On July 23, 2025 Boston Scientific reported second quarter 2025 financial results (Presentation, Boston Scientific, JUL 23, 2025, View Source [SID1234656858]).

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 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]).

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 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 Boston Scientific Corporation reported the company generated 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 [SID1234656859]). 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.

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 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.

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]).

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!

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 23, 2025 Lithea Pharma reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead investigational therapy, LIT1001, intended for the treatment of osteosarcoma (Press release, Lithea Pharma, JUL 23, 2025, View Source [SID1234656338]).

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 designation marks a key regulatory milestone and reinforces the potential of LIT1001 to address a critical unmet medical need in oncology. The ODD status provides significant development incentives, including seven years of market exclusivity upon approval, tax credits for clinical trial costs, waived FDA fees, and protocol assistance from the FDA.

"We are proud that the FDA acknowledges the potential of LIT1001 to outperform current standard-of-care treatments," said Ludvig Sjöberg, CEO of Lithea. "Our preclinical data demonstrate that LIT1001’s targeted delivery of doxorubicin significantly improves tumor control while reducing systemic toxicity – a promising advancement for young patients with osteosarcoma."

LIT1001: An innovative localized chemotherapy approach
LIT1001 is a next-generation chemotherapeutic formulation designed to deliver doxorubicin directly into the tumor environment, bypassing systemic exposure and enhancing local efficacy. Built on Lithea’s proprietary bone mineral platform – a biocompatible matrix of hydroxyapatite and calcium sulfate – LIT1001 enables sustained, controlled release of doxorubicin at the tumor site, with the goal of minimizing toxic side effects while maximizing therapeutic impact.

"Osteosarcoma is highly aggressive and unforgiving. In preclinical studies, LIT1001 has shown the ability to suppress local tumor growth while preserving healthy tissue," said Dr. Mathias Lidgren, Chief Medical Officer at Lithea. "By delivering chemotherapy directly to the tumor, we are pioneering a new paradigm for localized cancer treatment."

Osteosarcoma – a life-threatening diagnosis with no new treatments in over 40 years
Osteosarcoma is the most common primary bone cancer in children and young adults. Despite aggressive multimodal treatment, including surgery and systemic chemotherapy, survival rates have remained stagnant for decades. While localized disease has a 5-year survival rate of around 60–70%, metastatic or recurrent osteosarcoma has a 5-year survival rate below 30%. Critically, no new drugs have been approved for this indication in over 40 years.

A platform for future oncology therapies
Lithea’s proprietary platform is based on over 40 years of academic research, initially developed at Lund University and now validated across multiple preclinical oncology models. The underlying bone mineral matrix can be loaded with various anticancer agents and is designed to address a broad range of solid tumor indications. In addition, its unique ability to be "recharged" by systemically administered drugs offers further treatment flexibility and opens the door to combination therapies.

Multiple pipeline programs based on this platform are in development, targeting other hard-to-treat solid tumors with tailored, localized drug delivery.