On May 10, 2026 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted a third Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific fusion protein, IBI363, in combination with bevacizumab, for the treatment of patients with advanced microsatellite stable or proficient mismatch repair (MSS/pMMR) colorectal cancer (CRC) who have failed at least two prior lines of standard therapy. A Phase III clinical trial is about to initiate in China for this indication in the near term.

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Previously, IBI363 has received two BTDs from China’s NMPA CDE and two Fast Track Designations (FTDs) from the U.S. FDA, covering indications in non-small cell lung cancer and melanoma. The latest BTD further validates IBI363’s potential in addressing immunotherapy resistance and cold tumor challenges which represent a significant unmet medical need. The early-stage clinical data of IBI363 in advanced MSS/pMMR colorectal cancer were reported at 2025 ASCO (Free ASCO Whitepaper) conference (link), in which IBI363, in combination with bevacizumab, demonstrated promising efficacy in patients who have failed multiple prior lines of standard therapy.

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "IBI363 is a promising next-generation IO agent by combining dual mechanisms—PD-1 blockade and IL-2-driven tumor-specific T-cell populations expansion—thus reshaping the tumor microenvironment. The new regulatory milestone underscores its clinical value in addressing unmet needs. We are accelerating IBI363’s global development across multiple tumor types together with our partner Takeda, to bring innovation therapies at the forefront of immunotherapy to benefit global patients."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly.

About MSS/pMMR Colorectal Cancer

Colorectal cancer (CRC) is one of the most common malignancies worldwide, with MSS/pMMR being the predominant subtype, accounting for approximately 95% of advanced CRC cases. For patients with advanced MSS/pMMR CRC who have failed standard therapies, there remains a significant unmet medical need. Treatment options are limited, and prognosis remains poor.

About IBI363

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

(Press release, Innovent Biologics, MAY 10, 2026, View Source [SID1234665406])

On May 8, 2026 Azalea Therapeutics, Inc., a biotechnology company redefining precision genomic medicines in vivo, reported that first-in-primate data from its proprietary in vivo CAR T cell platform have been accepted as a late-breaking abstract for oral presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting, taking place May 11 – 15, 2026 in Boston, Massachusetts.

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The late-breaking abstract, titled "A first-in-primate demonstration of in vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration," describes the first in vivo generation of genomic site-specific engineered TRAC-CAR T cells in non-human primates. Azalea’s platform is designed to generate CAR T cells directly inside the body through a dual-vector approach that combines CD3-targeted enveloped delivery vehicles (EDVs) delivering transient Cas9 complexes with a T cell-tropic AAV (AAV-T) carrying a promoterless CAR gene flanked by TRAC homology arms. This approach enables precise insertion of the CAR gene at the TRAC locus, placing CAR expression under control of the endogenous T cell promoter.

In the study, six rhesus macaques received a single intravenous administration of EDV and AAV-T vectors at different dose levels without prior lymphodepletion. The study assessed in vivo TRAC-CAR T cell generation, TRAC-CAR-mediated B cell depletion in peripheral blood, lymph nodes and bone marrow, and safety parameters.

"These first-in-primate data represent a major milestone for Azalea and for the broader field of in vivo cell engineering," said Jenny Hamilton, Ph.D., co-founder, president and chief executive officer of Azalea Therapeutics. "In immune-competent non-human primates, a single intravenous administration of our dual-vector platform generated TRAC-CAR T cells in vivo and achieved complete target B cell depletion across peripheral blood, lymph nodes and bone marrow without lymphodepletion. We believe that achieving precise insertion at a defined genomic locus will be foundational to the safety, durability and physiologic regulation of future in vivo cell therapies. We believe these findings provide important translational support for our approach and the potential to make powerful cell therapies more accessible by eliminating the need for individualized ex vivo manufacturing."

First-in-Primate In Vivo TRAC-CAR T Cell Engineering

In the study, animals demonstrated in vivo generation of TRAC-CAR T cells, with TRAC-CAR T cells peaking as high as 41% of all peripheral T cells on Day 11. All six animals demonstrated deep B cell aplasia of greater than 90% in peripheral blood by Day 10.

The study also demonstrated potent target B cell clearance beyond peripheral blood. In lymph nodes and bone marrow, B cells were deeply depleted by greater than 90% in five of six animals at the highest dose level within two weeks following treatment.

Treatment was generally well tolerated, with no deaths, no neurotoxicity and a favorable safety profile. Molecular analyses confirmed no off-target CAR expression or integration in non-T cells in the blood.

"To our knowledge, this is the first demonstration of site-specific gene integration in T cells in a non-human primate in vivo. This study demonstrates that Azalea’s platform can achieve cell-selective delivery, genomic locus-specific CAR insertion and robust pharmacodynamic activity in a clinically relevant non-human primate model," said Connor Tsuchida, Ph.D., scientific co-founder, vice president of research and development at Azalea Therapeutics and presenting author of the abstract. "The combination of TRAC-targeted integration, endogenous promoter-driven CAR expression and activity across multiple tissue compartments supports continued advancement of this genome editing-based in vivo CAR T platform toward clinical translation."

Azalea will present these data at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting.

Abstract Title: A first-in-primate demonstration of in vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration
Presenting Author: Connor A. Tsuchida, Ph.D., Azalea Therapeutics
Session: Oral Abstract Sessions – Late-breaking abstracts
Date/Time: Friday, May 15, 2026, 8:00 am – 9:45 am ET
Location: Westin Seaport Commonwealth Ballroom ABC (Concourse Level)

(Press release, Azalea Therapeutics, MAY 8, 2026, View Source [SID1234665405])

On May 8, 2026 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, reported its financial and operating results for the first quarter ended March 31, 2026, and provided a business update.

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Recent Progress and Upcoming Catalysts:

TTI-109 (Healthy Volunteer Study): Study ongoing with topline data anticipated in June 2026. The Company plans to announce the clinical development strategy based on these results.
TTI-101 (HCC – REVERT LIVER CANCER study): Phase 1b/2 trial remains on track to report topline results in 2H 2026.
TTI-101 (IPF – REVERT IPF study additional analyses): Phase 2 trial showed that TTI-101 was associated with a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for placebo. Treatment with TTI-101 was also associated with a 4.5-fold greater decline in IL-6, a central STAT3-driven inflammatory cytokine.

Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We are approaching a key inflection point with topline data from our next-generation STAT3 inhibitor, TTI-109, expected in June. These results are expected to inform our future clinical development strategy."

"TTI-109 is designed to build on the preclinical and clinical activity observed with TTI-101 while potentially offering improved tolerability through its prodrug profile and enabling broader development across inflammatory and proliferative diseases driven by STAT3."

"In parallel, we remain on track to report topline data from our ongoing Phase 2 REVERT LIVER CANCER trial in the second half of this year. Prior interim findings demonstrated clinically meaningful activity across treatment settings, and we look forward to evaluating the full dataset."

"We continue to make significant progress advancing both programs, providing line of sight to two near-term value inflection points," Dr. Alibhai concluded.

Key Upcoming Milestones:

June 2026: TTI-109 Phase 1 healthy volunteer topline data and clinical development strategy
2H 2026: TTI-101 Phase 1b/2 HCC topline data

First Quarter 2026 Financial Results

Research and development expenses for the three months ended March 31, 2026, were $4.9 million as compared to $3.1 million for the comparable period in 2025. The increase was primarily driven by higher TTI-109 developmental costs, partly offset by declining clinical costs associated with TTI-101.

General and administrative expenses were $2.1 million for the three months ended March 31, 2026, as compared to $1.2 million for the three months ended March 31, 2025. The increase was primarily driven by higher personnel costs, including stock-based compensation, and professional fees, including costs associated with being a publicly traded company.

Net loss for the three months ended March 31, 2026, was $6.8 million, as compared to a net loss of $9.6 million for the comparable period in 2025.

Basic and diluted net loss per share attributable to common shareholders for the three months ended March 31, 2026, were a net loss of $(0.73), compared to a net loss of $(3.72) for the comparable period in 2025.

Cash, cash equivalents and short-term investments as of March 31, 2026, were $25.0 million, as compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 2026.

(Press release, Tvardi Therapeutics, MAY 8, 2026, View Source [SID1234665402])

On May 8, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported financial results for the first quarter ended March 31, 2026, and provided business updates.

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"We have successfully completed non-clinical and clinical modules for our first BLA submission. The remaining CMC module is progressing as planned, and we are on track to finalize our submission in the fourth quarter 2026. We are pleased to provide this additional guidance on expected BLA completion following focused filing discussions with FDA. Manufacturing inspection readiness activities continue to progress, including our commitment to sustainable long-term supply. The quality and execution of the rolling BLA has been a top priority for us, and we are confident that we are taking all appropriate measures to ensure a successful package. This has been a tremendous undertaking, and I am extremely proud of the team for their unwavering commitment," stated Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology.

"We look forward to a number of meaningful near-term milestones for CG, including anticipated topline data from the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC in the coming months, as well as the first results from the Phase 2 CORE-008 Cohort CX in high-risk BCG-exposed and BCG-unresponsive patients, to be presented at AUA."

Corporate Highlights

CORE-008 Cohort CX data podium and poster presentation at the Society of Urologic Oncology (SUO) session at the American Urological Association (AUA) 2026 Annual Meeting on May 16.
Title: First Results from CORE-008 Cohort CX- Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec with Gemcitabine in Patients with High-Risk BCG-Exposed or BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Strengthened Executive Leadership Team with the addition of life-science executive Jim DeTore.
In April 2026, the Company appointed Jim DeTore to Chief Financial Officer. Jim brings over 30 years of life sciences expertise including executive leadership roles at Neurogastrx, Inc., Bluebird Bio, and Proteostasis Therapeutics, in each case leading the company’s financing and investor relations strategies, helping to raise over a billion dollars in equity capital. He also served as vice president of corporate finance at Ironwood Pharmaceuticals where he worked directly on several debt and equity transactions, including the company’s initial public offering. Jim received his M.B.A. and bachelor’s degree in finance from Northeastern University in Boston.

Anticipated 2026 Milestones

CORE-008 Cohort CX (HR BCG-exposed and BCG-unresponsive NMIBC): First results from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26
PIVOT-006 (intermediate-risk NMIBC): Phase 3 topline data in 1H’26
Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 4Q’26
BOND-003 Cohort C (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), and CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1), durability data in 2026
First Quarter Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $1.1 billion, compared with $742.2 million as of December 31, 2025. The March 31, 2026, cash includes net proceeds of approximately $391.4 million from a total of 6,941,407 shares sold through the Company’s at-the-market (ATM) facility in Q1 based on reverse inquiries from existing and new, high-quality funds. The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations through 2029.
Research and Development (R&D) Expenses: R&D expenses were $43.7 million for the first quarter of 2026, as compared to $27.5 million for the prior year period. The increase was primarily due to an increase in clinical trial expenses, including CMC costs, and an increase in compensation costs due to increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $20.8 million for the first quarter of 2026, as compared to $14.8 million for the prior year period. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount, and an increase in professional and consulting fees.
Net Loss: Net loss was $60.2 million, or $(0.71) per share, for the first quarter of 2026, as compared to a net loss of $34.5 million, or $(0.45) per share, for the prior year period.

About Cretostimogene Grenadenorepvec

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 600 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a multi-cohort Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

(Press release, CG Oncology, MAY 8, 2026, View Source [SID1234665401])

On May 8, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the completion of enrollment in its ReSTART pivotal trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), a U.S. multicenter study evaluating the efficacy and safety of intratumoral Alpha DaRT for the treatment of patients with recurrent cutaneous squamous cell carcinoma (cSCC). This is the first U.S. pivotal clinical study of Alpha Tau to have completed enrollment, representing a landmark milestone in the Company’s journey towards potential FDA PMA approval of Alpha DaRT in this indication.

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Uzi Sofer, CEO of Alpha Tau, stated, "The completion of enrollment in the ReSTART pivotal trial is a watershed moment for Alpha Tau. Skin cancer was the very first clinical application of Alpha DaRT, and it has served as the cornerstone of our entire clinical development strategy. The years of evidence we have generated across multiple countries and numerous patients have consistently demonstrated the strength of our intratumoral radiotherapeutic approach – providing the foundation not only for this pivotal study, but also for our expanding clinical programs in additional indications. Completing enrollment in our first-ever U.S. pivotal trial – the study designed to support our first potential FDA approval – brings us closer than ever to potential commercialization. We look forward to continued progress on our modular PMA submission and to ultimately bringing Alpha DaRT to market."

A pivotal study is a definitive clinical trial designed to provide the primary evidence of a medical product’s safety and efficacy upon which the FDA relies when evaluating whether to grant market approval. The completion of enrollment in the ReSTART trial marks a critical transition from patient recruitment to follow-up and data maturation, bringing Alpha Tau one step closer to a potential commercial approval of Alpha DaRT in the United States.

The ReSTART trial is a prospective, multicenter, single-arm, open-label pivotal study which enrolled 88 patients with biopsy-proven recurrent cSCC who have failed at least first-line standard-of-care therapy and who are not indicated for surgery or conventional treatment, and for whom no curative systemic treatment is available. The study’s co-primary endpoints are the objective response rate (ORR) based on confirmed best overall response, and the duration of response (DOR) at six months from the initial observation of response. Secondary endpoints include progression-free survival and overall survival at one year, overall duration of response, local control, and quality of life. With enrollment now complete, the study will proceed through its follow-up period to allow for assessment of these primary and secondary endpoints.

Cutaneous squamous cell carcinoma is the second most common form of skin cancer, with an incidence that continues to rise globally. While surgical excision effectively treats the majority of cSCC cases, a meaningful subset of patients develops recurrent disease that can no longer be managed with surgery or conventional treatments. For these patients there remains a significant unmet need for effective, well-tolerated treatments. Alpha DaRT, designed to deliver a targeted intratumoral radiotherapeutic treatment directly to the tumor, seeks to offer a new approach for this underserved population.

The ReSTART pivotal study builds on a robust foundation of clinical evidence generated through multiple skin cancer studies conducted in Israel, Italy and France, as well as a pilot study in the U.S. Together, clinicians in these studies have treated hundreds of tumors and have consistently observed promising efficacy and favorable safety of Alpha DaRT. Alpha Tau has received Breakthrough Device Designation from the FDA for Alpha DaRT in the treatment of recurrent cSCC, and submitted the first module of its modular PMA application in January 2026.

Robert B. Den, MD, Chief Medical Officer of Alpha Tau, stated, "Alpha DaRT’s journey in skin cancer has spanned years and continents. It began with foundational studies in Israel and Italy, expanded to France, and progressed to a pilot study in the United States – each study building upon the last and reinforcing the clinical evidence behind this technology. The ReSTART pivotal study, with a very large patient population of 88, represents the most rigorous evaluation of Alpha DaRT to date, and I want to express my sincere gratitude to all of the principal investigators who recruited patients into this trial. Their belief in the potential of Alpha DaRT to make a real difference for patients with recurrent cSCC – patients who have exhausted surgical and other curative options – has been instrumental in reaching this milestone. It is their commitment to clinical excellence and to their patients that brought us to this point."

Liron Dimnik, VP Clinical Affairs at Alpha Tau, commented, "Completing enrollment in a multicenter pivotal trial is an enormous operational undertaking, and I am incredibly proud of the team that made it happen. I want to thank our clinical operations team at Alpha Tau, who worked tirelessly to ensure that every aspect of the study – from site activation to data quality to regulatory compliance – was executed to the highest standards. I also want to recognize the physicians, study coordinators and site teams at every participating center, whose day-to-day dedication to patient care and protocol adherence is the backbone of any successful clinical trial. We now transition into the follow-up phase with confidence, knowing that the foundation we have built together is strong."

About the ReSTART Trial

The ReSTART trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) is a prospective, multicenter, single-arm, open-label pivotal clinical study evaluating the efficacy and safety of intratumoral Alpha DaRT for the treatment of patients with recurrent cutaneous squamous cell carcinoma (cSCC) who have failed at least first-line standard-of-care therapy and are not indicated for surgery or conventional treatment. The study enrolled 88 patients across clinical centers in the United States, Israel, and Canada. The co-primary endpoints are the objective response rate (ORR) based on confirmed best overall response and the duration of response (DOR) at six months from the initial observation of response. Secondary endpoints include progression-free survival and overall survival at one year, overall duration of response, local control, and quality of life. Alpha DaRT has received Breakthrough Device Designation from the FDA for this indication, and the Company submitted the first module of its modular pre-market approval (PMA) application in January 2026. Additional information about the trial can be found at View Source

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal intratumoral treatment of solid tumors. Alpha DaRT sources are inserted directly into the tumor, where they release short-lived therapeutic particles that disperse locally with the goal of destroying the tumor. Since the therapeutic effect is confined to a short distance, Alpha DaRT aims to mainly affect the tumor and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, MAY 8, 2026, View Source [SID1234665400])