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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 9283. 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
PFE
Pfizer, Inc.
29.763 -0.88 %
–
–
–
169.6B
PDUFA Date
-
PDUFA
100%

homologous recombination repai

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1
GSK
GSK plc
51.08 0.62 %
$46.27
9.68%
–
103.3B
Phase 2 data presentation
dostarlimab (Jemperl

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PriorityRMAT
87%

Dostarlimab (Jemperli) is a PD-1 monoclonal antibody under development by GSK for the treatment of untreated stage II/III dMMR/MSI-H locally advanced rectal cancer. This subset of rectal cancer is particularly noteworthy due to its biomarker-defined characteristics, which suggest that immune checkpoint blockade could facilitate a non-surgical, organ-preserving treatment approach. The current development program is primarily supported by the registrational phase 2 AZUR-1 study (NCT05723562), a global, single-arm, open-label trial that has enrolled 154 patients diagnosed with previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer. Preliminary reports indicate that the study successfully met its primary endpoint of sustained clinical complete response at 12 months (cCR12), with earlier communications from the company highlighting unprecedented complete response rates among patients who completed the therapy. However, full efficacy metrics, including mature pathologic complete response (pCR), progression-free survival (PFS), overall survival (OS), p-values, and hazard ratios, have not been disclosed in the available public summary, which presents a significant limitation for a treatment aimed at curative intent. The safety profile of dostarlimab appears to align with the established safety expectations of PD-1 blockade, with no significant new safety signals reported in public disclosures. The primary concern revolves around the potential for long-term immune-related adverse events, delayed relapses, or risks associated with surgical delays that could impact the overall benefit-risk assessment. Given that this regimen is administered as monotherapy, it may offer advantages in terms of tolerability and quality of life compared to traditional chemoradiation-based approaches, provided that the durability of responses is maintained. Regulatory momentum for dostarlimab is robust. The drug has received Fast Track and Breakthrough Therapy designations, as well as Priority Review status for this specific indication. However, it is important to note that Orphan Drug designation and Accelerated Approval have not been confirmed for this particular use in rectal cancer and should be regarded as unknown rather than inferred from other indications. The FDA's acceptance of the supplemental Biologics License Application (sBLA) and the assignment of a February 2027 action date significantly de-risks the program. From a commercial perspective, while the target population is relatively small, the medical value is substantial, as standard treatment often involves radiation, surgery, and the potential for permanent functional consequences. This creates a meaningful unmet need despite the limited market size, which is estimated to be approximately $0.2-0.5 billion globally for untreated dMMR/MSI-H locally advanced rectal cancer. In terms of competitive positioning, dostarlimab is classified as best-in-class rather than first-in-class within the PD-1 inhibitor category, but it may be differentiated in this specific rectal cancer segment due to its notable response data and the organ-preservation narrative. Recent approvals of PD-1 inhibitors in biomarker-selected solid tumors provide a relevant context, where strong phase 2 data and significant unmet need have facilitated regulatory actions. Conversely, there have been setbacks in cases where responses were not durable or the datasets were deemed too immature. The primary risk associated with approval lies in whether the FDA will consider cCR12 from a single-arm trial as sufficient evidence for efficacy in a potentially curative setting. Nevertheless, with breakthrough-level results, clear biomarker selection, and an sBLA already filed under priority review, the estimated probability of approval stands at 87.0%.

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Phase 2
40%

untreated stage II/III dMMR/MS

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1
PFE
Pfizer, Inc.
29.763 -0.88 %
$23.67
26.87%
–
169.6B
Phase 3 data presentation
18%

Sigvotatug vedotin (SV), previously known as SGN-B6A, is an investigational antibody-drug conjugate (ADC) developed by Pfizer, targeting integrin β6 (IB6), a tumor-associated antigen in non-squamous non-small cell lung cancer (NSCLC). The pivotal clinical program for SV in this indication is the SigVie-002 trial (NCT06012435), an open-label, randomized, global phase 3 study that compares SV monotherapy to docetaxel in adults with previously treated locally advanced unresectable or metastatic NSCLC. The primary endpoint of this trial is overall survival (OS), with secondary assessments focused on standard efficacy and safety metrics. Recent developments in the SigVie-002 trial have raised significant concerns regarding the drug's potential for regulatory approval. Pfizer announced topline results indicating that SV did not achieve a statistically significant improvement in OS compared to docetaxel in the overall patient population. This outcome considerably weakens the case for regulatory approval for this specific indication. Although earlier phase 1 data suggested some level of activity, with a confirmed objective response rate of approximately 19.0% in a heavily pretreated and smaller cohort, these findings are insufficient to counterbalance the negative results from the phase 3 trial. The public data available does not provide mature, decision-grade hazard ratios or confidence intervals for OS or progression-free survival (PFS), leaving the evidence base incomplete and the topline conclusion unfavorable. The safety profile of SV remains a critical consideration, especially given the challenges associated with ADCs in lung cancer, where treatment-limiting toxicity is a significant concern. While ongoing evaluations and early tolerability reviews have been reported, comprehensive safety data from the phase 3 study are not fully disclosed in the available public sources. Given that docetaxel serves as the active comparator, regulatory expectations will likely require any future development to demonstrate not only meaningful efficacy but also a clear advantage in tolerability or biomarker selection. From a regulatory perspective, there are no specific designations such as Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval for the previously treated non-squamous NSCLC indication. It is important to note that designations applicable to other NSCLC settings do not automatically extend to this program. The commercial landscape for previously treated non-squamous NSCLC remains robust, with a global market size estimated at $15 billion and a significant unmet need, despite the presence of numerous approved therapies. SV is positioned as a first-in-class agent, as there are currently no established standards for IB6-directed ADCs in this disease context. Given the current circumstances, the probability of approval for SV stands at 18.0%. This low probability is primarily attributed to the phase 3 OS failure in the target indication, which typically poses a substantial barrier to approval unless compelling evidence emerges from biomarker subgroups or other secondary endpoints. Historical precedents in lung cancer indicate that negative OS results against docetaxel are challenging to overcome, even when early-phase data appear promising. As the development landscape evolves, the focus will remain on forthcoming data presentations and any potential shifts in regulatory strategy that may influence the drug's future.

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Phase 3
60%

previously treated non-squamou

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1
NBP
NovaBridge Biosciences
1.23 -10.22 %
$1.26
8.73%
–
142.5M
Phase 1b data presentation
givastomig (TJ033721

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Fast TrackAcceleratedOrphan
28%

Givastomig (TJ033721/ABL111) is a Claudin 18.2 × 4-1BB bispecific antibody under development by ABL Bio and NovaBridge Biosciences, specifically targeting biomarker-selected gastroesophageal adenocarcinoma (GEA). This drug is classified as a first-in-class conditional T-cell engager and immune amplifier, designed to enhance antitumor immunity by coupling tumor-binding via CLDN18.2 with localized 4-1BB co-stimulation, thereby aiming to limit systemic toxicity associated with 4-1BB activation. The commercial opportunity for Givastomig is promising but narrower than that of unselected gastric cancer therapies. The most relevant addressable population consists of the biomarker-defined first-line HER2-negative, CLDN18.2-positive, PD-L1-positive metastatic GEA subset, which is projected to support a multi-billion-dollar global peak market opportunity, although it does not extend to a broad pan-gastric franchise. The development status of Givastomig has progressed beyond initial Phase 1b exploration. Currently, a U.S. Phase 1b study is underway, evaluating the drug in combination with nivolumab and mFOLFOX6 in previously untreated, HER2-negative, CLDN18.2-positive patients, irrespective of PD-L1 status. This study includes three dose-escalation cohorts and two dose-expansion cohorts, with the primary endpoint focused on safety, while secondary endpoints encompass overall response rate (ORR), pharmacokinetics/pharmacodynamics (PK/PD), and duration of response. Additionally, a global randomized Phase 2 study (NCT07432295) has been initiated, indicating that the program is entering a more advanced stage of development. A prior Phase 1 monotherapy study (NCT04900818) demonstrated encouraging activity in CLDN18.2-positive gastric and gastroesophageal junction carcinoma, reporting 7 out of 43 responses in one efficacy-evaluable cohort (ORR of 16%) and disease control in 49% of patients. More recent disclosures from the company highlighted a stronger combination signal in first-line disease, with an overall ORR of 75%, 77% at 8 mg/kg, and 73% at 12 mg/kg, alongside a median progression-free survival (PFS) of 16.9 months and an 82% six-month landmark PFS rate in evaluable patients. While these results are promising, they remain non-randomized and should be interpreted as hypothesis-generating rather than definitive evidence for registration. Safety data thus far appear manageable; however, the complete adverse-event profile and comparative tolerability against standard chemotherapy and immunotherapy regimens are still under evaluation. A primary concern is whether the addition of 4-1BB agonism will maintain tolerability when combined with nivolumab and platinum/fluoropyrimidine chemotherapy. Notably, no evidence has been found to support Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval designations for this specific first-line metastatic gastroesophageal cancer indication. An orphan designation was previously reported for a different context but has not been verified for this specific target population. Competitive positioning for Givastomig could be favorable if efficacy is confirmed. The main comparator is the current standard of care, which involves nivolumab plus chemotherapy for HER2-negative advanced gastric or gastroesophageal junction cancer. Other approaches targeting CLDN18.2 include antibodies such as zolbetuximab and various pipeline assets. Givastomig's potential differentiation lies in its immunostimulatory 4-1BB biology combined with CLDN18.2 targeting, which could yield deeper and more durable responses than traditional target blockade, contingent upon validation from randomized data. The sponsor's FDA history is limited, with no prior approvals or rejections disclosed for this specific lineage, although there have been indications of alignment with the FDA regarding potential accelerated approval following positive Phase 1b data. Overall, the estimated probability of approval (PoA) stands at 28.0%, reflecting a credible biomarker-driven signal and a maturing clinical package, albeit constrained by the lack of randomized efficacy proof and the mechanistic and safety complexities inherent in the combination regimen.

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Phase 1b
20%

previously untreated, HER2-neg

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N/A
INBX
Inhibrx Biosciences, Inc.
88.05 -5.71 %
$79.25
17.83%
–
1.3B
Phase 2 data presentation
20%

Ordastobart, formerly known as INBRX-106, is under development by Inhibrx Biosciences (NASDAQ: INBX) as a hexavalent OX40 agonist antibody aimed at treating patients with PD-L1-high recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the first-line setting. The proposed therapeutic strategy involves combining ordastobart with pembrolizumab, leveraging OX40-mediated T-cell costimulation to enhance or sustain the antitumor immunity initiated by PD-1 blockade. This approach is considered mechanistically novel within this disease context and is classified as first-in-class, although clinical validation of OX40 agonism remains limited. The market for first-line PD-L1-high R/M HNSCC is estimated to be between $1.0 billion and $2.0 billion globally, with a midpoint estimate of $1.5 billion annually. Despite the presence of pembrolizumab as an established first-line treatment option, there remains a significant unmet need. While pembrolizumab is effective for some patients, response rates are limited, and most patients ultimately experience disease progression. Therefore, there is a pressing demand for durable combination strategies that can improve both progression-free survival (PFS) and overall survival (OS). The development status of ordastobart is encapsulated in the ongoing HexAgon-HN study, registered under NCT06295731. This seamless Phase 2/3 randomized trial targets previously untreated, locally advanced recurrent or metastatic HNSCC that is not amenable to local therapy and has a PD-L1 combined positive score (CPS) of 20 or higher. The Phase 2 component of the study randomizes patients to receive either ordastobart in combination with pembrolizumab or pembrolizumab alone. The planned Phase 3 component will introduce a placebo arm to maintain blinding. The Phase 2 segment is designed to enroll 60 patients with a 1:1 allocation, focusing on overall response rate (ORR) as the primary endpoint, while duration of response, PFS, and safety are considered important secondary measures. However, the trial has been reported as closed to accrual, with an estimated completion date for the broader study set for May 2029. Currently, there is no publicly available efficacy dataset for this specific indication, and key efficacy metrics such as ORR, duration of response, PFS, OS, p-values, hazard ratios, and confidence intervals are not yet reported. A primary analysis from the Phase 2 study is scheduled for presentation at ESMO 2026, although specific numerical findings have not been disclosed. Additionally, a mature safety profile, treatment discontinuation rates, and frequencies of immune-related adverse events remain unavailable. The primary safety concern involves the potential for additive immune toxicity resulting from the combination of checkpoint inhibition with an immune agonist, which may lead to significant inflammatory or organ-specific immune-mediated events. The regulatory landscape for ordastobart shows no established fast-track, orphan, breakthrough, priority review, or accelerated approval designations for this indication. Furthermore, Inhibrx lacks a demonstrated history of FDA approval for a marketed therapy, which introduces additional execution and regulatory risks. The competitive landscape is also challenging, as pembrolizumab serves as a formidable comparator, necessitating that ordastobart demonstrate clinically meaningful benefits over this established standard while managing acceptable levels of immune-mediated and treatment-related toxicity. The estimated probability of approval (PoA) for ordastobart stands at 20.0%. This figure reflects the active randomized Phase 2/3 program and the plausible mechanism of action, tempered by the absence of reported efficacy data, the small size of the Phase 2 cohort, unvalidated clinical benefits associated with OX40, the strength of the comparator, and the execution risks faced by the sponsor. The pivotal value inflection point will be the analysis of ORR and durability from the Phase 2 study, followed by confirmation in the randomized Phase 3 segment.

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Phase 2
40%

PD-L1–high recurrent/metastati

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5
LLY
Eli Lilly and Company
1278.8 0.36 %
$948
34.27%
–
1202.7B
Phase 1/2 data presentation
olomorasib (LY353798

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Breakthrough
34%

Olomorasib, also known as LY3537982, is an oral, next-generation KRAS G12C inhibitor developed by Eli Lilly. This drug covalently targets the KRAS G12C mutant protein and is designed to maintain effective target occupancy at relatively low absolute exposures, potentially enhancing its therapeutic index compared to earlier agents. Given that adagrasib and sotorasib have already validated KRAS G12C inhibition clinically, olomorasib is best classified as "best-in-class," rather than first-in-class or me-too. Its differentiation will hinge on factors such as potency, tolerability, intracranial activity, resistance management, and the ability to combine effectively with immunotherapy and chemotherapy. The regulatory designations for olomorasib in the context of first-line advanced/metastatic KRAS G12C-mutant non-small cell lung cancer (NSCLC) indicate that it does not currently hold Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations for the specific combination of olomorasib plus chemoimmunotherapy. It is important to note that the FDA granted a Breakthrough Therapy designation in September 2025 for olomorasib plus pembrolizumab in first-line unresectable advanced/metastatic KRAS G12C-mutant NSCLC with PD-L1 expression ≥50%. However, this designation does not extend to the broader indication analyzed here, which is olomorasib plus chemoimmunotherapy. Market analysis suggests that the addressable global market for targeted therapy in first-line advanced/metastatic KRAS G12C-mutant NSCLC is estimated to be between $2.0 billion and $3.0 billion at peak. However, a specific market estimate for olomorasib plus chemoimmunotherapy has not been publicly established. There is a significant unmet need in this space, as patients receiving first-line immunotherapy-based treatment often develop resistance, and KRAS G12C inhibition has yet to establish a definitive first-line standard. Durable systemic and intracranial control remain critical unmet needs. The estimated probability of approval (PoA) for the specific first-line olomorasib-plus-chemoimmunotherapy program stands at 34.0%. This estimate reflects the challenges and opportunities associated with the ongoing development of this regimen. The pivotal SUNRAY-01 trial must demonstrate clinically meaningful superiority over the current pembrolizumab-based standard of care, as early activity has not yet established a registration-level benefit. Additionally, the combination of KRAS G12C inhibition with pembrolizumab, platinum, and pemetrexed may lead to increased risks of hepatotoxicity, gastrointestinal toxicity, cytopenias, pneumonitis, and treatment discontinuations. Competition in this space is robust, with approved KRAS G12C inhibitors such as adagrasib and sotorasib, as well as other next-generation KRAS-directed combinations. The narrower FDA Breakthrough designation may not materially de-risk the broader indication for chemoimmunotherapy. Furthermore, no public pivotal hazard ratio, confidence interval, p-value, mature progression-free survival (PFS), or overall survival (OS) results have been identified for the requested first-line regimen. Upcoming catalysts include the presentation of updated integrated Phase 1/2 and SUNRAY-01 safety-lead-in data at ESMO 2026, scheduled for October 2026. The timing for the SUNRAY-01 Phase 3 pivotal readout has not been disclosed, and the SUNRAY-02 Phase 3 study is expected to reach primary completion by May 2029, although it evaluates resected or unresectable disease and is not the requested first-line metastatic chemoimmunotherapy study. In summary, while olomorasib presents a promising opportunity in the treatment of KRAS G12C-mutant NSCLC, significant uncertainties remain regarding its efficacy, safety profile, and competitive positioning. The 34% PoA reflects a Phase 3 program with regulatory momentum and a supportive biomarker rationale, tempered by the absence of mature randomized efficacy data, potential combination-toxicity risks, and the narrower scope of the current FDA designation.

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Phase 1/2
20%

first-line advanced/metastatic

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7

• 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.