Nurix Announces $10 Million Milestone Payment Associated with Initiation of a Phase 1 Clinical Trial of a STAT6 Degrader

On August 4, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that it has earned a $10 million milestone payment following the initiation by its collaborator, Sanofi, of the Phase 1 first-in-human clinical trial of SAR448272/NX-3911, an oral STAT6 degrader.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

STAT6 is a key transcription factor within the interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways that drive type 2 inflammation and play a central role in diseases including atopic dermatitis and asthma. With the receipt of the $10 million development milestone payment from Sanofi, Nurix will have received approximately $139 million under the companies’ 2019 collaboration agreement. Sanofi is solely responsible for the ongoing clinical development of SAR448272.

"Advancing SAR448272 into the clinic marks an important milestone for the STAT6 program and further validates the productivity of our DEL-AI drug discovery platform in generating differentiated degrader medicines for immunology," said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. "We look forward to seeing the program advance through clinical evaluation by our partner Sanofi."

"Today’s announcement represents another important advancement in our long-standing collaboration with Sanofi and further demonstrates our ability to discover innovative targeted protein degraders for major inflammatory diseases," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "The advancement of SAR448272 into Phase 1 builds on the strong momentum across our partnered immunology portfolio and reflects the continued execution of our strategy to create significant value through both our wholly owned and partnered degrader programs."

About the Nurix/Sanofi Collaboration
Under the 2019 collaboration agreement, Nurix deployed its proprietary DEL-AI drug discovery platform to identify novel agents that utilize E3 ligases to induce the degradation of specified proteins. In 2025, Sanofi exercised its license extension option for two programs targeting transcription factors for the treatment of autoimmune/inflammatory diseases including an undisclosed target and STAT6. For both programs, Nurix retains the option to co-develop and co-promote in the United States following demonstration of clinical proof of concept. Upon execution of the collaboration agreement in December 2019, Sanofi made an upfront payment to Nurix of $55 million and subsequently paid an additional $22 million to expand the scope of the collaboration. In June 2025, Sanofi exercised its exclusive license extension option for an undisclosed target and for the STAT6 program, triggering two $15 million license extension payments. Following the receipt of the $10 million milestone associated with initiation of the Phase 1 study, Nurix will have received a total of approximately $139 million under the Sanofi collaboration. Nurix remains eligible to receive approximately $453 million in future development, regulatory and commercial milestone payments associated with the STAT6 program, in addition to potential royalties on future product sales. Nurix also retains an option to co-develop, co-promote, and share profits and losses for the program equally in the United States.

(Press release, Nurix Therapeutics, AUG 4, 2026, View Source [SID1234669687])

Evexta Bio Announces Clinical Trial Collaboration and Supply Agreement with Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced / Metastatic Breast Cancer

On August 4, 2026 Evexta Bio S.A., a precision oncology company, founded by Truffle Capital (founder of Abivax and Carvolix), and focused on the discovery and development of targeted therapies, reported a clinical collaboration and supply agreement with plans to initiate a Phase 1b study combining its lead investigational compound, rupitasertib, with Roche’s investigational compound giredestrant, a selective estrogen receptor degrader (SERD), for the treatment of ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Rupitasertib is a first-in-class oral dual-node PI3K/AKT/mTOR (PAM) pathway inhibitor, which selectively inhibits S6K and AKT1/3. Rupitasertib was purposefully and rationally designed to target S6K for potent PAM inhibition and AKT1/3 to block the AKT compensatory feedback loop, while sparing AKT2 to avoid hyperglycemia, which we believe will lead to a superior efficacy and safety profile compared to other PAM pathway inhibitors.

Under the terms of the agreement, Roche will supply giredestrant and Evexta Bio will conduct the Phase 1b study assessing the safety, tolerability, and preliminary anti-tumor activity of rupitasertib in combination with giredestrant in ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer. The study is intended to enroll at least 15 patients and is expected to be initiated in Q4 2026.

Dr. Shawn M. Leland, PharmD, RPh, Board Chairman of Evexta Bio stated: "We are very pleased and excited to partner with Roche on Evexta Bio’s first clinical collaboration with rupitasertib. ER+, HER2-, ESR1-mutated breast cancer remains a significant unmet medical need. We are looking forward to being able to provide ER+, HER2-, ESR1-mutated breast cancer patients with the option to receive an all-oral regimen of a first-in-class, dual-node PAM pathway inhibitor and a SERD."

(Press release, Evexta Bio, AUG 4, 2026, View Source [SID1234669656])

Tyra Biosciences Reports Second Quarter 2026 Financial Results and Recent Highlights

On August 4, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the second quarter ended June 30, 2026, and highlighted recent corporate progress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"September marks an important milestone for TYRA as we prepare to share initial clinical data from SURF302 evaluating oral dabogratinib in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). Patients with IR NMIBC often endure a lifelong cycle of recurrent disease, repeated surgical procedures, catheterization, and ongoing surveillance, highlighting the need for more convenient and effective treatment options. We believe dabogratinib has the potential to redefine the treatment paradigm as the first targeted oral therapy for FGFR3-driven IR NMIBC, addressing the underlying biology of the disease while offering the convenience of an oral therapy," said Todd Harris, PhD, President and Chief Executive Officer of TYRA.

Dr. Harris continued, "Beyond SURF302, we continue to advance our broader pipeline, including progressing BEACH301 to a fifth dose level in achondroplasia, and strengthening our skeletal dysplasia leadership with the addition of Jonathan Day, whose work was instrumental in the development of vosoritide. Across our portfolio, we remain focused on realizing the full potential of oral dabogratinib for patients with FGFR3-driven conditions and diseases."

"Over the past decade, I’ve had the privilege of helping advance therapies that have transformed the treatment landscape for children with achondroplasia. I believe there is still meaningful opportunity to further improve outcomes, and TYRA’s highly selective approach to FGFR3 inhibition offers a compelling opportunity to do just that," commented Dr. Day, TYRA’s newly appointed Executive Vice President, Clinical Development. "I’m excited to join the team and help advance dabogratinib as we work to develop a differentiated oral therapy for children with achondroplasia and their families."

Second Quarter and Recent Corporate Highlights

Dabogratinib 3×3 Strategy

In the second quarter of 2026, TYRA continued to advance its "dabogratinib 3×3" strategy: developing the first orally available, FGFR3-selective inhibitor in 3 future potentially pivotal clinical studies to support regulatory submissions with the aim to commercialize in 3 potential blockbuster indications: LG-UTUC, IR NMIBC and ACH.

Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses (60 mg and 80 mg) in participants with low-grade upper tract urothelial carcinoma (LG-UTUC), a rare cancer where approximately 85% of tumors are driven by FGFR3. Initial results from this study are expected in 2027.
Phase 2 IR NMIBC Study – SURF302. SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses (50 mg and 60 mg) in participants with FGFR3-altered low-grade IR NMIBC. The Company will host a conference call and webcast in September 2026 to report initial results from the SURF302 study, including safety results from more than 40 patients and efficacy from more than 20 patients in the aggregate at both QD dose levels.
Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with achondroplasia (ACH). The study has enrolled the safety sentinel cohort and successfully cleared four dose levels, with no notable safety events reported to date. Given the favorable safety profile seen to date across dose levels 1 through 4 in BEACH301, the Data Safety Monitoring Committee authorized the opening of a fifth dose level to evaluate 0.625 mg/kg in the safety sentinel cohort. Initial results from the safety sentinel cohort, including 6-month annualized height velocity and safety data for dose levels 1-5, which will include an aggregate of approximately 25 children, are expected to be reported at the end of Q1 2027.
Corporate

Appointed Jonathan Day as EVP, Clinical Development for Skeletal Dysplasia Conditions. In June 2026, TYRA appointed Jonathan Day, MBBS, PhD, FFPM, FESC, as Executive Vice President, Clinical Development, where he will lead the Company’s development program and clinical strategy for oral dabogratinib in skeletal dysplasia conditions. Dr. Day is a physician-scientist and pharmaceutical executive with extensive experience leading late-stage clinical development programs in rare diseases. At BioMarin Pharmaceutical, he served as Head of R&D for the Skeletal Conditions Business Unit (previously Group Vice President, Late-Stage Clinical Development), where he led the global clinical development strategy for the company’s skeletal dysplasia portfolio, including vosoritide (Voxzogo) for achondroplasia. Before joining BioMarin, Dr. Day was Vice President and Global Medical Lead for Acute Cardiovascular Care at The Medicines Company, and earlier served as Medical Director for the UK & Ireland at AstraZeneca. Prior to industry, he trained in cardiothoracic surgery and completed a PhD at Imperial College London focused on thrombin inhibition and cardiovascular medicine. He is also a Fellow of the European Society of Cardiology and the Faculty of Pharmaceutical Medicine.
Amended ATM Sales Agreement. In August 2026, TYRA entered into an amended sales agreement with TD Securities (USA) LLC, under which TYRA may sell up to the amount registered on an effective registration statement under which the offering is made, subject to other limitations. Pursuant to the amended sales agreement, as of the date hereof, TYRA may sell an additional $250.0 million of shares of its common stock from time to time in "at-the-market" offerings.
SNÅP Platform and Pipeline

TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.
Second Quarter Financial Results

Cash, Cash Equivalents and Marketable Securities. As of June 30, 2026, TYRA had cash, cash equivalents and marketable securities of $353.9 million. The Company’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans into the second half of 2028.
Research and Development (R&D) Expenses. R&D expenses for the three months ended June 30, 2026 were $39.2 million compared to $24.3 million for the same period in 2025. The increase was primarily associated with development activities for oral dabogratinib, supporting the ongoing SURF303, SURF302 and BEACH301 clinical trials, partially offset by a decrease in development activities for other programs. There were also increases in personnel expenses, driven by headcount growth to support expanding clinical and development activities, and expenses for facilities and other costs.
General and Administrative (G&A) Expenses. G&A expenses for the three months ended June 30, 2026 were $9.8 million compared to $7.1 million for the same period in 2025. The increase was primarily driven by higher compensation and other personnel costs, driven by headcount growth.
Net Loss. Second quarter net loss was $45.6 million compared to $28.1 million for the same period in 2025.
Upcoming Anticipated Clinical Milestones:

SURF303: initial results – 2027
SURF302: initial results from both dose cohorts – September 2026
BEACH301: initial results from dose levels 1-5 of safety sentinel cohort – end of Q1 2027
About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3-selective inhibitor to enter clinical development, and it has been studied in more than 200 individuals to date across multiple clinical and healthy volunteer studies.

Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

Please visit the Patients page of our website for more information on our clinical trials.

(Press release, Tyra Biosciences, AUG 4, 2026, View Source [SID1234669672])

SHY Therapeutics Announces the First Patient Has Been Dosed in Phase 1 Clinical Trial Evaluating SHY-ONC6, a Novel, Oral Proteasome Inhibitor for the Treatment of Solid Tumors

On August 4, 2026 SHY Therapeutics ("SHY" or "the Company"), a clinical-stage biotechnology company developing small molecules that non-covalently target ATPases and GTPases and modulate their activity, reported that the first patient has been dosed in Luca-1, the Company’s first-in-human Phase 1 clinical trial evaluating SHY-ONC6, an investigational, novel and potentially first-in-class oral proteasome inhibitor for patients with advanced solid tumors. The Company expects initial Phase 1 data in 2027.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"SHY-ONC6 targets the ubiquitin-proteasome system, which governs the degradation of damaged or unneeded proteins. Unlike current FDA-approved proteasome inhibitors that target the 20S Core Particle, SHY-ONC6 inhibits the ATPases within the 19S Regulatory Particle of the proteasome, introducing a novel and differentiated mechanism of proteasome inhibition," said Yaron Hadari, Ph.D., SHY’s Chief Executive Officer and Co-Founder.

While treatment with the current FDA approved proteasome inhibitors is limited to hematologic malignancies, SHY-ONC6 is being developed to expand this clinically validated therapeutic approach to solid tumors. Preclinical studies of SHY-ONC6 have demonstrated robust anti-tumor activity and favorable tolerability in multiple in vivo models of solid tumors, with similarly strong activity observed in hematologic malignancy models, supporting potential future development in additional cancer types.

"Dosing the first patient represents an important milestone as SHY advances its first clinical program and validates our strategy of developing differentiated small molecules against high-value ATPase and GTPase targets," said Michael Schmertzler, Executive Chairman and Co-Founder of SHY Therapeutics. "We believe SHY-ONC6 has the potential to expand the clinical utility of proteasome inhibition beyond hematologic cancers, addressing a much broader population of patients with solid tumors, and look forward to generating the first clinical data from the program next year," added Mr. Schmertzler.

The Luca-1 trial is a first-in-human, open-label, multicenter Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SHY-ONC6 in patients with advanced solid tumors. Additional information about the trial is available at ClinicalTrials.gov.

(Press release, SHY Therapeutics, AUG 4, 2026, View Source [SID1234669688])

Nurix Therapeutics Announces First Patient Enrolled in Registrational Phase 3 DAYBreak CLL-306 Trial of Bexobrutideg in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

On August 4, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX) reported that the first patient has been enrolled in the global Phase 3 DAYBreak CLL-306 study (NCT07516093) evaluating bexobrutideg, a potential best-in-class targeted protein degrader of Bruton’s tyrosine kinase (BTK), in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor. The global study is being conducted under the collaboration between Nurix and Roche and marks the first Phase 3 trial for bexobrutideg. The registrational study is designed to demonstrate the superiority of bexobrutideg versus the non-covalent BTK inhibitor pirtobrutinib, the current standard of care in this treatment setting for patients whose disease has progressed following prior covalent BTK inhibitor therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This is an important milestone for the global bexobrutideg development program with the potential to redefine the treatment landscape for patients with CLL through a head-to-head comparison of BTK degradation versus non-covalent inhibition," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We believe targeted protein degradation offers a fundamentally differentiated approach to addressing disease targets as compared to traditional small molecule inhibition, and this trial is designed to test whether that differentiation translates into superior outcomes for patients. Together with Roche, we are committed to advancing an ambitious global development program intended to fully realize the potential of BTK degradation across oncology, immunology and neurology."

The randomized Phase 3 trial is expected to enroll approximately 620 patients with relapsed/refractory CLL/SLL who have previously progressed on a covalent BTK inhibitor. Patients will be randomized 1:1 to receive either bexobrutideg 600 mg orally once per day or pirtobrutinib. The dual primary endpoints are objective response rate (ORR) and progression free survival (PFS), as assessed by an independent review committee. The study is designed to evaluate the potential superiority of bexobrutideg relative to pirtobrutinib and support global regulatory submissions.

"Bexobrutideg has demonstrated robust clinical activity in the setting of relapsed/refractory CLL with a favorable safety and tolerability profile," said Paula O’Connor, M.D., chief medical officer of Nurix. "The initiation of DAYBreak CLL-306 reflects our commitment to bringing innovative treatment options to patients with CLL who continue to face significant unmet medical needs."

About Bexobrutideg (NX-5948)
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

​​​Bexobrutideg is currently being evaluated in a broad clinical development program in patients with chronic lymphocytic leukemia (CLL) including the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed/refractory CLL, the DAYBreak CLL-306 clinical trial (NCT07516093), a randomized Phase 3 trial comparing bexobrutideg to pirtobrutinib in patients with relapsed/refractory CLL, and the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed/refractory B-cell malignancies. Nurix’s plans also include the NX-5948-203 Phase 1/2 clinical trial (NCT07520006), assessing the combination of bexobrutideg with venetoclax with or without an anti-CD20 antibody in patients with relapsed/refractory CLL and treatment naïve CLL. A new tablet formulation of bexobrutideg is being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about these clinical trials can be found at clinicaltrials.gov.

(Press release, Hoffmann-La Roche, AUG 4, 2026, View Source [SID1234669657])