On July 14, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported that updated Phase 1a results from the ongoing FIT-001 Phase 1a/1b clinical trial (NCT06026410) evaluating darlifarnib in combination with cabozantinib in advanced renal cell carcinoma (RCC) will be featured in an oral presentation at the 2026 Kidney Cancer Research Summit (KCRS) in Boston.

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The presentation will highlight long-term follow-up results in heavily pretreated cabozantinib-naïve patients with refractory RCC, providing further evidence of darlifarnib’s potential as a combination agent with VEGFR-targeted therapies, a widely used treatment approach in this patient population. RCC is the most common form of kidney cancer, and clear cell RCC (ccRCC) is the most common histology in RCC, accounting for more than 61,000 new cases in the U.S. each year.1

"Despite meaningful advances in the treatment of renal cell carcinoma, there remains a significant need for combination strategies capable of delivering deeper and more durable responses," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "The updated FIT-001 data will further inform the potential of darlifarnib plus cabozantinib as a precision combination strategy in advanced ccRCC. More broadly, Kura’s KCRS presentation builds on the growing body of clinical evidence supporting darlifarnib’s mechanism of action across VEGF-TKI, KRAS and PI3Ka inhibitor combinations, supporting darlifarnib’s potential to enhance clinical activity of these targeted-therapy backbones."

The KCRS presentation adds to the FIT-001 RCC results presented at ESMO (Free ESMO Whitepaper) 2025 and additional findings in cabozantinib-exposed ccRCC patients presented at 2026 IKCS: Europe.

Kura is currently enrolling patients in the U.S. and E.U. in the randomized Phase 1b dose-optimization portion of FIT-001 in cabozantinib-naïve, refractory, advanced ccRCC. The randomized Phase 1b portion is evaluating darlifarnib plus cabozantinib versus cabozantinib alone and is designed to inform selection of a recommended Phase 3 dose for a registrational study planned for 2028.

The KCRS presentation represents another step in Kura’s broader strategy to establish darlifarnib as a precision combination agent capable of enhancing multiple targeted therapy classes through inhibition of adaptive mTORC1 signaling. The first planned expansion is expected to evaluate darlifarnib in combination with daraxonrasib in previously treated RAS-mutated pancreatic ductal adenocarcinoma.

2026 KCRS Presentation Details

Title: Farnesyl transferase inhibitor (FTI) darlifarnib combined with cabozantinib in renal cell carcinoma (RCC): Updated phase 1a results from FIT-001
Date: July 24, 2026
Time: 3:05 p.m. – 3:45 p.m. ET

Virtual Investor Event
Kura will host a webcast and conference call on July 27, 2026 at 5:00 a.m. PT / 8:00 a.m. ET featuring management and Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Director of Genitourinary Medical Oncology Research, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

About darlifarnib
Darlifarnib is a next-generation farnesyl transferase inhibitor (FTI) designed to inhibit farnesylation of RHEB and suppress mTORC1 signaling, a pathway implicated in adaptive signaling across multiple targeted therapy settings. By suppressing adaptive mTORC1 signaling, darlifarnib is designed to counter a key mechanism of resistance to targeted therapies, with the goal of enhancing the depth and durability of response across multiple targeted therapy classes.

(Press release, Kura Oncology, JUL 14, 2026, View Source [SID1234669208])

On July 14, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported that updated Phase 1a results from the ongoing FIT-001 Phase 1a/1b clinical trial (NCT06026410) evaluating darlifarnib in combination with cabozantinib in advanced renal cell carcinoma (RCC) will be featured in an oral presentation at the 2026 Kidney Cancer Research Summit (KCRS) in Boston.

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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

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The presentation will highlight long-term follow-up results in heavily pretreated cabozantinib-naïve patients with refractory RCC, providing further evidence of darlifarnib’s potential as a combination agent with VEGFR-targeted therapies, a widely used treatment approach in this patient population. RCC is the most common form of kidney cancer, and clear cell RCC (ccRCC) is the most common histology in RCC, accounting for more than 61,000 new cases in the U.S. each year.1

"Despite meaningful advances in the treatment of renal cell carcinoma, there remains a significant need for combination strategies capable of delivering deeper and more durable responses," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "The updated FIT-001 data will further inform the potential of darlifarnib plus cabozantinib as a precision combination strategy in advanced ccRCC. More broadly, Kura’s KCRS presentation builds on the growing body of clinical evidence supporting darlifarnib’s mechanism of action across VEGF-TKI, KRAS and PI3Ka inhibitor combinations, supporting darlifarnib’s potential to enhance clinical activity of these targeted-therapy backbones."

The KCRS presentation adds to the FIT-001 RCC results presented at ESMO (Free ESMO Whitepaper) 2025 and additional findings in cabozantinib-exposed ccRCC patients presented at 2026 IKCS: Europe.

Kura is currently enrolling patients in the U.S. and E.U. in the randomized Phase 1b dose-optimization portion of FIT-001 in cabozantinib-naïve, refractory, advanced ccRCC. The randomized Phase 1b portion is evaluating darlifarnib plus cabozantinib versus cabozantinib alone and is designed to inform selection of a recommended Phase 3 dose for a registrational study planned for 2028.

The KCRS presentation represents another step in Kura’s broader strategy to establish darlifarnib as a precision combination agent capable of enhancing multiple targeted therapy classes through inhibition of adaptive mTORC1 signaling. The first planned expansion is expected to evaluate darlifarnib in combination with daraxonrasib in previously treated RAS-mutated pancreatic ductal adenocarcinoma.

2026 KCRS Presentation Details

Title: Farnesyl transferase inhibitor (FTI) darlifarnib combined with cabozantinib in renal cell carcinoma (RCC): Updated phase 1a results from FIT-001
Date: July 24, 2026
Time: 3:05 p.m. – 3:45 p.m. ET

Virtual Investor Event
Kura will host a webcast and conference call on July 27, 2026 at 5:00 a.m. PT / 8:00 a.m. ET featuring management and Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Director of Genitourinary Medical Oncology Research, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

About darlifarnib
Darlifarnib is a next-generation farnesyl transferase inhibitor (FTI) designed to inhibit farnesylation of RHEB and suppress mTORC1 signaling, a pathway implicated in adaptive signaling across multiple targeted therapy settings. By suppressing adaptive mTORC1 signaling, darlifarnib is designed to counter a key mechanism of resistance to targeted therapies, with the goal of enhancing the depth and durability of response across multiple targeted therapy classes.

(Press release, Kura Oncology, JUL 14, 2026, View Source [SID1234669208])

On July 14, 2026 Merck, a leading global science and technology company, reported that the European Commission (EC) approved an update to the Erbitux (cetuximab) EU label on June 26, 2026. Erbitux is now indicated in combination with encorafenib for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) — both in first-line treatment in combination with FOLFOX (BREAKWATER regimen) and for patients who have received prior systemic therapy (BEACON regimen).

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The first-line approval is based on results from the Phase 3 BREAKWATER trial, which showed that the cetuximab–encorafenib–FOLFOX combination delivered statistically significant and clinically meaningful improvements in the dual primary endpoints of objective response rate (ORR) and PFS, as well as a significant overall survival benefit — reducing the risk of death by 51% versus chemotherapy with or without bevacizumab.

"The approval of Erbitux in combination with encorafenib and FOLFOX marks an important milestone for patients with BRAF V600E-mutant mCRC who can now benefit from a first targeted treatment option in the first-line setting," said Matthias Wernicke, Head of Global Therapeutic Area Specialty Care, in the healthcare business sector of Merck. "BRAF V600E-mutant mCRC is associated with a historically poor prognosis and limited effective options. This approval reinforces Erbitux as the backbone of anti-EGFR therapy in colorectal cancer — and reflects our ongoing commitment to addressing unmet needs for patients across the full treatment continuum."

BREAKWATER (NCT04607421) is a Phase 3, randomized, active-controlled, open-label, multicenter trial evaluating encorafenib in combination with cetuximab and FOLFOX in participants with previously untreated BRAF V600E-mutant mCRC. The trial was conducted by Pfizer, in collaboration with Merck, and Ono Pharmaceutical. The combination of cetuximab, encorafenib and FOLFOX received accelerated FDA approval in December 2024 for treatment-naïve patients based on ORR data, and full FDA approval in February 2026 based on PFS and OS data — with the indication expanded to include fluorouracil-based chemotherapy (FOLFOX or FOLFIRI).

The BREAKWATER regimen demonstrated statistically significant and clinically meaningful improvements across all key endpoints versus standard-of-care chemotherapy (FOLFOX/FOLFOXIRI/CAPOX with or without bevacizumab).[1],[2] Median PFS was 12.8 months versus 7.1 months (HR 0.53; 95% CI: 0.41–0.68; P<0.001), representing a 47% reduction in the risk of progression or death. Overall survival was likewise significantly improved, with a median OS of 30.3 months versus 15.1 months (HR 0.49; 95% CI: 0.38–0.63; P<0.001) — a 51% reduction in the risk of death, more than doubling median overall survival compared to standard care. Confirmed ORR was 65.7% (95% CI: 59.4–71.4) in the BREAKWATER arm versus 37.4% (95% CI: 31.6–43.7) in the control arm. Safety profiles were consistent with those previously established for each individual agent; serious adverse events occurred in 46.1% versus 38.9% in the standard-care arm.

The cetuximab–encorafenib–FOLFOX regimen has been endorsed as first-line standard of care by the April 2026 ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines (Recommendation Grade I, A) for patients with metastatic colorectal cancer harboring the BRAF V600E mutation.[3]

While the BREAKWATER regimen redefines first-line therapy, the Phase 3 BEACON CRC trial confirmed Erbitux as a standard of care in second-line and beyond. The combination of Erbitux and encorafenib — also approved by the EC on June 26, 2026 for patients with BRAF V600E-mutant mCRC who have received prior systemic therapy — significantly improved OS versus the irinotecan-based control (median 9.3 vs. 5.9 months; HR 0.61; 95% CI: 0.48–0.77; p<0.0001), reducing the risk of death by 39%.[4],[5] This regimen maintains quality of life with no increase in Grade ≥3 adverse events versus standard chemotherapy.

Erbitux is the first and only anti-EGFR therapy approved for both RAS wild-type and BRAF V600E-mutant mCRC patients — supporting patients throughout their treatment journey and across multiple lines of therapy.

Colorectal cancer remains a major global health challenge. It is the third most commonly diagnosed cancer worldwide and the second leading cause of cancer-related deaths, with 1.92 million new cases and approximately 900,000 deaths recorded in 2022 alone.[6] Projections indicate cases will increase by more than 85% and mortality will double in coming decades. Of patients presenting with metastatic disease — approximately 20% at diagnosis — 5-year survival remains at only 16.2%.

BRAF V600E mutations occur in approximately 8–12% of patients with mCRC and are associated with a particularly poor prognosis, with mortality risk more than double that of patients without the mutation. Extending the indication of Erbitux to this patient population represents a meaningful step toward more personalized and effective treatment — addressing a significant and clinically important unmet need.

With this dual approval — first-line (BREAKWATER) and second-line (BEACON) — Erbitux is now established as the pioneering anti-EGFR backbone across the mCRC treatment continuum. This milestone underscores Merck’s commitment to driving innovation in oncology and improving outcomes for patients with difficult-to-treat cancers.

(Press release, Merck & Co, JUL 14, 2026, View Source [SID1234669207])

On July 14, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that the Company will highlight its late-stage programs and the next chapter of its R&D strategy, including new pipeline assets, during its R&D Event being held today from 8:30 a.m. to 11:00 a.m. EDT.

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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

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"Today we are unveiling our new pipeline assets which reflect the continued evolution of our R&D capabilities, including our ability to leverage both external innovation and a library of internally developed next-generation menin inhibitors to expand our portfolio and create new growth opportunities," said Michael A. Metzger, Chief Executive Officer. "With a robust financial foundation, a track record of success, and multiple near-term catalysts, Syndax is positioned to deliver the next breakthroughs for patients and drive long-term value for shareholders."

"Syndax has established world-class R&D capabilities and strong partnerships with leading clinicians and scientists around the world to drive innovation and develop transformative new medicines for patients," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "Today’s event will highlight our strategy to expand our leadership in menin and CSF-1R inhibition and build our pipeline with two new differentiated assets supported by compelling preclinical data and mechanistic insights. With both Revuforj and Niktimvo, we demonstrated our ability to efficiently generate clinical data that validates new therapeutic targets, a strength we look forward to showcasing again as we advance the next chapter of our R&D strategy."

Guest speakers will include:

•
Toby M. Maher, MD, PhD, Professor of Clinical Medicine and Director of Interstitial Lung Disease, Keck Medical School of University of Southern California, will present on idiopathic pulmonary fibrosis (IPF) and the potential for axatilimab in IPF.
•
John D. Crispino, PhD, MBA, Director, Division of Experimental Hematology, St. Jude Children’s Research Hospital, will present on the potential for menin inhibition in myelofibrosis (MF).
•
Michael J. Eck, MD, PhD, Professor, Department of Cancer Biology, Dana-Farber Cancer Institute and Professor, Department of Biological Chemistry & Molecular Pharmacology, Harvard Medical School, will present on the development of SNDX-4321 for EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Highlighted R&D Day Topics

SNDX-4321, a novel, mutant-selective, allosteric EGFR inhibitor for NSCLC

•
SNDX-4321 is an EGFR inhibitor in development for NSCLC patient populations with significant unmet needs, such as those with L858R mutations, CNS metastases, atypical activating mutations, or acquired resistance to current therapies. In contrast to ATP-site directed third and fourth generation EGFR inhibitors, SNDX-4321 is a novel allosteric inhibitor which binds at a pocket adjacent to the ATP site that is only accessible in the presence of L858R and certain other EGFR mutations. The Company expects to submit an investigational new drug (IND) application for SNDX-4321 by the end of 2026 and to initiate a Phase 1 trial in EGFRm NSCLC in 2027. SNDX-4321 is an externally developed molecule that the Company has an exclusive worldwide license to develop and commercialize. During the R&D Event, the Company will highlight the potential advantages of an allosteric approach in EGFRm NSCLC and the supporting preclinical data.
SNDX-62122, a candidate from the Company’s library of internally developed next-generation menin inhibitors, selected for development in MF

•
SNDX-62122 is the first candidate from a library of wholly owned next-generation menin inhibitors that the Company intends to advance into new areas.
•
SNDX-62122 is in development for MF, with submission of an IND and initiation of a Phase 1 trial in MF expected in 2027. During the R&D Event, the Company will highlight recently published revumenib preclinical data showing that menin is a novel dependency in proliferative megakaryocytes, major drivers of MF. The Company expects the development of SNDX-62122 to be informed and de-risked by a Phase 1/2 proof-of-principal trial of revumenib in MF that is expected to initiate in the fourth quarter of 2026 with initial clinical data expected in the second half of 2027.
Ongoing late-stage trials of Revuforj (revumenib) and Niktimvo(axatilimab-csfr)

•
During the R&D event, the Company will highlight its late-stage revumenib and axatilimab programs in newly diagnosed acute leukemia and chronic GVHD, respectively, as well as the Phase 2 trial of axatilimab in IPF that is expected to readout in the fourth quarter of 2026. During the R&D event, Dr. Toby M. Maher will discuss the unmet patient needs, evolving treatment landscape, and the potential for axatilimab’s mechanism in IPF.
Webcast

Syndax will host an R&D Event today, July 14, 2026, from 8:30 a.m. to 11:00 a.m. ET in person and via webcast. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following link: View Source

For those unable to join the live webcast, a replay will be available in the Investors section of the Company’s website at View Source after the event and will be available for a limited time.

(Press release, Syndax, JUL 14, 2026, View Source [SID1234669205])

On July 14, 2026 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) reported it has completed its acquisition of XOMA Royalty Corporation ("XOMA Royalty"), a biotechnology royalty aggregator, for $39.00 per share of common stock in cash, for a total equity value of approximately $739 million. XOMA Royalty stockholders also received one non-transferable Contingent Value Right ("CVR") per share entitling the holder to receive a portion of 75% of the net proceeds that may result from certain pending litigation at XOMA Royalty.

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"At Ligand, we are focused on building a diversified portfolio of high-value royalty assets tied to innovative medicines that have the potential to improve patient outcomes around the world," said Todd Davis, CEO of Ligand. "Over the past several years, we have executed a disciplined strategy to expand, diversify and strengthen our royalty portfolio, and the acquisition of XOMA Royalty meaningfully advances that vision. This transaction adds exposure to high-quality commercial and development-stage assets and enhances our ability to generate durable, long-term shareholder value, marking an important milestone in our evolution as a leading biopharmaceutical royalty aggregator."

This acquisition strengthens Ligand’s royalty portfolio by adding seven commercial products, including Roche’s VABYSMO (faricimab-svoa), Servier’s OJEMDA (tovorafenib), and Zevra Therapeutics’ MIPLYFFA (arimoclomol). Additionally, it includes 14 late-stage development programs, featuring Takeda’s mezagitamab and certain assets from Takeda’s externalized asset portfolio, such as osavampator, volixibat, and OHB-607, along with more than 100 assets in various stages of development. As a result, Ligand’s portfolio has more than doubled in size, now comprising over 200 commercial, clinical, and preclinical stage royalty assets.

The closing of the transaction met Ligand’s original timeline expectations. The transaction is expected to be immediately accretive and to add approximately $0.50 and $1.50 per share to Ligand’s projected 2026 and 2027 adjusted earnings per share1, respectively. Ligand will provide an updated 5-year outlook during the Company’s Investor Day on December 8, 2026.

In connection with the completion of the transaction, XOMA Royalty common stock ceased trading on The Nasdaq Global Market.

Advisors

Stifel served as lead financial advisor, Citi served as financial advisor, Paul Hastings LLP served as legal advisor, and Collected Strategies served as strategic communications advisor to Ligand. Leerink Partners served as lead financial advisor, H.C. Wainwright & Co. served as financial advisor, and Gibson, Dunn & Crutcher LLP served as legal advisor to XOMA Royalty.

(Press release, Ligand, JUL 14, 2026, View Source [SID1234669204])