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Biotech Missed Milestones
Biotech companies tell investors when data, regulatory filings and trial starts will come. This page tracks those promises, word for word from their press releases filed with the SEC, and flags the windows that closed without an update.
In the last year BioRadar collected 5171 timing statements from 560 companies. Among the promised windows that closed in the last nine months, 18 were pushed back to a later date by the company itself, and 3 ended with the program or trial discontinued, each shown with the company's own words before and after. A slipped timeline is often the first public sign of trouble with enrollment, manufacturing or data, and it moves the date a trade depends on.
How to read this. Each row is a promise in the company's own words, with the date it was made and a link to the filing, next to what the company said later: a newer date for the same milestone, or the end of the program. Every row carries both quotes, so you can check it in one click. Full method
Limits. Only filings on SEC EDGAR are read: press releases and quarterly and annual reports (10-Q, 10-K). Earnings calls, conference talks and company websites are not. A no update found row means those filings are silent 45 days after the window closed; the company may have reported elsewhere, so treat it as a question to ask, not as proof of a delay. Deliveries are not listed. Vague windows (“in the coming months”) and statements that name no trial, drug code or drug are not judged.
Press releases checked daily on SEC EDGAR. Last update Oct 1, 2026, 04:13 UTC.
Pushed back to a later date
| Company | Original promise | Window | Newer statement |
|---|---|---|---|
| ANTXAN2 Therapeutics Inc. | Trial start · PV“PV is estimated to affect approximately 155,000 people in the U.S. The Company is proceeding through the regulatory process and plans to initiate the Phase 2 clinical trial in the third quarter of 2026.”Company press release, May 11, 2026 · SEC filing | third quarter of 2026closed Sep 30, 2026, 1 days ago | Now fourth quarter of 2026“As a result of this expansion, Phase 2 enrollment is anticipated to commence in the fourth quarter of 2026, beginning with an open-label sentinel cohort at a sub-therapeutic dose aimed at assessing pharmacokinetics and safety in PV patients.”Company press release, Aug 11, 2026 · SEC filing |
| AVBPArriVent BioPharma Inc. | Data or results · FURVENT“Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC is projected to be in mid-2026.”Company press release, May 11, 2026 · SEC filing | mid-2026closed Sep 30, 2026, 1 days ago | Now 2H 2026“Top-line data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC is anticipated in 2H 2026. · Initial Phase 1 data for ARR-217 .”Company press release, Aug 12, 2026 · SEC filing |
| CHRSCoherus Oncology Inc. | Data or results · casdozokitug/toripalimab/bevacizumab“Enrollment is complete in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC and the first data readout is expected in mid-2026.”Company press release, May 11, 2026 · SEC filing | mid-2026closed Sep 30, 2026, 1 days ago | Now 2H 2026“Enrollment is complete in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC and the first data readout is expected 2H 2026.”Company press release, Aug 5, 2026 · SEC filing |
| EQEquillium Inc. | Trial start · EQ504“Plans to initiate a Phase 1 proof-of-mechanism study in mid-2026, with data expected approximately six months thereafter.”Company press release, May 13, 2026 · SEC filing | mid-2026closed Sep 30, 2026, 1 days ago | Now fourth quarter of 2026“Advancing EQ504 toward the clinic, with the Phase 1 proof-of-mechanism study expected to initiate in the fourth quarter of 2026, and topline data anticipated approximately six months thereafter.”Company press release, Aug 13, 2026 · SEC filing |
| PRLDPrelude Therapeutics Incorporated | Trial start · PRT13722“PRT13722 remains on track for an IND filing in mid-2026 and subject to clearance, with Phase 1 study initiation planned in the 2 nd half of 2026.”Company press release, Apr 20, 2026 · SEC filing | mid-2026closed Sep 30, 2026, 1 days ago | Now fourth quarter of 2026“Prelude Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for PRT13722, Its First-in-Class Oral KAT6A Selective Degrader Phase 1 study of PRT13722 in patients with HR+ breast cancer anticipated to begin enrolling patients in the fourth quarter of 2026.”Company press release, Sep 10, 2026 · SEC filing |
| ACETAdicet Bio, Inc. | Regulatory submission · ADI-212“Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the first half of 2026.”Company press release, Jan 7, 2026 · SEC filing | first half of 2026closed Jun 30, 2026, 93 days ago | Now third quarter of 2026“Beyond prula-cel, we expect to submit a regulatory filing for ADI-212 for the treatment of mCPRC in the third quarter of 2026 with enrollment expected to begin in the fourth quarter of 2026.”Company press release, Mar 12, 2026 · SEC filing |
| ALXOALX Oncology Holdings Inc. | Data or results · ALX2004“ALX2004: Phase 1 trial enrollment began in August and remains on track to deliver initial safety data in 1H 2026.”Company press release, Nov 7, 2025 · SEC filing | 1H 2026closed Jun 30, 2026, 93 days ago | Now second half of 2026“Enrollment continues in the dose-escalation portion of the Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, and is on track to report safety data in the second half of 2026.”Company press release, Aug 6, 2026 · SEC filing |
| AXSMAxsome Therapeutics, Inc. | Trial start · AXS-05“Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in the second quarter of 2026.”Company press release, Feb 23, 2026 · SEC filing | second quarter of 2026closed Jun 30, 2026, 93 days ago | Now third quarter of 2026“Smoking Cessation: Axsome is on track to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in the third quarter of 2026.”Company press release, Aug 10, 2026 · SEC filing |
| DBVTDBV Technologies S.A. | Regulatory submission · VIASKIN Peanut“BLA submission in 4-7-year-olds on track for the first half of 2026”Company press release, Dec 16, 2025 · SEC filing | first half of 2026closed Jun 30, 2026, 93 days ago | Now third quarter of 2026“Continued productive engagement with the FDA in support of the BLA for the VIASKIN ® Peanut Patch in children aged 4 through 7 years, with submission of the BLA anticipated in the third quarter of 2026”Company press release, Jul 16, 2026 · SEC filing |
| GNPXGenprex Inc. | Enrollment · the Phase 2 expansion portion of the study“The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026 and expects the interim analysis in the second half of 2026.”Company press release, Feb 23, 2026 · SEC filing | first half of 2026closed Jun 30, 2026, 93 days ago | Now by the end of 2026“We expect to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study by the end of 2026 and expect the interim analysis in the first half of 2027.”Company press release, Jul 14, 2026 · SEC filing |
| KPTIKaryopharm Therapeutics Inc. | Data or results · XPORT-MM-031 (EMN29)“The Company expects to report top-line data from this event-driven trial in the first half of 2026.”Company press release, Nov 3, 2025 · SEC filing | first half of 2026closed Jun 30, 2026, 93 days ago | Now second half of 2026“Announce topline data from the event-driven Phase 3 XPORT-MM-031 (EMN29) trial expected in the second half of 2026. 2026 Financial Outlook Based on its current operating plans, Karyopharm expects the following for full year 2026:”Company press release, Aug 13, 2026 · SEC filing |
| KRYSKrystal Biotech Inc. | Trial start · KB304“Jeune Aesthetics, Inc. (Jeune), a wholly-owned subsidiary of the Company, remains on track to initiate a Phase 2 study of its lead program KB304 in 1H 2026 following feedback from the FDA on Jeune’s validated décolleté-specific photonumeric scale and Phase 2 study design in 2H 2025.”Company press release, Nov 3, 2025 · SEC filing | 1H 2026closed Jun 30, 2026, 93 days ago | Now in 2027“Jeune Aesthetics, Inc. ("Jeune"), a wholly-owned subsidiary of the Company, has aligned with the FDA on Jeune's validated décolleté-specific photonumeric scale and expects to now initiate a Phase 2 study of its lead program, KB304, in 2027.”Company press release, Feb 17, 2026 · SEC filing |
| NMRANeumora Therapeutics, Inc. | Trial start · NMRA-215“NMRA-215: Plans to initiate Phase 1 clinical program following class-leading preclinical data Neumora expects to initiate a clinical program evaluating NMRA-215 monotherapy and combination therapy for the treatment of obesity in the first half of 2026.”Company press release, Jan 5, 2026 · SEC filing | first half of 2026closed Jun 30, 2026, 93 days ago | Now by End of 2026“KEY PIPELINE HIGHLIGHTS NMRA-215 (NLRP3 Inhibitor): Phase 1 Study Expected to Initiate by End of 2026 Neumora is developing NMRA-215 for the treatment of obesity and cardiometabolic disease.”Company press release, Aug 14, 2026 · SEC filing |
| QNRXQuoin Pharmaceuticals Ltd. | Enrollment · QRX003“Enrollment in both studies is expected to be completed in the first half of 2026, with top-line data anticipated in the second half of 2026.”Company press release, Jan 20, 2026 · SEC filing | first half of 2026closed Jun 30, 2026, 93 days ago | Now by the end of 2026“Quoin expects to complete recruitment of all 20 participants in CL-QRX003-004 by the end of 2026 and report topline data in the second quarter of 2027.”Company press release, Aug 28, 2026 · SEC filing |
| QUREuniQure N.V. | Data or results · Phase I/IIa clinical trial“The Company expects to present updated results from the Phase I/IIa clinical trial in the first half of 2026.”Company press release, Nov 10, 2025 · SEC filing | first half of 2026closed Jun 30, 2026, 93 days ago | Now first half of 2027“uniQure expects to present updated results from the Phase I/IIa clinical trial in the first half of 2027.”Company press release, Jun 22, 2026 · SEC filing |
| TENXTenax Therapeutics Inc. | Enrollment“Based on these results, Tenax confirmed the target enrollment remains unchanged, and reiterated that enrollment is expected to complete in the first half of 2026.”Company press release, Dec 17, 2025 · SEC filing | first half of 2026closed Jun 30, 2026, 93 days ago | Now by the end of 2027“We expect to complete LEVEL-2 enrollment by the end of 2027.”Company press release, Jul 31, 2026 · SEC filing |
| OKYOOKYO Pharma Limited | Trial start · urcosimod in NCP patients“OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and is currently planning a second larger, multicenter trial of urcosimod in NCP patients that is planned to start in Q1 2026.”Company press release, Jan 5, 2026 · SEC filing | Q1 2026closed Mar 31, 2026, 184 days ago | Now second half of this year“OKYO plans to initiate a global Phase 3 pivotal clinical trial in the second half of this year, enrolling approximately 111 patients to evaluate a single-dose regimen of urcosimod for the treatment of NCP.”Company press release, Sep 9, 2026 · SEC filing |
| SPRBSpruce Biosciences Inc. | Regulatory submission · TA-ERT“The recent financing provides the capital resources to advance TA-ERT well beyond a biologics license application (BLA) submission expected in the first quarter of 2026.” Dr. Szwarcberg continued, “I am very proud of our team for the advancements we have made this year, appreciative of the unwavering support from our B…”Company press release, Nov 10, 2025 · SEC filing | first quarter of 2026closed Mar 31, 2026, 184 days ago | Now fourth quarter of 2026“BLA submission for TA-ERT for the treatment of MPS IIIB anticipated in the fourth quarter of 2026: Spruce continues to advance manufacturing readiness, regulatory interactions and commercial planning to support an anticipated BLA submission in the fourth quarter of 2026, seeking accelerated approval based on cerebrospi…”Company press release, Aug 12, 2026 · SEC filing |
Discontinued
| Company | Original promise | Window | What the company said later |
|---|---|---|---|
| MBXMBX Biosciences Inc. | Data or results · imapextide (MBX 1416)“Phase 2a trial of imapextide (MBX 1416) ongoing: Results from the ongoing Phase 2a STEADI TM trial of potential once-weekly imapextide for post-bariatric hypoglycemia are expected in Q2 2026.”Company press release, Mar 12, 2026 · SEC filing | Q2 2026closed Jun 30, 2026, 93 days ago | Discontinued“we will not be committing further investment toward a Phase 2b trial of imapextide in PBH.”Company press release, May 11, 2026 · SEC filing |
| NMRANeumora Therapeutics, Inc. | Data or results · KOASTAL-2 and KOASTAL-3“The Company expects a joint topline data readout for both KOASTAL-2 and KOASTAL-3 in the second quarter of 2026 and believes this approach optimizes assessment of navacaprant efficacy in major depressive disorder in the KOASTAL program.”Company press release, Jan 5, 2026 · SEC filing | second quarter of 2026closed Jun 30, 2026, 93 days ago | Discontinued“Navacaprant did not achieve the primary endpoint in KOASTAL-2 or -3; Company to discontinue development of navacaprant”Company press release, Jun 15, 2026 · SEC filing |
| TCRXTScan Therapeutics Inc. | Data or results · PLEXI-T“Plans to share safety and efficacy data on patients infused to date in the PLEXI-T solid tumor trial in the first quarter of 2026.”Company press release, Nov 12, 2025 · SEC filing | first quarter of 2026closed Mar 31, 2026, 184 days ago | Discontinued“In November 2025, the Company announced the discontinuation of the PLEXI-T™ trial.”Company press release, Mar 4, 2026 · SEC filing |
How this works
Source. Every day BioRadar reads the press releases that biotech and pharma companies file with the SEC as exhibits to Form 8-K (Items 2.02, 7.01 and 8.01) or Form 6-K. A sentence is kept as a promise only if it has a forward-looking verb (expects, anticipates, plans to), a milestone (data, topline results, a BLA or NDA submission, enrollment, a trial start) and a timing phrase such as “fourth quarter of 2026” or “by year-end”. The forward-looking-statements boilerplate at the end of each release is ignored. Sentences are stored word for word; no model rewrites them.
Window. The timing phrase sets the last day of the window: “Q4 2026” ends December 31, 2026, “first half of 2027” ends June 30, 2027 and “in 2026” ends December 31, 2026.
Status. After the window closes, later releases from the same company are checked. Pushed back: a newer statement gives the same milestone a later window, and the model has confirmed it is the same milestone and that it was not reported as done. Discontinued: a later release says the program, trial or plan was stopped. Milestones reported as done are not listed. The promise and the evidence must name the same trial (for example REGAL or ENGAGE) or, when no trial is named, the same drug code or drug. A language model first confirms that each statement is a concrete clinical or regulatory milestone and which program it names. Where the rules find no evidence, the model reads the company's later releases and must quote the sentence that shows a report, a new date or a discontinuation; the quote is checked word for word against the filing before it is shown. If the releases are silent, it also reads every passage that names the program in the newest 10-Q or 10-K filed after the window. Only when both are silent, and 45 days have passed, is the window listed as no update found. When a company repeats a promise, only the newest statement is judged. Windows that closed more than nine months ago drop off the page.
Frequently asked questions
What is a missed milestone in biotech?
A missed milestone is a date a company gave investors for data, a regulatory submission, full enrollment or a trial start that passed without the company reporting it or giving a new date. It often signals slower enrollment, manufacturing work or a changed plan.
Where do these promises come from?
From the companies' own press releases filed with the SEC as exhibits to Form 8-K or Form 6-K. Each row quotes the sentence word for word and links to the filing.
What does "no update found" mean?
The promised window closed at least 45 days ago, and neither the press releases the company filed with the SEC since then nor its newest quarterly or annual report says the milestone happened, got a new date or was stopped. Companies also report on earnings calls, at medical conferences and on their websites, so it is a question to ask the company, not proof of a delay.
How often is the page updated?
Daily. New press releases are read every morning and every closed window is re-checked against the company's later releases.
Is this investment advice?
No. It is a record of what companies said and whether their later filings show it happening. Always read the source filing.