On January 12, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress and outlined key anticipated milestones towards its first potential U.S. commercial launch under its "OnTarget 2026" operating plan.

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As part of this plan, Nuvalent anticipates the following 2026 milestones:

Commercial launch in the U.S. of zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI), pending U.S. Food and Drug Administration (FDA) review;
Submit data to FDA for potential indication expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026;
Submit a New Drug Application (NDA) for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC in the first half of 2026;
Progress the ongoing ALKAZAR Phase 3 randomized, controlled trial of neladalkib for TKI-naïve patients with ALK-positive NSCLC;
Progress the ongoing HEROEX-1 Phase 1a/1b trial of NVL-330 for patients with advanced HER2-altered NSCLC; and,
Disclose a new development candidate by year-end 2026.
"Over the past two years, the Nuvalent team has seamlessly executed against our OnTarget 2026 operating plan towards our goal of a first potential FDA approval, ending 2025 with the recent FDA acceptance of our NDA for zidesamtinib in TKI pre-treated ROS1-positive NSCLC and commercial preparedness activities well underway," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "If zidesamtinib is approved, a first commercial launch in 2026 would be a transformative moment for Nuvalent and the first step towards realizing our mission of becoming a sustainable company capable of not only discovering and developing, but delivering new medicines for patients with cancer."

"With cash runway anticipated into 2029, our strong financial position enables us to focus on the execution of a first U.S. launch while also supporting the continued advancement and expansion of both our commercial and development portfolios," said Alexandra Balcom, Chief Financial Officer at Nuvalent. "We have completed a pre-NDA meeting with the FDA for our ALK program and plan to move forward with an NDA submission of the data for TKI pre-treated patients with ALK-positive NSCLC from our ALKOVE-1 study of neladalkib in the first half of this year. In the second half of the year, we anticipate submitting data to support a potential indication expansion for zidesamtinib in ROS1-positive NSCLC, and growing our discovery portfolio with a new development candidate. Together, we believe the achievement of these anticipated 2026 milestones would position Nuvalent for continued, long-term growth driven by delivering meaningful impact for patients with NSCLC and beyond."

2025 Year-End Cash and Guidance

Nuvalent ended 2025 with approximately $1.4 billion in cash, cash equivalents and marketable securities (unaudited), which, based on its current operating plans, is expected to fund its operations into 2029. This amount is a preliminary, unaudited estimate only as of today, could change following completion of year-end closing procedures, and does not present all information necessary for an understanding of the company’s financial position as of December 31, 2025.

Presentation at 44th Annual J.P. Morgan Healthcare Conference

Dr. Porter will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 9:00 a.m. PT. A live webcast will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC.

About Neladalkib
Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About NVL-330
NVL-330 is an investigational, brain-penetrant, HER2-selective tyrosine kinase inhibitor designed to address the combined medical need of treating HER2-mutant tumors, including those with HER2 exon 20 insertion mutations, avoiding treatment related adverse events due to off-target inhibition of wild-type EGFR, and treating brain metastases.

(Press release, Nuvalent, JAN 12, 2026, View Source [SID1234661993])

On January 12, 2026 ARTBIO, Inc. ("ARTBIO"), a clinical-stage radiopharmaceutical company developing a new class of 212Pb alpha radioligand therapies (ARTs), reported dosing of two cohorts in the U.S. as part of its ARTISAN Phase 1 clinical trial of AB001, an ART being developed for the treatment of metastatic castration resistant prostate cancer (mCRPC). Patient cohorts include those with and without prior treatment with Lu177-PSMA targeted therapy.

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"The ARTBIO team is excited to continue to advance AB001 as our lead clinical asset for patients with and without prior Lu177-PSMA targeted therapy," said Margaret Yu, Chief Medical Officer of ARTBIO. "We are proud to collaborate with team members at BAMF Health and United Theranostics and are especially grateful to the patients who have enrolled in this study."

The ARTISAN clinical trial is being conducted across multiple clinical trial sites in the U.S. The company plans to expand the ARTISAN trial outside of the US in the second half of 2026.

"I’m proud to support prostate cancer patients by using United Theranostics infrastructure to bring access to the ARTISAN trial and to bring a new therapeutic option to patients," said Dr. Munir Ghesani, Chief Medical Officer at United Theranostics. "The ARTBIO team are passionate innovators who have constructed this trial with a strong patient-centric mindset."

BAMF Health Medical Director and principal investigator for the trial, Dr. Brandon Mancini, said, "AB001 PSMA-targeted radioligand therapy has the potential to reshape the treatment landscape for patients with metastatic castration-resistant prostate cancer who urgently need additional pathways forward."

About AB001
AB001 is an Alpha Radioligand Therapy (ART) consisting of a prostate-specific membrane antigen (PSMA)-targeted small molecule radiolabeled with 212Pb. PSMA is commonly overexpressed in mCRPC and has become an attractive target for imaging agents and therapies. It is the lead program for ARTBIO. In September 2025, an Investigational New Drug (IND) application for AB001 was cleared by The U.S. Food and Drug Administration (FDA). For more information about AB001 clinical trials, visit www.clinicaltrials.gov.

About the ARTISAN Study
ARTISAN is an open label, multi-center phase 1 study to investigate the safety, tolerability, pharmacokinetics, biodistribution and antitumor activity of the alpha radioligand therapy AB001 in patients with metastatic castration resistant prostate cancer (mCRPC).

(Press release, ARTBIO, JAN 12, 2026, View Source [SID1234661992])

On January 12, 2026 Curasight A/S ("Curasight" or "the Company" – TICKER: CURAS), a clinical-stage radiopharmaceutical company developing first-in-class drug candidate uTREAT targeting uPAR (urokinase-type plasminogen activator receptor), the functional driver of invasion, angiogenesis, and metastasis across most solid tumors, reported encouraging preliminary data from the first patient dosed in ongoing Phase 1 clinical trial in patients with high-grade gliomas.

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Position emission tomography (PET)-images from the first treated patient showed clear and sustained uptake of uTREAT in the tumor, confirming that the drug successfully targets cancer tissue. The signal remained visible for at least 24 hours, indicating prolonged tumor binding and supporting the potential for effective radiation delivery to the tumor. The patient’s PET signal persisted until the last PET scan (24 hours), demonstrating that uTREAT has protracted binding kinetics, translating to a maximized tumor absorbed dose.

These early results provide support for Curasight’s uPAR-targeted approach in radiopharmaceuticals and the potential of uTREAT as a novel therapy for patients with high-grade gliomas and other uPAR expressing aggressive solid tumors (>85% of solid tumors).

The preliminary dosimetry readout of uTREAT was in line with expectations and supports to continue with additional GBM patients. Currently more patients are enrolled, and top-line data is expected in Q2 2026.

"This first-patient data represents an important early milestone for Curasight and uTREAT," says Ulrich Krasilnikoff, CEO of Curasight. "The clear tumor uptake and high retention observed in aggressive glioblastoma provide early clinical validation of our uPAR-targeted radiopharmaceutical approach. The results further support the potential of uTREAT as a next generation radiopharmaceutical targeting uPAR for multiple solid aggressive tumors using one drug and one target. It further supports our theranostic uPAR platform designed to provide highly specific and personalized treatment for certain types of cancer".

About the uTREAT Phase 1 trial in glioblastoma

The phase 1 clinical trial is designed to evaluate the dosimetry and safety of Curasight’s drug candidate uTREAT as a first-in-class uPAR targeted radiopharmaceutical therapy in patients with newly diagnosed, verified or suspected glioblastoma (GBM). Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders.

About the uPAR theranostic platform

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE (highly precise PET imaging diagnostic) and uTREAT (highly precise radiopharmaceutical therapy) both targeting uPAR (urokinase-type plasminogen activator receptor) with the same uPAR binding peptide AE105. Together, they form an integrated approach to next generation radiopharmaceuticals in aggressive solid tumors. uTRACE is fully developed, GMP manufactured and validated in 9 clinical trials (450 patients). uTRACE is partnered with Curium Inc. in the field of diagnostics for prostate cancer.

About high grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors, and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approx. 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50 % of the patients die within 14 months and after five years from diagnosis only 5 % are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.

(Press release, Curasight, JAN 12, 2026, View Source [SID1234661991])

On January 12, 2026 Kainova Therapeutics ("Kainova" or "the Company"), a catalyst for breakthrough treatments for patients in immuno-oncology and inflammation, reported a transformative rebrand. The new name and brand reflect the Company’s clinical momentum, global focus, and readiness for the next chapter of strategic growth, anchored by a mature pipeline of G Protein-Coupled Receptor (GPCR)-modulating therapies.

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The name "Kainova" combines "Kairos," the opportune or decisive moment, and "Nova," symbolizing innovation and renewal. It embodies the Company’s transformation and ambition, reflecting its drive to innovate, determination to deliver, and commitment to therapies that truly transform lives. Built on a strong scientific foundation, a proprietary discovery platform, an integrated development approach, and experienced leadership, the new brand underscores Kainova’s commitment to clinical excellence, value creation, and lasting impact.

"The rebrand is not a break from our scientific or strategic roots", said Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics. "It is the clearer expression of who we are today and the impact we strive to deliver for patients. It highlights a continuation between our past successes and the growth path we envision for the future. Above all, Kainova Therapeutics embodies our belief that better is always possible."

Leveraging decades of scientific and medical expertise and a proven track record of collaborations with pharma, Kainova is advancing innovative, clinically differentiated therapies designed to unlock the untapped potential of GPCRs.

Kainova employs a fully integrated, forward-thinking approach to GPCR drug discovery and smart development, moving programs efficiently from concept to clinic and strengthening its position as a leader in the field. The Company’s leading programs include DT-7012, a Treg-depleting anti-CCR8 antibody with competitive properties in Phase I/II trials for solid tumors, DT-9046, a first-in-modality, pre-IND biased PAR2 antagonist in inflammation, and DT-9081, a Phase II-ready EP4 receptor antagonist for solid tumors.

With operations in North America, France, and Australia, and a growing clinical pipeline, Kainova is entering its next chapter, shaping the future of GPCR-modulating therapies, transforming lives, and expanding its global reach.

The Kainova leadership will be in San Francisco during the J.P. Morgan Healthcare Conference, January 12–15, 2026, and welcomes the opportunity to share how the Company is advancing its clinical pipeline of GPCR-modulating therapies to create a meaningful impact for patients.

(Press release, Domain Therapeutics, JAN 12, 2026, View Source [SID1234661989])

On January 12, 2026 AbbVie (NYSE: ABBV) and RemeGen reported an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 (PD-1)/Vascular Endothelial Growth Factor (VEGF)-targeted bispecific antibody. RC148 is currently being developed by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumors.

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PD-1/VEGF-targeted bispecific antibodies represent a new class of cancer therapies that aim to help the immune system fight tumors more effectively and potentially overcome tumor resistance mechanisms by blocking both PD-1 and VEGF simultaneously. Additionally, given their potential to modulate both immune suppression and foster a favorable tumor microenvironment for antibody-drug conjugate (ADC) activity, PD-1/VEGF bispecific antibodies are also being explored in combination with ADCs. In early clinical studies, RC148 has shown initial favorable antitumor activity in combination with an ADC.

RC148 further strengthens AbbVie’s diverse oncology portfolio. In particular, it may offer new opportunities to explore combination regimens with AbbVie’s ADCs such as investigational telisotuzumab adizutecan (Temab-A), across multiple solid tumors with high unmet need including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

"Our partnership with RemeGen reflects AbbVie’s commitment to not only advance novel oncology treatments, but also to build strong collaborations with biopharmaceutical innovators globally as an increasingly important source of scientific and clinical progress," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology at AbbVie. "By combining the immune checkpoint inhibition and anti-angiogenic activity of RC148 together with the targeted cytotoxic activity of ADCs, we have the potential to identify meaningful options for patients across a range of solid tumors."

"This collaboration is a significant milestone for RemeGen, highlighting the innovative potential of RC148 in addressing critical unmet medical needs in cancer treatment," said Dr. Jianmin Fang, chief executive officer of RemeGen. "The deal further underscores RemeGen’s commitment to bringing cutting-edge therapies to patients worldwide. Working with AbbVie, we look forward to maximizing RC148’s clinical and commercial potential in China and globally."

Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize RC148 outside of the Greater China territory. RemeGen will receive an upfront payment of USD $650 million and is eligible to receive up to USD $4.95 billion in aggregate development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales outside the Greater China territory.

(Press release, AbbVie, JAN 12, 2026, View Source [SID1234661988])