Every stored oracle finding for this trial, including pending, dismissed, rejected, superseded, and accepted items.
NO_DECISIONDismissed100% confidenceGrok 4.20 (xAI)
Will the results be positive?
Trial status Active Not Recruiting per ClinicalTrials.gov, est. prim. completion Jan 2026. No public readout or results found in searches of SIGA releases, news, or web as of Apr 2026. Mentions of completion in 2024 contexts likely refer to different JYNNEOS trials (PEP/PK). Evidence incomplete, no framing available.
Found Apr 6, 2026, 2:57 PMReviewed Apr 6, 2026, 3:00 PM
NO_DECISIONDismissed85% confidenceGrok 4.20 (xAI)
Will the results be positive?
Trial is active/not recruiting with estimated primary completion Jan 2026. No results posted on ClinicalTrials.gov or public readouts found. No sources report positive, negative, or interpretive outcomes for this specific Phase 2 immunogenicity/safety trial.
Found Apr 6, 2026, 2:08 PMReviewed Apr 6, 2026, 2:23 PM
NO_DECISIONDismissed93% confidenceGPT-5.4 (OpenAI)
Will the results be positive?
No clear positive or negative public readout is established for NCT04957485. ClinicalTrials.gov still shows the study as active/not recruiting, and later public commentary says the immunogenicity assay yielded lower-than-expected responses in both arms, potentially preventing the planned non-inferiority analysis; samples were being re-tested.
Found Apr 3, 2026, 4:01 PMReviewed Apr 3, 2026, 4:48 PM
ClinicalTrialsclinicaltrials.govJun 1, 2025, 12:00 AM
Study Details | NCT04957485 | Study to Assess the Safety and Immunogenicity of TPOXX When Administered Orally for 28 Days With JYNNEOS
ClinicalTrials.gov lists NCT04957485 as Phase 2 and active, not recruiting, rather than posting a clear completed-results readout.
Web Searchcloudfront.netMar 13, 2026, 12:00 AM
SIGA Technologies | Business strength intact, timing risk overdone
This report says the JYNNEOS co-administration immunogenicity study showed lower-than-expected measurable immune responses in both arms, which may limit the planned non-inferiority endpoint; CDC was re-testing samples.
Web Searchinvesting.comAug 8, 2023, 12:00 AM
Earnings call: SIGA Technologies outlines 2023 financial targets and updates on TPOXX trials
The earnings-call summary says preliminary analysis found no meaningful immunogenicity difference between placebo and TPOXX groups, but also noted fewer-than-expected measurable vaccine responses, leaving the trial interpretation inconclusive.
NO_DECISIONDismissed60% confidenceClaude Opus 4.6 (Anthropic)
Will the results be positive?
The trial is still listed as 'Active Not Recruiting' with primary completion estimated Jan 2026. SIGA's Q4 2023 and Q3 2025 earnings calls describe the immunogenicity results as ambiguous: no meaningful difference between TPOXX and placebo groups (positive for non-interference), but immune responses in both arms were lower than expected, making the non-inferiority determination 'difficult to assess.' Samples are being retested by CDC. No definitive positive or negative readout has been publicly declared for this specific trial.
Found Apr 1, 2026, 8:59 PMReviewed Apr 2, 2026, 5:08 PM
NO_DECISIONDismissed72% confidenceClaude Opus 4.6 (Anthropic)
Will the results be positive?
The Edison Group report (May 2024) and SIGA Q3 2025 earnings call indicate this exact immunogenicity trial (NCT04957485) completed clinical activities but found immune responses in both groups were lower than expected. Samples are being retested by the CDC. As of Q4 2025 earnings (March 2026), immunogenicity sample analysis remains underway with FDA submission targeted in the next 12 months. No definitive positive or negative readout has been publicly issued for this specific trial.
Found Apr 1, 2026, 7:55 PMReviewed Apr 1, 2026, 8:58 PM
NO_DECISIONDismissed95% confidenceGPT-5.4 (OpenAI)
Will the results be positive?
No public trial-specific Phase 2 readout was found. The ClinicalTrials.gov record for NCT04957485 still shows the study as active/not recruiting and explicitly says no results are posted, so there is not enough evidence to label the outcome positive or negative.
Found Mar 31, 2026, 9:44 PMReviewed Apr 1, 2026, 6:34 AM
NO_DECISIONDismissed95% confidenceGPT-5.4 (OpenAI)
Will the results be positive?
I did not find a clear, trial-specific positive or negative public readout for NCT04957485. The strongest trial-specific evidence says the immunogenicity study showed lower-than-expected measurable immune responses in both arms, which may prevent the originally planned non-inferiority analysis, and that samples were still being re-tested/re-analyzed with regulatory filing timing pushed out. Sponsor commentary expresses belief that TPOXX will not affect JYNNEOS immune response, but that is a forward-looking expectation rather than a reported positive readout from this exact Phase 2 trial.
Found Mar 30, 2026, 4:35 AMReviewed Mar 30, 2026, 7:04 AM
ClinicalTrialsclinicaltrials.govMay 15, 2025, 12:00 AM
Study Details | NCT04957485 | Study to Assess the Safety and Immunogenicity of TPOXX When Administered Orally for 28 Days With JYNNEOS | ClinicalTrials.gov
ClinicalTrials.gov lists NCT04957485 as a Phase 2 study sponsored by SIGA Technologies. The record was last updated on May 15, 2025 and describes the trial as examining whether administering TPOXX with JYNNEOS concomitantly affects JYNNEOS immunogenicity in healthy adult subjects. No posted public results or outcome interpretation were identified from this record in the search results used.
Sponsorq4cdn.comNov 6, 2025, 12:00 AM
SIGA Technologies, Inc. – Third Quarter 2025 Earnings Call, November 6, 2025 (edited)
SIGA stated: "Turning to our late-stage pipeline, we continue to advance the TPOXX post-exposure prophylaxis program, or PEP, for smallpox. Collaboration with CDC continues. As a reminder, the CDC is analyzing samples collected to support the study's immunogenicity objective. Based on TPOXX mechanism of action, we believe that TPOXX will not have an impact on JYNNEOS’s immune response when administered concomitantly with JYNNEOS. Therefore, we continue to move forward toward an FDA submission."
Web Searchedisongroup.comMar 12, 2025, 12:00 AM
SIGA Technologies — Entering a crucial period for business outlook - Edison Group
Edison wrote: "while all clinical trial-related activities were completed in 2023 (the expanded safety study did not indicate any drug-related serious adverse events), samples from the immunogenicity trial (testing TPOXX together with JYNNEOS, an FDA-approved smallpox vaccine) are being retested by the Centers for Disease Control and Prevention (CDC) after the trial indicated the measurable immune response to the JYNNEOS vaccine in both groups was lower than expected, which could potentially prevent non-inferior statistical determination from being the primary endpoint of the study as originally planned."