On September 22, 2026 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has granted final approval for BRAVNETSA (lutetium Lu 177 dotatate), a bioequivalent and therapeutically equivalent radiopharmaceutical to LUTATHERA (lutetium Lu 177 dotatate). BRAVNETSA is indicated for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

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"As the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to LUTATHERA approved in the United States, BRAVNETSA’s approval marks an important milestone for Lantheus as we continue to expand our radiopharmaceutical portfolio, bringing additional treatment options to people living with GEP-NETs," said Mary Anne Heino, Executive Chairperson and CEO, Lantheus. "We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access."

BRAVNETSA was approved through the FDA’s Abbreviated New Drug Application (ANDA) pathway. As part of this review, BRAVNETSA is the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to the reference product, LUTATHERA.

"For more than 70 years, Lantheus has helped define what’s possible in radiopharmaceuticals. As the first radioligand therapy approved through the ANDA pathway, BRAVNETSA represents a breakthrough for our industry and opens a new regulatory pathway for innovation," said Ludger Dinkelborg, PhD, Head of Research and Development, Lantheus. "Innovation comes in many forms, and this approval reflects Lantheus’ ability to apply our deep radiopharmaceutical expertise in navigating the ANDA process and gives clinicians another FDA-approved option to support treatment decisions based on each patient’s needs."

Visit www.BRAVNETSAhcp.com for more information on when the product will be available.

About GEP-NETs

Neuroendocrine tumors (NETs) are rare, often slow-growing cancers that can develop throughout the body. A subset known as gastroenteropancreatic NETs (GEP-NETs) affects the digestive system and pancreas and may be functional or non-functional depending on hormone activity.1 Over the last few decades, the incidence of GEP-NETs has increased significantly, with the prevalence in the U.S. estimated to be approximately 200,000 patients.2 Because GEP-NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, with patients waiting an average of 4.3 years from symptom onset to diagnosis.3,4

About BRAVNETSA

BRAVNETSA (lutetium Lu 177 dotatate), previously referred to as PNT2003, is bioequivalent and therapeutically equivalent to LUTATHERA.

INDICATION

BRAVNETSA is indicated for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

IMPORTANT SAFETY INFORMATION IN ADULTS

WARNINGS AND PRECAUTIONS

Risk From Radiation Exposure

BRAVNETSA contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer.

Radioactivity may be detected in the urine for up to 30 days following BRAVNETSA administration. Minimize radiation exposure in patients, medical personnel, and household contacts during and after treatment with BRAVNETSA consistent with institutional good radiation safety practices, patient management procedures, Nuclear Regulatory Commission patient release guidance, and provide instructions to the patient for follow-up radiation protection at home.

Myelosuppression

In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared with patients receiving high-dose, long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0% vs 54%/1%), thrombocytopenia (53%/1% vs17%/0%), and neutropenia (26%/3% vs11%/0%). In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose. Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels. The median time to platelet recovery was 2 months. Fifteen of the 19 patients in whom platelet recovery was not documented had post-nadir platelet counts. Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3. Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of myelosuppression.

Secondary Myelodysplastic Syndrome and Leukemia

In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (sMDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared with no patients receiving high-dose, long-acting octreotide. In ERASMUS, 16 patients (2%) developed sMDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (9 to 45 months) for sMDS and 55 months (32 to 125 months) for acute leukemia.

Renal Toxicity

In ERASMUS, 8 patients (<1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection. Two of these patients had underlying renal impairment or risk factors for renal failure (eg, diabetes or hypertension) and required dialysis. Administer the recommended amino acid solution before, during, and after BRAVNETSA to decrease the reabsorption of lutetium Lu 177 dotatate through the proximal tubules and decrease the radiation dose to the kidneys. Advise patients to hydrate and to urinate frequently before, on the day of, and the day after administration of BRAVNETSA. Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of renal toxicity. Patients with baseline renal impairment may be at increased risk of toxicity due to increased radiation exposure.

Hepatotoxicity

In ERASMUS, 2 patients (<1%) were reported to have hepatic tumor hemorrhage, edema, or necrosis, with 1 patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure. Monitor transaminases, bilirubin, serum albumin, and the international normalized ratio during treatment. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of hepatotoxicity.

Hypersensitivity Reactions

Hypersensitivity reactions, including angioedema, occurred in patients treated with lutetium Lu 177 dotatate injection. Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis, during and following BRAVNETSA administration for a minimum of 2 hours in a setting where cardiopulmonary resuscitation medication and equipment are available. Discontinue the infusion upon the first observation of any signs or symptoms consistent with a severe hypersensitivity reaction and initiate appropriate therapy. Premedicate patients with a history of Grade 1 or 2 hypersensitivity reactions to BRAVNETSA before subsequent doses. Permanently discontinue BRAVNETSA in patients who experience Grade 3 or 4 hypersensitivity reactions.

Neuroendocrine Hormonal Crisis

Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm, and hypotension, occurred in <1% of patients in ERASMUS and typically occurred during or within 24 hours following the initial lutetium Lu 177 dotatate injection dose. Two patients (<1%) were reported to have hypercalcemia. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction, or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.

Embryo-Fetal Toxicity

BRAVNETSA can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating BRAVNETSA. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BRAVNETSA and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BRAVNETSA and for 4 months after the last dose.

Risk of Infertility

BRAVNETSA may cause infertility in males and females. The recommended cumulative dose of 29.6 GBq of BRAVNETSA results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

ADVERSE REACTIONS

The most common Grades 3-4 adverse reactions (≥4% with a higher incidence in the BRAVNETSA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia, and hypokalemia.

DRUG INTERACTIONS

Somatostatin Analogs

Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each BRAVNETSA dose. Administer short-and long-acting octreotide during BRAVNETSA treatment as recommended.

Glucocorticoids

Avoid repeated administration of high doses of glucocorticoids during treatment with BRAVNETSA.

USE IN SPECIFIC POPULATIONS

Advise patients not to breastfeed during BRAVNETSA treatment.

To report SUSPECTED ADVERSE REACTIONS, contact Lantheus at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for BRAVNETSA.

(Press release, Lantheus, SEP 22, 2026, View Source [SID1234670988])

On September 22, 2026 Alligator Bioscience AB ("Alligator Bioscience" or the "Company"), reported the final outcome of the rights issue of units that was announced on 23 July 2026 (the "Rights Issue"). The final outcome shows that 523,797,503 units, corresponding to approximately 16.7 percent of the Rights Issue, have been subscribed for by exercise of unit rights. In addition, 14,311,260 units have been subscribed for without exercise of unit rights, corresponding to approximately 0.5 percent of the Rights Issue. Thus, the Rights Issue is subscribed to a total of approximately 17.1 percent and hence guarantee commitments will be utilized with approximately 29.7 percent of the Rights Issue. Through the Rights Issue, Alligator Bioscience initially receives SEK 58.8 million before issue costs and repayment of bridge loans of SEK 19 million. Upon exercise of the issued warrants series TO 15 and warrants series TO 16, Alligator Bioscience might receive additional proceeds in January 2027 and January 2028, respectively.

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Final outcome of the Rights Issue
The subscription period in the Rights Issue ended on 18 September 2026. The Rights Issue comprised a maximum of 3,140,534,240 units whereof each unit consists of two (2) ordinary shares, one (1) warrant series TO 15 and one (1) warrant series TO 16.

One (1) warrant series TO 15 will entitle the holder to subscribe for one (1) new ordinary share in the Company at an exercise price corresponding to 70 percent of the volume-weighted average price of the Company’s share on Nasdaq Stockholm during the period from and including 16 December 2026 up to and including 4 January 2027, however not lower than the quota value of the share or SEK 0.01, whichever is highest (where the exercise price shall always be rounded off to the nearest whole öre). The exercise period will run between 8 to 22 January 2027.

One (1) warrant series TO 16 will entitle the holder to subscribe for one (1) new ordinary share in the Company at an exercise price corresponding to 70 percent of the volume-weighted average price of the Company’s share on Nasdaq Stockholm during the period from and including 17 December 2027 up to and including 3 January 2028, however not lower than the quota value of the share or SEK 0.01, whichever is highest (where the exercise price shall always be rounded off to the nearest whole öre). The exercise period will run between 7 to 21 January 2028.

The final outcome shows that 523,797,503 units, corresponding to approximately 16.7 percent of the Rights Issue, have been subscribed for by exercise of unit rights. In addition, 14,311,260 units have been subscribed for without exercise of unit rights, corresponding to approximately 0.5 percent of the Rights Issue. Thus, the Rights Issue is subscribed to a total of approximately 17.1 percent and hence guarantee commitments will be utilized with approximately 29.7 percent of the Rights Issue.

Through the Rights Issue, the Company initially receives SEK 58.8 million before issue costs and repayment of bridge loans of SEK 19 million. Upon full exercise of all warrants series TO 15 issued as part of the Rights Issue, assuming an exercise price corresponding to the subscription price in the Rights Issue, the Company might receive additional proceeds of up to approximately SEK 29.4 million in January 2027, before issue costs. Upon full exercise of all warrants series TO 16 issued as part of the Rights Issue, assuming an exercise price corresponding to the subscription price in the Rights Issue, the Company might receive additional proceeds of up to approximately SEK 29.4 million in January 2028, before issue costs.

Allotment of units subscribed for without exercise of unit rights
Allotment of units subscribed for without exercise of unit rights has been made in accordance with the principles stated in the prospectus that the Company published on 31 August 2026 in connection with the Rights Issue (the "Prospectus"). Notification of such allocation will be made separately though a settlement note. Payment of subscribed and allotted units shall be made through cash payment in accordance with the instructions in the settlement note. Nominee registered shareholders will receive notification on allocation in accordance with instructions from the respective nominee.

Changes in share capital and number of shares as well as dilution
Through the Rights Issue, the total number of ordinary shares in the Company will increase by 2,940,000,000 shares, which results in that the total number of outstanding shares in the Company increases from 628,106,848 shares to 3,568,106,848 shares, whereof all outstanding shares are ordinary shares. The share capital increases with SEK 14,700,000, from SEK 3,140,534.24 to SEK 17,840,534.24 (calculated on the new quota value following the share capital decreases). This corresponds to a dilution effect of approximately 82.4 percent of the total number of ordinary shares in the Company after the Rights Issue.

If all outstanding warrants series TO 15 issued as part of the Rights Issue are exercised in full for subscription of new ordinary shares in January 2027, the total number of shares in the Company will increase by an additional 1,470,000,000 shares, from 3,568,106,848 shares to 5,038,106,848 shares, whereof all outstanding shares are ordinary shares, and the share capital will increase by an additional SEK 7,350,000, from SEK 17,840,534.24 to SEK 25,190,534.24, corresponding to a dilution effect of approximately 29.2 percent of the total number of ordinary shares in the Company after the Rights Issue and exercise of warrants series TO 15.

If all outstanding warrants series TO 16 issued as part of the Rights Issue are exercised in full for subscription of new ordinary shares in January 2028, the total number of shares in the Company will increase by an additional 1,470,000,000 shares, from 5,038,106,848 shares to 6,508,106,848 shares, whereof all outstanding shares are ordinary shares, and the share capital will increase by an additional SEK 7,350,000, from SEK 25,190,534.24 to SEK 32,540,534.24, corresponding to a dilution effect of approximately 22.6 percent of the total number of ordinary shares in the Company after the Rights Issue and exercise of warrants series TO 15 and TO 16.

In addition to what is stated above, the potential issue of units as compensation to guarantors may entail additional dilution.

Compensation for guarantee commitments
In connection with the Rights Issue, the Company has entered into guarantee commitments with Vator Securities AB and Mangold Fondkommission AB. According to the guarantee agreements, a guarantee commission of on average approximately 13.6 percent of the guaranteed amount is payable in cash, or on average approximately 15.6 percent in the event guarantors elect to receive compensation in the form of newly issued units in the Company, with the same terms and conditions as for units in the Rights Issue, including the subscription price in the Rights Issue. If all guarantors were to choose to receive guarantee compensation in units, a total maximum of 213,000,000 units containing 426,000,000 ordinary shares, 213,000,000 warrants series TO 15 and 213,000,000 warrants series TO 16 would be issued as guarantee compensation. The guarantors will inform whether they want to receive their compensation in cash or in units no later than 25 September 2026.

The issue of units as compensation to the guarantors is, if applicable, intended to be resolved upon by the Company’s Board of Directors based on the authorization granted by the extraordinary general meeting on 26 August 2026. Information about the issue resolution will, if applicable, be announced through a separate press release.

Trading in BTU
Trading in paid subscribed units (BTU) is currently ongoing on Nasdaq Stockholm under the short name ATORX BTU and will cease on 6 October 2026. Thereafter, BTU will be converted into ordinary shares, warrants series TO 15 and warrants series TO 16. The ordinary shares and warrants will be admitted to trading on Nasdaq Stockholm as soon as possible after conversion.

Resolution on Articles of Association
The extraordinary general meeting on 26 August 2026 resolved to change the provisions of the Articles of Association regarding the limits of the Company’s share capital and number of shares, and that the Board of Directors would be authorized to register the Company’s new Articles of Association according to one of four options (alternatively not to register any new Articles of Association at all) based on the outcome in the Rights Issue. Due to the outcome of the Rights Issue, the Board of Directors has decided to change the Articles of Association in accordance with option "B". The new Articles of Association will be registered with the Swedish Companies Registration Office in connection with the registration of the Rights Issue.

Issue of warrants to Fenja Capital II A/S
In accordance with the Company’s press release from 23 July 2026, the Company has, in connection with the Rights Issue, renegotiated the outstanding loan from Fenja Capital II A/S ("Fenja Capital"), which was originally raised in 2024. As part of the renegotiation, Alligator Bioscience has undertaken to issue warrants series 2026/2031 to Fenja Capital, free of charge. The warrants series 2025/2030 that were issued to Fenja Capital in connection with the Company’s previous rights issue in 2025 will be cancelled. The number of warrants series 2026/2031 to be issued shall correspond to a total dilution of five percent calculated on the total number of ordinary shares outstanding in the Company immediately after the completion of the Rights Issue (including any ordinary shares issued as part of the units issued as guarantee compensation). The Board of Directors therefore intends to resolve on a directed issue of warrants series 2026/2031 to Fenja Capital pursuant to the authorization from the extraordinary general meeting on 26 August 2026, no later than five business days following the registration of the Rights Issue with the Swedish Companies Registration Office. Further information on the issue of warrants, including terms, number of warrants and any future dilution, will be presented through a separate press release.

Advisers
APREA Partners AB acts as financial adviser in connection with the Rights Issue. Setterwalls Advokatbyrå AB is legal adviser to Alligator Bioscience. Vator Securities AB acts as the issuing agent in connection with the Rights Issue.

(Press release, Alligator Bioscience, SEP 22, 2026, View Source [SID1234670987])

On September 22, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, reported that China’s National Medical Products Administration (NMPA) has approved the company’s investigational new drug (IND) application for ADG138, a double-masked HER2×CD3 bispecific T cell engager built on Adagene’s proprietary SAFEbody precision masking technology. Adagene expects to initiate a first-in-human Phase 1 study of ADG138 for the treatment of advanced solid tumors in the fourth quarter of 2026.

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"The NMPA’s rapid approval of our IND application for ADG138 speaks to the strength of the preclinical package and allows us to bring a differentiated, double-masked T-cell engager into the clinic for patients with HER2-expressing solid tumors," said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. "In preclinical studies, ADG138 achieved potent, T-cell mediated anti-tumor activity in Enhertu (DS-8201) resistant tumor models while retaining a substantial reduction in cytokine release and a wider therapeutic window relative to an unmasked T-cell engager. We look forward to advancing ADG138 into first-in-human studies and building on the safety and efficacy profile we believe our SAFEbody platform can bring to T-cell engagers in solid tumors."

A Phase 1, first-in-human, open-label clinical study is designed to evaluate the safety and preliminary efficacy of ADG138 in patients with advanced solid tumors as well as to determine the recommended dose for Phase 2.

About ADG138

ADG138 is a double-masked HER2×CD3 bispecific T cell engager designed using Adagene’s SAFEbody precision masking technology, which covalently links masking peptides to both the HER2- and CD3-binding arms of the molecule. In its inactivated state, ADG138 is designed to minimally bind HER2-expressing cancer cells and T cells; the molecule becomes activated within the tumor microenvironment and engages T cells to selectively kill HER2-expressing tumor cells while limiting off-target toxicity.

Preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in 2022 showed that double-masked ADG138 achieved approximately 220-fold and greater than 1,000-fold reductions in binding to HER2 and CD3, respectively, yet translating to high efficiency in T cell-mediated tumor cell killing and T cell activation. ADG138 drove regression in both HER2-high and HER2-low tumor models, including a model refractory and/or resistant to the Enhertu (DS-8201), and showed synergistic anti-tumor activity in combination with anti-CTLA-4, anti-PD-1, or anti-CD137 antibodies. In addition, ADG138 was tolerated at doses over 300-fold higher than an unmasked T-cell engager, with markedly reduced cytokine release and a favorable pharmacokinetic profile, including a longer apparent half-life and higher systemic exposure than the parental molecule.

(Press release, Adagene, SEP 22, 2026, View Source [SID1234670986])

On September 22, 2026 PureTech Health reported its half-yearly results for the six months ended June 30, 2026.

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(Press release, PureTech Health, SEP 22, 2026, View Source [SID1234670985])

On September 21, 2026 Vironexis Biotherapeutics reported encouraging clinical results from the ongoing SENTRY-CD19 study of VNX-101, its investigational, one-time in vivo immunotherapy, in patients with relapsed or refractory CD19-positive hematologic malignancies. VNX-101 is designed to turn a patient’s own liver into a "biofactory" capable of producing GP101, a CD19/CD3 bispecific T-cell–engaging protein, following a single administration.

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Among the first three patients with relapsed/refractory (R/R) ALL who were antibody negative at baseline, all three achieved measurable residual disease (MRD)-negative complete responses following a single administration of VNX-101. All three MRD-negative complete responses were confirmed by clonoSEQ. In addition, one of the three patients who also had extensive extramedullary disease achieved a complete response at all disease sites on PET imaging by 28 days.

Importantly, the responses observed to date in these three patients have shown encouraging durability in this difficult-to-treat population. The patients all remain MRD-negative, with the first patient showing complete response through Day 260, at which point the treating physician elected to proceed to hematopoietic stem cell transplantation while the patient was in MRD-negative complete response. Additionally, the T-cell-engaging protein was still detected at therapeutic levels post transplant, proving durability through at least 9 months post infusion.These observations are particularly notable given that VNX-101 is administered once, rather than through repeated or continuous protein infusions.

"While early, these results are highly encouraging after delivering just a single, off-the-shelf administration of VNX-101, which enables the body to produce a CD19/CD3 T-cell–engaging protein," said Samit Varma, Chief Executive Officer of Vironexis. "These three patients have tried multiple lines of therapy and, sadly, exhausted available treatment options. We believe the depth, consistency, and emerging durability of these responses provide important clinical validation of our in vivo therapeutic protein platform, and compelling proof of concept for its potential to transform the body into a meaningful, durable source of highly active cancer therapeutics."

Mr. Varma continued, "Further, we believe VNX-101 has achieved an important first for the field: demonstrating that a systemically delivered, one-time in vivo therapy can translate into clinical antitumor activity in patients with blood cancer and extramedullary disease."

The safety profile observed to date is consistent with the potent immune activation expected from a CD19/CD3 T-cell-engaging therapy and is informing ongoing dose optimization. Immune-mediated events, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), were observed during dose escalation and completely resolved with standard of care. The Company continues to evaluate dose and treatment-management approaches as part of the ongoing study.

The broader SENTRY-CD19 study has dosed nine patients at sites in the U.S., across multiple CD19-positive hematologic malignancies, including ALL, diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. Based on the emerging clinical profile, Vironexis intends to prioritize development of VNX-101 in antibody-naïve relapsed/refractory ALL.

International expansion is also underway, with SENTRY-CD19 study sites in South Korea approved and expected to activate in the coming weeks.

Board Appointments

Vironexis also announced today the appointments of Kevin Sharer, former Chief Executive Officer of Amgen, as Chairman of the Company’s Board of Directors, and Nobel Prize laureate James Allison, Ph.D. to its Scientific Advisory Board. Dr. Allison is the Regental Professor and Chair of Immunology, Vice President of Immunobiology and Founding Director of the James P. Allison Institute at The University of Texas MD Anderson Cancer Center.

Mr. Sharer commented, "I’m delighted to join Vironexis’ Board of Directors as Chairman at this exciting time for the company, as it unveils highly encouraging initial clinical data demonstrating the potential of its revolutionary new approach to one-time, off-the-shelf in vivo immunotherapy. I look forward to contributing my experience as Vironexis continues to build momentum advancing VNX-101 and its broader pipeline targeting cancer and other serious diseases."

About VNX-101

VNX-101 is an investigational, one-time in vivo immunotherapy designed to enable the body to produce GP101, a CD19/CD3 T-cell–engaging protein, following a single administration. By delivering the genetic instructions for therapeutic protein production directly in vivo, Vironexis is developing an approach intended to combine the potency of T-cell-engaging therapeutics with the potential convenience and durability of a one-time treatment. VNX-101 has received U.S. FDA Fast Track, Orphan Drug, and Rare Pediatric Disease designations.

About the SENTRY-CD19 Clinical Trial

The SENTRY-CD19 Clinical Trial [NCT06533579] is a Phase 1/2, first-in-human, open-label, dose-escalating study designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19 positive hematologic malignancies. The trial is currently active across nine national clinical sites, with the core principal site at UT MD Anderson Cancer Center. Visit the clinicaltrials.gov listing for more information on the trial.

(Press release, Vironexis Biotherapeutics, SEP 21, 2026, View Source [SID1234670983])