Boston Scientific announces results for first quarter 2026

On April 22, 2026 Boston Scientific Corporation reported net sales of $5.203 billion during the first quarter of 2026, growing 11.6 percent on a reported basis and 9.4 percent on an operational1 and organic2 basis, all compared to the prior year period. The company reported GAAP net income attributable to Boston Scientific common stockholders of $1.341 billion or $0.90 per share (EPS), compared to $674 million or $0.45 per share a year ago, and achieved adjusted3 EPS of $0.80 for the period, compared to $0.75 a year ago.

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"Our global team and the strength of our category leadership strategy enabled us to deliver solid results this quarter," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We remain focused on executing our long-term strategy and advancing our differentiated pipeline to drive meaningful impact for patients, physicians and hospital systems."

First quarter financial results and recent developments:

Reported net sales of $5.203 billion, representing an increase of 11.6 percent on a reported basis, compared to the company’s guidance range of 10.5 to 12.0 percent; and 9.4 percent on an operational and organic basis, compared to the company’s guidance range of 8.5 to 10.0 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.90 per share, and achieved adjusted EPS of $0.80 per share, compared to the guidance range of $0.78 to $0.80 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 7.8 percent reported, 5.7 percent operational and organic
Cardiovascular: 13.5 percent reported, 11.2 percent operational and organic
Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 10.9 percent reported and operational
Europe, Middle East and Africa (EMEA): 10.1 percent reported and 1.2 percent operational
Asia-Pacific (APAC): 14.7 percent reported and 12.0 percent operational
Latin America and Canada (LACA): 19.0 percent reported and 12.0 percent operational
Announced clinical trial results that were presented in late-breaking sessions at the 75th Annual Scientific Session of the American College of Cardiology and simultaneously published in The New England Journal of Medicine including:
The CHAMPION-AF study of the WATCHMAN FLX Left Atrial Appendage Closure Device as a first-line option for stroke risk reduction, which met all primary and secondary endpoints and demonstrated superior bleeding risk reduction and similar efficacy of the WATCHMAN FLX device compared to oral anticoagulants in a broad population of patients with non-valvular atrial fibrillation (AF).
The HI-PEITHO clinical trial evaluating the EKOS Endovascular System for the treatment of acute pulmonary embolism (PE) in patients with intermediate-risk PE, which demonstrated the EKOS system plus anticoagulation was superior to anticoagulation alone.
Announced positive outcomes from the ADVENT Long-Term Outcomes clinical trial, which demonstrated greater long-term AF treatment success, fewer hospital-based arrhythmia interventions and lower repeat ablation rates at four years with FARAPULSE Pulsed Field Ablation (PFA) compared to thermal ablation.
Received National Medical Products Association approval in China for the OPAL HDx Mapping System, which enables catheter visualization during FARAPULSE PFA procedures.
Published in Chronic Pain and Management Journal outcomes from the 24-month COMFORT clinical trial demonstrating durable and statistically significant pain relief and improved quality of life with peripheral nerve stimulation therapy with the Nalu Neurostimulation System compared to conventional medical management in patients with chronic pain.
Received U.S. Food and Drug Administration 510(k) clearance for the Asurys Fluid Management System, designed to provide real-time irrigation management during endoscopic urologic procedures; when used with the LithoVue Elite Single-Use Flexible Ureteroscope System, it also supports intrarenal pressure (IRP) management during ureteroscopy.
Completed the acquisition of Valencia Technologies Corporation, a privately held company focused on the development and commercialization of the eCoin System, an implantable tibial nerve stimulation device for the treatment of urge urinary incontinence.
Elected to the company’s board of directors Cathy Smith, chief financial officer of Starbucks, and Christophe Weber, president and chief executive officer of Takeda Pharmaceutical.

(Press release, Boston Scientific, APR 22, 2026, View Source [SID1234669158])

Tempest Announces Key Manufacturing Milestone for TPST-2003 Dual-Targeting CD19/BCMA CAR-T

On April 22, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported that it has achieved a key milestone in the development of TPST-2003, Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma ("rrMM"). Earlier this month, Tempest’s manufacturing partner, Cincinnati Children’s Applied Gene and Cell Therapy Center ("AGCTC"), took delivery of the TPST-2003 lentiviral vector, a critical component used in the manufacturing of TPST-2003. This milestone supports Tempest’s plans to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, including patients who are experiencing extramedullary disease ("EMD"), later this year.

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Tempest recently announced that, as of a January 31, 2026 data cutoff, a total of 36 patients with rrMM had received one infusion of TPST-2003, including 24 patients in a prior Phase 1/2 investigator-initiated trial ("IIT") and 12 patients in the ongoing REDEEM-1 trial, representing one of the largest datasets evaluating a CD19/BCMA dual-targeting CAR-T therapy. As of the data cutoff, all six efficacy evaluable patients enrolled in the REDEEM-1 trial had achieved a complete response according to the International Myeloma Working Group uniform response criteria. Among 25 evaluable patients with measurable disease at baseline across both studies, the overall response rate was 100% (25/25). The IIT also demonstrated durable disease control, with median progression-free survival ("PFS") of 23.1 months across all patients and median PFS of 23.1 months in patients with EMD. Tempest plans to present the results of the REDEEM-1 trial and updated results from the IIT at a scientific meeting later this year.

"We are pleased by the rapid progress we have been making in partnership with AGCTC," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "The delivery of lentiviral vector, which is a critical component in the manufacturing of autologous CAR-T products, has enabled us to proceed with the manufacturing activities required for the pivotal development of TPST-2003. We are grateful for our partnership with AGCTC, and we are looking forward to continued rapid progress toward the initiation of a potentially registrational study for TPST-2003 later this year."

AGCTC is a research, development, and manufacturing hub advancing future cell and gene therapy (CGT) treatments for patients with unmet needs. Established in 2001, the center has evolved into a nationally recognized leader in CTG CDMO services with a proven track record that reflects Cincinnati Children’s commitment to solving unmet medical needs through translational science. AGCTC is part of the Cincinnati Children’s Cancer and Blood Diseases Institute, which is ranked #1 in the nation by U.S. News & World Report for pediatric cancer care.

"We are excited to have achieved this important milestone in the development of TPST-2003," said Dr. Chaozhong Zou, Executive Director and General Manager of AGCTC, Cancer and Blood Diseases Institute, Cincinnati Children’s Hospital Medical Center. "The clinical data generated so far support the idea that the parallel-structure dual-targeting CAR architecture of TPST-2003 could offer patients with rrMM a meaningful new treatment option, and we are grateful to be in position to support the development of TPST-2003 by leveraging our extensive experience making novel CAR-T programs IND-ready. We look forward to generating the information needed to support the pivotal development of TPST-2003."

About TPST-2003

TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma ("rrMM") through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics ("Novatim"). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia.

About REDEEM-1

REDEEM-1 (Study nos. CTR20233309/NCT06223646) is a Phase 1/2a clinical trial evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The REDEEM-1 trial has a targeted full enrollment of 29 patients. The REDEEM-1 trial is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of eight clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), The First Affiliated Hospital of Nanchang University (Dr. Fei Li), Peking University First Hospital (Dr. Yujin Dong), Henan Cancer Hospital (Dr. Baijun Fang), Shanxi Provincial Cancer Hospital (Dr. Liping Su), The Second Xiangya Hospital of Central South University (Dr. Hongling Peng), The First Affiliated Hospital of China Medical University (Dr. Xiaojing Yan), and The Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College (Dr. Dehui Zou).

Additional clinical trials evaluating TPST-2003

A Phase 1/2 IIT (Study no. NCT04714827) is evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The IIT is sponsored and being conducted by Tempest’s partner, Novatim, with a total of two clinical sites registered in China: Shanghai Fourth People’s Hospital (Dr. Weijun Fu; lead site) and Shanxi Provincial Cancer Hospital (Dr. Liping Su).

A Phase 1 trial (Study nos. CTR20242409/NCT06518876) is evaluating TPST-2003 in patients with POEMS, a rare blood disorder caused by abnormal plasma cells. The Phase 1 trial is sponsored and being conducted by Tempest’s partner, Novatim, with a total of three clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), Xuanwu Hospital Capital Medical University (Dr. Wanling Sun), and West China Hospital, Sichuan University (Dr. Yu Wu).

(Press release, Tempest Therapeutics, APR 22, 2026, View Source [SID1234664691])

BBOT Presents Preclinical Data Demonstrating pan-KRAS Inhibitor BBO-11818 Has Robust Anti-Tumor Activity in KRAS-Mutant Preclinical Models at the AACR Annual Meeting 2026

On April 22, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported new preclinical data for BBO-11818, a selective, orally bioavailable non-covalent inhibitor that targets mutant KRAS in both the ON (active GTP-bound) and OFF (inactive GDP-bound) states with robust anti-tumor activity in KRAS-mutant preclinical models. The data underscore BBO-11818’s differentiated activity across multiple KRAS-mutant cancer types. The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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"BBO-11818 addresses a significant unmet need by targeting multiple KRAS variants for which no approved therapies exist, including KRASG12D and KRASG12V," said Pedro J. Beltran, PhD, Chief Scientific Officer of BBOT. "Its ability to inhibit KRAS in both its inactive and active states drives potent tumor regressions in pancreatic, lung, and colorectal cancer models — and its efficacy is meaningfully amplified in combination with BBO-10203, cetuximab, and anti-PD-1, underscoring its potential as a combination backbone in KRAS-mutant cancers."

Highlights from the poster include:

BBO-11818 potently inhibits ERK phosphorylation and proliferation in KRAS-dependent cell lines in vitro.
BBO-11818 demonstrates robust efficacy in KRASG12D and KRASG12V CDX models.
BBO-11818 exhibits in vivo combination effect with BBO-10203, a RAS:PI3K⍺ breaker, and cetuximab in KRAS-mutant CDX and PDX models.
BBO-11818 also shows combination benefit with anti-PD-1 treatment, resulting in complete tumor regressions and the induction of an adaptive immune response in the CT26 syngeneic model.
The presentation is titled "BBO-11818: an orally bioavailable, highly potent and selective non-covalent pan-KRAS (ON) and (OFF) inhibitor with robust anti-tumor activity in KRAS-mutant preclinical models." A copy of the poster will be available on the "Publications" page of the BBOT website following the conference.

About BBO-11818
BBO-11818 is a selective, orally bioavailable non-covalent inhibitor that targets KRAS in both the ON and OFF states, has high selectivity over HRAS and NRAS, and displays strong activity in KRAS-mutant preclinical models, including KRASG12D and KRASG12V. In addition, it potently suppresses MAPK signaling and inhibits cell proliferation in KRAS-mutant cell lines. BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors.

(Press release, BridgeBio Oncology Therapeutics, APR 22, 2026, View Source [SID1234664707])

ACCENT TRIAL MATURE DATA PRESENTED AT INTERNATIONAL CONFERENCE

On April 22, 2026 Amplia Therapeutics limited (ASX:ATX | OTCQB:INNMF), ("Amplia" or the "Company") reported that an oral presentation highlighting mature data from the Company’s ACCENT trial in metastatic pancreatic cancer is being delivered today at the annual meeting of the AACR (Free AACR Whitepaper). The presentation includes more detailed analysis of the recently reported data from the ACCENT study, which is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of- care chemotherapy.

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The presentation is included as part of a mini-symposium entitled Advances in Precision Oncology being held in the San Diego Convention Center, San Diego USA, and will be delivered by Amplia’s Director of Translational Biology, Dr Terrie-Anne Cock, at 3:44 pm local time. A copy of the slides is included with this announcement.

• Narmafotinib displays a manageable toxicity profile, with no significant tolerability burden over chemotherapy alone
• Independent (central) reading of data identified 5 confirmed Complete Responses (CR’s) from 64 patients, an 8% CR rate compared to a 0.2% rate for chemotherapy alone
• A response rate of 36% is observed (23 of 64 patients); 42% if unconfirmed responses included
• A Disease Control Rate (DCR) of 70% was determined, compared to 50% for chemotherapy alone
• Median overall survival (mOS) was found to be 11.1 months, while median progression-free survival (mPFS) was 7.7 months, both showing improvements of over two months compared to chemotherapy alone
• A trend to improved Overall Survival is observed when comparing Stable Disease, Partial
Response and Complete Response patients
• The combined efficacy data is superior to chemotherapy alone across all measures despite the intermittent narmafotinib dosing schedule employed (12 days of each 28 day treatment cycle)
• Subsequent trials will employ a daily dosing regimen of narmafotinib given the tolerability observed to date, which may lead to improved responses

Dr Chris Burns, CEO and Managing Director of Amplia, commented: "We are excited to present this mature ACCENT data at the AACR (Free AACR Whitepaper) annual meeting. Being able to present the extremely promising clinical responses to colleagues and peers at one of the world’s most prestigious oncology conferences allows us to demonstrate the potential narmafotinib has in the treatment of this terrible disease. We are now focused on building on this promising data with additional clinical studies, including a pivotal study based on the ACCENT trial, as well as combination studies with the exciting new class of drugs called kRAS inhibitors."

(Press release, Amplia Therapeutics, APR 22, 2026, View Source [SID1234664627])

TuHURA Biosciences Announces $50 Million Credit Facility and Royalty Transaction Extending Anticipated Cash Runway into 2028

On April 22, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that it has entered into a loan agreement providing a credit facility of up to $50 million in funding to support the Company’s pipeline, ongoing clinical trials, and general corporate expenses. The lender is an affiliate of the Company’s largest stockholder, K&V Investment One LLC.

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Under the terms of the loan agreement, TuHURA will have the ability to draw down monthly on the facility on an as-needed basis to fund monthly expenses for ongoing clinical development and operations. The facility bears a 12% annual interest rate on outstanding funds drawn, with interest paid monthly and principal repayment due at a 5-year maturity date of April 21, 2031. The loan facility is secured by the assets of the Company and its subsidiaries. In connection with the credit facility, the Company granted the lender a low to mid-single digit percentage royalty on annual commercial sales by the Company or its sublicensees of products based on IFx-2.0.

"We are gratified to have established this non-equity based source of operating capital on what we believe are attractive terms for a company such as TuHURA. This agreement allows us to fund operations through anticipated key milestones this year and beyond through anticipated top-line Phase 3 results of our lead IFx-2.0 program. Importantly, we control the timing and amount of funds drawn under this facility while preserving the ability to be opportunistic in securing other potential sources of capital, including corporate partnerships or equity financings," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "We believe that it is unusual to access such an attractive source of capital in advance of a BLA submission or pending FDA approval. This funding is a testament to the conviction our largest shareholder has in our strategy and in the potential for the clinical and commercial success of IFx-2.0."

Additional information regarding the credit facility and royalty agreement, including the terms and provisions of the loan agreement, can be found in the Company’s Current Report on Form 8-K filed today with the Securities and Exchange Commission.

(Press release, TuHURA Biosciences, APR 22, 2026, View Source [SID1234664692])