Innoviva (INVA) Company Report

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.

Dec 12, 2025, 9:56 PM

Press Release

Innoviva Specialty Therapeutics Announces Positive Zoliflodacin Phase 3 Data and FDA Review Update

INVA

Product Launch

New Projects/Investments

Innoviva Specialty Therapeutics announced the publication of positive Phase 3 data for its investigational single-dose, oral antibiotic zoliflodacin in The Lancet.
The Phase 3 trial demonstrated zoliflodacin's non-inferiority compared to the combination of ceftriaxone and azithromycin for the treatment of uncomplicated urogenital gonorrhea.
The U.S. FDA granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation and accepted its New Drug Application (NDA) for review in June 2025.
The FDA has assigned a target action date of December 15, 2025, for zoliflodacin's NDA under the Prescription Drug User-Fee Act (PDUFA).

Dec 11, 2025, 11:35 PM

Press Release

Imviva Biotech Presents Validating Data for CAR-T Cell Therapies CTD402 and CTA311

INVA

New Projects/Investments

Imviva Biotech presented promising data for its allogeneic CAR-T cell therapies, CTD402 and CTA311, at the 67th American Society of Hematology (ASH) Annual Meeting on December 8, 2025.
CTD402, an investigational anti-CD7 CAR-T therapy for T-cell mediated diseases, is being evaluated in the Phase 1b/2 TENACITY-01 trial for R/R T-ALL/LBL and a Phase I trial for SAA, having received Rare Pediatric Disease Designation (RPDD) and Regenerative Medicine Advanced Therapy (RMAT) from the FDA for R/R T-ALL.
In a Phase 1 trial for Relapsed/Refractory (R/R) B-ALL, CTA311 demonstrated strong efficacy with 78% of evaluable patients achieving CR/CRi/CRh and 86% being MRD-negative, with no dose-limiting toxicities or GvHD.
The company also highlighted its manufacturing innovation for CTD402, demonstrating consistent product quality and efficacy across multiple production lots and donors, supporting its potential as a scalable "off-the-shelf" solution.

Dec 8, 2025, 11:00 PM

Press Release

Imviva Biotech Presents Positive Clinical Data for CTD402 at ASH Meeting

INVA

Product Launch

New Projects/Investments

Imviva Biotech presented positive clinical data for CTD402, an investigational allogeneic anti-CD7 CAR-T cell therapy, at the 67th American Society of Hematology (ASH) Annual Meeting on December 8, 2025.
In relapsed/refractory acute myeloid leukemia (R/R AML), CTD402 demonstrated a 62.5% response rate (100% MRD negative) in CD7 high patients, with some maintaining remissions exceeding four years.
For relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma (T-ALL/LBL), CTD402 achieved a 64.1% complete remission rate in 39 evaluable patients, with 91.7% of responders achieving disease-negative status.
The therapy exhibited a well-tolerated safety profile across both indications, with manageable cytokine release syndrome and no graft-versus-host disease or immune effector cell-associated neurotoxicity observed.
CTD402, which has been granted Rare Pediatric Disease Designation (RPDD) and Regenerative Medicine Advanced Therapy (RMAT) designation for T-ALL, is currently enrolling patients in a global Phase 1b/2 study (TENACITY-01).

Dec 8, 2025, 10:15 PM

Press Release

Innoviva Discusses Diversified Business Model and Growth Drivers at Piper Sandler Conference

INVA

New Projects/Investments

M&A

Share Buyback

Innoviva operates a diversified business model comprising a royalty business generating approximately $250 million annually from respiratory assets with patent exclusivity into the early 2030s, a rapidly growing Innoviva Specialty Therapeutics (IST) operating business with over $100 million in annual revenue, and strategic healthcare assets valued at approximately $500 million.
The IST segment, focused on hospital-based anti-infectives, is experiencing over 50% year-over-year growth driven by key products such as Giapreza for septic shock, Xacduro for resistant Acinetobacter infections, and the recently launched Zevtera for Staph aureus bacteremia, with all IST products protected into the 2030s.
Innoviva recently acquired Lyndra, a long-acting oral drug delivery platform, and holds a significant stake in Armata, a bacterial phage platform company showing strong data in Staphylococcus aureus bacteremia.
The company maintains approximately $500 million in cash on its balance sheet and recently announced a $125 million share buyback program, providing flexibility for future M&A, strategic investments, and shareholder returns.

Dec 2, 2025, 9:30 PM

Transcript

Innoviva Discusses Diversified Business Model, Growth Drivers, and Strategic Investments

INVA

Revenue Acceleration/Inflection

New Projects/Investments

Share Buyback

Innoviva's business is diversified into three main parts: a royalty business generating approximately $250 million annually from respiratory assets (Breo Ellipta and Anoro Ellipta) with patent protection into the early 2030s; an Innoviva Specialty Therapeutics (IST) operating business delivering over $100 million in rapidly growing revenue from hospital-focused products; and strategic healthcare assets valued at approximately $500 million.
The IST segment's rapid growth is driven by products such as Giapreza (septic shock), Xacduro (resistant Acinetobacter infections), and the recently launched Zevtera (Staph aureus bacteremia), with all IST products protected by patents into the 2030s.
Innoviva holds approximately $500 million on its balance sheet for M&A and investments and recently announced a $125 million share buyback program.
The company is also advancing Zoliflodacin, an orally available drug for ceftriaxone-resistant gonorrhea with a PDUFA coming up, and is actively seeking additional synergistic assets for its hospital channel platform, including potential antifungals.

Dec 2, 2025, 9:30 PM

Transcript

Innoviva Discusses Diversified Business Model, Growth Drivers, and Strategic Investments at Piper Sandler Conference

INVA

New Projects/Investments

Revenue Acceleration/Inflection

Share Buyback

Innoviva operates a diversified business model consisting of a royalty-focused respiratory assets segment generating approximately $250 million in annual revenue, an Innoviva Specialty Therapeutics (IST) operating business delivering over $100 million in annual revenue and growing rapidly, and strategic healthcare assets valued at approximately $500 million.
The royalty business, which includes products like Breo Ellipta and Anoro Ellipta, provides consistent cash flows with patent exclusivity extending into the early 2030s. The IST segment focuses on hospital-based anti-infectives and critical care products such as Giapreza, Xacduro, Xerava, and the newly launched Zevtera, with no impending losses of exclusivity for its current portfolio.
Innoviva maintains a strong financial position with approximately $500 million on its balance sheet and recently announced a $125 million share buyback program. The company is actively seeking additional assets for its IST platform, prioritizing organic growth and potential acquisitions in the broader hospital channel or anti-infective space.

Dec 2, 2025, 9:30 PM

Transcript

Beacon Biosignals Raises $86M in Series B Funding

INVA

New Projects/Investments

M&A

Beacon Biosignals announced an oversubscribed $86 million Series B funding round on November 13, 2025, bringing its total funding to more than $121 million.
The funding, backed by investors including Innoviva, Google Ventures (GV), and Takeda, will be used to build the world’s largest neurodiagnostic dataset and advance AI-driven biomarkers for brain health.
The company's core technology, the Beacon Platform, combines FDA-cleared wearable EEG technology with advanced AI to generate objective, quantitative biomarkers of brain function, now enhanced by the recent acquisition of CleveMed’s home sleep-testing technology.