On July 29, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage biotechnology company, reported that the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted Marketing Authorization for ANKTIVA (nogapendekin alfa inbakicept) across two indications. The authorization covers ANKTIVA 0.4 mg in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC. With this action, the UAE becomes the fifth regulatory jurisdiction to authorize ANKTIVA, expanding its global footprint to 34 countries. The UAE has taken the lead in the broadest approval of ANKTIVA to date. The NMIBC authorization is the first anywhere in the world to span carcinoma in situ (CIS) and papillary disease, including patients with papillary-only tumors in the absence of CIS.

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World’s First Approval Spanning the Full Spectrum of BCG-Unresponsive Disease in NMIBC

Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors and BCG-unresponsive NMIBC with papillary tumors. Eligible patients therefore include those with CIS alone, CIS accompanied by papillary tumors, and papillary disease alone without CIS.

BCG-unresponsive NMIBC carries a high risk of progression and, historically, radical cystectomy has been the standard option for patients who fail BCG. An approval that spans CIS and papillary disease addresses a defined unmet need across the disease spectrum by offering an alternative immunotherapy option.

"For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options. This approval by the Emirates Drug Establishment is the first in the world to reach across the entire spectrum of non-muscle invasive bladder cancer from carcinoma in situ with or without papillary tumors, and, for the first time, papillary disease alone. Since the National Cancer Institute ranked IL-15 as the number one priority cytokine for cancer immunotherapy in 2007, we have worked to translate that biology into an immunotherapy that activates the trifecta of natural killer cells, CD8+ killer T cells, and memory T cells to deliver durable responses. That same immunological backbone now extends to lung cancer, where ANKTIVA, by stimulating NK cells which target tumor cells that have lost MHC-I T cell receptors, can restore the immune response in patients whose disease has progressed on checkpoint therapy. This approval in lung cancer patients who failed checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.

Authorization in Checkpoint-Refractory Metastatic Non-Small Cell Lung Cancer

Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alterations should have disease progression on approved therapy for those alterations, before receiving ANKTIVA in combination with immune checkpoint inhibitors. In this indication, ANKTIVA is administered as a fixed 1 mg subcutaneous dose once every 21 days for the duration of checkpoint inhibitor therapy.

Checkpoint inhibitor resistance represents a defined unmet need in metastatic NSCLC, with limited options and poor survival after progression. By activating the natural killer and memory T cells that checkpoint inhibitors alone do not reach, ANKTIVA is designed to restore anti-tumor immunity in this setting.

Clinical Evidence Supporting the Approvals

NMIBC Indication: The NMIBC authorization is supported by QUILT-3.032, the multicenter registrational trial of ANKTIVA plus BCG in BCG-unresponsive NMIBC (ClinicalTrials.gov NCT03022825).

Papillary Disease Alone (QUILT-3.032, Cohort B): In the papillary-only cohort (papillary disease without CIS; N=80), the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a median disease-free survival of 25.3 months, and 83.1% of patients avoided cystectomy at 36 months as shown in the table below.

In the QUILT-3.032 program, most treatment-related adverse events were Grade 1 or 2; Grade 3 treatment-related adverse events occurred in 1% of patients, and no Grade 4 or Grade 5 treatment-related events were reported.

NSCLC Indication: The NSCLC authorization is supported by QUILT-3.055 (ClinicalTrials.gov NCT03228667), a Phase 2 study of ANKTIVA in combination with a checkpoint inhibitor in patients with advanced NSCLC whose disease had progressed on prior checkpoint inhibitor therapy (N=79). Median overall survival was 14.6 months (95% CI: 12.0, 19.5). Among the 77% of patients who achieved an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival was 16.2 months (95% CI: 13.8, 22.0). The table below summarizes these findings.

In QUILT-3.055, the most common NAI-related adverse drug reactions were injection site reaction (86%), chills (46%), fatigue (32%), pyrexia (28%), nausea (16%), injection site erythema and injection site pruritus (15% each), injection site pain (14%), influenza like illness (13%), decreased appetite (10%).

Regulatory Details

The EDE issued Marketing Authorization approval for both presentations with first registration in July 2026 and validity through July 2031. ANKTIVA 0.4 mg (solution for intravesical instillation), indicated for BCG-unresponsive NMIBC, is registered under No. 78609-45860-260486. ANKTIVA 1.2 mg (solution for subcutaneous injection), indicated for metastatic NSCLC, is registered under No. 78609-1572-260487. ImmunityBio, Inc. is the Marketing Authorization Holder, with Modern Pharmaceutical Company serving as the local agent in the United Arab Emirates. The UAE is the fifth regulatory jurisdiction to authorize ANKTIVA, following the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the European Union, and expands the global footprint of ANKTIVA to more than 30 countries.

"With this authorization, the global regulatory footprint for ANKTIVA now includes 34 countries. Securing approvals across two distinct indications, bladder cancer and lung cancer, on the strength of the same data packages we submitted to the FDA, positions us to broaden access across the Gulf region through our partnership with Modern Pharmaceutical Company, in markets where the need for new treatment options is significant," said Richard Adcock, President and Chief Executive Officer of ImmunityBio.

Sources

Chamie K, et al. IL-15 Superagonist NAI (N-803) plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. NEJM Evidence. 2023;2(1). (CIS cohort complete response rate.)
QUILT-3.032 updated analyses, including the papillary-only (Ta/T1) cohort and extended duration-of-response follow-up, as presented at AUA 2025 and disclosed by ImmunityBio, Inc.
QUILT-3.055 Phase 2 overall survival results in checkpoint-refractory advanced NSCLC, as disclosed by ImmunityBio, Inc. (ClinicalTrials.gov NCT03228667).
gov Identifiers NCT03022825 (QUILT-3.032) and NCT03228667 (QUILT-3.055).
Emirates Drug Establishment, Product Marketing Authorization Approval certificates and approved Summaries of Product Characteristics, Registration Nos. 78609-45860-260486 (NMIBC) and 78609-1572-260487 (NSCLC), first registration 24 July 2026.
Immunotherapy Agent Workshop, July 12, 2007 NCI, View Source
Cancer Immune Evasion Through Loss of MHC Class I Antigen Presentation. Karthik Dhatchinamoorthy, et. al. View Source
About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, JUL 29, 2026, View Source [SID1234669490])

On July 29, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics"), (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia, reported the pricing of its $1.6 million private placement offering (the "Offering") with a group of investors, including officers, directors and an existing stockholder of the Company, (each, and "Investor" and collectively, the "Investors’). Pursuant to a securities purchase agreement entered into with the Investors (the "Purchase Agreement"), the Company agreed to issue and sell an aggregate of 618,682 units (the "Units"), with each Unit consisting of (i) one share of the Company’s common stock, par value $0.0001 per share ("Common Stock"), or, in lieu thereof, one pre-funded warrant to purchase one share of Common Stock (a "Pre-Funded Warrant"), and (ii) the right to receive one common stock purchase warrant (a "Common Warrant") to purchase one share of Common Stock upon, and subject to, stockholder approval of the issuance thereof.

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In connection with the Offering, the Company will issue 218,682 shares of Common Stock and 400,000 Pre-Funded Warrants. Subject to stockholder approval, which the Company is obligated to seek pursuant to the terms of the Purchase Agreement, the Investors will also be entitled to receive Common Warrants to purchase up to an aggregate of 618,682 shares of Common Stock.

Hing C. Wong, Ph.D., the Company’s Founder and Chief Executive Officer, Scott Garrett, a member and the Chairman of the Company’s Board of Directors, and Lee Flowers, the Company’s Senior Vice President of Business Development, participated in the Offering on the same terms and conditions as the other Investor. The closing of the Offering is expected to occur on or about July 29, 2026, subject to the satisfaction of customary closing conditions.

The combined purchase price for each Unit consisting of one share of Common Stock and the right to receive one Common Warrant upon, and subject to, stockholder approval of the issuance thereof, was $2.585 per Unit. The combined purchase price for a Pre-Funded Warrant and the right to receive one Common Warrant upon, and subject to, stockholder approval of the issuance thereof, was $2.5849 per Unit. The Pre-Funded Warrants have an exercise price of $0.0001 per share of Common Stock, are exercisable immediately and will not expire until exercised in full. The Common Warrants will have an exercise price of $2.585 per share and will expire on the five and one half (5.5) year anniversary of their issuance. Under Nasdaq Listing Rule 5635(d), the Company is required to obtain stockholder approval before issuing the Common Warrants because the potential issuance of shares upon exercise of the Common Warrants could exceed the thresholds set forth in such rule. Following receipt of stockholder approval, the Company will issue the Common Warrants to the Investors in accordance with the Purchase Agreement.

The Company intends to use the net proceeds from this Offering to continue clinical trials for HCW9302, advance its IND-enabling studies for its T-Cell Engager, HCW11-018b, and its second-generation immune checkpoint inhibitor, HCW11-040, and for general corporate purposes.

On July 29, 2026, the Company also entered into a registration rights agreement with the Investors, pursuant to which the Company agreed to submit to the U.S. Securities and Exchange Commission (the "SEC") a registration statement on Form S-1 within 15 trading days of the closing of the Offering covering the resale of the shares of Common Stock sold in the Offering, the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants and the shares of Common Stock issuable upon exercise of the Common Warrants. The Company also agreed to use commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within 60 days following the closing of the Offering.

The number of shares of Common Stock the Company that may be held by an Investor, including those shares issued at closing and upon the exercise of Pre-Funded Warrants from time to time in the Offering, may not exceed 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such issuances.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

(Press release, HCW Biologics, JUL 29, 2026, View Source [SID1234669489])

On July 29, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended June 30, 2026.

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Financial Results

"Our oncology and Cushing’s syndrome businesses delivered strong results in the second quarter.
In our oncology business, over 1,300 patients have now started treatment with Lifyorli following FDA approval in March 2026. Demand for Lifyorli has accelerated each month with physicians responding favorably to Lifyorli’s efficacy and safety profile, oral administration and lack of biomarker requirement.

Our Cushing’s syndrome business, once again, had a record number of new prescriptions written for our medications as physicians increasingly recognize hypercortisolism’s true prevalence and the necessity of appropriate treatment. We expect this trend to continue as the findings from our CATALYST and MOMENTUM studies are fully incorporated into clinical practice.

We anticipate continued strength across our businesses and have increased our 2026 revenue guidance to $1.1 – $1.2 billion," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Corcept’s second quarter 2026 revenue was $256.1 million, compared to $194.4 million in the second quarter of 2025. Korlym and authorized generic product revenue was $208.6 million, compared to $194.4 million in the prior year period. Lifyorli product revenue was $47.6 million in its first quarter of availability.

Second quarter 2026 operating expenses were $214.8 million, compared to $167.8 million in the same period in 2025, due to increased spending to launch Lifyorli and investments in our Cushing’s syndrome business. Net income per common share (diluted) was $0.36 in the second quarter of 2026, compared to $0.29 in the prior year period.
Cash and investments were $544.6 million at June 30, 2026, compared to $515.4 million at March 31, 2026.

Clinical Development

"The FDA’s approval of Lifyorli (relacorilant) in platinum-resistant ovarian cancer is the first step in advancing glucocorticoid receptor antagonism as a treatment for many types of cancer. Our oncology development program aims to establish the broad utility of our medicines to help many more patients. We anticipate that the European Medicines Agency will approve our Marketing Authorization Application of relacorilant in platinum-resistant ovarian cancer later this year. We expect results from our trial of relacorilant with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer by the end of this year. Our studies of relacorilant to treat platinum-sensitive ovarian, endometrial, cervical and pancreatic cancers are expected to produce results by the end of next year. Our study of nenocorilant with the PD-1 checkpoint inhibitor nivolumab to treat a variety of solid tumors will also produce results by the end of next year," said Dr. Belanoff.
"We resubmitted our New Drug Application (NDA) for relacorilant in Cushing’s syndrome in June. Relacorilant has the potential to help many patients and it’s important it is available as quickly as possible. We expect a decision on our NDA by December 17, 2026.
In addition, results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH), are expected by the end of this year. We also plan to start a Phase 3 trial of dazucorilant in patients with ALS, with the goal of replicating the significant survival benefit observed in our Phase 2 DAZALS study," added Dr. Belanoff.

Hypercortisolism (Cushing’s Syndrome)

•Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026
•GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in The Lancet Diabetes & Endocrinology (Pivonello et al, February 2026)
•CATALYST and MOMENTUM – New data presented at American Diabetes Association’s (ADA) 86th Scientific Sessions in June
"Our studies have shown that patients with hypercortisolism who receive relacorilant experience clinically and statistically significant improvements in the multiple signs and symptoms of the disease. Importantly, relacorilant delivers these improvements without the off-target effects and serious adverse events associated with currently available treatments," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Relacorilant has the potential to become the new standard of care."
"The need for better treatment for patients with hypercortisolism is urgent. Our CATALYST and MOMENTUM studies demonstrate that hypercortisolism is an underlying driver of disease for many patients with diabetes and hypertension whose health is at risk because their disease isn’t adequately managed with standard-of-care treatments. These findings will lead to increased screening and improved treatment for patients with hypercortisolism," added Dr. Guyer.

Oncology

Relacorilant in Combination with Chemotherapy
•FDA approved Lifyorli (relacorilant) plus nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer in March 2026
•Lifyorli plus nab-paclitaxel added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen in April 2026
•Marketing Authorization Application (MAA) – European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of this year
•ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – Both dual primary endpoints (progression-free and overall survival) met – Results published in The Lancet (Lorusso et al, April 2026)
•BELLA Part A – Enrollment completed in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer – Results expected by the end of this year.

•BELLA Part B – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor – Results expected by the end of next year
•BELLA Part C – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy) – Results expected by the end of next year
•STELLA – Initiated Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy), conducted in collaboration with ARCAGY-GINECO – Results expected by the end of next year
•TRIDENT – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 60 patients with pancreatic cancer – Results expected by the end of next year
Relacorilant in Combination with Androgen Deprivation Therapy
•Prostate cancer – Enrollment continues in randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in 90 patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
Nenocorilant in Combination with Immunotherapy
•SYNERGY – Enrollment continues in Phase 1b dose-finding trial of nenocorilant plus nivolumab in 30 patients with a variety of solid tumors – Results expected by the end of next year
"There is tremendous potential for glucocorticoid receptor antagonism to help treat many types of solid tumors. Our Phase 3 ROSELLA trial demonstrated that adding Lifyorli to nab-paclitaxel chemotherapy reduced the risk of death in patients with platinum-resistant ovarian cancer by 35 percent, without the need for biomarker selection. Our ongoing oncology studies, many of which will produce results by the end of next year, build on these findings by evaluating the role of our medications across a broad range of tumor types and treatment combinations. We will continue to advance and expand our research to realize the substantial opportunity before us," added Dr. Guyer.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

•MONARCH – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 175 patients with biopsy-confirmed or presumed MASH – Results expected by the end of this year
"Data from our Phase 1b study demonstrated that miricorilant rapidly reduced liver fat while improving fibrosis, liver enzymes and other markers of liver health, including key metabolic and lipid measures. We look forward to building on these promising findings in our Phase 2b MONARCH study, with results expected by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)
•DAZALS – Exploratory analyses showed that patients who received dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009) – This benefit persisted into the study’s second year with an 87 percent reduction in risk of death (hazard ratio: 0.13, p-value: < 0.0001)
•Phase 3 trial – Planned to begin early next year
"Patients with ALS often have elevated cortisol levels. Data from our Phase 2 DAZALS study showed that patients treated with dazucorilant exhibited a profound reduction in early mortality, during a period when many patients with ALS still retain significant function and maintain good quality of life," said Dr. Guyer. "Our ongoing dose-titration study’s goal is to improve gastrointestinal tolerability and inform next steps for this program."

Conference Call
We will hold a conference call on July 29, 2026, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

(Press release, Corcept Therapeutics, JUL 29, 2026, View Source [SID1234669488])

On July 29, 2026 Boston Scientific Corporation (NYSE: BSX) reported net sales of $5.442 billion during the second quarter of 2026, growing 7.5 percent on a reported basis and 7.0 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 $907 million or $0.61 per share (EPS), compared to $797 million or $0.53 per share a year ago, and achieved adjusted3 EPS of $0.86 for the period, compared to $0.75 a year ago.

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"Our team delivered a solid quarter while continuing to navigate a dynamic environment," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We are focused on disciplined execution and prioritizing investments in our highest-impact opportunities, and we remain confident in Boston Scientific’s long-term growth, anchored by our category leadership strategy and our commitment to meaningful innovation for patients and physicians."

Second quarter financial results and recent developments:

Reported net sales of $5.442 billion, representing an increase of 7.5 percent on a reported basis, compared to the company’s guidance range of 5.5 to 7.5 percent; and 7.0 percent on an operational and organic basis, compared to the company’s guidance range of 5 to 7 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.61 per share, and achieved adjusted EPS of $0.86 per share, compared to the guidance range of $0.82 to $0.84 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 5.9 percent reported, 5.4 percent operational and organic
Cardiovascular: 8.3 percent reported, 7.8 percent operational and organic
Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 6.2 percent reported and operational
Europe, Middle East and Africa (EMEA): 6.1 percent reported and 4.2 percent operational
Asia-Pacific (APAC): 11.2 percent reported and operational
Latin America and Canada (LACA): 22.4 percent reported and 16.2 percent operational
Completed the previously announced $2 billion accelerated share repurchase program, repurchasing approximately 40 million shares.
Invested $1.5 billion in MiRus LLC, which is developing and commercializing proprietary biomaterials, implants and procedural solutions for the treatment of cardiovascular and orthopedic diseases, including the SIEGEL Balloon Expandable Transcatheter Aortic Valve Replacement (TAVR) system, in return for an approximately 34% equity stake and exclusive option to acquire the MiRus TAVR business.4
Presented late-breaking findings at EuroPCR from the FRACTURE Investigational Device Exemption trial, which met its primary endpoints with the SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter, demonstrating high rates of freedom from major adverse cardiac events at 30 days as well as procedural success in patients with severely calcified coronary artery disease.4
Announced clinical trial results that were presented in late-breaking sessions at Heart Rhythm 2026 including:
The AVANT GUARD study of FARAPULSE Pulsed Field Ablation (PFA) for the treatment of persistent atrial fibrillation (AF) in patients who had not previously been treated for their condition. Data met all safety and effectiveness endpoints and demonstrated statistical superiority of FARAPULSE PFA over anti-arrhythmic drugs with significantly higher primary effectiveness.
The ELEVATE-PF feasibility study of the FARAFLEX Mapping and PFA Catheter — a novel large focal, high-density map-and-ablate catheter — in patients with paroxysmal and persistent AF. The trial demonstrated strong lesion durability validated by cardiac remapping, with no reported cases of pulmonary vein stenosis, hemolysis, coronary spasm or clinical stroke.4
Commenced enrollment in the pivotal FARADIGM clinical trial to evaluate the safety and effectiveness of the FARAFLEX Mapping and PFA Catheter for treating patients with paroxysmal and persistent AF.4
Received U.S. Food and Drug Administration 510(k) clearance for the TruSelect 2.6 Microcatheter, expanding Boston Scientific’s embolization portfolio with a device designed to provide physicians with a single solution for navigation and efficient embolic delivery during minimally invasive procedures.
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 impact of certain charges (credits) as defined below within the "Use of Non-GAAP Financial Measures" section.

4.

The SIEGEL Balloon Expandable TAVR system, the SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter and the FARAFLEX Mapping and PFA Catheter are investigational devices. Limited by Federal (or U.S.) law to investigational use only. Not available for sale.

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)

2026

2025

Endoscopy

$ 793

$ 737

7.6 %

(0.7) %

7.0 %

— %

7.0 %

Urology

684

676

1.1 %

(0.3) %

0.8 %

— %

0.8 %

Neuromodulation

341

303

12.7 %

(0.6) %

12.2 %

— %

12.2 %

MedSurg

1,818

1,716

5.9 %

(0.5) %

5.4 %

— %

5.4 %

Cardiovascular

3,624

3,345

8.3 %

(0.6) %

7.8 %

— %

7.8 %

Net Sales

$ 5,442

$ 5,061

7.5 %

(0.5) %

7.0 %

— %

7.0 %

Increase/(Decrease)

Three Months Ended

June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2026

2025

U.S.

$ 3,426

$ 3,224

6.2 %

— %

6.2 %

EMEA

932

878

6.1 %

(1.9) %

4.2 %

APAC

878

790

11.2 %

(0.0) %

11.2 %

LACA

206

169

22.4 %

(6.2) %

16.2 %

Net Sales

$ 5,442

$ 5,061

7.5 %

(0.5) %

7.0 %

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 2026

The company now estimates net sales growth for the full year 2026, versus the prior year period, to be approximately 5.5 to 6.5 percent on a reported basis and 5 to 6 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 now estimates adjusted EPS, excluding certain charges (credits), of $3.28 to $3.32.

The company estimates net sales growth for the third quarter of 2026, versus the prior year period, to be approximately 3 to 5 percent on a reported and 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 adjusted EPS, excluding certain charges (credits), of $0.80 to $0.82.

The company has not provided reconciliations of the forward-looking adjusted EPS guidance to GAAP guidance as it is unable to predict with reasonable certainty and without unreasonable efforts the impact of certain items such as intangible asset impairment charges, acquisition-related charges, restructuring and restructuring-related charges and litigation-related charges. The combined impact of these items is uncertain, dependent on various factors and cannot be predicted with reasonable certainty, and could be material to our GAAP measures of financial results.

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.

(Press release, Boston Scientific, JUL 29, 2026, View Source [SID1234669487])

On July 29, 2026 Biogen Inc. (Nasdaq: BIIB) reported second quarter 2026 financial results.

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"This quarter is a reflection of the significant progress Biogen has made repositioning the company for long-term growth. Not only did our growth portfolio revenue exceed that of our legacy MS portfolio, delivering 24% of year-over-year growth, we also delivered strong revenue performance from our two recently acquired products, providing an opportunity for our pipeline to build on a growing business," said President and Chief Executive Officer Christopher A. Viehbacher. "At the same time, our scientific leadership continues to translate into commercial momentum, with a successful launch of SPINRAZA HD and historic approval of LEQEMBI IQLIK at-home initiation. As we enter a period of registrational data readouts beginning this year, we are realizing our vision for the New Biogen — one positioned for sustainable growth with a growing commercial business, a multi-year late-stage data flow, and an expanding early-stage pipeline."

Second quarter 2026 Growth Portfolio highlights

•SPINRAZA revenue of $402 million, up 2% year-over-year, driven by demand and stocking for the high-dose regimen partially offset by shipment timing in certain ex-U.S. markets; conversion to the high-dose regimen has been ahead of Company expectations in all launched geographies
•VUMERITY second quarter revenue of $197 million, down 7% year-over-year, primarily impacted by inventory dynamics; first half growth of 7% year-over-year
•LEQEMBI global in-market sales of $184 million, up 15% year-over-year, with U.S. in-market sales of $97 million, representing continued sequential growth; LEQEMBI IQLIK, a first-of-its-kind anti-amyloid treatment offering at-home administration, approved by the FDA as an initiation dose
•SKYCLARYS revenue of $168 million, up 29% year-over-year, primarily related to an increase in global demand mostly driven by the continued launch in Europe and certain other international markets
•ZURZUVAE revenue of $71 million, up 53% year-over-year, driven by demand growth; now launched in Germany, the first commercial launch outside the U.S. for PPD
•SYFOVRE revenue of $162 million for the full second quarter, up 8% year-over-year, showed its strongest quarterly demand since launch. $97 million of revenue recognized by Biogen following the close of the Apellis acquisition on May 14, 2026
•EMPAVELI revenue of $46 million for the full second quarter, up 123% year-over-year, driven by demand growth. $30 million of revenue recognized by Biogen following the close of the Apellis acquisition on May 14, 2026

The Company is now advancing the next potential wave of growth drivers with five registrational readouts from the late-stage pipeline expected over the next four quarters; continuing to build the early-stage pipeline to deliver long-term value
•Registrational data for litifilimab in SLE expected by end of 2026 and additional Phase 3 readouts for litifilimab in CLE, felzartamab in AMR, and zorevunersen in Dravet syndrome anticipated next year
•Diranersen demonstrated proof-of-concept in Alzheimer’s disease as the first tau-directed agent to show clinical efficacy and a reduction of tau pathology in the brain — Biogen plans to advance to Phase 3
•Expected initiation of a new Phase 2 study of felzartamab in Graves’ disease, expanding the potential of felzartamab in autoimmune disease
•Pending RayThera acquisition expected to add multiple immunology programs to Biogen’s portfolio, including a lead program now in Phase 1 development
Apellis acquisition now completed with strong second quarter 2026 revenue performance for SYFOVRE and EMPAVELI. With the integration progressing well, Biogen expects approximately $0.85 dilution to Non-GAAP diluted EPS for full year 2026, driven largely by lower interest income and higher interest expense associated with the transaction financing, and remains on track for the transaction to be accretive to Non-GAAP diluted EPS in 2027. Transaction run rate synergies exiting 2027 are expected to be at least $250 million.
Full year 2026 guidance updated to reflect a strengthening in underlying business performance outlook adjusted for the impact from completed and expected transactions and milestones
Financial Highlights
Q2 ’26 Q2 ’25 △
r (CC*)
Total Revenue (in millions) $2,736 $2,646 3% 2%
GAAP diluted EPS $0.66 $4.33 (85)% N/A
Non-GAAP diluted EPS $3.60 $5.47 (34)% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q2 ’26 Q2 ’25 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$963 $1,107 (13)% (14)%
Rare disease revenue(2)
$602 $543 11% 9%
Specialized immunology revenue(3)
$128 $— —% —%
Biosimilars revenue $153 $182 (16)% (20)%
Other product revenue(4)
$71 $47 51% 51%
Total product revenue $1,916 $1,879 2% —%
Revenue from anti-CD20 therapeutic programs $514 $467 10% 10%
Alzheimer’s collaboration revenue(5)
$64 $55 16% 16%
Contract manufacturing, royalty and other revenue $242 $245 (1)% (5)%
Total revenue $2,736 $2,646 3% 2%

•Second quarter 2026 Legacy MS Portfolio, which includes AVONEX, PLEGRIDY, TECFIDERA, and TYSABRI, generated $767 million of revenue, driven by resilient performance from TYSABRI.
Expense Summary
(in millions) Q2 ’26 Q2 ’25 △
GAAP cost of sales*
$777 $605 (28)%
% of Total Revenue 28% 23%
Non-GAAP cost of sales*
$612 $554 (10)%
% of Total Revenue 22% 21%
GAAP R&D expense $530 $399 (33)%
Non-GAAP R&D expense $490 $394 (24)%
GAAP SG&A expense $710 $584 (22)%
Non-GAAP SG&A expense $680 $579 (17)%
GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense $164 $47 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

•The increase in second quarter 2026 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix.

•The increase in second quarter 2026 GAAP R&D expense included approximately $38 million of step-up amortization related to SKYCLARYS inventory used in clinical trials. The increase in second quarter 2026 GAAP and Non-GAAP R&D expense was driven by higher spend on clinical trials, including felzartamab, salanersen and litifilimab, as well as the inclusion of operating expenses from Apellis, and a reduction in R&D funding received from Royalty Pharma.

•The increase in second quarter 2026 GAAP and Non-GAAP SG&A was primarily due to the inclusion of the commercial and management operations of Apellis subsequent to the acquisition of the company and an increase in operational spending on sales and marketing activities in support of our U.S. and international product launches.

•Second quarter 2026 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was $164 million.
Other Financial Highlights

•Second quarter 2026 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $69 million, which includes approximately $45 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $24 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. for the commercialization of ZURZUVAE in the U.S.

•Second quarter 2026 GAAP other expense was approximately $19 million driven by net interest expense partially offset by net unrealized gains on equity securities. Second quarter 2026 Non-GAAP other expense was approximately $60 million primarily driven by net interest expense. Net interest expense includes financing costs related to the Apellis transaction.

•Second quarter 2026 GAAP and Non-GAAP effective tax rates were 26.4% and 17.2%, respectively. Second quarter 2025 GAAP and Non-GAAP effective tax rates were 14.7% and 13.5%, respectively. The year-over-year increase in the GAAP effective tax rate was primarily driven by non-deductible expenses related to the Apellis acquisition. The year-over-year increase in both GAAP and Non-GAAP effective tax rates were impacted by the favorable deferred tax impacts of decreases in foreign withholding taxes recorded in the second quarter of 2025.

Financial Position and Cash Flows

•Second quarter 2026 net cash flow from operations was approximately $449 million. Capital expenditures were approximately $41 million, and free cash flow, a Non-GAAP financial measure defined as net cash flow from operations less capital expenditures, was approximately $408 million.

•As of June 30, 2026, Biogen had cash and cash equivalents totaling approximately $1.3 billion and approximately $8.1 billion in total debt, resulting in net debt of approximately $6.8 billion.

•For the second quarter of 2026, the Company’s weighted average diluted shares were approximately 149 million.
Full Year 2026 Financial Guidance

Biogen is updating its full year 2026 financial guidance to reflect a strengthening in underlying business performance outlook with reported guidance adjusted for the impact from completed and expected transactions and milestones. Full year 2026 Non-GAAP diluted EPS range is expected as follows:

FY 2026 Non-GAAP Diluted EPS Guidance February 2026 April 2026 July 2026 Change
Underlying guidance $15.25 to $16.25 $15.25 to $16.25 $15.85 to $16.85 +$0.60
Approximate impact from acquired IPR&D and milestone charges – ($1.00) ~($3.00) ~($2.00)
Expected dilution from the Apellis acquisition – – ~($0.85) ~($0.85)
Reported Guidance $15.25 to $16.25 $14.25 to $15.25 $12.00 to $13.00

Full year total revenue is now expected to increase by a mid-single digit percentage for 2026 as compared to 2025 driven by continued revenue growth from our Growth Portfolio.

Biogen expects combined Non-GAAP R&D expense and Non-GAAP SG&A expense to be between $2.65 billion and $2.70 billion for the second half of 2026.

This guidance also assumes that foreign exchange rates as of July 24, 2026, will remain in effect for the remainder of the year, net of hedging activities.

Other than the acquired IPR&D and milestone impact expressly stated above, this financial guidance does not include any other potential future acquired IPR&D and milestone charges, impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are difficult to predict. Other important financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2026 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a
reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Other Key Recent Events

•Today Biogen announced Phase 2 data for BIIB091 in relapsing-remitting multiple sclerosis, which showed that BIIB091 has achieved proof-of-concept and the Company will be exploring next steps for the asset.

•In the second quarter of 2026, Biogen exercised its option to obtain from Ionis a worldwide exclusive, royalty-bearing license to develop and commercialize BIIB147, a Phase 1 ready investigational antisense oligonucleotide targeting stathmin-2 pre-mRNA in people with broad ALS. As part of the option exercise, Biogen paid Ionis a $15 million one-time license fee recorded in acquired IPR&D upfront and milestone expense.

Conference Call and Webcast

The Company’s earnings conference call for the second quarter will be broadcast via the internet at 8:30 a.m. ET on July 29, 2026 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, JUL 29, 2026, View Source [SID1234669486])