Latest News

Oslo, Norway, October 18, Photocure ASA (OSE: PHO) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Cysview® on a priority review basis. With the FDA granting a priority review, a decision is expected in the first half of 2018.

Photocure is supporting a Societe Internationale d’Urologie (SIU) educational program on Blue Light Cystoscopy (BLC™) with Hexvix®/Cysview®. The first module is an expert panel debate on White Light versus Blue Light Cystoscopy in evaluating Bladder cancer. The second module will be available on-line in 2018, and will feature “Hints and Tips” on getting the most out of the technology.

Oslo, Norway, 23 August 2017: Photocure ASA (OSE:PHO), today reported a Hexvix/Cysview revenue growth of 10% to NOK 37.6 million in the second quarter of 2017 (Q2 2016: NOK 34.2), with an EBITDA of NOK 4.7 million for the Hexvix/Cysview commercial franchise. The company reported a revenue growth of 55% for the important US market, were the company recently has announced several significant developments.

Oslo, Norway, August 18, 2017: Photocure ASA (OSE: PHO) today announced that a prospective controlled study investigating the introduction of Blue Light Cystoscopy (BLC™) with Hexvix® at first presentation in patients with non-muscle invasive bladder cancer (NMIBC) in routine clinical practice has been published in the World Journal of Urology.

Photocure will present its second quarter and first half year report on Wednesday 23 August 2017 at Hotel Continental, Oslo, Norway.

Oslo, Norway, August 16th Photocure ASA (OSE: PHO) announced today that it has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for BLC™ with Cysview® for use during surveillance cystoscopy to detect recurrence of bladder cancer using a flexible cystoscope.

Oslo, Norway, July 31,2017: Photocure ASA (OSE: PHO) today announced that a study investigating the use of Blue Light Flexible Cystoscopy with Hexvix® (BLFC™) in patients with Carcinoma in Situ (CIS) has been published in the Scandinavian Journal of Urology.

Oslo, Norway, July 17, 2017: Photocure ASA (OSE: PHO), announced today that the United States Centers for Medicare & Medicaid Services (CMS) has released the Proposed Rule outlining its 2018 plan to reimburse hospital outpatient departments using Blue Light Cystoscopy (BLC^TM) with Cysview^®. To Ensure appropriate reimbursement for BLC^TM with Cysview, CMS has proposed to create a new set of codes specific to Blue Light Cystoscopy allowing for improved reimbursement for those procedures.

New studies show that blue light cystoscopy offers a significant advantage over white light cystoscopy identifying bladder tumors, according to Gary Steinberg, MD, Professor of Surgery and Director of Urologic Oncology at the University of Chicago Medical Center.

Interview with Dr. Joe Liao, Stanford University / Palo Alto VA Medical Center: Improved visualization, more complete TURBT.

Oslo, Norway, 23 May 2017: Photocure ASA (OSE: PHO) today reported a Hexvix/Cysview revenue growth of 9% to NOK 36.5 million in the first quarter of 2017 (Q1 2016: NOK 33.5), with an EBITDA of NOK 4.9 million for the Hexvix/Cysview commercial franchise. The company reported a growth of 32% for the important US market, were the company recently unveiled the new growth strategy towards 2020.

Photocure ASA today announced that new Phase 3 study results with Blue Light Flexible Cystoscopy (BLFC™) with Hexvix®/Cysview® were presented during a late-breaking plenary session at the American Urological Association (AUA) Annual Meeting in Boston, Massachusetts on Sunday May 14th. The study showed that BLFC with Cysview detected bladder cancer recurrence in 21.5% of the patients undergoing surveillance cystoscopy that otherwise would have been missed with white light (WL) alone, which is highly significant (p<0.0001).>

Oslo, Norway, May 12th, 2017: Photocure ASA (Photocure, PHO:OSE), today announced that a Phase 3 trial investigating Blue Light Flexible Cystoscopy (BLFC™) with Cysview^®/Hexvix^® in the surveillance setting met the study primary end point. Results from the study showed a highly statistically significant improvement (p <0.0001) in the detection of patients with recurrence of bladder cancer using blfc with cysview compared to white light (wl) alone in patients with non-muscle invasive bladder cancer (nmibc) undergoing surveillance cystoscopy. detailed data from the study will be presented during a late-breaking plenary abstract session on may 14th at the american urological association, 2017 meeting.>

Oslo, Norway, May 5 2017: Photocure ASA (OSE:PHO), today announced the appointment of Jeremy Bahr as Chief Business Officer.

Oslo, Norway April, 28, 2017: Photocure ASA (OSE:PHO), a specialty pharmaceutical company and world leader in photodynamic technology for treatment of bladder cancer, today announced the appointment of Jan Hendrik Egberts,M.D., Johanna Holldack,M.D. and Gwen Melincoff to its board of directors with Dr. Egberts as the new board chairman.

Oslo, 27 April 2017: Photocure ASA (OSE: PHO), held its annual general meeting on 27 April 2017 at 17:00 hours (CET).

Data on US Registry Study for BLC™ with Cysview/Hexvix will also be Presented at AUA.

Oslo, 6 April 2017: Photocure ASA (OSE: PHO), calls for the annual general meeting of PHO to be held at Hoffsveien 4, 1st floor, 0275 Oslo, Norway on 27 April 2017 at 17:00 hours (CET).