Taiho Oncology Appoints Peter Melnyk as President & Chief Executive Officer

On January 28, 2026 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported that Peter Melnyk has been appointed to President & Chief Executive Officer, effective immediately. Mr. Melnyk succeeds Tim Whitten, who has retired after 13 years of service.

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"Peter has spent his career working to bring transformative oncology treatments to patients around the world," said Masa Kobayashi, President & Representative Director of Taiho Pharmaceutical Co., Ltd. "With Peter as President & CEO, we are positioning the company for a successful future to help as many people affected by cancer as possible. We trust Peter to guide TOI’s continued growth and innovation as we pursue our mission to improve the lives of patients with cancer, their families and their caregivers."

"During Tim Whitten’s tenure, TOI launched its first commercial product and has grown from one product in one indication to three products in five indications with a robust pipeline and a bright future," Mr. Kobayashi continued. "The Taiho organization has deep gratitude for Tim’s strong, compassionate leadership and the positive impact that he has made – both within the company and more broadly, in oncology. We thank him for the positive impact he has had on the lives of patients with cancer and wish him well in his retirement."

Mr. Melnyk has more than 30 years of proven experience in oncology commercialization and leadership across pharmaceuticals, medical devices and biotech sectors. Mr. Melnyk joined Taiho Oncology from Alpha Tau Medical, where he was the Chief Commercial Officer and former board member and led the global commercialization efforts for a novel alpha-emitting radiotherapeutic. He was also the CEO of Fortovia Therapeutics and drove the transformation and portfolio expansion in oncology supportive care. In addition, Mr. Melnyk was the Chief Commercial Officer at Novocure, where he built the global commercial infrastructure and launched Optune, a novel medical device for the treatment of glioblastoma.

"I’m deeply honored to be part of Taiho’s next chapter and with my colleagues, continue making a lasting impact for the patients we serve," Mr. Melnyk said. "Together, we will continue to build upon Taiho Oncology’s strong foundation – combining rigorous science, strategic thinking and heartfelt dedication to patients. Thank you to every Taiho team member for your continued commitment to patients and innovation."

(Press release, Taiho, JAN 28, 2026, View Source [SID1234662341])

Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201

On January 28, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), the global leader in relapsed/refractory AL Amyloidosis, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

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Per FDA, Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

The FDA Breakthrough Therapy designation is based on Phase 2 NXC-201 interim clinical results from the NEXICART-2 clinical trial, presented December 7, 2025 in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, FL.

"We are grateful to FDA for recognizing NXC-201 as the only granted FDA Breakthrough Designation for a therapy in active development in relapsed/refractory AL Amyloidosis, where no approved therapies exist for patients today," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We are looking forward to completing enrollment of NEXICART-2 with the goal of delivering this promising therapy to patients upon planned BLA submission this year."

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is expected to enroll 40 patients.

About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.

The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

(Press release, Immix Biopharma, JAN 28, 2026, View Source [SID1234662326])

Accent Therapeutics to Utilize Inocras’ CancerVision™ and MRDVision™ Platforms in Phase 1/2 ATX-295 Clinical Study

On January 28, 2026 Inocras, a bioinformatics-led company harnessing the power of whole genome data and proprietary analytics to deliver curated insights, reported that Accent Therapeutics will deploy Inocras’ CancerVision and MRDVision whole genome platforms in its first-in-human Phase 1/2 dose-escalation study of ATX-295, a potential best-in-class inhibitor of the KIF18A protein.

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Through this collaboration, Inocras’ CancerVision platform is being applied to characterize the detailed genomic status of clinical samples, while MRDVision provides ultra-sensitive monitoring of treatment response during dose escalation. Together, these platforms enable a comprehensive view of tumor dynamics.

"This collaboration marks an inflection point in how whole genome data drives clinical execution," said Jehee Suh, CEO of Inocras. "By deploying our CancerVision and MRDVision platforms, we are empowering Accent’s team with the comprehensive, ultra-sensitive insights needed to accelerate their groundbreaking ATX-295 program. This partnership underscores that whole genome profiling is no longer just for research; it is a critical tool for next-generation drug development."

"Access to a robust, clinically validated, whole-genome cancer profiling platform such as CancerVision has been critical to accelerating translational insights and clinical execution for our ATX-295 program," said Serena Silver, Ph.D., Chief Scientific Officer of Accent Therapeutics. "We are eager to use the insights gained from the Inocras platform to help advance ATX-295 in the clinic."

(Press release, Accent Therapeutics, JAN 28, 2026, View Source [SID1234662342])

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides a Corporate Update

On January 28, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported financial results for the fiscal quarter ended November 30, 2025, and highlighted significant progress across its clinical programs and strategic collaborations.

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"The fourth quarter marked a pivotal inflection point for Nurix as we initiated the DAYBreak registrational program for bexobrutideg and strengthened our balance sheet to support execution across our pipeline," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "With regulatory alignment on Phase 2 dose, compelling Phase 1 clinical data in CLL, and the continued advancement of our autoimmune and immuno-oncology programs, we believe we are well positioned to deliver the benefits of degrader-based medicines to significant populations of patients in need of new therapies."

Recent Business Highlights

Bexobrutideg (NX-5948): Compelling Clinical Activity and Durability Presented at ASH (Free ASH Whitepaper) 2025

At the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Nurix presented updated and maturing clinical data from the ongoing Phase 1a/1b NX-5948-301 study of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), demonstrating durable and deepening responses in a heavily pretreated population. In the Phase 1a cohort, bexobrutideg achieved an objective response rate (ORR) of 83.0%, including two complete responses, with a median progression-free survival (PFS) of 22.1 months and a median duration of response of 20.1 months across all doses tested. Emerging data from the randomized Phase 1b cohort comparing 200 mg and 600 mg once-daily dosing showed higher response rates and a favorable trend toward longer PFS at the 600 mg dose, supporting its selection as the recommended Phase 2 dose in alignment with FDA’s Project Optimus. Bexobrutideg was well tolerated, with a consistent safety profile across dose levels and no dose-limiting toxicities, no systemic fungal infections, and no Grade 4 infections observed. Collectively, these data reinforce the differentiated efficacy, durability, and tolerability profile of bexobrutideg and provide a strong foundation for the ongoing DAYBreak pivotal clinical program in relapsed or refractory CLL.

Bexobrutideg (NX-5948): Transitioned to Pivotal-Stage Development in CLL

During the fourth quarter of 2025, Nurix initiated the DAYBreak pivotal Phase 2 single-arm study evaluating bexobrutideg at 600 mg once daily in patients with relapsed or refractory CLL (r/r CLL) who have progressed following treatment with a covalent BTK inhibitor (cBTKi), a BCL-2 inhibitor (BCL-2i), and a non-covalent BTK inhibitor (ncBTKi). Dose selection was supported by comparative analysis conducted under Project Optimus and achieved alignment with global regulatory authorities.

Bexobrutideg: Encouraging Activity in Waldenström Macroglobulinemia Presented at ASH (Free ASH Whitepaper) 2025

At the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Nurix presented new Phase 1 clinical data demonstrating encouraging efficacy and favorable tolerability of bexobrutideg in patients with relapsed or refractory Waldenström macroglobulinemia (WM). In this heavily pre-treated population, bexobrutideg achieved an objective response rate of 75.0%, including three very good partial responses, with responses observed across patients regardless of their baseline mutations in MYD88 and CXCR4. With a median follow-up of 8.1 months, median duration of response and progression-free survival were not reached, underscoring the durability of clinical benefit. Bexobrutideg was well tolerated in patients with WM, consistent with the overall study population and previous disclosures. Collectively, these results support continued development of bexobrutideg in WM and further reinforce its potential as a differentiated therapeutic option across BTK-driven B-cell malignancies.

October Bexobrutideg Update

During the quarter, Nurix continued to strengthen the clinical and scientific differentiation of bexobrutideg through ongoing clinical execution and new mechanistic insights. In an October 2025 investor update, management highlighted how bexobrutideg is designed to overcome key limitations of existing BTK inhibitors by catalytically degrading the BTK protein, thereby eliminating both its kinase and scaffolding functions and enabling deeper, more durable pathway suppression at low free-plasma concentrations. The data presented profiled bexobrutideg’s best-in-class in vitro potency, exceptional proteomic selectivity, and broad activity across clinically relevant BTK resistance mutations that limit the effectiveness of both covalent and non-covalent BTK inhibitors.

IRAK4 Degrader Program (GS-6791 / NX-0479, partnered with Gilead)

In September, Nurix and its collaboration partner Gilead presented preclinical data at the 2025 European Academy of Dermatology and Venereology Congress demonstrating that GS-6791, a novel oral IRAK4 degrader, achieved potent and sustained degradation of IRAK4, resulting in robust inhibition of IL-1 and IL-36 signaling pathways. The data also showed suppression of pro-inflammatory cytokine production and meaningful efficacy in a mouse model of dermatitis, supporting the differentiated potential of IRAK4 degradation compared with kinase inhibition alone. GS-6791 is currently being evaluated in an ongoing first-in-human Phase 1 study in healthy volunteers, which includes pharmacodynamic biomarker assessments in the skin, and these results support continued advancement toward autoimmune and inflammatory disease indications.

NX-1607 (CBL-B Inhibitor): Continued Clinical and Translational Validation

At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November, Nurix presented new translational data from its ongoing Phase 1 study of NX-1607 demonstrating dose-dependent target engagement, peripheral immune activation, and enhanced T-cell proliferation, with greater immune activation observed in patients achieving stable disease compared with those with progressive disease. These findings provide mechanistic evidence linking systemic immune activation to tumor microenvironment remodeling. In addition, clinical data presented at the 2025 European Society for Medical Oncology Congress showed evidence of single-agent anti-tumor activity across multiple solid tumor types, including durable stable disease and a confirmed partial response in heavily pretreated patients. Collectively, these data support continued dose expansion and combination strategies for NX-1607 as a potential next-generation immune checkpoint therapy.

Corporate and Financial Strengthening

In October 2025, Nurix completed a $250.0 million underwritten registered offering of the Company’s common stock, with participation from leading healthcare-focused institutional investors. The proceeds from the offering significantly strengthened the Company’s balance sheet and enabled accelerated execution of pivotal clinical programs, including the registrational development of bexobrutideg, as well as continued investment in pipeline expansion and autoimmune disease opportunities.

In November 2025, Nurix appointed accomplished biopharmaceutical leader Roger Dansey, M.D., to its Board of Directors, adding deep expertise in oncology research, clinical development, and commercialization as the Company advances toward late-stage development and potential registration.

Upcoming Program Highlights*

DAYBreak CLL-201
Nurix will continue enrollment and execution of the DAYBreak pivotal Phase 2 single-arm study (NCT07221500) of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia, which is designed to support a potential Accelerated Approval submission. The DAYBreak study is enrolling patients whose disease has progressed following treatment with a cBTKi, a BCL-2i, and an ncBTKi inhibitor, representing a population with significant unmet medical need.
DAYBreak CLL-306
Nurix plans to initiate a global randomized confirmatory Phase 3 trial in the first half of 2026, following continued engagement with regulatory authorities, to support full approval. The Phase 3 study is expected to compare bexobrutideg monotherapy to pirtobrutinib in patients with relapsed or refractory CLL whose disease has progressed after prior BTK inhibitor therapy. Together, these studies are intended to form a comprehensive registrational program designed to establish the clinical benefit, safety, and durability of bexobrutideg and support its advancement toward regulatory approval.
NX-5948-301
Nurix also continues enrollment in the NX-5948-301 Phase 1a/1b clinical trial of bexobrutideg in patients with relapsed or refractory B cell malignancies. To support future development of bexobrutideg in autoimmune and inflammatory diseases, Nurix is enrolling a Phase 1b cohort for patients with CLL and autoimmune hemolytic anemia and is conducting the necessary Phase 1 healthy volunteer studies to support a potential autoimmune IND in 2026. More information on the ongoing Phase 1a/1b trial of bexobrutideg is available at www.clinicaltrials.gov.
Zelebrudomide
Zelebrudomide is an orally bioavailable degrader of BTK and the cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) designed for the treatment of relapsed or refractory B-cell malignancies. Nurix is conducting a Phase 1a/1b clinical trial, including a Phase 1b expansion cohort focused on patients with diffuse large B-cell lymphoma and mantle cell lymphoma. Nurix is enrolling a dose escalation study within the current Phase 1a/1b trial using the chirally controlled drug product. Additional information on the zelebrudomide clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
NX-1607
NX-1607 is an investigational 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 and lymphomas. 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).
Continued pipeline advancement of strategic collaborations with Gilead, Sanofi and Pfizer: Nurix and Sanofi continue to advance the STAT6 degrader, NX-3911, in IND-enabling studies and future updates are anticipated. Nurix expects to continue to achieve substantial research collaboration milestones throughout the terms of its collaborations with Gilead, Sanofi, and Pfizer.

Nurix expects to provide additional preclinical, clinical, and program updates throughout 2026 to multiple key audiences, including the European Hematology Association (EHA) (Free EHA Whitepaper), the European Society for Medical Oncology, the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper).

*Expected timing of events throughout this press release is based on calendar year quarters.

Fiscal Fourth Quarter 2025 Financial Results

Revenue for the three and twelve months ended November 30, 2025, was $13.6 million and $84.0 million, respectively, compared with $13.3 million and $54.5 million for the three and twelve months ended November 30, 2024, respectively. The increase for the twelve-month period was primarily due to $30 million of license revenue from the achievement of two Sanofi license extensions. During the year ended November 30, 2025, Nurix achieved research milestones under its collaborations with Sanofi and Pfizer totaling $7.0 million and $5.0 million, respectively. In addition, Nurix also achieved a clinical milestone under its collaboration with Gilead of $5 million for the twelve-month period. The increase was partially offset by a decrease in revenue from the collaborations with Sanofi and Gilead as the initial research term for certain drug targets ended.

Research and development expenses for the three and twelve months ended November 30, 2025, were $83.0 million and $316.9 million, respectively, compared with $67.2 million and $221.6 million for the three and twelve months ended November 30,2024, respectively. For the twelve-month period, the increase was primarily related to compensation and related personnel costs, clinical costs and contract manufacturing costs as Nurix continued to accelerate the enrollment of patients in the ongoing trial of bexobrutideg and prepare for the initiation of pivotal trials.

General and administrative expenses for the three and twelve months ended November 30, 2025, were $13.6 million and $52.7 million, respectively, compared with $10.7 million and $45.9 million for the three and twelve months ended November 30, 2024, respectively. The increase for the twelve-month period was primarily due to an increase in compensation and related personnel costs.

Net loss for the three and twelve months ended November 30, 2025, was $78.2 million or ($0.82) per share and $264.5 million or ($3.05) per share, respectively, compared with $58.5 million or ($0.75) per share and $193.6 million or ($2.88) per share, for the three and twelve months ended November 30, 2024, respectively.

Cash, cash equivalents and marketable securities was $592.9 million as of November 30, 2025, compared to $609.6 million as of November 30, 2024.

(Press release, Nurix Therapeutics, JAN 28, 2026, View Source [SID1234662327])

Cycle Pharmaceuticals Announces Extension of Applied Therapeutics Tender Offer

On January 28, 2026 Cycle Group Holdings Limited ("Cycle" or "Parent") reported that AT2B, Inc., a Delaware corporation ("Purchaser") and indirect wholly owned subsidiary of Cycle, has extended the expiration date of its tender offer to purchase all of the outstanding shares of common stock, par value $0.0001 per share of Applied Therapeutics, Inc., a Delaware corporation ("Applied") for (i) $0.088 per share, net to the seller in cash, without interest, plus (ii) one non-tradeable contingent value right per share.

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The offer, which was previously scheduled to expire at one minute following 11:59 p.m., Eastern time, on January 27, 2026 is extended until one minute following 11:59 p.m., Eastern time, on January 28, 2026.

Equiniti Trust Company, LLC, the depositary for the offer, has advised Cycle that, as of 11:59 p.m., Eastern time, on January 27, 2026, approximately 63,684,636 shares (which include 3,735,684 shares subject to guaranteed delivery) have been validly tendered and not properly withdrawn pursuant to the offer, representing approximately 41.29% of the outstanding shares of Applied. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to this extension.

The offer is being made pursuant to the terms and conditions described in the offer to purchase, filed on December 29, 2025 (together with any amendments and supplements hereto), copies of which are attached to the tender offer statement on Schedule TO filed by Cycle and Purchaser with the US Securities and Exchange Commission, as amended.

The offer is conditioned upon the fulfilment of certain conditions described in Section 15—"Conditions to the Offer" of the offer to purchase, including, but not limited to, the tender of a majority of the then-outstanding shares of Applied’s common stock.

MacKenzie Partners, Inc. is acting as information agent for the offer. Requests for documents and questions regarding the offer may be directed to MacKenzie Partners, Inc by telephone, toll-free at 1-800-322-288. Bankers and Brokers may call at 212-929-5500.

(Press release, Cycle Pharmaceuticals, JAN 28, 2026, View Source [SID1234662343])