On July 23, 2025 Nerviano Medical Sciences Srl (NMS Srl or NMS), a clinical stage biopharmaceutical leader in oncology innovation, reported its strategic plan to focus its research and development resources to progress its three biological targets, composed of PARP1, PARP7, and MPS1, and on its proprietary ADC platform composed of novel ADC payloads (Press release, Nerviano Medical Sciences, JUL 23, 2025, View Source [SID1234654482]).

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Itareparib (PARP1 Inhibitor)
A next-generation, highly selective PARP1 inhibitor engineered to avoid PARP trapping, a key source of toxicity in healthy cells. Its differentiated profile enables safe and effective combination with DNA-damaging agents like chemotherapy and ADCs. Currently in Phase II for relapsed glioblastoma (IDH wild type) in combination with temozolomide, itareparib has shown strong bone marrow tolerability1 supporting its expansion into astrocytoma, small cell lung cancer, and non-BRCA ovarian cancer.

Atamparib (PARP7 Inhibitor)
A potent, oral PARP7 inhibitor targeting tumors driven by mono-ADP ribosylation activity. With high selectivity and a strong safety profile in early trials, atamparib offers a novel approach in oncology where PARP7 plays a critical role in disease progression. Positioned for Phase II entry in 2025, it addresses significant unmet needs in targeted patient populations.

NMS-153 (MPS1/TTK Inhibitor)
A selective mitotic kinase inhibitor designed to disrupt cancer cell division and trigger immune-activating cell death. Currently in Phase I/II for hepatocellular carcinoma in combination with Atezolizumab, MPS1 has shown confirmed responses in monotherapy2 and combination activity in preclinical models, offering a versatile mechanism for tumors resistant to standard therapies.

ADC Platform
A next-generation ADC platform centered on proprietary novel payload-linker technologies designed to overcome drug resistance. The platform offers a compelling balance of potency and safety, with modular design enabling seamless integration with external antibody assets. NMS’s ADC platform can support the expansion of NMS’s own internal ADC pipeline and a growing network of external collaborations.

While NMS’s three biological targets exhibit compelling differentiation based on strong preclinical validation and favorable emerging clinical data, its ADC platform also has potential for strong growth based on advanced next-generation payloads.

In order to focus its research and development resources on the above activities, NMS Srl has informed its unions and employees of its intention to wind down laboratory operations at the BioN campus in Nerviano, Italy. NMS Srl will also relocate its office-based operational headquarters to Corsico (Milan), Italy.

"This is a pivotal moment for NMS," said Hugues Dolgos, Pharm.D., CEO of NMS. "By streamlining operations and strategically focusing our research and development resources efforts on our most promising biological targets and clinical assets, we are taking decisive steps to drive our long-term success based on our unique successful history and capabilities."

NMS expects the transition to be implemented immediately after the conclusion of the information and consultation procedure with labor unions. NMS’s clinical programs and business development activities will continue and will not be affected during or after the information and consultation procedure.

On July 13, 2025 MAA Laboratories Inc., a specialty pharmaceutical company focused on developing value-added and clinically differentiated drug products, reported that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Nintedanib Esylate Nanoparticle Tablets, developed using the company’s proprietary NanoCont technology platform (Press release, MAA Laboratories, JUL 23, 2025, View Source [SID1234654481]).

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This regulatory milestone enables MAA Laboratories to initiate its Phase I clinical trial in healthy volunteers under the FDA’s 505(b)(2) regulatory pathway.

"We are pleased to receive IND clearance from the FDA for our second clinical-stage product," said Anjani Jha, Founder and CEO of MAA Laboratories. "This milestone continues to validate the potential of our NanoCont platform to deliver enhanced oral drug products with meaningful clinical and development advantages."

On July 23, 2025 GSK plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for Blenrep combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy (Press release, GlaxoSmithKline, JUL 23, 2025, View Source [SID1234654480]). The new Prescription Drug User Fee Act (PDUFA) action date is 23 October 2025 and provides the FDA with time to review additional information provided in support of the application.

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The BLA is supported by efficacy results shown by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma. These include statistically significant and clinically meaningful progression-free survival results for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival versus a daratumumab-based triplet in DREAMM-7. The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.

GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review.

Blenrep combinations are currently approved in the UK2, Japan3, Canada, Switzerland (DREAMM-8 only at this time) and the United Arab Emirates. Applications are currently under review in all major markets globally, including the EU4 and China5 (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.6,7 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.9 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.10,11

About Blenrep
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication
Blenrep combinations were approved in relapsed or refractory multiple myeloma in the UK in April 2025.

In the UK, Blenrep is indicated in adults for the treatment of multiple myeloma:

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
IMPORTANT SAFETY INFORMATION FOR BLENREP
More information can be found in the Blenrep Summary of Product Characteristics and Patient Information leaflets available on the MHRA Products website.12

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5 mg/kg intravenously every three weeks in combination for the first eight cycles and then continued as a single agent. The primary endpoint was progression-free survival (PFS) as per an independent review committee, with secondary endpoints including overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

In DREAMM-7, BVd nearly tripled median PFS versus DVd (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001). DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

PFS results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024 and published in the New England Journal of Medicine. OS results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2024.13,14

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5 mg/kg intravenously for the first cycle and then 1.9 mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

At the primary analysis at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the Blenrep combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5). A positive OS trend was observed but not statistically significant (HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and further analyses are planned.

With additional follow-up, a clinically meaningful benefit continued to be observed, with a near-tripling of the median PFS for the Blenrep combination versus the bortezomib combination (32.6 months versus 12.5 months, respectively (HR: 0.49 [95% CI: 0.35-0.68]). At the end of one year, 71% (95% CI: 63-78) of patients in the BPd combination group compared to 51% (95% CI: 42-60) in the PVd combination group were alive and had not progressed. A benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics.

Results were first presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.15 Updated PFS results were presented at European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA) (Free EHA Whitepaper) 2025.

On July 23, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $5.061 billion during the second quarter of 2025, growing 22.8 percent on a reported basis, 21.6 percent on an operational1 basis and 17.4 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 23, 2025, View Source [SID1234654479]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $797 million or $0.53 per share (EPS), compared to $324 million or $0.22 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.62 a year ago.

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"This was another excellent quarter — marked by exceptional top-line performance — that delivered margin expansion and prioritized investment for future growth," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am incredibly grateful to our dedicated global team for demonstrating clinical and commercial excellence across the company and positioning us for differentiated long-term performance."

Second quarter financial results and recent developments:

Reported net sales of $5.061 billion, representing an increase of 22.8 percent on a reported basis, compared to the company’s guidance range of 17.5 to 19.5 percent; 21.6 percent on an operational basis; and 17.4 percent on an organic basis, compared to the company’s guidance range of 13 to 15 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.53 per share, compared to the company’s guidance range of $0.45 to $0.47 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.71 to $0.73 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 15.7 percent reported, 14.7 percent operational and 7.0 percent organic
Cardiovascular: 26.8 percent reported, 25.5 percent operational and 23.2 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 30.7 percent reported and operational
Europe, Middle East and Africa (EMEA): 6.8 percent reported and 1.8 percent operational
Asia-Pacific (APAC): 18.0 percent reported and 15.4 percent operational
Latin America and Canada (LACA): 4.0 percent reported and 8.9 percent operational
Emerging Markets4: 11.6 percent reported and 12.1 percent operational

Received U.S. Food and Drug Administration approval to expand instructions for use labeling to include the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF) with the FARAPULSE Pulsed Field Ablation (PFA) System.

Commenced enrollment in the ReMATCH IDE clinical trial to evaluate the safety and effectiveness of the FARAWAVE and FARAPOINT PFA Catheters in patients with persistent AF who previously received a cardiac ablation and experienced a recurrence of the condition.5

Received CE mark for the WATCHMAN FLX Pro Left Atrial Appendage Closure Device, which is optimized for healing and designed to improve visualization during device placement and treat a broader range of patient anatomies.

Completed the acquisition of Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.

Completed the acquisition of SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational renal nerve denervation technology designed to treat hypertension.5
1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union (EU) Medical Device Regulation (MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4. Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

5. The FARAPOINT PFA Catheter and the TIVUS Intravascular Ultrasound System are investigational devices. Restricted by Federal law to investigational use only. Not available for sale in the U.S.

Net sales for the second quarter by business and region:

View News Release Full Screen

Increase/(Decrease)

Three Months Ended
June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

Impact of
Certain
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2025

2024

Endoscopy

$ 737

$ 676

9.1 %

(1.3) %

7.8 %

— %

7.8 %

Urology

676

525

28.9 %

(0.8) %

28.0 %

(21.7) %

6.3 %

Neuromodulation

303

282

7.2 %

(0.6) %

6.6 %

— %

6.6 %

MedSurg

1,716

1,483

15.7 %

(1.0) %

14.7 %

(7.7) %

7.0 %

Cardiology

2,647

2,047

29.3 %

(1.4) %

27.9 %

— %

27.9 %

Peripheral Interventions

698

590

18.3 %

(1.1) %

17.1 %

(10.2) %

7.0 %

Cardiovascular

3,345

2,637

26.8 %

(1.3) %

25.5 %

(2.3) %

23.2 %

Net Sales

$ 5,061

$ 4,120

22.8 %

(1.2) %

21.6 %

(4.2) %

17.4 %

Increase/(Decrease)

Three Months Ended

June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2025

2024

U.S.

$ 3,224

$ 2,466

30.7 %

— %

30.7 %

EMEA

878

822

6.8 %

(5.0) %

1.8 %

APAC

790

670

18.0 %

(2.6) %

15.4 %

LACA

169

162

4.0 %

4.9 %

8.9 %

Net Sales

$ 5,061

$ 4,120

22.8 %

(1.2) %

21.6 %

‌

Emerging Markets4

$ 758

$ 680

11.6 %

0.5 %

12.1 %

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of certain acquisitions/divestitures are not prepared in accordance with U.S. GAAP.

Guidance for Full Year and Third Quarter 2025

The company estimates net sales growth for the full year 2025, versus the prior year period, to be approximately 18 to 19 percent on a reported basis and 14 to 15 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $1.89 to $1.93 and estimates adjusted EPS, excluding certain charges (credits), of $2.95 to $2.99.

The company estimates net sales growth for the third quarter of 2025, versus the prior year period, to be in a range of approximately 17 to 19 percent on a reported basis, and 12 to 14 percent on an organic basis. Third quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.44 to $0.46 and estimates adjusted EPS, excluding certain charges (credits), of $0.70 to $0.72.

Conference Call Information
Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

On July 22, 2025 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory and infectious diseases, reported detailed results from a Danish validation study, published in the Journal of Surgical Oncology (Press release, SkylineDx, JUL 22, 2025, View Source [SID1234654477]). The study demonstrates that SkylineDx’s Merlin Assay (CP-GEP) can identify cutaneous melanoma patients, in particular pT1 and pT2 patients, that have a low risk for nodal metastasis and therefore may forgo Sentinel lymph node biopsy (SLNB) surgery. Merlin is a genomic test to guide treatment decisions in early-stage melanoma.

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In the independent blinded multicenter study, primary cutaneous melanoma tissue from a cohort of 536 newly diagnosed pT1-pT3 melanoma patients who had undergone SLNB between 2010 and 2015 was collected and analyzed with CP-GEP. Merlin’s outcome labels were compared to patients’ sentinel lymph node status and a nomogram that is widely used on an international basis for SLN metastasis risk.

Key findings of the study include:

The potential SLNB reduction rate was highest for the pT1-subgroup at 72.7% (NPV 94.5%) In pT1-pT3 melanoma, 41% of patients were classified as CP-GEP Low-Risk and could have forgone SLNB surgery, which is in line with previous validation studies.
Comparison with an internationally recognized nomogram showed that CP-GEP would result in a notably larger SLNB reduction rate compared to the internationally recognized nomogram (44.2% vs. 7.8%) particularly for T1- T3 patients.
"The Merlin test is a promising and well-validated non-invasive tool for refining SLNB selection, with consistent findings across several independent cohorts," said First Author Dr. Marie B.-M. Weitemeyer from Copenhagen University Hospital-Herlev and Gentofte. "In our Danish cohort, Merlin demonstrated the potential to reduce unnecessary SLNB procedures by more than 40%."

"Merlin performance is consistent with previous study cohorts," said SkylineDx Chief Scientific Officer, Jvalini Dwarkasing, PhD. "Compared to the internationally recognized nomogram, CP-GEP demonstrated a significantly higher SLNB reduction rate while maintaining a high NPV, underscoring its potential for greater clinical benefit."

SLNB is the gold standard in staging primary melanoma patients. According to current guidelines, patients with pT1b melanoma and higher may be eligible for SLNB surgery. However, approximately 85% of these patients will not show SLN metastasis while undergoing this invasive procedure, under general anesthesia, with the risk of potential surgical complications. Also, SLNB poses a substantial burden on healthcare resources. Therefore, tools are warranted beyond clinical guidelines to stratify patients based on their risk of nodal metastasis. SkylineDx’s CP-GEP is currently the only GEP-based prediction tool specifically developed to identify melanoma patients at low risk of SLN metastasis.

About the Merlin Assay (CP-GEP)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com.