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Delevering Novel Therapies for RAS/MAPK pathway-driven cancers

On January 8, 2026 Verastem presented its corporate presentation.

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(Presentation, Verastem, JAN 8, 2026, View Source [SID1234661855])

Revolution Medicines Announces FDA Breakthrough Therapy Designation for Zoldonrasib

On January 8, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to zoldonrasib, a RAS(ON) G12D-selective inhibitor, for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.

The Breakthrough Therapy Designation is based on data from the monotherapy cohort of the Phase 1 RMC-9805-001 clinical trial evaluating zoldonrasib in patients with advanced KRAS G12D solid tumors. Results from the monotherapy cohort of the trial have demonstrated a robust clinical profile, including encouraging antitumor activity and acceptable safety and tolerability.

"The Breakthrough Therapy Designation for zoldonrasib, our RAS(ON) G12D-selective covalent inhibitor – the first ever granted for an investigational drug specifically targeting the RAS G12D mutation – underscores the significant unmet need for patients with KRAS G12D cancers, which currently lack any approved targeted therapies," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "This recognition expands upon prior designations for the RAS(ON) multi-selective inhibitor daraxonrasib and G12C-selective inhibitor elironrasib, further recognizing the promise of our first three clinical-stage RAS(ON) inhibitors as potentially transformative therapies for people living with RAS-addicted cancers."

Zoldonrasib is an innovative tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS G12D(ON) mutant. Revolution Medicines is evaluating zoldonrasib as a monotherapy and combination treatment across multiple tumor types and lines of therapy.

Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions and address significant unmet medical needs. Pursuant to FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines.

About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancers, with more than 197,000 people diagnosed in the U.S. each year.1,2,3 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. G12D is the most common oncogenic driver of human cancers and represents 4% of NSCLC cases.

(Press release, Revolution Medicines, JAN 8, 2026, View Source [SID1234661854])

Personalis Reports Select Preliminary Fourth Quarter and Full Year 2025 Results and Recent Highlights

On January 8, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported certain unaudited preliminary financial and operational results for the fourth quarter and full year ended December 31, 2025.

Fourth Quarter Strategic and Operational Highlights

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Secured Milestone Medicare Coverage: Received Medicare coverage approval for the surveillance of cancer recurrence in breast cancer patients, a key catalyst for clinical revenue and market share growth in the MRD space.
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Published Landmark TRACERx Data: Announced the publication of one of the largest and most comprehensive non-small cell lung cancer (NSCLC) patient cohorts to date in the journal Cell, demonstrating the clinical importance of Personalis’ ultrasensitive MRD approach.
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Validation of ctDNA Dynamics: Published VHIO data in Clinical Cancer Research titled "Broad Utility of Ultrasensitive Analysis of ctDNA Dynamics across Solid Tumors Treated with Immunotherapy," further reinforcing the clinical validity of the NeXT Personal platform in a broad array of cancer types.
Preliminary Full Year 2025 Financial Results

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Total Revenue: Expected to be in the range of $69.0 to $70.0 million compared with $84.6 million for 2024.
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Clinical Momentum: Clinical test revenue reached approximately $2.0 million, more than doubling the $0.8 million reported in 2024.
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Volume Outperformance: Clinical test volume reached approximately 16,233 tests, a nearly 400% increase over the 3,285 tests delivered in 2024. This performance exceeded the company’s internal growth targets by more than 20% and signals a significant shift in market adoption for ultrasensitive MRD testing.
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Core Revenue Streams: Pharma tests, services, and all other customers contributed approximately $49.0 million to $50.0 million. Revenue from enterprise sales (Natera) and population sequencing (the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP)) totaled approximately $18.0 million.
Preliminary Fourth Quarter 2025 Financial Results

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Quarterly Revenue: Expected to be in the range of $17.0 million to $18.0 million.●
Accelerating Volume: Delivered 6,183 clinical tests in the fourth quarter, representing a 41% sequential increase over the third quarter of 2025.
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Clinical Revenue: Preliminary clinical test revenue of approximately $0.9 million, compared with $0.2 million in the prior year period.
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Core Revenue Streams: Pharma tests, services, and all other customers contributed approximately $11.6 million to $12.6 million. Revenue from enterprise sales (Natera) and population sequencing (the VA MVP) totaled approximately $4.5 million.
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Strong Liquidity: Ended the year with approximately $240.0 million in cash, cash equivalents, and short-term investments. This includes approximately $109.0 million in net proceeds from the company’s At-The-Market (ATM) sales program, executed at a weighted-average price of $8.43 per share.
CEO Commentary

"Personalis championed a defining year in 2025 demonstrating that our Win-in-MRD strategy is working," said Chris Hall, Chief Executive Officer and President. "While we entered the year with an ambitious goal to grow clinical volumes by 30% to 40% sequentially through the year, we ultimately surpassed those targets with nearly 400% clinical volume growth over last year. This exponential growth, culminating in over 16,000 tests, proves that oncologists are increasingly demanding the ultrasensitivity that NeXT Personal has pioneered."

Hall continued: "Securing Medicare coverage for breast cancer surveillance in the fourth quarter was a pivotal milestone that transforms our commercial trajectory. With a fortified balance sheet of ~$240 million of cash, we enter 2026 with the capital and the clinical evidence required to expand our sales footprint, secure reimbursement coverage for additional indications, and continue to execute on our Win-in-MRD strategy."

The above preliminary unaudited financial results are preliminary and subject to Personalis’ normal quarter and year-end accounting procedures and external audit by the company’s independent registered public accounting firm. In addition, these preliminary unaudited results are not a comprehensive statement of the company’s financial results for the year ended December 31, 2025, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

(Press release, Personalis, JAN 8, 2026, View Source [SID1234661853])

IMMUPHARMA ATTENDING JP MORGAN CONFERENCE & BIOTECH SHOWCASE

On January 8. 2026 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that Tim McCarthy, CEO, Dr Tim Franklin, COO, and Dr Sebastien Goudreau, CSO, will be attending both the JP Morgan Conference and the Biotech Showcase from 12-14 January 2026, in San Francisco, USA.

The JP Morgan conference and Biotech Showcase are annual premier partnering events, designed to provide biotechnology companies with the opportunity to present to and connect with global Biopharma companies and investors.

(Press release, ImmuPharma, JAN 8, 2026, View Source [SID1234661852])

CytomX Therapeutics Announces Business Update and Company Milestones for 2026

On January 8, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported a business update and anticipated milestones for 2026.

"We are excited to build on our transformational progress at CytomX with Varseta-M and will be focused on advancing this novel, potential first-in-class ADC towards a registrational study in late-line CRC. Varseta-M was specifically designed to address a broad, unselected CRC patient population based on the universally high and uniform expression of EpCAM. The promising initial clinical activity we have presented to date in Phase 1 dose escalation underscore this potential. We look forward to providing CRC Phase 1 expansion data later this quarter," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Dr. McCarthy continued, "Given our highly encouraging start in late line CRC we aim to move rapidly towards a potentially registrational trial and advance Varseta-M into earlier lines of CRC treatment to maximize impact in this area of high unmet medical need. We also plan to capitalize on our platform leadership by progressing our broader pipeline of PROBODY Therapeutics, including our masked interferon-alpha-2b program, CX-801, in combination with KEYTRUDA in advanced melanoma."

Clinical Program Updates and 2026 Milestones:

Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051)

Varseta-M Phase 1 dose expansions across the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) are ongoing with a focus on selecting a dose or doses for a potential registrational study in advanced CRC.
Total Phase 1 study enrollment is projected to reach approximately 100 patients by the planned Varseta-M Phase 1 update in Q1 2026.
The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
A Phase 1 Varseta-M combination study with bevacizumab in CRC is expected to start in Q1 2026, data from which is intended to inform potential late-phase development in earlier lines of CRC.
Initiation of Phase 1 expansion cohort(s) in additional indications is planned for 2H 2026.
CX-801 (PROBODY Interferon alpha-2b)

The CX-801 Phase 1 study is ongoing with a focus in advanced melanoma. CX-801 monotherapy dose escalation has reached the fourth dose level.
CX-801 monotherapy has been well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.1
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level.
CX-801 monotherapy biomarker data in advanced melanoma patients were presented at the 2025 Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting that support CX-801’s mechanism of action and the ongoing combination study with KEYTRUDA (pembrolizumab).
Initial clinical data for CX-801 in combination with KEYTRUDA in advanced melanoma is anticipated by the end of 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

CytomX JP Morgan Healthcare Conference Presentation
Dr. Sean McCarthy will present at the JP Morgan Healthcare Conference on January 14, 2026, at 9 a.m. PST. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source

(Press release, CytomX Therapeutics, JAN 8, 2026, View Source [SID1234661851])