Earnings summaries and quarterly performance for Vera Therapeutics.
Executive leadership at Vera Therapeutics.
Board of directors at Vera Therapeutics.
Research analysts covering Vera Therapeutics.
Recent press releases and 8-K filings for VERA.
Vera Therapeutics Provides Update on Atacicept FDA Review and Commercial Strategy
VERA
Product Launch
New Projects/Investments
- Vera Therapeutics' atacicept application for IgAN has been accepted by the FDA with priority review, and the PDUFA date is July 7th. The company does not anticipate any delays related to CMC or inspections.
- The company expects a broad label for atacicept, similar to Otsuka's Voyxact, without a proteinuria threshold, which would expand the treatable patient population. Atacicept has shown a transformative GFR profile with a slope of minus 0.6 at two years.
- Vera's sales force is fully hired and will be trained three months before launch, targeting approximately half of the nephrologists in the U.S.. The company anticipates over 70% commercial pay for the product.
- The intellectual property for atacicept includes regulatory exclusivity of 12 years in the U.S. and 10 years in Europe, with patents extending protection through 2047.
3 days ago
Vera Therapeutics Provides Update on Atacicept FDA Review and Commercial Strategy
VERA
Product Launch
New Projects/Investments
- Vera Therapeutics is confident in receiving FDA approval for atacicept by its July 7th PDUFA date with priority review, noting the review process is straightforward and no CMC issues are expected to cause delays.
- The company anticipates a broad label for atacicept, similar to Otsuka's Voyxact, which would expand the treatable IgAN patient population in the U.S., estimated at 160,000 prevalent patients with 80,000 in a rapid progression pool. Over 70% of the market opportunity is in commercial pay.
- Vera Therapeutics is commercially prepared for launch, having hired an 82-person sales force and conducted over 20 Pre-Approval Information Exchanges with large payers to ensure market access. Atacicept is expected to differentiate with its transformative GFR profile and a patient-friendly once-weekly low-volume auto-injector.
- The company has secured IP protection for atacicept through 2047 and is actively developing a monthly dosing formulation for atacicept and a pre-clinical pipeline candidate (VT109) aimed at even less frequent dosing intervals.
3 days ago
Vera Therapeutics Provides Update on Atacicept FDA Review and Commercial Strategy
VERA
Product Launch
New Projects/Investments
- Vera Therapeutics is confident in the July 7th PDUFA date for atacicept, with no expected delays from FDA review, CMC, or inspections.
- The company is preparing for a commercial launch, including a fully hired 82-person sales force and a patient hub, targeting a U.S. IgAN market of 160,000 prevalent patients with over 70% commercial pay.
- Atacicept's GFR profile (slope of minus 0.6 at two years) is highlighted as a key differentiator, and the company expects a broad label without a proteinuria threshold.
- Vera has secured IP protection for atacicept through 2047 and is advancing a monthly dosing study for atacicept, with data expected this year, and a new pipeline candidate, VT-109, for even longer dosing intervals.
3 days ago
Vera Therapeutics Reports Full Year 2025 Financial Results and Provides Business Update
VERA
Earnings
Guidance Update
Product Launch
- Vera Therapeutics reported a net loss of $299.6 million for the full year ended December 31, 2025, compared to a net loss of $152.1 million for the year ended December 31, 2024. The net loss per diluted share was $4.66 for 2025, up from $2.75 in 2024.
- As of December 31, 2025, the company held $714.6 million in cash, cash equivalents, and marketable securities. This, combined with availability under its debt facility, is believed to be sufficient to fund operations beyond the potential approval and U.S. commercial launch of atacicept.
- The FDA granted priority review to the Biologics License Application (BLA) for atacicept for the treatment of IgA nephropathy (IgAN), assigning a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026.
- Vera Therapeutics plans for a potential commercial launch of atacicept in mid-2026, pending FDA approval.
Feb 26, 2026, 12:30 PM
Vera Therapeutics Reports Full Year 2025 Financial Results and Provides Atacicept Regulatory Update
VERA
Earnings
Product Launch
Debt Issuance
- Vera Therapeutics received priority review from the FDA for its atacicept Biologics License Application (BLA) for IgA nephropathy (IgAN), with a Prescription Drug User Fee Act (PDUFA) date of July 7, 2026, and anticipates a potential commercial launch in mid-2026.
- The company reported positive Phase 3 data from the ORIGIN 3 study of atacicept in IgAN, which was presented at ASN Kidney Week and published in the New England Journal of Medicine.
- For the full year ended December 31, 2025, Vera Therapeutics reported a net loss of $299.6 million and a net loss per diluted share of $4.66.
- Vera Therapeutics ended 2025 with $714.6 million in cash, cash equivalents, and marketable securities, bolstered by $800 million in combined potential gross proceeds from equity and debt financings in 2025, which is expected to fund operations beyond the potential atacicept approval and U.S. commercial launch.
Feb 26, 2026, 12:30 PM
Vera Therapeutics Files BLA for Atacicept Following Positive Phase 3 Results
VERA
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Vera Therapeutics, a San Francisco-based biotechnology company, has filed a Biologics License Application (BLA) for atacicept following positive Phase 3 results for IgA nephropathy (IgAN), with a PDUFA target action date of July 7, 2026.
- Atacicept, a dual BAFF/APRIL inhibitor, demonstrated significant efficacy in the ORIGIN 3 interim analysis, showing a 42% mean UPCR reduction at Week 36 compared to placebo, along with 68% Gd-IgA1 reduction and 81% hematuria resolution.
- The drug also exhibits a differentiated safety profile with no serious infections or clinically relevant hypogammaglobulinemia, and offers desirable patient-centric features like at-home, weekly administration.
- Vera Therapeutics projects a US launch for atacicept in 2027 and full approval in 2028, targeting a potential $10B+ market opportunity in pipeline autoimmune diseases.
Jan 28, 2026, 12:00 PM
Vera Therapeutics Provides Atacicept Commercial Launch Outlook and Regulatory Update
VERA
Product Launch
Guidance Update
- Vera Therapeutics' lead product candidate, atacicept, received priority review from the U.S. FDA with a PDUFA date of July 7, 2026, and is on track for commercialization in IgAN this July.
- The pivotal phase III trial for atacicept met its primary endpoint, demonstrating a 42% placebo-adjusted reduction in proteinuria at 36 weeks, with a safety profile similar to placebo.
- The company reported a strong cash position of $779 million (pro forma) and access to $425 million in non-dilutive capital as of January 13, 2026.
- Vera is preparing for the U.S. commercial launch with a planned sales force of 82 representatives to target the estimated 160,000 diagnosed IgAN patients in the U.S..
- Two-year confirmatory GFR results from the ongoing phase III trial are expected in early 2027, with full approval projected for 2028.
Jan 13, 2026, 10:15 PM
Vera Therapeutics Provides 2026 Outlook, Highlights Atacicept PDUFA Date and Commercial Launch Plans
VERA
Product Launch
Guidance Update
- Vera Therapeutics is preparing for the commercial launch of its lead product candidate, atacicept, for IgA nephropathy (IgAN), with a U.S. FDA PDUFA date of July 7, 2026, following priority review.
- The company reported a strong financial position with $779 million in pro forma cash and access to $425 million in non-dilutive capital.
- The pivotal phase III trial for atacicept met its primary endpoint, demonstrating a 42% placebo-adjusted delta reduction in proteinuria at 36 weeks.
- Vera plans to hire 82 sales representatives for the U.S. launch to target over half of the 11,000 nephrologists in the country.
- Intellectual property for atacicept's methods of use extends to 2041, with a goal to reach 2047 and beyond.
Jan 13, 2026, 10:15 PM
Vera Therapeutics Provides 2026 Outlook and Atacicept Commercialization Update
VERA
Product Launch
Guidance Update
New Projects/Investments
- Vera Therapeutics' lead product candidate, atacicept, a dual BAFF/APRIL inhibitor for IgA nephropathy (IgAN), received priority review from the U.S. FDA with a PDUFA date of July 7, 2026, and is on track for commercialization in IgAN in July 2026.
- The pivotal phase III trial for atacicept met its primary endpoint, demonstrating a 42% placebo-adjusted reduction in proteinuria at 36 weeks, with a clinical safety profile similar to placebo.
- The company reported a strong pro forma cash position of $779 million and access to $425 million in non-dilutive capital.
- Vera estimates the U.S. market for diagnosed IgAN patients at approximately 160,000 and is hiring 82 sales representatives for the upcoming launch.
- Vera is also developing a monthly formulation of atacicept, with data from an ongoing dose range finding study expected around mid-2026.
Jan 13, 2026, 10:15 PM
Vera Therapeutics' Atacicept BLA Granted Priority Review by FDA
VERA
Product Launch
New Projects/Investments
- Vera Therapeutics announced that its Biologics License Application (BLA) for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN) was accepted for Priority Review by the U.S. Food and Drug Administration (FDA).
- The FDA has assigned a PDUFA target action date of July 7, 2026.
- If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN and is designed for once-weekly, at-home self-administration.
- The BLA submission is supported by data from the ORIGIN 3 trial, which demonstrated a 46% reduction from baseline in proteinuria and a 42% reduction in UPCR compared to placebo at week 36.
Jan 7, 2026, 12:30 PM
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