Revolution Medicines to Present Updated Elironrasib Safety and Efficacy Data in Patients with KRAS G12C Non-Small Cell Lung Cancer Following Treatment with a KRAS(OFF) G12C Inhibitor

On October 22, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported updated clinical data for elironrasib, a RAS(ON) G12C-selective inhibitor, in previously treated patients with KRAS G12C non-small cell lung cancer (NSCLC) who had received a prior KRAS(OFF) G12C inhibitor. These results will be highlighted in an oral presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics in Boston, October 23-25.

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"The compelling clinical activity, durable response and acceptable tolerability profile seen with elironrasib underscore the potential of this differentiated RAS(ON) G12C-selective inhibitor, including in patients who have progressed on G12C(OFF) inhibitors," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "These findings reinforce the promise of our RAS(ON) inhibitor platform to deliver a range of therapies that target the active, GTP-bound state of RAS proteins with the potential to create new global standards of care."

As of the August 4, 2025 data cutoff date, patients with KRAS G12C NSCLC, who had received prior therapy with a KRAS(OFF) G12C inhibitor, were treated with elironrasib at the recommended Phase 2 dose of 200 mg orally twice daily (BID) and were evaluated on key safety and antitumor activity endpoints. These patients (n=24) were heavily pretreated, with a median of three prior lines of therapy (range 2-6), with 92% (22 out of 24 patients) having progressed on a prior KRAS(OFF) G12C inhibitor.​ Elironrasib demonstrated compelling antitumor activity, with a confirmed objective response rate of 42% (95% CI: 22-63) and a disease control rate of 79% (95% CI: 58-93). The median duration of response was 11.2 months (95% CI: 5.9-not estimable), and the median progression-free survival was 6.2 months (95% CI: 4.0-10.3). The median overall survival (OS) was not yet reached and 12-month OS rate was 62% (95% CI: 40-78).

These results are from RMC-6291-001, an ongoing multicenter, Phase 1 trial designed to evaluate elironrasib (RMC‑6291) monotherapy in patients with advanced KRAS G12C solid tumors.

Elironrasib is an innovative, mutant-selective inhibitor that binds selectively and covalently to the oncogenic RAS(ON) form of the RAS G12C variant that drives approximately 12% of cases of NSCLC. Revolution Medicines is exploring elironrasib monotherapy and combinations in various treatment settings and continues work to prioritize among multiple options for advancing its development. In July 2025, elironrasib was granted Breakthrough Therapy Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.

NSCLC accounts for 80%-85% of all lung cancers, and most patients have advanced or metastatic disease at initial diagnosis.1,2 KRAS mutations are found in nearly 30% of NSCLC cases, among which KRAS G12C is the most common.

Advancing RAS(ON) Inhibitor Platform Across Tumor Types
Jan Smith, Ph. D., chief scientific officer of Revolution Medicines will also highlight encouraging preclinical data supporting the RAS(ON) inhibitor doublet of zoldonrasib and daraxonrasib during a plenary session at the start of the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium.

Several other presentations to be featured at the meeting demonstrate continued progress across Revolution Medicines’ RAS(ON) inhibitor portfolio, including:

"Targeting the Oncogenic State of RAS with Tri-Complex Inhibitors"
"RAS(ON) Inhibitor In-Pathway Combinations Maximize RAS Pathway Suppression in KRAS Mutant CRC Models"
"Resistance Mechanisms to Monotherapy Daraxonrasib (RMC-6236) in RAS Mutant PDAC"
"RASolve 301: A Phase 3 Study of Daraxonrasib (RMC-6236) vs. Docetaxel in RAS-Mutant NSCLC"
Further details and information on presentations can found on the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium website.

About Non-Small Cell Lung Cancer
More than 197,000 people are diagnosed with non-small cell lung cancer (NSCLC) in the U.S. each year.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.

(Press release, Revolution Medicines, OCT 22, 2025, View Source [SID1234656902])

Ipsen delivers strong sales in the first nine months of 2025 and further upgrades its full-year guidance

On October 22, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its sales for the year to date and the third quarter of 2025.

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YTD 2025 YTD 2024 % change Q3 2025 Q3 2024 % change
€m €m Actual CER €m €m Actual CER
Oncology 1,912.0 1,829.8 4.5 % 6.6 % 624.0 604.0 3.3 % 7.0 %
Rare Disease 255.4 129.7 97.0 % 101.0 % 102.0 50.8 100.8 % 109.1 %
Neuroscience 567.3 536.4 5.8 % 9.5 % 188.9 181.9 3.9 % 9.1 %
Total Sales 2,734.8 2,495.9 9.6 % 12.1 % 915.0 836.6 9.4 % 13.7 %

"We have demonstrated strong momentum through the first nine months of 2025, with solid growth across all three therapeutic areas and increasing contributions from our rare liver disease franchise. As a result, we are further upgrading our full-year guidance to reflect this performance." said David Loew, Chief Executive Officer, Ipsen.
"This quarter, we were also pleased with the data from the Phase II LANTIC trial in aesthetics, with a differentiated first-in-class long-acting molecule, IPN10200. With the proposed acquisition of ImCheck Therapeutics announced this morning, we are adding a first-in-class asset to expand our oncology pipeline. Our efforts remain focused on advancing science with purpose to bring the benefits patients are looking for, as we believe everyone deserves a life fully lived."

Full-year 2025 guidance
Based on the strong performance in the third quarter, Ipsen further upgrades its financial guidance for 2025:

Total sales growth of around 10.0%, at CER (prior guidance greater than 7.0%). Based on the average level of exchange rates in September 2025, an adverse impact on total sales of around 3% from currencies is expected
Core operating margin of around 35.0% of total sales (prior guidance greater than 32.0%)
This guidance assumes a limited impact from lanreotide generic on Somatuline sales and an accelerated sales growth from the rest of the portfolio.

Pipeline update for Q3 2025
On 22 September 2025 Ipsen announced that the LANTIC Phase II trial in aesthetics delivered a first-in-class, differentiated long-acting clinical profile for IPN10200, a recombinant, first-in-class molecule uniquely engineered to generate increased receptor affinity and internalization that produces a longer duration of action. Data showed a rapid onset of action, peak effect superior to placebo and a substantial majority of patients experiencing clinically significant longer duration of effect vs placebo and vs Dysport, defined as a score of "none" or "mild" of line severity at Week 24. The data will be presented at an upcoming scientific conference in H1 2026, and Phase III start-up activities have been initiated.

On 19 September 2025 Ipsen announced regulatory approval for Bylvay (odevixibat) for the treatment of pruritus associated with progressive familial intrahepatic cholestasis (PFIC) in Japan, offering a non-surgical treatment option for infants, young children and adults.

On 23 July 2025, Ipsen received European Commission approval for Cabometyx (cabozantinib) in previously treated advanced neuroendocrine tumors (NETs), based on positive outcomes from the Phase III CABINET trial.

Business development
On 22 October 2025 Ipsen announced a definitive share purchase agreement to acquire ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The acquisition is focused on the lead Phase I/II program ICT01 in first line unfit acute myeloid leukemia (AML) with a Phase IIb/III to start in 2026. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and which has received Orphan Drug Designation from the U.S. Food and Drug Administration and Orphan designation from the European Medicines Agency in July 2025.

Under the terms of the agreement, shareholders of ImCheck Therapeutics will receive a €350m cash payment at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones. The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions.

Conference call
A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

(Press release, Ipsen, OCT 22, 2025, View Source [SID1234656869])

Harbour BioMed Announces Positive Phase II Results for HBM4003 and Tislelizumab Combination in MSS mCRC

On October 22, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported positive Phase II clinical data for porustobart (HBM4003), a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody, in combination with tislelizumab, in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC).

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The multicenter, open-label Phase II study (NCT05167071) enrolled 24 heavily pretreated patients with non-liver-metastatic (NLM) MSS mCRC. Patients received HBM4003 (0.3 mg/kg) plus tislelizumab (200 mg) every 21 days. The primary efficacy endpoint was objective response rate (ORR) per RECIST 1.1 criteria. The findings showed promising antitumor activity and a manageable safety profile for the combination therapy in this difficult-to-treat population.

Key findings include:

Baseline: All patients (N=24) had received ≥2 prior lines of therapy; 16/24 (66.7%) had lung metastases.
Efficacy: Among the 23 evaluable patients, the combination therapy achieved:
Objective Response Rate (ORR): 34.8% (8 partial responses)
Disease Control Rate (DCR): 60.9% (8 partial responses + 6 stable diseases)
Median Progression-Free Survival (mPFS): 4.2 months
Safety: The regimen was well-tolerated, with no Grade 4 or fatal treatment-emergent adverse events (TEAEs) observed.
TRAEs were reported in 87.5% (21/24) of patients, most commonly (incidence ≥20%) liver function test abnormalities, hematological abnormalities, and pyrexia (mostly Grade 1-2).
Treatment-related serious adverse events (SAEs) occurred in 37.5% (9/24) of patients.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented: "The 2025 Nobel Prize in Physiology or Medicine was awarded to three immunologists for their groundbreaking discoveries in regulatory T cells (Treg cells) and their role in controlling the immune system. HBM4003, a next-generation anti-CTLA-4 antibody discovered through our HCAb Harbour Mice platform, is a direct clinical application arising from this foundational research. The positive results from this Phase II clinical study mark an important milestone for Harbour BioMed and underscore the therapeutic potential of HBM4003. We will continue to advance HBM4003 with the goal of delivering transformative immuno-oncology therapies to patients worldwide."

About Porustobart (HBM4003)

Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, CRC, NEN and HCC. Final data from the study of HBM4003 in combination with toripalimab for advanced HCC were published in Clinical Cancer Research in August 2025.

(Press release, Harbour BioMed, OCT 22, 2025, View Source [SID1234656903])

Quest Diagnostics Reports Third Quarter 2025 Financial Results; Raises Guidance for Full Year 2025

On October 21, 2025 Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, reported financial results for the third quarter ended September 30, 2025.

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"We delivered another quarter of robust top- and bottom-line growth, underscoring strong demand for our clinical solutions and diligent execution of our strategy," said Jim Davis, Chairman, CEO and President. "Revenues grew 13.1%, including 6.8% organic growth, driven by broad-based adoption of our clinical innovations, contributions from acquisitions, and growth in our consumer channel as we build our presence as the preferred lab engine inside top health and wellness brands. We also announced an agreement with Corewell Health to create a major lab services joint venture serving the state of Michigan. In addition, we will deploy our comprehensive Co-Lab Solutions across Corewell’s nearly two dozen hospitals. Given our strong performance year-to-date, we are again raising our full year 2025 guidance."

Recent highlights:

Entered into an agreement with Corewell Health to establish a lab services joint venture in Michigan. In addition, Quest will deploy a comprehensive suite of Co-Lab Solutions, from reference testing and lab analytics to supply chain and blood management, supporting quality, innovation access and productivity. With this collaboration, annual revenues for Co-Lab Solutions are expected to reach approximately $1 billion next year as services scale across 21 Corewell hospitals.
Completed the acquisition of select dialysis testing assets from Fresenius Medical Care and, under a separate enterprise agreement, began to scale clinical lab testing for Fresenius Medical Care’s U.S. dialysis centers serving approximately 200,000 dialysis patients annually.
Formed collaborations to be the lab engine inside the mobile apps of WHOOP, the human performance company, and ŌURA Health, maker of the world’s leading smart ring, to serve growing consumer interest in wellness and preventive health.
Announced a collaboration with Epic to be the technology partner for Project Nova, a multi-year initiative to streamline systems and improve experiences for patients and providers, regardless of the electronic health record system they use.
Published data in Neurology Clinical Practice on the confirmatory accuracy of two Quest AD-Detect tests for aiding Alzheimer’s disease diagnosis.
Announced collaborations that leverage Quest’s national scale in phlebotomy and connectivity to broaden access to cancer-screening liquid biopsy tests.
Secured FDA breakthrough device designation for our Haystack MRD test and formed collaborations with Mass General Brigham and Rutgers Cancer Institute to trial Haystack MRD in guiding postoperative therapy decisions.
Named Thomas Koch, a veteran of the lab and medical device industries, to be the company’s senior vice president of R&D.
Recognized as a Top Corporate Wellness Innovator by Fast Company for our leadership in employee well-being.

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

Change

2025

2024

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,816

$ 2,488

13.1 %

$ 8,229

$ 7,251

13.5 %

Diagnostic Information Services revenues

$ 2,755

$ 2,427

13.5 %

$ 8,043

$ 7,058

14.0 %

Revenue per requisition

0.8 %

0.2 %

Requisition volume

12.5 %

13.8 %

Organic requisition volume

3.9 %

1.8 %

Operating income (a)

$ 386

$ 330

16.8 %

$ 1,170

$ 985

18.7 %

Operating income as a percentage of net revenues (a)

13.7 %

13.3 %

0.4 %

14.2 %

13.6 %

0.6 %

Net income attributable to Quest Diagnostics (a)

$ 245

$ 226

8.5 %

$ 747

$ 649

15.0 %

Diluted EPS (a)

$ 2.16

$ 1.99

8.5 %

$ 6.57

$ 5.74

14.5 %

Cash provided by operations

$ 563

$ 356

57.4 %

$ 1,421

$ 870

63.1 %

Capital expenditures

$ 144

$ 106

37.0 %

$ 369

$ 302

22.3 %

Adjusted (a):

Operating income

$ 458

$ 385

18.9 %

$ 1,330

$ 1,132

17.5 %

Operating income as a percentage of net revenues

16.3 %

15.5 %

0.8 %

16.2 %

15.6 %

0.6 %

Net income attributable to Quest Diagnostics

$ 296

$ 262

13.1 %

$ 845

$ 758

11.5 %

Diluted EPS

$ 2.60

$ 2.30

13.0 %

$ 7.43

$ 6.70

10.9 %

(a)

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Updated Guidance for Full Year 2025

The company updates its full year 2025 guidance as follows:

Updated Guidance

Prior Guidance

Low

High

Low

High

Net revenues

$10.96 billion

$11.00 billion

$10.80 billion

$10.92 billion

Net revenues increase

11.0 %

11.4 %

9.4 %

10.6 %

Reported diluted EPS

$8.58

$8.66

$8.60

$8.80

Adjusted diluted EPS

$9.76

$9.84

$9.63

$9.83

Cash provided by operations

Approximately $1.8 billion

Approximately $1.55 billion

Capital expenditures

Approximately $500 million

Approximately $500 million

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, gains and losses associated with changes in the carrying value of our strategic investments, impairment charges and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on October 21, 2025 until midnight Eastern Time on November 4, 2025, by phone at 866-388-5361 for domestic callers or 203-369-0416 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

(Press release, Quest Diagnostics, OCT 21, 2025, View Source [SID1234656870])

AdvanCell’s 212Pb-ADVC001 demonstrates encouraging safety and compelling anti-tumor activity in Phase 1b in prostate cancer

On October 21, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported results from the Phase 1b dose escalation of the TheraPb Phase 1/2 clinical trial (NCT05720130) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 congress. The presentation featured the first clinical results of 212Pb-ADVC001, a novel Lead-212-based PSMA-targeted alpha therapy in mCRPC.

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"We are very encouraged by the completion of the treatment period of our Phase 1 trial, which has demonstrated a favorable safety profile and compelling anti-tumor activity for 212Pb-ADVC001," said Anna Karmann, MD PhD, Chief Medical Officer of AdvanCell. "These results underscore the potential of our therapy to meaningfully impact patients’ lives and advance treatment options in metastatic prostate cancer. I want to sincerely thank the investigators, clinical teams, and most importantly the patients and their families, whose commitment has made this important milestone possible."

"The TheraPb Phase 1 trial of 212Pb-ADVC001 marks a pivotal step forward in the evolution of PSMA-targeted radioligand therapy," said Aaron Hansen, MD, Principal Investigator at Princess Alexandra Hospital. "We’ve observed a compelling therapeutic index, including marked reductions in tumor volume and PSA, alongside a promising safety and dosimetry profile. The ability to administer alpha therapy easily and efficiently in an outpatient setting is a major clinical advantage. I am excited about the potential of 212Pb-ADVC001 to redefine treatment for patients with prostate cancer."

Oliver Sartor, MD, Director of the Transformational Prostate Cancer Research Center at East Jefferson General Hospital, remarked, "The results from this Phase 1 trial demonstrate a strong efficacy signal combined with an excellent safety profile. This is an extremely promising step forward in delivering targeted alpha therapy to patients with prostate cancer."

The abstract submitted to ESMO (Free ESMO Whitepaper) was based on a data cut-off as of May 9, 2025. The presentation at ESMO (Free ESMO Whitepaper) includes updated safety and efficacy data from all seven treatment cohorts as of an October 2, 2025 cut-off.

The TheraPb Phase 1b dose escalation study enrolled 22 patients with mCRPC. Escalating doses of 60–200 MBq of 212Pb-ADVC001 were administered at prespecified schedules every 6, 4, 2 and 1 week(s) for up to six cycles. After cohort 1, six subsequent treatment cohorts were enrolled within ten months.

TheraPb Phase 1b dose escalation results as of October 2, 2025 cut-off:

Encouraging safety and tolerability

No dose-limiting toxicities, treatment-related serious adverse events or treatment-related adverse events leading to dose modification or treatment discontinuation
Xerostomia predominantly Grade 1, with evidence of reversibility
Promising anti-tumor activity

80% PSA50 biochemical response at therapeutic doses ≥ 160 MBq
100% ORR in patients with RECIST-measurable lesions, including two CRs
PSA, imaging and clinical responses within weeks of treatment start
Favorable dosimetry and kinetics

Low normal-organ radiation exposure that supports a dosing strategy beyond six cycles and enhanced dose intensity
Fast clearance and no relevant metabolic breakdown
The data represent the first clinical trial results of a 212Pb-based PSMA therapy. The findings support the further development of 212Pb-ADVC001 and may offer a new reference point in the treatment landscape for metastatic prostate cancer, both within and beyond the PSMA-targeted class.

Phase 2 expansion will evaluate 160 MBq and 200 MBq of 212Pb-ADVC001 using a randomized multi-dose-response design and adaptive dosing strategies to optimize clinical outcomes in three indications: mCRPC (chemo-naïve, and post-177Lu-PSMA) and mHSPC.

The poster presentation is available on AdvanCell’s website at: AdvanCell ESMO (Free ESMO Whitepaper) 2025 Poster.

(Press release, Advancell, OCT 21, 2025, View Source [SID1234656886])