Protara Therapeutics Highlights Recent Updates and Anticipated 2026 Milestones

On January 12, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported recent updates and anticipated 2026 milestones.

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"On the heels of a remarkable year marked by meaningful progress across the entirety of our pipeline, we are entering 2026 with unwavering resolve to continue to execute on our mission to deliver transformative therapies to patients with cancer and rare diseases," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "For our non-muscle invasive bladder cancer (NMIBC) program, our growing body of clinical data continue to support that TARA-002 could serve as a differentiated, easy to administer treatment option across the NMIBC treatment landscape. Following our recent ADVANCED-2 update in which TARA-002 demonstrated meaningful and durable activity in BCG-Naïve NMIBC patients, we look forward to providing an interim update on the registrational BCG-Unresponsive trial later this quarter."

Mr. Shefferman added, "We have also made important progress in our rare disease programs. Following positive results from the ongoing Phase 2 STARBORN-1 trial of TARA-002 in lymphatic malformations (LMs), we were pleased that the FDA granted this program both Breakthrough Therapy and Fast Track designations and we expect to provide a regulatory update defining the path to registration in the first half of this year. Additionally, we were pleased to announce that the first patient has been dosed in our registrational THRIVE-3 trial of IV Choline Chloride in patients on long-term parenteral support (PS) and expect to provide an interim analysis in the second half of 2026. We believe we are well positioned for continued success with several key milestones anticipated in the year ahead."

Recent Company Updates and Planned 2026 Milestones

TARA-002 in NMIBC

Protara remains on track to report in the first quarter of 2026 interim results in approximately 25 six-month evaluable patients from its ongoing Phase 2 open-label ADVANCED-2 trial in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive.

In December 2025, the Company reported positive interim results from its ongoing Phase 2 open-label ADVANCED-2 trial in NMIBC patients with CIS (± Ta/T1) who are BCG-Naïve at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) in which TARA-002 demonstrated meaningful response rates at six and 12 months and a favorable safety and tolerability profile. Based on feedback from the U.S. Food and Drug Administration (FDA), the Company plans to commence a registrational trial of TARA-002 compared to intravesical chemotherapy in BCG-naïve patients in the second half of 2026.

Protara continues to evaluate subcutaneous dosing through priming and maintenance combined with intravesical dosing, as well as exploring combination treatments with TARA-002 in NMIBC patients with CIS.

TARA-002 in LMs

Protara recently announced that the FDA granted TARA-002 both Fast Track and Breakthrough Therapy designations for the treatment of pediatric patients with macrocystic and mixed cystic LMs. TARA-002 previously was granted Rare Pediatric Disease designation for the treatment of LMs.

The Company plans to share a regulatory update on the path forward for registration for TARA-002 in LMs in the first half of 2026.

TARA-002 Manufacturing Update

Protara recently announced that TARA-002 has been selected to participate in this year’s FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. The initiative is designed to promote earlier and more structured engagement between sponsors and FDA on CMC development strategies, and since its inception, has led to increased collaboration with the FDA so sponsors can confidently scale up manufacturing capacity while clinical development is ongoing.

IV Choline Chloride for Patients on PS

The Company recently announced that the first patient has been dosed in THRIVE-3 (NCT06910943), a seamless Phase 2b/3 trial designed to assess the efficacy and safety of low and high dose IV Choline Chloride in adolescent and adult patients receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated. Following an 8-week Phase 2b open-label, dose-confirmation trial in 24 patients, approximately 105 additional patients will be enrolled in a 24-week Phase 3 double-blinded, randomized, placebo-controlled trial. The primary endpoint of the trial is the change in plasma choline concentration from baseline compared to placebo. The Company expects to report interim results in the second half of 2026.

Corporate Update

In December 2025, the Company announced that it closed an underwritten public equity offering of approximately $86 million before deducting underwriting discounts and commissions and offering expenses payable by Protara. The proceeds from the offering are expected to extend the Company’s cash runway into 2028.

(Press release, Protara Therapeutics, JAN 12, 2026, View Source [SID1234661965])

ORIC® Pharmaceuticals Provides Operational Highlights for 2025 and Anticipated Upcoming Milestones

On January 12, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported operational highlights for 2025 and anticipated upcoming milestones.

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"2025 was a transformative and highly productive year for ORIC, marked by meaningful progress across our pipeline, including data that further strengthened our conviction in the potential best-in-class profiles of rinzimetostat in prostate cancer and enozertinib in lung cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "We also bolstered our leadership team and substantially extended our cash runway into 2H 2028 in anticipation of these programs advancing towards registrational studies and, ultimately, commercialization."

2025 Key Accomplishments

Rinzimetostat: a potent and selective allosteric inhibitor of PRC2

Completed Phase 1b dose exploration in prostate cancer and selected provisional recommended Phase 2 doses (RP2Ds) of rinzimetostat to be tested in combination with the approved doses of darolutamide and apalutamide in dose optimization.
Reported potential best-in-class efficacy and safety dose exploration data in combination with darolutamide and apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Data demonstrated:
PSA responses and ctDNA reductions across all rinzimetostat dose levels and at comparable rates in combination with apalutamide or with darolutamide.
Broad and deep PSA responses that compare favorably to competitor PRC2 inhibitors, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed).
Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.
Both combination regimens demonstrated a clearly differentiated safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition.
Presented preclinical data at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics demonstrating potential utility of rinzimetostat combined with AR inhibition in castration-sensitive prostate cancer and combined with KRAS inhibition in KRAS G12C-mutant NSCLC and colorectal cancer models.

Enozertinib: a brain-penetrant inhibitor that selectively targets EGFR exon 20 and EGFR PACC mutations

Reported potential best-in-class efficacy and safety data from a Phase 1b trial of enozertinib at the ESMO (Free ESMO Whitepaper) Asia Congress 2025 in NSCLC patients with EGFR exon 20 and EGFR PACC mutations. Data demonstrated:
Systemic activity in 2L EGFR exon 20 and pretreated EGFR PACC exceeding competitor benchmarks.
Highly competitive preliminary 1L systemic activity, with 67% ORR in EGFR exon 20 and 80% ORR in EGFR PACC.
Convincing 1L CNS activity, with 100% intracranial ORR in EGFR exon 20 and 100% intracranial ORR in EGFR PACC in patients with measurable CNS disease, including in patients with active brain metastases.
Competitive safety profile, with no significant off-target toxicity, resulting in low rate of treatment discontinuations.
Announced a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate enozertinib in combination with amivantamab and hyaluronidase-lpuj subcutaneous injection (SC amivantamab) for the 1L treatment of NSCLC patients with EGFR exon 20 mutations.
Announced publication in Cancer Research of preclinical data demonstrating enozertinib’s exquisite selectivity, strong potency, brain-penetrance, and anti-tumor activity across a broad range of EGFR atypical mutant models, including intracranial lung cancer xenografts.

Corporate Highlights:

Announced the appointment of Kevin Brodbeck, PhD, to the newly established role of Chief Technical Officer (CTO).
Strengthened cash position and extended runway with $244 million in gross proceeds raised from new and existing top-tier healthcare specialist funds via private placement in May 2025 and under the ATM (at-the-market) program throughout 2025.

Anticipated Program Milestones:

ORIC anticipates the following upcoming milestones:

Rinzimetostat in mCRPC:
1Q 2026: Combination dose optimization data with AR inhibitor
1H 2026: Initiate first global Phase 3 registrational trial in mCRPC
2H 2026: Program update
Enozertinib in NSCLC:
2H 2026: 1L EGFR exon 20 monotherapy data and combination data with SC amivantamab
2H 2026: 1L EGFR PACC monotherapy data

Financial Guidance
As of September 30, 2025, cash, cash equivalents and investments totaled $413.0 million, which the company expects will be sufficient to fund its operating plan into 2H 2028, beyond several potential value inflection points, including anticipated primary endpoint readout from first Phase 3 trial of rinzimetostat.

Presentation and Webcast
Jacob M. Chacko, M.D., president and chief executive officer, will present a company overview at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2025, at 9:45 a.m. PT. A live webcast will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

(Press release, ORIC Pharmaceuticals, JAN 12, 2026, View Source [SID1234661964])

Corporate overview

On January 12, 2026 Olema Oncology presented its corporate presentation.

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(Presentation, Olema Oncology, JAN 12, 2026, View Source [SID1234661963])

Nurix Therapeutics Outlines 2026 Goals and Objectives for Advancing Bexobrutideg and Its Pipeline of Novel Degrader-Based Medicines in Cancer and Autoimmune Diseases

On January 12, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune diseases, reported the Company’s achievements in 2025 and outlined key objectives and anticipated milestones for 2026, which will be the subject of Nurix’s corporate update at the 44th Annual J.P. Morgan Healthcare Conference today at 4:30 p.m. PT, in San Francisco.

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"2025 was a defining year for Nurix, having advanced our potentially best-in-class BTK degrader, bexobrutideg, into pivotal development for patients with relapsed or refractory CLL," said Arthur T. Sands, president and chief executive officer of Nurix. "As we enter 2026, we are focused on executing the DAYBreak CLL-201 study and initiating the confirmatory Phase 3 trial, DAYBreak CLL-306. We are also excited to advance our pipeline of wholly owned and partnered programs in inflammation and autoimmune diseases, including our new tablet formulation of bexobrutideg, our IRAK4 degrader program partnered with Gilead, and our STAT6 degrader program partnered with Sanofi. With our pivotal DAYBreak program underway, a strong balance sheet, and multiple catalysts across oncology and immunology, we believe Nurix is exceptionally well positioned to make 2026 a transformative year for the Company and the field of targeted protein degradation."

2025 Select Accomplishments and Business Highlights

Potential Best-in-Class BTK degrader, Bexobrutideg, in CLL

Presented new and updated clinical and preclinical data supporting a potential best-in-class BTK degrader profile. New and updated clinical data were presented in December 2025 at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH2025) that provide a maturing clinical picture of bexobrutideg’s efficacy, durability, and tolerability. Highlights included an 83% objective response rate, including two complete responses (4.3%) in CLL patients with a median of four prior lines of treatment. Responses were durable and deepened over time with a median progression-free survival estimated at 22.1 months, which is highly competitive with currently approved agents in a similar line of therapy. Bexobrutideg was well tolerated with no dose-limiting toxicities across all doses tested. New preclinical data were presented in October 2025 that support bexobrutideg’s potential best-in-class BTK degrader profile, demonstrating superior degradation potency, broad coverage of clinically relevant BTK mutations, and exquisite selectivity. These findings strengthen the Company’s conviction that bexobrutideg may prove to be a clinically superior medicine for the treatment of patients with CLL and other B-cell driven diseases.

Successfully addressed FDA’s Project Optimus with the selection of the 600 mg once daily dose for pivotal development in r/r CLL. The selection of the 600 mg dose was supported by data from a randomized cohort within the Phase 1b study comparing 200 mg and 600 mg in accordance with Project Optimus and reflects alignment with global regulators, including the U.S. Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency. The results, subsequently reported at ASH (Free ASH Whitepaper)2025, demonstrated a trend toward a higher objective response rate and longer progression-free survival with the 600 mg dose without an increase in adverse events. The clearance by regulators of the 600 mg dose allows Nurix to optimize bexobrutideg’s therapeutic effect, providing patients the opportunity to regain control of CLL that has progressed or has failed to respond to other therapies.

Initiated pivotal clinical development in patients with relapsed or refractory CLL. In October 2025, Nurix initiated enrollment in the DAYBreak CLL-201 pivotal Phase 2 study (NCT07221500). This single-arm, global study is evaluating bexobrutideg at 600 mg once daily in patients with relapsed or refractory CLL whose disease progressed following treatment with a BTK inhibitor and a BCL2 inhibitor. The trial is designed to support accelerated approval of bexobrutideg in triple-exposed CLL/SLL patients. Nurix plans to initiate a randomized confirmatory Phase 3 trial in 2026 to support full approval of bexobrutideg.

First-in-class CBL-B Inhibitor NX-1607

Presented positive Phase 1a clinical data demonstrating immune activation and clinical activity. New Phase 1a clinical data for NX-1607 were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October and the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November, demonstrating dose-dependent pharmacologic activity and signals of clinical activity across a diverse set of 82 patients with eleven different tumor types. Clinical activity was observed through reductions in tumor-specific biomarkers such as prostate-specific antigen (PSA) in prostate cancer and carcinoembryonic antigen (CEA) in colorectal cancer. Notably, there was a confirmed partial response in a patient with micro-satellite stable colorectal cancer (MSS CRC), a tumor type typically unresponsive to immune checkpoint therapy. As anticipated, treatment with NX-1607 led to increased peripheral T cell activation and proliferation, indicating active T-cell receptor engagement and immune responsiveness, suggesting its potential as an active immune-oncology agent with a unique mechanism distinct from PD-1/PD-L1 therapies.

Advancing Pipeline in Inflammation and Autoimmune Diseases

Introduced new tablet formulation of bexobrutideg into Phase 1 testing to support an IND for inflammation and autoimmune indications. In 2025, Nurix initiated a Phase 1 single ascending and multiple ascending dose (SAD/MAD) study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), and safety of a new tablet formulation of bexobrutideg. This study is intended to support an IND filing and enable expansion into inflammatory and autoimmune indications beginning in 2026.

Partner Gilead initiated Phase 1 testing of IRAK-4 degrader. In April 2025, Nurix announced that the FDA cleared the Investigational New Drug (IND) application for GS-6791 (previously NX-0479), a novel, potentially best-in-class oral degrader of IRAK4 being developed in collaboration with Gilead Sciences. GS-6791 is designed to selectively degrade IRAK4, a key signaling protein that drives inflammation in autoimmune and inflammatory diseases. Gilead subsequently initiated an ongoing Phase 1 trial in healthy volunteers, the results of which will inform Nurix’s option for a 50/50 co-development and U.S. profit share.

Partner Sanofi advanced STAT6 degrader program into IND enabling studies: In June 2025, Nurix announced that Sanofi exercised its option to extend its license for Nurix’s STAT6 program, including the development candidate NX-3911. NX-3911 is an oral, highly selective degrader of STAT6, a key transcription factor within the IL-4/IL-13 signaling pathways that drive inflammation in allergic and type 2 inflammatory conditions, which currently is in IND enabling studies. Sanofi is responsible for all development activities, and Nurix retains an option for a 50/50 U.S. profit share and co-promotion after initial clinical proof of concept.

Corporate and Leadership

Strengthened financial position to support execution of bexobrutideg pivotal program and expansion into inflammation and autoimmune disease. In October 2025, Nurix closed an underwritten registered offering of 24,485,799 shares of its common stock, providing gross proceeds to Nurix of $250.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Nurix. In addition, Nurix earned $47.0 million in non-dilutive capital through its strategic collaborations with Gilead, Sanofi and Pfizer. Nurix is well capitalized with pro forma cash/investments of $663.8 million1.

Strengthened leadership with appointments of chief commercial officer and new board members with deep experience in drug development and commercialization. In 2025, Nurix announced the hiring of John Northcott as chief commercial officer, bringing extensive U.S. and global commercial leadership experience, including both pre-launch planning and on-market commercialization in hematology, oncology and a wide range of other therapeutic areas. In addition Nurix also appointed two board members: Roy Baynes, MB.Bch., M.Med., Ph.D., who has extensive experience in the development of innovative, blockbuster medicines during a distinguished career in hematology and oncology, and Roger Dansey, M.D., senior leader in drug development and operations with over 25 years of executive experience in pharmaceutical and biotech companies across both U.S. and international markets.

2026 Outlook: Executing the Next Phase of Growth

Execute pivotal development pathway in CLL:
Enrollment of pivotal Phase 2 trial – DAYBreak CLL-201
Initiation of a confirmatory Phase 3 study in patients with r/r CLL in the 2L+ setting comparing bexobrutideg monotherapy to pirtobrutinib – DAYBreak CLL-306
Initiation of a Phase 1b/2 clinical study in patients with CLL in combination with other therapeutic agents including venetoclax (BCL-2 inhibitor)
Advance Degrader Programs in I&I:
Bexobrutideg – data from new tablet formulation SAD/MAD study supporting IND in I&I
GS-6791 IRAK4 degrader – potential Phase 1 results2
NX-3911 STAT6 degrader – potential IND filing by Sanofi2
Report Ongoing Clinical Data Updates:
Bexobrutideg Phase 1a/b CLL cohorts
Bexobrutideg Phase 1a/b NHL cohorts
Zelebrudomide Phase 1a cohorts
Progress Research and Development Pipeline:
Leverage DEL-AITM platform to fuel wholly owned and partnered drug discovery programs
Earn additional research milestones and potential licensing fees from its collaborations with Gilead, Sanofi, and Pfizer.

1Represents cash balance as of August 31, 2025, plus the net proceeds from the October 2025 registered direct offering

2Statements include Nurix estimate for partnered programs using industry standard timelines based on current stage of development (not official guidance of partners).

About Bexobrutideg (NX-5948)
Bexobrutideg is an investigational, orally bioavailable, brain penetrant, highly selective small molecule degrader of BTK currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia. Bexobrutideg also continues to be studied in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B cell malignancies.

About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

(Press release, Nurix Therapeutics, JAN 12, 2026, View Source [SID1234661962])

Nerviano Medical Sciences announces NMPA Clearance of IND for PARP7-Selective Inhibitor Atamparib in Promising New Therapeutic Setting

On January 12, 2026 NMS Group (NMS), a global leader in oncological innovation, reported that the China’s National Medical Products Administration (NMPA) has granted approval to the Investigational New Drug (IND) application for its first-in-class, orally bioavailable PARP7-selective inhibitor, atamparib, enabling its clinical studies in patients with advanced solid tumors.

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The phase Ib/II clinical trial expected to start in the first quarter of 2026 is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib in patients with advanced solid tumors, with a focus on a promising new therapeutic sub-setting. The goal is to validate the molecule’s differentiated mechanism of action and its favorable safety and tolerability with more than 200 patients treated so far, both in late-line patients and in future combination with standard-of-care in earlier treatment settings.

"The IND approval in China represents a key strategic milestone for the development of atamparib," said Hugues Dolgos, CEO of NMS Srl. "Recent data generated across preclinical and clinical programs, along with the newly published mechanism of action, have enabled us to reposition this asset into a promising sizeable indication where we believe it can deliver meaningful clinical benefit."

"Conducting the study in China is expected to support atamparib global clinical development by enabling timely access to a clinically relevant patient population and facilitating the potential availability of new treatment options for patients in China and worldwide," said Dadong Li, CEO of NMS Shanghai. "This milestone marks an important step in advancing the development of atamparib and exploring its potential to expand treatment options for patients."

In parallel, NMS is advancing a dual inhibitor program currently in preclinical development, targeting PARP7 and another undisclosed target, which is expected to complement the clinical development strategy of atamparib and underscores the company’s commitment to building a differentiated portfolio of innovative therapeutic candidates.

(Press release, Nerviano Medical Sciences, JAN 12, 2026, View Source [SID1234661961])