On October 21, 2025 Hanmi reported third quarter financial results for the year 2025 (Press release, Hanmi, OCT 21, 2025, View Source [SID1234661651]).

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!

On October 21, 2025 Iambic Therapeutics, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, reported it has entered into a research collaboration and drug supply agreement with Jazz Pharmaceuticals. Under the agreement, Jazz will provide zanidatamab (Ziihera), a HER2-targeted bispecific antibody, at no cost to Iambic for evaluation in combination with IAM1363, Iambic’s brain-penetrant HER2 small-molecule tyrosine kinase inhibitor (TKI). The combination will be studied in patients with HER2-positive breast cancer that have previously been treated with trastuzumab deruxtecan (T-DXd; Enhertu).

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!

"We are enthusiastic to pair our potential best-in-class HER2 TKI, IAM1363, with zanidatamab, the leading HER2-targeted bispecific antibody," said Neil Josephson, M.D., Chief Medical Officer of Iambic. "Together, these agents represent a powerful new strategy with the potential to transform treatment for patients with advanced HER2-positive breast cancer whose disease has progressed following first- or second-line treatment."

As part of the Phase 1/1b IAM1363-01 study, Iambic will initiate a cohort in patients with HER2-positive breast cancer to evaluate IAM1363 in combination with zanidatamab and capecitabine.

Alongside the research collaboration announcement, Iambic has reported clinical data for IAM1363 monotherapy at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting in Berlin, showing anti-tumor activity, safety, and tolerability. The IAM1363 clinical data show activity in patients with HER2-mutant NSCLC and HER2-positive breast and gastric cancers, as well as indications lacking approved HER2-directed TKIs or antibodies, such as HER2-mutant renal cell cancer and HER2-amplified NSCLC and ovarian cancer. IAM1363 was specifically engineered to overcome the limitations of current HER2-directed therapies, demonstrating >5,000-fold selectivity for HER2 over EGFR, ten-fold greater CNS penetration than approved TKIs, and broad activity against both wild-type and mutant HER2.

Iambic’s Phase 1/1b trial, NCT06253871, is an open-label, multi-center, dose escalation and dose optimization study, designed to evaluate tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 in patients with advanced HER2 cancers. The study, which has multiple sites in the U.S., recently opened in the EU and will continue to expand into additional sites across the U.S. and EU and into the UK and APAC in Q4 2025.

(Press release, Iambic Therapeutics, OCT 21, 2025, View Source [SID1234656885])

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.

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!

"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])

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.

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!

"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])

On October 21, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT"), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported that it has commenced an underwritten public offering of shares of its common stock. In addition, RAPT expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of common stock RAPT is offering, at the public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by RAPT. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

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!

Leerink Partners, TD Cowen, Guggenheim Securities, Wells Fargo Securities and LifeSci Capital are acting as joint bookrunning managers for the proposed offering. H.C. Wainwright & Co. and Clear Street are acting as lead managers for the proposed offering.

The offering is being made pursuant to a shelf registration statement, including a base prospectus, filed by RAPT with the Securities and Exchange Commission (the "SEC"), which was declared effective by the SEC on August 17, 2023. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-800-808-7525 ex. 6132 or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; Wells Fargo Securities, LLC, Attention: Wells Fargo Securities, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, at 800-645-3751 (option #5) or email a request to [email protected]; or LifeSci Capital LLC at 1700 Broadway, 40th Floor, New York, New York 10019, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, RAPT Therapeutics, OCT 21, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-proposed-public-offering-common-1 [SID1234656871])