On August 21, 2025 Oncopeptides reported second quarter 2025 financial results (Presentation, Oncopeptides, AUG 21, 2025, View Source [SID1234655618]).

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On August 21, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will participate in the following investor conferences in September (Press release, UroGen Pharma, AUG 21, 2025, View Source [SID1234655426]).

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Wells Fargo Healthcare Conference

Date / Time: September 3rd, at 2:15 PM ET
Format: Fireside Chat
Location: Boston, MA

Cantor Fitzgerald Global Healthcare Conference

Date / Time: September 4th, at 3:55 PM ET
Format: Fireside Chat
Location: New York, NY

H.C. Wainwright 27th Annual Global Healthcare Conference

Date / Time: September 8th, at 9:00 AM ET
Format: Fireside Chat
Location: New York, NY

The conference webcasts will be available through the Events section of the Company’s Investor Relations website. Replays will be available for approximately 90 days following the event.

On August 21, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the European Commission has approved a new film-coated tablet formulation of BRUKINSA (zanubrutinib) for all approved indications (Press release, BeOne Medicines, AUG 21, 2025, View Source [SID1234655427]).

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"Developed to meet the real-world needs of patients, the new BRUKINSA tablet formulation aims to simplify treatment, reduce pill burden, and enhance ease of administration, reflecting our continuous focus on patient-centered innovation," said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. "With more than 200,000 patients treated globally and the broadest label of any BTK inhibitor in Europe, BRUKINSA’s differentiated clinical profile continues to make an impact for people facing certain B-cell cancers."

The recommended dose of BRUKINSA continues to be 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake from four pills to two. Additionally, they are smaller than the capsules and have film coatings, which make them easier to swallow.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency.

The information provided in this press release is intended for a global audience.

About BRUKINSA (zanubrutinib)

BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is the only BTK inhibitor to demonstrate PFS superiority to a first-generation BTK inhibitor in a Phase 3 study.

The global BRUKINSA clinical development program includes approximately 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved for at least one indication in more than 75 markets, and more than 200,000 patients have been treated globally.

ON August 21, 2025 Oncopeptides, a biotech company focused on difficult-to-treat cancers, reported the financial report for the second quarter 2025 (Press release, Oncopeptides, AUG 21, 2025, View Source [SID1234655620]).

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"This is our third consecutive quarter of more than 30 percent quarter-on-quarter sales growth," says Sofia Heigis, CEO of Oncopeptides. "The results reflect robust organic growth in our largest market, Germany, combined with faster-thanexpected market access in both Spain and Italy. With July sales also confirming our strong topline momentum with tripled sales compared to the same month last year, we remain confident we are on track to profitability by the end of 2026."

Financial overview April – June
• Net sales amounted to SEK 19.2 (8.2) million
• Operating profit amounted to SEK -56.2 (-73.3) million
• Profit after tax amounted to SEK -62.8 (-73.2) million
• Earnings per share, before and after dilution -0.30 (-0.48) SEK
• Cash and cash eq

Significant events April – June
• New Real-World Data support effectiveness and tolerability of Pepaxti in heavily pretreated Multiple Myeloma patients.
• Oncopeptides launches new Real-World Evidence study of Pepaxti in Spain, first patient enrolled.
• U.S. Food and Drug Administration removes clinical hold of OPD5.

Events after the period
• Oncopeptides’ drug Pepaxti included in European Guidelines for the treatment of multiple myeloma.
• Oncopeptides announces acceptance of poster presentations of Spanish and Italian Real-World data at IMS Annual Meeting.
• Oncopeptides Partners with SD Pharma to further broaden Pepaxti’s reach in Spain.
• Oncopeptides announces rights issue.

On August 21, 2025 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS), a commercial-stage biotechnology company, reported an update on development plans for KB707, the Company’s redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 (IL-2) and interleukin-12 (IL-12) in the tumor microenvironment and promote systemic immune-mediated tumor clearance following inhaled or intratumoral delivery to solid tumors (Press release, Krystal Biotech, AUG 21, 2025, View Source [SID1234655428]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Based on promising early evidence of efficacy in the treatment of non-small cell lung cancer (NSCLC), the Company was granted an End of Phase 2 meeting with the United States Food and Drug Administration (FDA) in October to discuss potential development pathways to support the registration of inhaled KB707.

"The acceleration of our work on inhaled KB707 is a reflection of both the clear and acute unmet need that exists for new treatments of NSCLC and the promising efficacy profile we have observed to date with inhaled KB707," said Suma Krishnan, President of Research and Development of Krystal Biotech. "We look forward to meeting with the FDA and bringing another urgently needed therapeutic option to patients."

Evidence supporting the prioritization of inhaled KB707, including monotherapy activity and durable responses in heavily pre-treated patients with NSCLC, was disclosed by the Company at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting earlier this year. As of data cut-off of April 15, 2025, the objective response rate in this heavily pre-treated NSCLC patient cohort was 36%. Median duration of response and progression free survival were not reached. Inhaled KB707 continued to be safe and generally well tolerated and amenable to administration in an outpatient setting, with no Grade 4 or 5 adverse events observed.

Enrollment continues in the Company’s KYANITE-1 study, a Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating inhaled KB707 in patients with locally advanced or metastatic solid tumors of the lung. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT06228326.

With the prioritization of inhaled KB707, the Company has paused enrollment in OPAL-1, a Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating intratumoral KB707 in patients with locally advanced or metastatic solid tumor malignancies. Patients on OPAL-1 continue to be followed and based on safety and efficacy results from OPAL-1, the Company may adjust development plans for intratumoral KB707. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT05970497.