On June 24, 2026 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported that the New York State Department of Health’s (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) has approved the company’s Haystack MRD test, a circulating tumor DNA (ctDNA) liquid biopsy test, for use in identifying residual or recurring disease in patients with a range of solid tumor cancers.

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!

New York maintains a highly rigorous clinical laboratory oversight program, requiring formal technical review and approval of laboratory developed tests before they may be offered to patients in the state. With this approval, Haystack MRD is now authorized for patient testing in all 50 U.S. states. The test was developed under CLIA regulations and has been available for clinician ordering since late 2024 in 49 states and the District of Columbia.

"This approval represents the culmination of our many years of hard work and commitment to delivering a highly accurate test that can meaningfully improve patient care," said Dan Edelstein, Vice President and General Manager for Haystack Oncology, a Quest Diagnostics company. "Haystack MRD was designed to give oncologists the confidence to detect residual disease earlier, catch recurrence before it becomes clinically apparent, and help identify response to treatment. New York’s approval is another proof point for Haystack MRD’s quality and technical sophistication, and we look forward to extending access to this important innovation for clinicians and patients in the state."

In addition, Haystack MRD’s clinical utility has been demonstrated in rigorous investigational settings, including the landmark study of non-operative management of patients with locally advanced mismatch repair–deficient (dMMR) solid tumors, which was led by Dr. Andrea Cercek and colleagues at Memorial Sloan Kettering Cancer Center and published in The New England Journal of Medicine in May 2025. In that study, ctDNA testing, using Haystack MRD, was found to be a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months, compared to more than 6 months using imaging methods.

"In our study of non-operative management for dMMR solid tumors, the use of MRD testing provided additional molecular information that complemented traditional assessments such as imaging and endoscopy," said Dr. Cercek, Medical Oncologist, Memorial Sloan Kettering Cancer Center. "For patients who may avoid surgery, having multiple tools to evaluate treatment response and monitor for recurrence is important. These findings highlight the crucial role of MRD testing in informing patient management and underscore the need for continued study as these approaches are integrated into clinical practice."

(Press release, Quest Diagnostics, JUN 24, 2026, View Source,-Broadening-Patient-Access-to-ctDNA-Minimal-Residual-Disease-Testing [SID1234668936])

On June 24, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), is approved in the European Union (EU), as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This approval, which also covers KEYTRUDA SC [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this combination the first and only PD-1 inhibitor plus ADC regimen available for these patients in the EU.

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!

This approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rate versus surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. KEYTRUDA plus Padcev reduced the risk of EFS events by 60% (HR=0.40 [95% CI, 0.28-0.57]; p<0.0001) versus surgery alone. Median EFS was not reached (NR) (95% CI, 37.3-NR) for KEYTRUDA plus Padcev versus 15.7 months (95% CI, 10.3-20.5) for surgery alone. KEYTRUDA plus Padcev also reduced the risk of death by 50% (HR=0.50 [95% CI, 0.33-0.74]; p=0.0002) versus surgery alone. Median OS was NR (95% CI, NR-NR) for KEYTRUDA plus Padcev versus 41.7 months (95% CI, 31.8-NR) for surgery alone. The trial demonstrated a statistically significant difference in pCR rate (57.1% [95% CI: 49.3, 64.6] vs. 8.6% [95% CI: 4.9, 13.8]; p<0.0001). The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), received in May 2026.

"Patients with resectable muscle-invasive bladder cancer who are ineligible for cisplatin‑containing chemotherapy face an aggressive disease and few effective therapies, with surgery alone as the longstanding standard of care," said Professor Christof Vulsteke, head of Integrated Cancer Center Ghent (IKG) and Clinical Trial Unit Oncology Ghent and KEYNOTE-905 principal investigator. "Based on robust data from the KEYNOTE-905 trial, this approval marks a turning point in bladder cancer care. It introduces a potentially practice-changing perioperative treatment option that may significantly improve outcomes and extend survival for this underserved patient population across the European Union."

"For patients with resectable muscle-invasive bladder cancer in Europe, this approval represents a meaningful advance after years of limited progress in the field," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "As the first PD-1 inhibitor plus antibody-drug conjugate regimen approved in this setting, this treatment is poised to address a crucial unmet need, reflecting our continued commitment to delivering innovative KEYTRUDA-based therapies to patients with bladder cancer worldwide."

This approval authorizes marketing of this KEYTRUDA treatment regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA for this indication in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.

In November 2025, KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, were approved by the U.S. Food and Drug Administration (FDA), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy.

About KEYNOTE-905/EV-303

KEYNOTE-905, also known as EV-303, is an open-label, randomized, multi-arm, controlled Phase 3 trial (ClinicalTrials.gov, NCT03924895) evaluating perioperative KEYTRUDA, with or without Padcev, versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. The trial enrolled 595 patients who were randomized to receive either:

Arm A: Three cycles of neoadjuvant KEYTRUDA, followed by surgery to remove the bladder (RC), followed by 14 cycles of adjuvant KEYTRUDA;
Arm B: Surgery alone;
Arm C: Three cycles of neoadjuvant KEYTRUDA plus enfortumab vedotin, followed by surgery to remove the bladder (RC), followed adjuvantly by six cycles of KEYTRUDA plus enfortumab vedotin and then eight cycles of KEYTRUDA alone.
The primary objective of this trial is to compare EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. The key secondary objectives are to compare OS and the difference in pCR rate between arm C and arm B, as well as EFS, OS and the difference in pCR rate between arm A and arm B. The study remains ongoing to test hypotheses between arm A and arm B.

About bladder cancer

Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally. In Europe, it is estimated there were approximately 224,700 patients diagnosed with bladder cancer and more than 70,300 deaths from the disease in 2022. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC has been neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.

(Press release, Merck & Co, JUN 24, 2026, View Source [SID1234668935])

On June 24, 2026 GSK plc (LSE/NYSE: GSK) reported that Harmony Row Acquisition Co. ("Purchaser"), a direct wholly-owned subsidiary of ‎GlaxoSmithKline LLC ("GSK LLC"), which is an ‎indirect wholly-owned subsidiary of GSK, has commenced a tender offer to purchase all of the issued and outstanding shares of Class A Common Stock, par value $0.0001 per share (the "Class A Shares"), and Class B Common Stock, par value $0.0001 per share (the "Class B Shares" and, together with the Class A Shares, the "Shares") of Nuvalent, Inc. ("Nuvalent") (NASDAQ: NUVL), for $124.00 per Share, net to the seller in cash, without interest, subject to any applicable withholding taxes, and upon ‎the terms and subject to the conditions set forth in the Offer to Purchase, dated June 24, 2026, and the accompanying Letter of Transmittal ‎‎(together, and with other related materials, as they may be amended or supplemented from time to time, the "Offer").

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!

The Offer is being made pursuant to an Agreement and Plan of Merger, dated as of June 9, 2026, by and among Nuvalent, GSK LLC, Purchaser and solely for purposes of Section 9.14 therein, GSK. As soon as practicable following consummation of the Offer and subject to the satisfaction or waiver of certain conditions, Purchaser will merge with and into Nuvalent (the "Merger") and the separate existence of Purchaser will cease and Nuvalent will continue as the surviving corporation and as a direct wholly-owned subsidiary of GSK LLC. The Merger will be governed by Section 251(h) of the General Corporation Law of the State of Delaware, as amended (the "DGCL"), which does not require a vote or action by written consent of Nuvalent’s stockholders. ‎

Nuvalent’s Board of Directors (the "Nuvalent Board") has published a Solicitation/Recommendation Statement on Schedule 14D-9 (the "Schedule 14D-9") filed with the Securities and Exchange Commission (the "SEC"), which includes, among other things, the recommendation of the Nuvalent Board that Nuvalent’s stockholders accept the Offer and tender their Shares to Purchaser pursuant to the Offer.

The Offer and withdrawal rights will expire at one minute following 11:59 p.m., ‎Eastern Time, on July 14, 2026, unless the Offer is ‎extended or earlier terminated (such date, or any subsequent date to which the ‎expiration of the Offer is extended, the "Expiration Date"). ‎Any extension, delay, termination or amendment of the Offer will be followed as promptly as practicable by a ‎public announcement thereof, and such announcement, in the case of an extension, will be made no later than 9:00 a.m., Eastern Time, on the next business day after the previously scheduled Expiration Date. Purchaser is not providing for guaranteed delivery procedures.

Purchaser’s obligation to pay for ‎Shares validly tendered (and not validly withdrawn) pursuant to the Offer is subject to certain conditions, including, among others, (a) the Minimum Tender Condition (as defined below); and (b) the expiration or termination of the waiting period (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The "Minimum Tender Condition" means that there shall have been validly tendered in the Offer and "received" by the "depositary" (as such terms are defined in Section 251(h) of the DGCL), and not validly withdrawn prior to the Expiration Date that number of Class A Shares that, together with the number of Class A Shares, if any, then owned beneficially by GSK LLC and Purchaser (together with their wholly-owned subsidiaries), represents at least a majority of the Class A Shares outstanding as of the consummation of the Offer. ‎The Offer is not subject to a financing condition.

The documentation relating to the Offer (including the Offer to Purchase, the Letter of Transmittal and Schedule 14D-9) can be accessed at the following link: www.readourmaterials.com/gsk2026/. The Offer to Purchase, the related Letter of Transmittal and the Schedule 14D-9 (which contains the recommendation of the Nuvalent Board and ‎the reasons therefor) contain important information. Nuvalent’s stockholders should carefully read all documents in ‎their entirety before any decision is made with respect to the Offer. ‎

Questions or requests for assistance may be directed to Innisfree M&A Incorporated (the "Information Agent") at ‎the address and telephone numbers set forth below. Requests for copies of the Offer to Purchase, the related Letter ‎of Transmittal and other tender offer materials may be directed to the Information Agent or to brokers, dealers, ‎commercial banks or trust companies. Such copies will be furnished promptly at Purchaser’s expense.

(Press release, GlaxoSmithKline, JUN 24, 2026, View Source [SID1234668934])

On June 24, 2026 Antares Therapeutics, Inc. ("Antares"), a biotechnology company developing first-in-class precision medicines for cancer and other serious diseases, reported a strategic collaboration with Novartis to discover, develop and commercialize small molecule therapies against promising but historically undruggable oncology targets. The agreement underscores the productivity and breadth of Antares’ discovery capabilities, which have repeatedly delivered development candidates against targets long considered intractable.

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!

Under the terms of the agreement, Antares will receive a $105 million upfront payment and is eligible to receive up to $1.8 billion in additional payments across programs, inclusive of option exercise, development, regulatory, and commercial milestones, as well as tiered royalties on global net sales up to the low double-digit range. Antares will lead all research and apply its proprietary discovery engine to a limited number of historically undruggable targets until option exercise. In parallel, Antares will continue to advance its wholly owned and partnered portfolio of precision medicines for cancer and other serious diseases.

"From the outset, our goal has been to build a discovery engine that systematically unlocks high-value, challenging targets and delivers first-in-class precision medicines," said Adam Friedman, M.D., Ph.D., Chief Executive Officer of Antares. "This collaboration lets us scale that engine alongside Novartis’ world-class development capabilities and global reach, so we can translate our science into transformative therapies for patients faster than either of us could alone. It builds on the work of a team that has consistently produced highly selective medicines against some of the hardest targets in drug discovery."

The collaboration pairs Antares’ covalent drug discovery expertise – proprietary screening libraries, chemical proteomics capabilities, structure-driven computational chemistry and a machine-learning suite purpose-built for compelling first-in-class targets – with Novartis’ world-class R&D and global resources.

"Novartis is committed to advancing innovative approaches to cancer drug discovery and expanding the boundaries of what’s possible in oncology treatment," said Fiona Marshall, President of Biomedical Research at Novartis. "Many of the most compelling targets today in oncology have historically been considered undruggable. We believe this collaboration has the potential to unlock a new wave of targeted therapies and bring meaningful advances to patients."

(Press release, Antares Therapeutics, JUN 24, 2026, View Source [SID1234668933])

On June 24, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones that position the Company for what management believes could be a pivotal period in its evolution as a clinical-stage oncology company.

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!

At the center of AIM’s strategy is Ampligen (rintatolimod), the Company’s proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer.

Pancreatic cancer remains one of the deadliest forms of cancer worldwide, with limited treatment options and an urgent need for innovative therapies capable of extending survival and improving quality of life. AIM believes Ampligen’s unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease.

Execution Continues to Drive Momentum

Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development:

Completed Phase 2 DURIPANC enrollment ahead of schedule
Achieved the important clinical milestone of dosing the final patient in the study
Reported positive interim clinical updates from the ongoing trial
Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates
Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center
Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations
Maintained orphan drug designation for pancreatic cancer in major markets
Regained compliance with NYSE American continued listing standards
Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities
These accomplishments represent important de-risking events that management believes support the advancement of Ampligen toward a potential registration-directed development pathway.

Growing Clinical Foundation Supports Advancement

Ampligen’s pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations.

Recent interim updates from DURIPANC have continued to support management’s confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition.

Importantly, the combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment.

Multiple Near-Term Catalysts Ahead

With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company’s recent history.

Key anticipated milestones include:

Additional clinical updates from the ongoing DURIPANC study
Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027
Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027
Continued immune monitoring and biomarker analyses
Regulatory interactions supporting future development planning
Further expansion of the Company’s global intellectual property portfolio
Advancement of Phase 3 planning activities
Potential design and initiation activities associated with a registration-focused pivotal study
Management believes each of these milestones has the potential to further validate Ampligen’s clinical profile and strengthen the Company’s strategic position.

A Clear Focus on Shareholder Value Creation

AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value.

The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority.

As the biotechnology sector continues to place significant value on late-stage oncology assets, AIM believes successful execution of its pancreatic cancer strategy could substantially enhance the value of the Ampligen franchise.

With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period.

"We have built meaningful momentum across every aspect of the Ampligen pancreatic cancer program," said Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. "Our focus remains clear: facilitate the DURIPANC study, continue generating meaningful clinical data, advance regulatory planning, and position Ampligen for a potential pivotal development pathway. We believe these efforts have the potential to unlock significant value for patients, partners and our stockholders."

As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment today.

(Press release, AIM ImmunoTech, JUN 24, 2026, View Source [SID1234668932])