Recent 8-K filings for RARE

• May 18, 2026, 2:15 PM ET other material materiality 0.60 neutral item 5.02item 5.07item 9.01

  Ultragenyx shareholders OK 14.5M-share equity plan; re-elect directors

  Third Amended and Restated 2023 Incentive Plan approved; up to 14.5M new shares available plus shares from prior plans.

• May 5, 2026, 7:59 PM ET earnings materiality 0.60 neutral item 2.02item 9.01 ◈ Earnings Releases

  Ultragenyx Q1 revenue $136M, net loss $1.84/share; reaffirms 2026 guidance; GTX-102 Phase 3 data H2 2026

  Total revenue $136M (Q1 2025: $139M); Crysvita $93M, Dojolvi $18M, Evkeeza $18M, Mepsevii $7M.

• April 2, 2026, 7:59 PM ET regulatory materiality 0.65 positive item 8.01

  FDA accepts resubmitted BLA for UX111 gene therapy; PDUFA date Sept 19, 2026

  FDA accepted for review resubmitted BLA for UX111 (rebisufligene etisparvovec) AAV9 gene therapy.

• March 30, 2026, 7:59 PM ET regulatory materiality 0.55 positive item 8.01

  Ultragenyx receives FDA IND clearance for UX016 in GNE myopathy; Phase 1/2 to start H2 2026

  FDA cleared IND for UX016, a prodrug of sialic acid for GNE myopathy, a rare inherited neuromuscular disorder.

• March 12, 2026, 7:59 PM ET other material materiality 0.85 positive item 8.01

  Ultragenyx DTX301 Phase 3 meets primary endpoint: 18% ammonia AUC reduction (p=0.018) in OTC deficiency

  DTX301-treated patients (n=18) showed 18% reduction in 24-hour plasma ammonia AUC vs placebo (n=19) at Week 36 (p=0.018).

• February 23, 2026, 6:59 PM ET regulatory materiality 0.75 positive item 8.01

  FDA accepts Ultragenyx's BLA for DTX401 gene therapy for GSDIa with Priority Review, PDUFA Aug 23, 2026

  FDA accepted Biologics License Application for DTX401 (pariglasgene brecaparvovec) to treat Glycogen Storage Disease Type Ia.

• February 12, 2026, 6:59 PM ET earnings materiality 0.85 negative item 2.02item 2.05item 9.01 ◈ Restructurings & Charges

  Ultragenyx Q4 rev $207M (+25%), net loss $129M; restructures 10% headcount; UX111 gets IRL

  Full year 2025 total revenue $673M (+20% YoY); Crysvita $481M, Dojolvi $96M, Evkeeza $59M.

• February 3, 2026, 6:59 PM ET other material materiality 0.85 positive item 8.01

  Ultragenyx UX111 gene therapy shows significant cognitive benefit in MPS IIIA; BLA resubmitted with PDUFA Q3 2026

  Children under 2 treated with UX111 showed +23.2 point improvement in Bayley-III cognitive raw score vs natural history (p<0.0001).

• January 30, 2026, 6:59 PM ET regulatory materiality 0.80 positive item 8.01

  Ultragenyx resubmits UX111 BLA for Sanfilippo type A to FDA; PDUFA expected Q3 2026

  Resubmitted BLA for UX111 gene therapy for Sanfilippo type A on Jan 30, 2026.

• January 12, 2026, 6:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01

  Ultragenyx prelim 2025 revenue $672-674M beats guidance; cash $735M; two gene therapy approvals possible in 2026

  Preliminary FY2025 total revenue $672-674M, ~20% YoY, exceeding top end of guidance.

• December 30, 2025, 6:59 PM ET regulatory materiality 0.85 positive item 8.01

  Ultragenyx completes rolling BLA submission for DTX401 gene therapy to FDA for GSDIa

  BLA submission for DTX401 (pariglasgene brecaparvovec) completed for glycogen storage disease type Ia; based on 52 treated patients with up to 6 years follow-up.

• December 29, 2025, 6:59 PM ET other material materiality 0.85 negative item 8.01

  Ultragenyx's setrusumab fails Phase 3 primary endpoints in OI; expense cuts planned

  Orbit and Cosmic studies did not meet primary endpoint of reducing annualized clinical fracture rate versus comparators.

• November 4, 2025, 6:59 PM ET earnings materiality 0.85 neutral item 1.01item 2.02item 9.01

  Ultragenyx Q3 revenue $160M (+15% YoY); sells 25% Crysvita royalty for $400M

  Total revenue $160M (+15% YoY); Crysvita $112M, Dojolvi $24M, Evkeeza $17M.

• October 30, 2025, 7:59 PM ET other material materiality 0.65 neutral item 8.01

  Ultragenyx doses first patient in Aurora study of GTX-102 for Angelman; Aspire Phase 3 fully enrolled

  First patient dosed in global Aurora study (NCT07157254) evaluating GTX-102 (apazunersen) for Angelman syndrome across all genotypes and ages 1 to <65.

• September 8, 2025, 7:59 PM ET other material materiality 0.80 positive item 8.01

  Ultragenyx reports positive longer-term Phase 3 data for DTX401 gene therapy in GSDIa

  DTX401 met primary endpoint at Week 48: mean cornstarch reduction 41% vs 10% placebo (p<0.0001).

• August 18, 2025, 7:59 PM ET other material materiality 0.70 positive item 8.01

  Ultragenyx starts rolling BLA submission for DTX401 gene therapy in GSDIa

  Initiated rolling BLA submission to FDA for DTX401 AAV gene therapy for Glycogen Storage Disease Type Ia.

• August 5, 2025, 7:59 PM ET earnings materiality 0.70 negative item 2.02item 9.01

  Ultragenyx Q2 revenue $166M (+13% YoY); net loss narrows; UX111 BLA receives CRL

  Q2 total revenue $166M, Crysvita $120M, Dojolvi $23M; net loss $115M ($1.17/sh) vs $132M loss prior year.

• July 31, 2025, 7:59 PM ET other material materiality 0.65 neutral item 8.01

  Ultragenyx fully enrolls Phase 3 Aspire study (129 patients) for GTX-102 in Angelman Syndrome

  Phase 3 Aspire study fully enrolled with ~129 patients ages 4-17 with maternal UBE3A deletion.

• July 11, 2025, 7:59 PM ET regulatory materiality 0.75 negative item 8.01

  FDA issues Complete Response Letter for Ultragenyx UX111 BLA; resubmission planned with 6-month review

  FDA CRL received July 11, 2025, for UX111 (ABO-102) AAV gene therapy for Sanfilippo syndrome type A.

• July 9, 2025, 7:59 PM ET other material materiality 0.60 positive item 8.01

  Ultragenyx's UX143 Phase 3 Orbit passes DMC safety review; final analysis year-end 2025

  DMC confirms acceptable safety profile for UX143 in pediatric/young adult OI patients; study continues to final analysis.

• June 27, 2025, 7:59 PM ET regulatory materiality 0.75 positive item 8.01

  Ultragenyx receives FDA Breakthrough Therapy Designation for GTX-102 in Angelman syndrome

  FDA granted Breakthrough Therapy Designation for GTX-102 (apazunersen) for Angelman syndrome.

• May 19, 2025, 7:59 PM ET other material materiality 0.55 neutral item 5.02item 5.07item 9.01

  Ultragenyx shareholders approve amended incentive plan, elect directors, ratify auditor

  Stockholders approved Second Amended and Restated 2023 Incentive Plan, authorizing up to 11.5M new shares plus forfeited shares from prior plans.

• May 6, 2025, 7:59 PM ET earnings materiality 0.60 neutral item 2.02item 9.01

  Ultragenyx Q1 revenue $139M, reaffirms FY2025 guidance; UX111 PDUFA Aug 18, 2025

  Q1 total revenue $139M (+28% YoY); net loss $151M ($1.57/share) vs $171M ($2.03) in Q1 2024.

• February 13, 2025, 6:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01

  Ultragenyx Q4 revenue $165M, FY $560M; guides 2025 revenue $640-670M

  Q4 2024 total revenue $165M (+29% YoY); FY 2024 total revenue $560M (+29% YoY).

• January 13, 2025, 6:59 PM ET earnings materiality 0.80 positive item 2.02item 9.01

  Ultragenyx preliminary 2024 revenue $555-560M above guidance; 2025 guide $640-670M

  Preliminary 2024 total revenue $555-560M, exceeding top end of guidance, ~29% YoY growth.

• December 19, 2024, 6:59 PM ET regulatory materiality 0.70 positive item 8.01

  Ultragenyx submits BLA to FDA for UX111 gene therapy in Sanfilippo syndrome type A

  Submitted BLA to FDA seeking accelerated approval for UX111 (AAV gene therapy) in Sanfilippo syndrome type A (MPS IIIA).

• December 19, 2024, 6:59 PM ET other material materiality 0.75 neutral item 8.01

  First patient dosed in Ultragenyx Phase 3 Aspire study of GTX-102 for Angelman syndrome

  Global Phase 3 Aspire study will enroll ~120 children ages 4-17 with full maternal UBE3A deletion.

• November 12, 2024, 6:59 PM ET other material materiality 0.85 positive item 8.01

  Ultragenyx reports positive Phase 1/2 data for GTX-102 in Angelman syndrome; Phase 3 Aspire study well powered

  Week 48 Bayley-4 Cognition GSV mean change +6.7 vs minimally important difference +5 (n=40).

• November 5, 2024, 6:59 PM ET earnings materiality 0.70 positive item 2.02item 9.01

  Ultragenyx Q3 revenue $139M (+42% YoY); Breakthrough Therapy for setrusumab; DTX401 crossover 62% cornstarch reduction

  Total revenue $139M, up 42% YoY; Crysvita $98M (+31%), Dojolvi $21M (+29%), Evkeeza $11M.

• October 7, 2024, 7:59 PM ET regulatory materiality 0.75 positive item 8.01

  Ultragenyx gets FDA Breakthrough Therapy Designation for setrusumab in osteogenesis imperfecta

  Received FDA Breakthrough Therapy Designation for setrusumab (UX143) for OI Type I, III, IV in patients ≥2 years.

• October 3, 2024, 7:59 PM ET other material materiality 0.75 positive item 8.01

  UX701 gene therapy shows clinical activity; 6 of 15 Wilson disease patients tapered off standard-of-care

  15 patients enrolled across 3 dose cohorts; 6 completely tapered off chelators/zinc therapy; 1 additional began tapering.

• August 1, 2024, 7:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01

  Ultragenyx Q2 revenue $147M (+36% YoY), raises 2024 guidance; key FDA agreements advance pipeline

  Q2 total revenue $147M (Crysvita $114M, Dojolvi $19M); net loss narrows to $132M from $160M.

• July 17, 2024, 7:59 PM ET regulatory materiality 0.70 positive item 8.01

  Ultragenyx aligns with FDA on Phase 3 design for GTX-102 in Angelman syndrome

  FDA alignment on EoP2 meeting for GTX-102; Phase 3 trial to enroll ~120 UBE3A deletion patients.

• June 21, 2024, 7:59 PM ET other material materiality 0.30 neutral item 5.02item 5.07item 9.01

  Ultragenyx stockholders approve amended 2023 incentive plan and elect directors at annual meeting

  Class II directors Dunsire, Narachi, and Sanders elected with over 66M votes each for terms until 2027.

• June 17, 2024, 7:59 PM ET other material materiality 0.70 neutral item 1.01item 9.01

  Ultragenyx raises ~$330.7M in public offering of common stock and pre-funded warrants

  Offering of 7,435,898 shares at $39/share plus pre-funded warrants for 1,538,501 shares at $38.999.

• June 12, 2024, 7:59 PM ET other material materiality 0.75 positive item 8.01

  Ultragenyx and Mereo report setrusumab cuts fracture rate 67% and boosts BMD 22% in OI Phase 2

  Median annualized fracture rate reduced 67% from 0.72 to 0.00 (p=0.0014) over mean 16 months in 24 patients.

• June 12, 2024, 7:59 PM ET regulatory materiality 0.75 positive item 8.01

  FDA agrees CSF heparan sulfate as surrogate endpoint for UX111 accelerated approval BLA in MPS IIIA

  FDA agreed cerebral spinal fluid heparan sulfate is a reasonable surrogate endpoint supporting accelerated approval for UX111 gene therapy in Sanfilippo syndrome type A (MPS IIIA).

• May 30, 2024, 7:59 PM ET other material materiality 0.85 positive item 8.01item 9.01

  Ultragenyx Phase 3 DTX401 gene therapy meets primary endpoint in GSDIa

  DTX401 reduced daily cornstarch intake by 41.3% vs 10.3% for placebo at Week 48 (p<0.0001).

• May 2, 2024, 7:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01 ◈ Earnings Releases

  Ultragenyx Q1 2024 revenue $109M (+8% YoY); net loss $171M; reaffirms guidance; pipeline advances

  Q1 total revenue $109M (+8% YoY); Crysvita $83M (+9%), Dojolvi $16M (+14%).

• April 15, 2024, 7:59 PM ET other material materiality 0.85 positive item 8.01item 9.01

  Ultragenyx reports positive Phase 1/2 GTX-102 data in Angelman syndrome with rapid, sustained improvements

  Expansion Cohorts A&B (24 patients) at Day 170 showed clinically meaningful improvements across cognition, behavior, sleep, motor, and communication domains vs natural history.

• February 15, 2024, 6:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01 ◈ Earnings Releases

  Ultragenyx FY2023 revenue $434M (+20% YoY); net loss narrows; 2024 guide $500-530M

  Total revenue 2023 $434M (+20% YoY); Crysvita $328M (+17%), Dojolvi $71M (+27%).

• January 8, 2024, 6:59 PM ET other material materiality 0.65 neutral item 2.02item 9.01 ◈ Earnings Releases ×2

  Ultragenyx reports preliminary 2023 revenue $430-435M; guides 2024 revenue $500-530M

  Preliminary 2023 total revenue $430-435M; Crysvita $325-330M, Dojolvi $70-71M.

• December 21, 2023, 6:59 PM ET other materiality 0.25 neutral item 5.03item 9.01

  Ultragenyx amends bylaws to align with Delaware law and SEC universal proxy card rules

  Board approved Second Amended and Restated Bylaws effective December 15, 2023.

Earnings & guidance

Materiality & sentiment trend

Max materiality 0.85 · Median 0.75 · Most common event other_material

25 positive 4 negative 14 neutral

source · RARE on sec.gov