Innoviva (INVA) Company Report

Imviva Biotech announced that its abstract detailing positive interim clinical results from an ongoing Phase 1/2 trial of CTA313, a CD19/BCMA dual-targeted allogeneic CAR-T cell therapy for systemic lupus erythematosus (SLE), has been accepted for presentation at the 15th European Lupus Meeting (ELM 2026) on March 6, 2026.
As of February 6, 2026, interim data from 24 SLE patients showed 100% achieved SRI-4 response, 73.7% achieved LLDAS, and 42.1% achieved DORIS remission at a median 6-month follow-up.
CTA313 demonstrated a favorable safety profile, with Grade 1 cytokine release syndrome in 41.7% of patients and no cases of immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease, or lupus-induced cytokine-associated toxicity syndrome.
The therapy is an investigational off-the-shelf allogeneic CAR-T cell therapy leveraging Imviva's proprietary ANSWER™ platform.

5 days ago

Press Release

Innoviva Provides Business Overview and 2026 Outlook at Oppenheimer Conference

INVA

Guidance Update

Product Launch

Share Buyback

Innoviva's Innoviva Specialty Therapeutics (IST) business delivered $120 million in US sales last year and is expected to generate at least $150 million this year, following its best quarter ever with $34 million in U.S. sales.
The company reported a comfortable cash position of over half a billion dollars and announced a $125 million share buyback program at the end of last year.
Key product updates include the FDA approval of NUZOLVENCE (zoliflodacin) in December last year, with commercialization planned for the second half of 2026, and continued progress for ZEVTERA, which received J-code designation and New Technology Add-on Payment status in Q4.
GIAPREZA achieved $72 million in 2025 U.S. net sales (34% growth) and is expected to become an over $100 million product soon, while Zegdura generated $33 million in U.S. net sales in 2025 (over 100% increase) with analysts expecting $150 million-$200 million.
Strategic healthcare assets, valued at over $600 million, show strong growth potential, exemplified by Armata's breakthrough clinical results and planned Phase 3 trial, and Syndeio's potential Phase 2 readout in major depressive disorder.

Feb 26, 2026, 3:00 PM

Transcript

Innoviva Reports Strong 2025 Performance, Projects 2026 Growth, and Announces Share Buyback

INVA

Guidance Update

Product Launch

Share Buyback

Innoviva reported strong momentum across its diversified business segments, with the Innoviva Specialty Therapeutics (IST) business delivering $34 million in U.S. sales in Q4 2025 and $120 million for the full year 2025, with an expectation to generate at least $150 million in 2026. The company's royalty business generated $250 million in gross royalty revenue in 2025, and its strategic healthcare assets are valued at over $600 million.
Within the IST portfolio, GIAPREZA delivered $72 million in 2025 U.S. net sales (34% growth), and Zegdura brought in $33 million in 2025 U.S. net sales (over 100% growth).
The company is preparing for the commercialization of NUZOLVENCE (zoliflodacin), approved in December 2025, in the second half of 2026, with a potential total addressable market of up to half a billion dollars.
Innoviva announced a $125 million share buyback program and highlighted significant progress in its strategic healthcare assets, including Armata's plans to initiate a Phase 3 study in H2 2026 and Syndeio's potential Phase 2 readout in 2026.

Feb 26, 2026, 3:00 PM

Transcript

Innoviva CEO Discusses 2025 Performance, 2026 Outlook, and Product Pipeline

INVA

Guidance Update

Product Launch

Share Buyback

Innoviva's CEO highlighted strong 2025 performance, with the Innoviva Specialty Therapeutics (IST) business delivering $120 million in U.S. sales and expecting at least $150 million in 2026, representing a third consecutive year of 50% annual growth. The royalty business generated $250 million in gross royalty revenue last year.
The company announced a $125 million share buyback program and holds over half a billion dollars in cash.
Key product developments include the FDA approval of NUZOLVENCE (zoliflodacin) in December 2025, with commercialization planned for the second half of 2026, and positive initial feedback for ZEVTERA, launched in Q3 2025.
Innoviva's strategic healthcare assets, valued at over $600 million, saw significant progress, notably with Armata's positive Phase II data and plans for a Phase III study in the second half of 2026.

Feb 26, 2026, 3:00 PM

Transcript

Innoviva Reports Strong Full Year 2025 Financial Results and FDA Approval for NUZOLVENCE®

INVA

Earnings

Product Launch

Share Buyback

Innoviva reported total revenue of $411.3 million for the full year 2025, representing a 15% increase compared to 2024, and achieved net income of $271.2 million.
The Innoviva Specialty Therapeutics (IST) platform generated U.S. net product sales of $119.2 million for the full year 2025, reflecting 47% year-over-year growth, and anticipates $150 million or more in IST U.S. net product sales in 2026.
The company received U.S. FDA approval for NUZOLVENCE® in December 2025, a first-in-class treatment for uncomplicated urogenital gonorrhea, with commercialization planned for the second half of 2026.
Innoviva initiated a $125 million share repurchase program in the fourth quarter of 2025, having repurchased 797,298 shares for $16.0 million since the program's inception.

Feb 25, 2026, 9:57 PM

8-K

Innoviva Reports Strong Q4 and Full Year 2025 Financial Results

INVA

Earnings

Product Launch

Share Buyback

Innoviva reported full year 2025 total revenue of $411.3 million, a 15% increase from 2024, with net income of $271.2 million and $4.02 basic earnings per share.
Innoviva Specialty Therapeutics (IST) achieved $119.2 million in U.S. net product sales for full year 2025, representing 47% year-over-year growth, and projects $150 million or more in IST U.S. net product sales in 2026.
The company received U.S. FDA approval for NUZOLVENCE® in December 2025 and initiated a $125 million share repurchase program in the fourth quarter of 2025.
Innoviva's strategic asset portfolio was valued at $614.0 million as of December 31, 2025, including $397.9 million in Armata Pharmaceuticals investments.

Feb 25, 2026, 9:05 PM

Press Release

Inventiva Reports Preliminary Full Year 2025 Financial Results

INVA

Earnings

Guidance Update

Inventiva reported cash and cash equivalents of €99.3 million and short-term deposits of €131.6 million as of December 31, 2025.
The company's revenues for 2025 amounted to €4.5 million.
Inventiva completed a U.S. registered public offering for gross proceeds of approximately $172.5 million (€149 million) and received €115.6 million from the second tranche of a structured financing in 2025.
The company estimates its cash runway will extend until the middle of the first quarter of 2027.

Feb 17, 2026, 7:30 AM

Press Release

Imviva Biotech Receives FDA Orphan Drug Designation for CTD402

INVA

New Projects/Investments

Imviva Biotech's investigational allogeneic anti-CD7 CAR-T cell therapy, CTD402, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL).
This designation provides regulatory support and extended market exclusivity, along with tax credits for clinical research and waiver of prescription drug user fees, for therapies treating rare diseases affecting fewer than 200,000 patients in the U.S..
CTD402 is currently being evaluated in the global Phase 1b/2 TENACITY-01 clinical trial, which has shown early data of a 64.1% complete remission (CR) rate and 91.7% MRD-negative status in R/R T-ALL/LBL.
The first patient in the U.S. was dosed in December 2025, with Phase 1b interim data expected by mid-2026 and study completion by late 2028.

Jan 27, 2026, 1:30 PM

Press Release

Imviva Biotech Doses First Patient in TENACITY-01 Clinical Trial

INVA

New Projects/Investments

Product Launch

Imviva Biotech has successfully dosed the first patient in the United States in its TENACITY-01 clinical trial (NCT07070219) for CTD402, an allogeneic CAR-T cell therapy targeting relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL).
The first patient, treated at Stanford Medicine, demonstrated a well-tolerated safety profile and achieved complete remission (CRi), enabling progression to consolidative hematopoietic stem cell transplantation.
The company plans to release Phase 1b interim data by mid-2026, with the TENACITY-01 study projected to be completed by late 2028.
CTD402 holds Rare Pediatric Disease Designation (RPDD) and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for relapsed or refractory T-ALL.

Dec 22, 2025, 1:30 PM

Press Release

Innoviva's NUZOLVENCE® Receives FDA Approval

INVA

Product Launch

New Projects/Investments

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., announced that the U.S. FDA has approved NUZOLVENCE® (zoliflodacin), a first-in-class, single-dose, oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents.
This approval is significant as NUZOLVENCE is one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades.
The FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection, demonstrating non-inferiority compared to standard injectable therapy, including against drug-resistant strains.
Innoviva plans to commercialize NUZOLVENCE in the second half of 2026, either independently or in collaboration with a commercialization partner.