European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma




European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma

• Lunsumio provides high rates of deep and long-lasting responses in third-line and later follicular lymphoma, a disease that typically becomes harder to treat each time a patient relapses^1,2
• Lunsumio subcutaneous offers a new treatment option that can significantly reduce administration time to approximately one minute
• Availability of Lunsumio SC allows patients to receive treatment aligned to clinical requirements and lifestyle preferences

Basel, 19 November 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional marketing authorisation of Lunsumio® (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. Approval is based on results from the phase I/II GO29781 study, which showed that Lunsumio SC had pharmacokinetic non-inferiority compared with intravenous (IV) administration, with no unexpected safety signals.³

“Building on the benefits of its fixed-duration dosing schedule, Lunsumio can now be administered with a one-minute subcutaneous injection, providing people with relapsed or refractory follicular lymphoma an additional treatment option to help meet their individual clinical requirements and lifestyle preferences,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Developing new formulations of our medicines is part of our commitment to offering greater flexibility and a better treatment experience for patients.”

Lunsumio SC is a fixed-duration treatment that can be initiated in the outpatient setting and has the potential to substantially reduce treatment administration time with an approximately one-minute injection, compared with a 2-4 hour IV infusion.

Lunsumio has shown a favourable benefit-risk profile and high rates of deep and durable remissions with both IV and SC administration routes in third-line or later (3L+) FL.^1,4 Lunsumio IV was the first bispecific antibody approved for 3L+ FL and has shown sustained responses, with 57% of patients who achieved a CR still in remission at five years.¹ Long-term data from the SC and IV arms of the GO29781 study will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

These data have been submitted to other healthcare authorities around the world, including the US Food and Drug Administration.

Phase III studies involving Lunsumio SC are ongoing, including the MorningLyte trial investigating Lunsumio SC in combination with lenalidomide in previously untreated FL. Lunsumio, along with Columvi® (glofitamab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio. Continuing to explore new formulations and combinations of these medicines across different disease areas and lines of treatment is part of Roche’s commitment to improve the patient experience and provide more choice to suit diverse patient and healthcare system needs.

About the GO29781 study
The GO29781 study is a phase II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab), administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The primary objective for the SC cohort was to show pharmacokinetic (PK) non-inferiority of the SC formulation of Lunsumio compared with the IV formulation, based on the study’s co-primary endpoints. Key secondary endpoints include complete response (CR) rate, objective response rate (ORR), duration of response, progression-free survival, safety and tolerability.

This approval is based on a primary analysis that explored Lunsumio administered subcutaneously in patients with 3L+ follicular lymphoma. Results from the primary analysis showed PK non-inferiority compared with IV administration, and the ORR and CR rates in patients treated with the fixed-duration, subcutaneous formulation of Lunsumio were 74.5% (95% confidence interval [CI]: 64.4-82.9%) and 58.5% (95% CI: 46.9-68.6%), respectively, as evaluated by the independent review faculty. The median duration of CR was 20.8 months (95% CI: 18.8-not evaluable [NE]) for patients receiving Lunsumio SC. The most common all-grade adverse events were injection-site reactions (60.6%; all Grade 1-2), fatigue (35.1%), and cytokine release syndrome (CRS; 29.8%). Overall, the rate and severity of CRS were low; events were low grade (Grade 1-2, 27.7%; Grade 3, 2.1%), occurred during cycle 1 and all fully resolved in a median of two days (range 1-15 days).³

About follicular lymphoma
Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.^2,5 It typically responds well to treatment but is often characterised by periods of remission and relapse.² The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis.⁵ It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.^5,6

About Lunsumio® (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, other blood cancers and autoimmune disorders.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Budde E, et al. Fixed treatment duration mosunetuzumab continues to demonstrate clinically meaningful outcomes in patients with relapsed/refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies: 5-year follow-up of a pivotal Phase II study. Presented at: ASH Annual Meeting and Exposition; 2025 Dec 6-9; San Diego, CA, USA. Abstract #5352.
[2] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited November 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.
[3] Roche data on file.
[4] Assouline S, et al. Fixed-duration subcutaneous mosunetuzumab continues to demonstrate high rates of durable responses in patients with relapsed/refractory follicular lymphoma after ≥2 prior therapies: 3-year follow-up from a pivotal Phase II study. Presented at: ASH Annual Meeting and Exposition; 2025 Dec 6-9; San Diego, CA, USA. Abstract #5353.
[5] Cancer.Net. Lymphoma – Non-Hodgkin: Subtypes. [Internet; cited November 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.
[6] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited November2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche Investor Relations

Investor Relations North America

Attachment

• 20251119_Lunsumio SC EU

Olema Oncology Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants




Olema Oncology Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

SAN FRANCISCO, Nov. 18, 2025 (GLOBE NEWSWIRE) — Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced its plans to commence a public offering, subject to market and other conditions, to issue and sell shares of its common stock, or for certain investors that so choose, in lieu of shares of common stock, pre-funded warrants to purchase shares of its common stock. All of the securities are being offered by Olema.

In connection with the proposed offering, Olema expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of common stock Olema is offering plus the shares of common stock underlying the pre-funded warrants. There can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

TD Cowen is acting as book-running manager for the proposed offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the “SEC”) on January 6, 2025 and declared effective on January 15, 2025. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may be obtained, when available from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective ER degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “expect,” “may,” “plan,” “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include, among others, statements regarding the timing, terms, size and completion of the proposed public offering and the anticipated grant to the underwriters of an option to purchase additional shares. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, the preliminary prospectus supplement related to the proposed public offering and other filings and reports that Olema makes from time to time with the SEC. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements.

Media and Investor Relations Contact
Courtney O’Konek
Vice President, Corporate Communications
Olema Oncology
media@olema.com

Protara Therapeutics to Host Conference Call and Webcast to Review New Interim Data from Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients with Lymphatic Malformations on Wednesday, November 19, 2025




Protara Therapeutics to Host Conference Call and Webcast to Review New Interim Data from Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients with Lymphatic Malformations on Wednesday, November 19, 2025

NEW YORK, Nov. 18, 2025 (GLOBE NEWSWIRE) — Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, November 19, 2025, to review new data from an interim analysis of the ongoing Phase 2 open-label STARBORN-1 trial assessing TARA-002, the Company’s investigational cell-based therapy, in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs).

The live event and accompanying slides can be accessed by visiting https://protara-therapeutics-update-call.open-exchange.net/registration, or via the Events and Presentations section of the Company’s website: https://ir.protaratx.com. A replay of the webcast will be archived for a limited time following the event.

About TARA-002 in LMs

TARA-002 is an investigational, genetically distinct strain of streptococcus pyogenes that is inactivated while retaining its immune-stimulating properties. It was developed from the same master cell banks as OK-432, which was originally granted marketing approval by the Japanese Ministry of Health for the treatment of LMs and has been the standard of care in Japan for 30 years. In addition, OK-432 was studied in a large Phase 2 trial in LMs in over 500 patients with significant clinical success. TARA-002 has been granted Rare Pediatric Disease designation by the U.S. Food and Drug Administration for the treatment of LMs.

About Lymphatic Malformations

Lymphatic malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels and lymphatics; recurrent infection; and cosmetic and other functional disabilities.

About Protara Therapeutics, Inc.

Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include but are not limited to, statements regarding Protara’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Protara’s business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials (including the timing of any particular phases of such trials and the timing of the announcement of any data produced during such trials or phases thereof); statements related to expectations regarding interactions with the U.S. Food and Drug Administration (FDA); Protara’s financial position; statements regarding the anticipated safety or efficacy of Protara’s product candidates; and Protara’s outlook for the remainder of the year and future periods. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the uncertain nature of the forward-looking statements include: risks that Protara’s financial guidance may not be as expected, as well as risks and uncertainties associated with: Protara’s development programs, including the initiation and completion of non-clinical studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; general market conditions; changes in the competitive landscape; changes in Protara’s strategic and commercial plans; Protara’s ability to obtain sufficient financing to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the impact of market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S. and foreign, economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated with Protara’s business and financial condition in general, including the risks and uncertainties described more fully under the caption “Risk Factors” and elsewhere in Protara’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law.

Company Contact:

Justine O’Malley
Protara Therapeutics
Justine.OMalley@protaratx.com
646-817-2836

Profound Medical Celebrates The Hong Center’s 200th Independent TULSA Procedure for Prostate Disease




Profound Medical Celebrates The Hong Center’s 200th Independent TULSA Procedure for Prostate Disease

Renowned urologist Dr. Mark Hong sets new global benchmark for urologist-led, MRI-guided prostate treatment, leading a growing movement toward incision-free prostate therapy

TORONTO, Nov. 18, 2025 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, announced today that The Hong Center Scottsdale, led by Dr. Y. Mark Hong of Integrative Urology in Phoenix, Arizona, has achieved a world-first milestone: 200 TULSA Procedures™ performed independently by a urologist, without radiologist involvement. This landmark establishes a new model for delivering MRI-guided prostate therapy.

“Dr. Hong’s longstanding commitment to innovation and compassion for his patients made him a pioneer in bringing the TULSA Procedure, a clinically proven, advanced prostate disease treatment, to patients,” said Profound Medical CEO and Chairman, Arun Menawat. “This 200-procedure milestone is more than a number – it represents the hundreds of men who are now living cancer-free, with preserved quality of life, thanks to his expertise and dedication.”

The TULSA Procedure, performed using Profound’s TULSA-PRO^® system, is a significant advancement in prostate care. Instead of surgery or radiation, treatment is performed inside an MRI suite using robotically controlled, directional ultrasound to precisely ablate prostate tissue while protecting surrounding structures. TULSA-PRO is the only AI-powered, MR-guided robotic system for prostate therapy, enabling real-time MRI thermography and autonomous temperature control. This allows physicians to see, monitor and adjust treatment throughout the procedure — delivering personalized therapy with exceptional precision. Often, TULSA Procedures have involved collaboration between urologists and radiologists. Dr. Hong’s independent workflow proves that a urologist alone can safely execute the full procedure — from image planning to ablation — while achieving excellent outcomes.

Among the earliest adopters of the TULSA Procedure, Dr. Hong built one of the world’s first urology-driven practices to offer incision-free prostate care at The Hong Center Scottsdale. Treating patients from Arizona, nationally and internationally, Dr. Hong routinely performs whole-gland, focal, BPH and salvage cases with consistent, high-volume success, achieving exceptional outcomes without procedural blood loss or hospitalization. His experience and expertise have allowed him to treat the most complex of cases with rapid recovery, high cure rates, and preserved urinary and sexual function.

“Having performed hundreds of robotic prostatectomies, I recognized early the potential of the TULSA Procedure to transform prostate cancer treatment,” said Dr. Hong. “Since accountability is the most important factor to improving as an independent surgeon, we are proud of refining the TULSA technique over 200 cases to cure cancer while not causing harm. In my view, TULSA represents the future of prostate disease treatment, one that will ultimately replace radical prostatectomy as a first-line option for prostate cancer.”

Dr. Hong is one of the world’s first board-certified urologists to complete a fellowship in Integrative Medicine. A graduate of Stanford University School of Medicine, Dr. Hong completed his general surgery training at Brigham and Women’s Hospital and his urological surgery residency at Harvard Medical School. His research on prostate cancer and the fear of cancer recurrence remains one of the first works of its kind in the published literature. Dr. Hong completed a robotic and minimally invasive surgery fellowship at George Washington University in Washington, D.C. He has published extensively in nearly every international urological journal.

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO^®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve^®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, any express or implied statements or guidance regarding current or future financial performance; the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma; and the success of Profound’s commercialization strategy and activities for TULSA-PRO^®. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Profound, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition, statements and projections regarding financial guidance and goals and the attainment of such goals may differ from actual results based on market factors and Profound’s ability to execute its operational and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management’s expected ranges. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound’s Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.ca and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849

Susan Thomas
Public Relations
sthomas@profoundmedical.com
T: 619.540.9195

SI-BONE To Present at Piper Sandler 37th Annual Healthcare Conference on December 2, 2025




SI-BONE To Present at Piper Sandler 37th Annual Healthcare Conference on December 2, 2025

SANTA CLARA, Calif., Nov. 18, 2025 (GLOBE NEWSWIRE) — SI-BONE, Inc. (Nasdaq: SIBN), a medical device company dedicated to solving sacropelvic disorders, today announced that the company will be participating in the upcoming Piper Sandler 37^th Annual Healthcare Conference in New York, NY. Management will be hosting a fireside chat on Tuesday, December 2, 2025, at 9:00 a.m. Pacific Time/ 12:00 p.m. Eastern Time.

Investors interested in listening to the conference call may do so by registering at this link: SIBN Investors. Live audio of the webcast will be available on the “Investors” section of the company’s website at: www.si-bone.com. The webcast will be archived and available for replay for at least 90 days after the event.

About SI-BONE, Inc.

SI-BONE (NASDAQ: SIBN) is a global leader in developing unique technologies for surgical treatment of sacropelvic disorders. Since pioneering minimally invasive SI joint surgery in 2009 with the iFuse Implant System^®, SI-BONE has supported over 4,900 physicians in performing a total of over 135,000 procedures. A unique body of clinical evidence supports the use of SI-BONE’s technologies with over 180 peer reviewed publications including four randomized controlled trials. SI-BONE has leveraged its leadership in minimally invasive SI joint fusion to commercialize novel solutions for adjacent markets, including adult deformity, spinopelvic and sacropelvic fixation and pelvic trauma.

For additional information on the company or the products, including risks and benefits, please visit www.si-bone.com.

SI-BONE, Sacropelvic Solutions, iFuse Implant System^®, iFuse Bedrock Granite, and iFuse TORQ, are registered trademarks, and iFuse 3D, iFuse TORQ TNT, and iFuse INTRA are trademarks of SI-BONE, Inc. ©2025 SI-BONE, Inc. All Rights Reserved. 

Investor Contact: Saqib Iqbal investors@si-bone.com

BBOT to Participate in Upcoming December Investor Healthcare Conferences




BBOT to Participate in Upcoming December Investor Healthcare Conferences

SOUTH SAN FRANCISCO, Calif., Nov. 18, 2025 (GLOBE NEWSWIRE) — BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced that members of its leadership team will participate in two investor conferences in December.

Details of the company’s participation are as follows:

• Piper Sandler 37^th Annual Healthcare Conference
  Presentation: Tuesday, December 2, at 2:00 p.m. ET

• 8th Annual Evercore Healthcare Conference
  Presentation: Wednesday, December 3, at 9:35 a.m. ET

Live webcasts of the presentations will be accessible on the “Events” page of the BBOT website at https://investors.bbotx.com/news-events/events. Replays of the webcasts will be available for at least 90 days following the event.

About BBOT
BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3Kα malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information, please visit www.bbotx.com and follow us on LinkedIn.

BBOT Contacts:

Investor Contact:
Heather Armstrong
BBOT
Heather.Armstrong@bbotx.com

Media Contact:
Jake Robison
Inizio Evoke Comms
Jake.robison@inizioevoke.com

Genmab Announces Pricing of Private Offering of Senior Secured Notes and Senior Unsecured Notes and Completion of Syndication of New Senior Secured Term Loan Facility




Genmab Announces Pricing of Private Offering of Senior Secured Notes and Senior Unsecured Notes and Completion of Syndication of New Senior Secured Term Loan Facility

Media Release

COPENHAGEN, Denmark; November 18, 2025

Genmab A/S (Nasdaq: GMAB) (“Genmab”) announced today that it and its wholly owned subsidiary Genmab Finance LLC (“Genmab Finance”) have priced their previously announced offering of $1.5 billion of 6.250% senior secured notes due 2032 (the “Secured Notes”) and $1.0 billion of 7.250% senior unsecured notes due 2033 (the “Unsecured Notes,” and together with the Secured Notes, the “Notes”). The issue price of the Notes is 100.000%. The offering is expected to close on December 3, 2025, subject to the satisfaction of customary closing conditions.

Genmab also announced that it has completed the previously announced syndication of the new $2.0 billion senior secured term loan “B” facility, which term loan “B” facility is in addition to the $1.0 billion senior secured term loan “A” facility and $500 million senior secured revolving credit facility (collectively, the “New Credit Facilities”) that Genmab previously syndicated to certain lenders as part of the financing for the pending acquisition (the “Acquisition”) of Merus N.V. (“Merus”).

Genmab intends to use the net proceeds from this offering of the Notes, together with borrowings under the New Credit Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition of Merus and related fees and expenses in connection with the Acquisition, the borrowings under the New Credit Facilities and the issuance of the Notes.

Prior to the Acquisition closing, the Notes and the related guarantees from Genmab subsidiaries will be secured solely by segregated accounts of Genmab in which the gross proceeds of the Notes will be held. Following the purchase of all Merus common shares tendered in the previously announced tender offer by Genmab, the Secured Notes will be secured by a first priority security interest in certain assets of Genmab and its subsidiaries that will guarantee the obligations under the New Credit Facilities, in accordance with certain customary practices in the relevant jurisdictions, and subject to certain thresholds, exceptions and permitted liens. The Secured Notes will be unconditionally guaranteed on a senior secured basis and the Unsecured Notes will be unconditionally guaranteed on a senior unsecured basis by certain subsidiaries of Genmab that will guarantee the obligations under the New Credit Facilities.

The indentures governing the Notes are expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of Genmab and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to persons who are either (1) reasonably believed to be “qualified institutional buyers” as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This announcement shall not constitute an offer to sell or a solicitation of an offer to purchase any securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The offering of the Notes may be made only by means of an offering memorandum.

Contact:

Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E:mmp@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E:acn@genmab.com

Forward-looking Statements

In this announcement, we make statements concerning our expectations, beliefs, plans, objectives, goals, strategies, and future events or performance, including, but not limited to, the statements about the offering of Notes, our intention to issue the Notes at the closing, and the expected use of proceeds. Genmab cautions investors that any forward-looking statements or projections made by Genmab, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in Genmab’s filings with the SEC, including those included in Genmab’s most recent Annual Report on Form 20-F, which is available at www.genmab.com and www.sec.gov. Genmab is providing the information in this announcement as of this date, and Genmab does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^® and KYSO^®.

Media Release no. 24
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

Attachment

• 181125_i24_Pricing

argenx Announces Results of Extraordinary General Meeting of Shareholders




argenx Announces Results of Extraordinary General Meeting of Shareholders

November 18, 2025 – 10:01 PM CET

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the results of its Extraordinary General Meeting of shareholders held on November 18, 2025.

The remuneration policy, which was the sole voting item on the agenda, was approved by the required majority of votes. The Company’s remuneration policy was approved by a 95.67% majority, with 91.1% of share capital represented at the Extraordinary General Meeting.

The voting result and all documents relating to the shareholders’ meeting will be available on the argenx
website at www.argenx.com/investors/shareholder-meetings.

About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube.

For further information, please contact:  

Media:

Ben Petok
Bpetok@argenx.com

Investors:

Alexandra Roy
aroy@argenx.com 

Comprehensive Healthcare Takes Next Step Toward Expanding Access to Behavioral Healthcare in Central Washington




Comprehensive Healthcare Takes Next Step Toward Expanding Access to Behavioral Healthcare in Central Washington

Organization selected as one of 10 Certified Community Behavioral Health Clinic (CCBHC) pilot sites in the state

YAKIMA, Wash., Nov. 18, 2025 (GLOBE NEWSWIRE) — Comprehensive Healthcare today announced that it was selected to Washington’s first Certified Community Behavioral Health Clinic (CCBHC) Pre-Certification Cohort, an important milestone in the organization’s ongoing efforts to innovate and expand access to mental health and substance use treatment across Central Washington.

The CCBHC model is a national effort designed to transform how community-based behavioral healthcare is delivered. CCBHCs are required to provide a comprehensive range of mental health and substance use services, offer 24/7 crisis response, and coordinate care with hospitals, primary care providers, law enforcement and other community partners. The model emphasizes whole-person care and, through a sustainable funding framework, ensures that no one is turned away, regardless of insurance status or ability to pay.

Leaders at Comprehensive Healthcare have advocated for Washington state to adopt the model statewide and have invested in testing the program regionally.

“We believe deeply in the philosophy and vision behind the CCBHC model, and it’s an honor to be selected as a pilot site,” said Jodi Daly, Ph.D., CEO of Comprehensive Healthcare. “Our selection recognizes eight years of hard work, persistence and collective dedication to improving access to behavioral healthcare. Becoming a CCBHC pilot site isn’t just a recognition – it’s a strategic leap forward, and we’re proud to continue making meaningful change for our communities.”

Through Washington state’s pilot program launching in January 2026, Comprehensive Healthcare will gain access to technical expertise and support to shift key service lines, including outpatient mental health care, to the CCBHC model. The pre-certification cohort receives training and planning resources to enhance service delivery, strengthen operational capacity, invest in staff development and refine technology systems to meet national standards for data reporting and more.

Comprehensive Healthcare was selected for the program through a competitive application process that evaluated community behavioral health providers across the state based on a range of readiness indicators and geographic representation.

A recipient of several federal CCBHC advancement and development grants, Comprehensive Healthcare has long been at the forefront of advancing the model in Washington. Over the past several years, the organization has worked diligently to align its operations with the CCBHC model, introducing new programs, expanding existing services, and bolstering its team of clinicians and support staff. These efforts have positioned the agency to build on its momentum and take the next step toward full implementation.

“The CCBHC grants we’ve received have enabled us to break down barriers to care and connect clients with the help they need – when they need it,” said Natalie McGillen, Chief of Special Projects at Comprehensive Healthcare. “This funding has allowed us to better understand the needs of our communities through comprehensive assessments and translate those insights into responsive solutions that make a real difference. We’re looking forward to continuing to drive this work forward as an official CCBHC pilot site.”

Comprehensive Healthcare’s Substance Use Disorder (SUD) Same-Day Access program is one such solution, offering faster entry into care since its launch in March. In Yakima, 91 percent of clients who completed a screening and assessment through the program attended their first service appointment, and in Walla Walla, 87 percent – clear signs of improved engagement and fewer no-shows.

The organization’s crisis services have also seen meaningful progress in strengthening client engagement. From March 2024 to June 2025, more than 300 clients were supported across hundreds of encounters, with over half involving new or previously inactive individuals. Consistent and timely follow-up further reinforced ongoing engagement, contributing to a 40 percent completion rate of intake assessments among those referred to SUD Same-Day Access.

By adopting the CCBHC model, Comprehensive Healthcare joins a growing movement to create a modernized behavioral health system that prioritizes accessibility, collaboration and equity. The approach focuses on meeting people where they are – an ethos already deeply ingrained in Comprehensive Healthcare’s mission.

“Our progress in bringing the CCBHC model to Central Washington is thanks to our incredible team, whose passion and persistence in improving access to care and meeting the needs of our communities inspire everything we do,” Daly said. “I’m confident in our continued success because of their dedication and expertise. We’ll celebrate this milestone as both a recognition of our achievements and a renewed call to keep improving the health and wellbeing of our communities.”

For more information about Comprehensive Healthcare, visit CompHC.org.

About Comprehensive Healthcare: 
As one of largest behavioral health organizations in the state of Washington, Comprehensive Healthcare serves clients in the Greater Columbia Region. Comprehensive Healthcare is a Joint Commission accredited organization, providing compassionate, individualized behavioral healthcare since 1972. As a non-profit organization, Comprehensive Healthcare is dedicated to delivering high quality, evidence-based services to individuals, families and organizations. To learn more, visit Comprehensive Healthcare’s website at comphc.org.

Media Contacts: 
Cassidy Brown 
Comprehensive Healthcare 
(509) 317-2876 
cassidy.brown@comphc.org 

Kate Hughes
kate@firmani.com

Comprehensive Healthcare Takes Next Step Toward Expanding Access to Behavioral Healthcare in Central Washington




Comprehensive Healthcare Takes Next Step Toward Expanding Access to Behavioral Healthcare in Central Washington

Organization selected as one of 10 Certified Community Behavioral Health Clinic (CCBHC) pilot sites in the state

YAKIMA, Wash., Nov. 18, 2025 (GLOBE NEWSWIRE) — Comprehensive Healthcare today announced that it was selected to Washington’s first Certified Community Behavioral Health Clinic (CCBHC) Pre-Certification Cohort, an important milestone in the organization’s ongoing efforts to innovate and expand access to mental health and substance use treatment across Central Washington.

The CCBHC model is a national effort designed to transform how community-based behavioral healthcare is delivered. CCBHCs are required to provide a comprehensive range of mental health and substance use services, offer 24/7 crisis response, and coordinate care with hospitals, primary care providers, law enforcement and other community partners. The model emphasizes whole-person care and, through a sustainable funding framework, ensures that no one is turned away, regardless of insurance status or ability to pay.

Leaders at Comprehensive Healthcare have advocated for Washington state to adopt the model statewide and have invested in testing the program regionally.

“We believe deeply in the philosophy and vision behind the CCBHC model, and it’s an honor to be selected as a pilot site,” said Jodi Daly, Ph.D., CEO of Comprehensive Healthcare. “Our selection recognizes eight years of hard work, persistence and collective dedication to improving access to behavioral healthcare. Becoming a CCBHC pilot site isn’t just a recognition – it’s a strategic leap forward, and we’re proud to continue making meaningful change for our communities.”

Through Washington state’s pilot program launching in January 2026, Comprehensive Healthcare will gain access to technical expertise and support to shift key service lines, including outpatient mental health care, to the CCBHC model. The pre-certification cohort receives training and planning resources to enhance service delivery, strengthen operational capacity, invest in staff development and refine technology systems to meet national standards for data reporting and more.

Comprehensive Healthcare was selected for the program through a competitive application process that evaluated community behavioral health providers across the state based on a range of readiness indicators and geographic representation.

A recipient of several federal CCBHC advancement and development grants, Comprehensive Healthcare has long been at the forefront of advancing the model in Washington. Over the past several years, the organization has worked diligently to align its operations with the CCBHC model, introducing new programs, expanding existing services, and bolstering its team of clinicians and support staff. These efforts have positioned the agency to build on its momentum and take the next step toward full implementation.

“The CCBHC grants we’ve received have enabled us to break down barriers to care and connect clients with the help they need – when they need it,” said Natalie McGillen, Chief of Special Projects at Comprehensive Healthcare. “This funding has allowed us to better understand the needs of our communities through comprehensive assessments and translate those insights into responsive solutions that make a real difference. We’re looking forward to continuing to drive this work forward as an official CCBHC pilot site.”

Comprehensive Healthcare’s Substance Use Disorder (SUD) Same-Day Access program is one such solution, offering faster entry into care since its launch in March. In Yakima, 91 percent of clients who completed a screening and assessment through the program attended their first service appointment, and in Walla Walla, 87 percent – clear signs of improved engagement and fewer no-shows.

The organization’s crisis services have also seen meaningful progress in strengthening client engagement. From March 2024 to June 2025, more than 300 clients were supported across hundreds of encounters, with over half involving new or previously inactive individuals. Consistent and timely follow-up further reinforced ongoing engagement, contributing to a 40 percent completion rate of intake assessments among those referred to SUD Same-Day Access.

By adopting the CCBHC model, Comprehensive Healthcare joins a growing movement to create a modernized behavioral health system that prioritizes accessibility, collaboration and equity. The approach focuses on meeting people where they are – an ethos already deeply ingrained in Comprehensive Healthcare’s mission.

“Our progress in bringing the CCBHC model to Central Washington is thanks to our incredible team, whose passion and persistence in improving access to care and meeting the needs of our communities inspire everything we do,” Daly said. “I’m confident in our continued success because of their dedication and expertise. We’ll celebrate this milestone as both a recognition of our achievements and a renewed call to keep improving the health and wellbeing of our communities.”

For more information about Comprehensive Healthcare, visit CompHC.org.

About Comprehensive Healthcare: 
As one of largest behavioral health organizations in the state of Washington, Comprehensive Healthcare serves clients in the Greater Columbia Region. Comprehensive Healthcare is a Joint Commission accredited organization, providing compassionate, individualized behavioral healthcare since 1972. As a non-profit organization, Comprehensive Healthcare is dedicated to delivering high quality, evidence-based services to individuals, families and organizations. To learn more, visit Comprehensive Healthcare’s website at comphc.org.

Media Contacts: 
Cassidy Brown 
Comprehensive Healthcare 
(509) 317-2876 
cassidy.brown@comphc.org 

Kate Hughes
kate@firmani.com