecific antibody developed by Summit Therapeutics (SMMT) in partnership with Akeso. This innovative immuno-oncology agent uniquely combines checkpoint blockade with anti-angiogenic activity within a single molecule, positioning it as a first-in-class program rather than merely another me-too antibody. The indication for first-line treatment of PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) presents a significant commercial opportunity, with the global market estimated at $15 billion. Despite the existing success of pembrolizumab and similar regimens, there remains a considerable unmet need, as many patients either progress early or fail to achieve durable benefits from current therapies. The clinical development program for ivonescimab is primarily focused on the HARMONi-2 trial (NCT05499390), a randomized, double-blind, Phase 3 study comparing ivonescimab monotherapy to pembrolizumab monotherapy in treatment-naïve patients with PD-L1-positive advanced NSCLC. The trial successfully enrolled 398 patients, and recruitment has been completed. Preliminary efficacy data indicates a robust progression-free survival (PFS) advantage for ivonescimab over pembrolizumab, with median PFS reported at approximately 11.1 months compared to 5.8 months, yielding a hazard ratio of around 0.51 with a p-value of less than 0.0001. Additionally, a statistically significant overall survival (OS) benefit was announced in 2026, which strengthens the case for approval; however, detailed mature OS confidence intervals and subgroup analyses remain critical for comprehensive evaluation. Safety profiles for ivonescimab have been generally acceptable, with no significant disqualifying signals emerging from public reports. The primary concerns revolve around typical immunotherapy-related toxicities and the added complexities associated with VEGF-pathway biology, which could raise issues such as hypertension, proteinuria, bleeding, thrombotic events, and immune-related adverse events. The essential consideration is not merely the presence of activity but whether the overall benefit-risk profile is sufficiently robust to support broad first-line use against well-established competitors. In terms of regulatory designations, ivonescimab has received Fast Track status from the FDA for the treatment of PD-L1-positive advanced NSCLC. However, there is no public evidence indicating that it qualifies for orphan drug, breakthrough therapy, priority review, or accelerated approval for this specific indication in the U.S. Summit Therapeutics has a limited track record with the FDA, and this program is largely characterized by licensing and development collaborations rather than a history of multiple U.S. approvals or rejections. The FDA has generally shown a willingness to approve lung cancer therapies based on strong randomized evidence, yet it has also been stringent when overall survival data are immature or when the evidentiary package lacks regional breadth. Recent precedents in NSCLC suggest that superior PFS alone is rarely sufficient for lasting differentiation; additional OS data, safety profiles, and reproducibility are essential. The estimated probability of approval (PoA) for ivonescimab stands at 74.0%. This figure is supported by the randomized Phase 3 trial framework, a clearly defined biomarker population, a strong PFS advantage, and the reported OS benefit. However, key downside risks include the generalizability of regulatory findings, competition from entrenched PD-1 therapies, and the potential for the FDA to require further confirmatory evidence or to impose restrictions on the label.

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Phase 3
60%

PD-L1-positive locally advance

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5
BIVI
BioVie Inc.
1.78 4.04 %
$0.96$2.05
112.57%
-16.1%
13.4M
Phase 2 topline data readout
18%

Bezisterim (NE3107) is an oral small-molecule candidate developed by BioVie, currently under investigation for its efficacy in treating cognitive impairment and fatigue associated with Long COVID. The ongoing Phase 2 ADDRESS-LC study, registered under NCT06847191, is a multicenter, randomized, triple-blind, placebo-controlled proof-of-concept trial targeting adults who have experienced neurocognitive symptoms and fatigue for at least three months post-COVID. The trial aims to enroll approximately 208 patients, utilizing a 1:1 randomization to administer either a twice-daily dose of 20 mg Bezisterim or a matching placebo. The primary endpoint focuses on changes measured by a bespoke Cogstate Cognitive Battery, while secondary endpoints encompass various assessments including PROMIS Cognitive Function, Fatigue, Sleep Disturbance, SF-12 physical and mental scores, and the DePaul Symptom Questionnaire's post-exertional malaise domain. Full enrollment was achieved in May 2026, with the last on-treatment visit completed by late August 2026, and topline data is anticipated before the end of September 2026. However, no efficacy results have been publicly disclosed to date, leaving key metrics such as overall response rate (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, or p-values unavailable for this indication. The safety profile of Bezisterim remains limited, as the ongoing Phase 2 program has not yet provided detailed adverse-event data or discontinuation rates. The study is designed to evaluate efficacy, safety, and tolerability, but the subjective nature of the endpoints and the potential for significant placebo effects present a high clinical bar. Additionally, the absence of FDA designations such as Fast Track, Breakthrough Therapy, Orphan Drug, Priority Review, or Accelerated Approval for the Long COVID indication indicates that the regulatory pathway may be conventional and heavily reliant on the data generated from the trial. Bezisterim is classified as first-in-class for Long COVID, as its proposed mechanism of action—targeting anti-inflammatory and neuroinflammation pathways—is novel within this context, and there are currently no approved disease-modifying competitors. The unmet need in this area is substantial, with cognitive dysfunction and fatigue being prevalent, disabling, and lacking approved therapeutic options. While precise market sizing is challenging, the broader economic burden associated with Long COVID has been estimated at approximately $1 trillion annually on a global scale, suggesting a significant theoretical market opportunity should a therapy demonstrate meaningful clinical benefit. BioVie’s development history is characterized as mixed, with the company being a clinical-stage sponsor engaged in multiple programs across neurodegeneration and liver disease, yet lacking any approved products to date. The Long COVID trial is fully funded through a grant from the U.S. Department of War, which mitigates some financial risk associated with the study, though it does not alleviate clinical risks. Precedents for FDA decisions in Long COVID and similar post-viral syndromes are limited; regulatory outcomes typically hinge on clear, reproducible benefits on patient-relevant endpoints alongside an acceptable safety profile. For Bezisterim, the primary approval drivers will be a robust placebo-controlled signal demonstrating improvements in cognition and fatigue, coupled with a tolerable safety profile. Conversely, the main risks include the potential for negative or marginal efficacy results, endpoint fragility, and the lack of regulatory de-risking. The estimated probability of approval stands at 18.0%, reflecting a notable upside potential in a setting marked by significant unmet needs, albeit with considerable risk stemming from reliance on a single Phase 2 proof-of-concept readout.

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Phase 2
40%

Long COVID (cognitive impairme

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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.