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Photocure fundamentale forhold (PHO)

Ser du på plottet egentlig? Var jo en periode rett før corona veksten var eksplosiv, så flatet det helt ut igjen. Er sånn trend de trenger igjen, uten at kostnadene stiger særlig.

Screenshot_20251029_121429_TekInvestor

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Det kan være grunn til å legge vekt på de senere NMIBC-rapportene og at selskapet mener det vil gi vedvarende inntektsvekst.

DS skriver: Looking ahead, we anticipate sustained revenue growth, fueled by rigid kit adoption, expansion of mobile BLC, and HD upgrades that enhance utilization and sales. The tailwinds from a wave of recently approved NMIBC therapeutics are raising awareness around early detection and personalized disease management, validating Photocure’s position at the center of this rapidly evolving ecosystem.

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Photocure ASA: Notification of primary insider transaction

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New budget impact model study in 4 European countries concludes that BLC use offers a clinically meaningful and economically rational approach to NMIBC management

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https://photocure.com/newsletters/news-from-photocure-117?utm_source=email&utm_medium=email_campaign&utm_campaign=newsletter.

Photocure receives prestigious Innovation Prize from the Norwegian Cancer Society: Recognition for Groundbreaking Contributions in Bladder Cancer Diagnostics

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The impact of avoiding recurrence: New BRAVO Study abstract at SUO 2025 demonstrates Cost Neutrality in Blue Light versus White Light Cystoscopy comparison

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Financial calendar

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New publication: examining 12-months recurrence-free survival following photo coagulation of bladder tumor versus TUR-BT

Photocure announces the publication of the study “In-office laser coagulation of Ta bladder tumor compared to TUR-BT: 12 months follow-up randomized clinical trial” in the Journal of Urology last week. A first abstract of the study’s 12-month data had been presented at the European Association of Urology (EAU) 2024 congress. Photocure has supported this program and the specific study since 2016.

Laser III is a prospective, randomized, non-inferiority trial conducted in Denmark (NCT02886026) aimed to determine whether in-office photo coagulation bladder tumor (PC-BT) is non-inferior to standard TUR-BT regarding 12-months recurrence-free survival (RFS) in patients with recurrent Ta low grade bladder tumor. Both the office-based laser procedure and TUR-BT procedure were performed under BLC-guidance, comparing the procedures with the most complete detection technology and without compromising clinical or oncological safety. From 2016 to 2022 a randomized controlled clinical trial was performed comparing PC-BT with 980 nm diode laser under local anesthesia with gold standard TUR-BT under general anesthesia, in 300 patients in a hospital setting in Denmark.

Study results show 12 months recurrence-free survival was 43.5% after PC-BT and 43.0% after TUR-BT, the difference 0.5% in favor of TUR-BT met the noninferiority criterion.

The authors conclude: “Office-based laser photo coagulation of bladder tumor is non-inferior to TUR-BT regarding 12-months recurrence-free survival and is a safe, efficient treatment for recurrent Ta low-grade bladder tumors”

This is another quality clinical study supporting the utility of BLC for improving surgical performance, by enhancing detection of tumors and visibility of tumor margins, and its impact on clinical outcomes ,” said Anders Neijber Chief Medical Officer of Photocure.

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https://photocure.com/news/new-publication-examining-12-months-recurrence-free-survival-following-photo-coagulation-of-bladder-tumor-versus-tur-bt-118

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New publication of Hexvix trial data from China: blue light cystoscopy with Hexvix significantly improves the detection of bladder cancer using modern HD equipment

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Photocure’s stock performed strongly through 2025, with a year-end rally culminating in a mid-January peak before a subsequent pullback. Despite the correction, we continue to see multiple value-accretive catalysts in the pipeline, underpinned by strong underlying fundamentals and supportive of further upside potential. We therefore reiterate our BUY recommendation and raise our TP to NOK 90/sh. (85), viewing the post-correction valuation as an attractive entry point. Key risks include pending approvals, execution timelines and potential delays, regulatory developments, and commercialisation progress; however, at this stage we see no indications that these risks are evolving in a way that would materially undermine our investment case.
(Fra Nornes siste oppdatering idag.)

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Photocure ASA: Invitation to presentation of 4th quarter and preliminary full year 2025 financial results

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Photocure ASA: Results for the fourth quarter of 2025

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Asieris Announces European Medicines Agency Accepts Marketing Authorization Application for APL-1702

SHANGHAI, China, February 27, 2026 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company specializing in genitourinary tumors and women’s health, announced today that its marketing authorization application (MAA) for APL-1702 (CEVIRA) for the treatment of high-grade squamous intraepithelial lesions (HSIL) has been accepted by the European Medicines Agency (EMA).

APL-1702 is a globally first-in-class, China-originated photodynamic therapy(PDT) product. As a drug-device co-packaging product, it integrates hexaminolevulinate hydrochloride ointment with a disposable, single-use cervical photodynamic light applicator. Through its innovative localized drug delivery and intravaginally positioned cold light source, APL-1702 represents a breakthrough in the treatment paradigm of HSIL…

Designed for convenient “treat-and-go” outpatient use, the therapy is administered by gynecologists during a routine outpatient visit without the need for anesthesia, the entire placement procedure is typically completed within 10 minutes. After device placement, patients may immediately return to normal work and daily activities and are not required to remain in the hospital during the illumination period. Upon completion of treatment, the device can be safely removed by the patient at home.

This “short outpatient placement followed by at-home treatment completion” model substantially improves clinical efficiency and treatment accessibility, and supports broader implementation in primary and community healthcare settings.

Additionally, APL-1702 incorporates an innovative cold light source technology that enhances treatment comfort by maintaining tissue temperature at the treatment site below 42°C, Clinical data indicate that 97% of patients reported no pain in the cervical treatment area, with no observed cervical structural damage, thereby avoiding the risk of thermal injury associated with conventional photodynamic therapy, minimizing local irritation, and significantly improving overall patient tolerability.

APL-1702 Non-surgical Photodynamic Therapy Procedure Diagram: Easy administration for enhanced absorption; excellent patient compliance.

The MAA submitted to the EMA is primarily supported by data from an international, multicenter Phase III clinical trial of APL-1702, which included more than 20% patients from Europe.

The pivotal study results were formally published in December 2025 in Med , a Cell Press journal. The study was led by Academicians Lang Jinghe and Zhu Lan from Peking Union Medical College Hospital, with Professor Peter Hillemanns from Hannover Medical School serving as a senior author.

In addition, the clinical data were disseminated through invited oral presentations at several major international conferences, including the European Research Organization on Genital Infection and Neoplasia (EUROGIN) 2024, the Society of Gynecologic Oncology (SGO) Annual Meeting 2024, and the Photodynamic Therapy & Photodiagnosis Update 2024.

Further academic exchanges and scientific discussion with basic researchers and clinical specialists from China and abroad took place at the 27th National Clinical Oncology Conference & 2024 CSCO Annual Meeting, the International Papillomavirus Conference (IPVC) 2024, and the 37th Public Health Symposium 2025.

“The acceptance of APL-1702’s European marketing application in Europe further underscores Asieris’ strong and enduring commitment to addressing critical unmet medical needs on a global scale,” said Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals. “Building on our deep and proven expertise in the development of drug-device combination products, we have successfully advanced a truly non-invasive, patient-centred therapy from clinical research to the European regulatory review stage. This important milestone validates both our strategic focus and our ability to execute with discipline and rigor… We remain firmly committed to accelerating the global development of APL-1702, with the goal of bring this transformative treatment option to women worldwide and contributing meaningfully to global efforts toward cervical cancer elimination.”

https://www.photocure.com/news/photocure-partner-asieris-announces-that-ema-has-accepted-marketing-authorization-application-for-cevira-in-europe-5314429

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Cevira godkjent i Kina

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Fantastisk :blush::blush::blush:

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At fucking last

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EMA har nå akseptert MAA for Cevira. Det er ikke godkjenning, men det betyr at søknaden er validert og inne i full regulatorisk review i Europa. Sammen med pågående NMPA prosess i Kina og publiserte Phase III data begynner dette å ligne et globalt produktløp og ikke bare en opsjon. For meg reduserer dette regulatorisk risiko betydelig og styrker hele Cevira caset.

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Cevira fremstår som de har stålkontroll på det regulatoriske, så jeg må si jeg anser at likelyhood of approval i Europa er skyhøy.

Ville prøve meg å se om jeg klarte å ettergå dette selv:

Regner med dette er url:

Engelsk oversetting i nettleseren:

Aha, og så helt nede på 69. plass ref screenshottet til @Haltopen . Ser legit ut! :smiley:

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Der kom den.

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