Diskusjon Triggere PortefĂžljer AksjonĂŠrlister

Photocure smĂ„prat (PHO) 🔩 2

Er det ikke det som skal informeres om i dagens presentasjon da?

Jo, og i biotek er det Ă„penbart asset og hovedvirksomhet i mine Ăžyne og skal deles med markedsaktĂžrer.

Helt standard biotek virksomhet

Og om Cevira. Lovende kommentar fra Asieris:

«Breaking News! Our multinational Phase III Clinical Study hits the mark! The world is one step closer to a non-vaccine treatment for cervical HSIL: ow.ly/iIOZ50PP27p #asieris #clinicaltrial #phaseIII #cervical #HSIL»

Hva tenker du @Savepig nÄr selskapet gÄr ut slik med Cevira og Hexvix resultater i fase III studiene?

Og der kom pressemeldingen!

1 Like

Photocure\ 254x65
View in browser

Positive Results for Hexvix Phase III Clinical Trial in China Presented at the SIU 2023 Congress

Press Release – Oslo, Norway, October 12, 2023: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has today unveiled the results of its HexvixÂź (APL-1706) Phase III clinical trial in China. A presentation scheduled for today at the 43rd Congress of the SociĂ©tĂ© Internationale d’Urologie (SIU), confirms that, in a Chinese population, Hexvix blue light cystoscopy (BLCÂź) outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability.

The highly statistically significant results corroborate the findings of Photocure’s own randomized controlled trials (RCTs) that demonstrate the clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection and a favorable tolerability profile with no serious adverse events. Moreover, Asieris’ Phase III Hexvix trial is the first RCT conducted with high definition 4K blue light capital equipment.

“This randomized-controlled trial reinforces the benefits of BLC with Hexvix in tumor detection over WLC alone with clinically convincing and statistically significant results. This is on the backdrop of this Chinese trial being the first RCT conducted with 4K high definition (HD) blue light equipment, making it a valuable addition to the body of evidence already available on BLC with Hexvix. It confirms that BLC with Hexvix is additive to WL also with high quality HD imaging technology. We are pleased to see and acknowledge that our partners at Asieris are driving innovation to support unmet needs in bladder cancer” , said Anders Neijber, Photocure’s Chief Medical Officer.

The trial results have been selected as a “late-breaking abstract” at the 43rd Congress of the SociĂ©tĂ© Internationale d’Urologie (SIU) in Istanbul, Turkey, October 11-14. The clinical study data will be presented today, October 12, in the form of an Oral ePoster at 1:45pm local time.

The study is a prospective, self-controlled, multicenter Phase ⅱ study intended to evaluate the safety and detection benefits of blue light cystoscopy (BLC¼) with Hexvix compared to white light cystoscopy (WLC) in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. The study included a total of 158 patients, of which 114 underwent BLC. Of the 97 patients diagnosed with NMIBC, a total of 42 patients (43.3%) had one or more additional lesions detected with Hexvix BLC compared to WLC (p<0.0001). Among the 114 patients, 11.4% (13/114) had CIS lesions, and among these, 11 patients (84.6%, 11/13) had additional CIS lesions detected under Hexvix BLC that were not found under WLC. The detection rates for PUNLMP, CIS, Ta, T1, and T2-T4 tumor lesions in the BLC group were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while in the WLC group, they were NA, 42.1%, 76.1%, 91.2%, and 100%, respectively.

Read Asieris’ full media release here: Asieris Unveiled Results of Its Phase III Clinical Study for APL-1706, an Imaging Drug for Diagnosis or Surgery of Bladder Cancer, at the SIU 2023 Congress - Asieris Pharmaceuticals

Asieris Pharmaceuticals is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases.

In January 2021, Asieris entered into a license agreement with Photocure ASA to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan.

14 Likes

Bare Ă„ skyndte seg Ă„ sell on news i dag :sweat_smile:

Bare la de selge, sÄ aksjene bytter hender til folk som Þnsker Ä vÊre langsiktige.

1 Like

The study included a total of 158 patients, of which 114 underwent BLC. Of the 97 patients diagnosed with NMIBC, a total of 42 patients (43.3%) had one or more additional lesions detected with Hexvix BLC compared to WLC (p<0.0001). Among the 114 patients, 11.4% (13/114) had CIS lesions, and among these, 11 patients (84.6%, 11/13) had additional CIS lesions detected under Hexvix BLC that were not found under WLC. The detection rates for PUNLMP, CIS, Ta, T1, and T2-T4 tumor lesions in the BLC group were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while in the WLC group, they were NA, 42.1%, 76.1%, 91.2%, and 100%, respectively.

Dette er de beste tallene jeg har sett vs WLC. Tidligere har de brukt Ä ligge pÄ 30% sÄnn ca mener jeg Ä huske.

10 Likes

Algoene jobber pÄ spreng med Ä fÄ deg til Ä selge aksjene dine, ved Ä la deg tro at den faller tilbake grunnet dÄrlige resultater. Helt ufattelig at de fÄr det til.

Bare Ă„ sitte i ro, amigos y amigas.

3 Likes

Det er det som stadig skjer i denne aksjen. Mulig det er mer lÞnnsomt? Vi fÄr vente Ä se.

1 Like

La nÄ resultatene synke inn og presentasjonen gjennomfÞres i det internasjonale markedet / konferansen. Gode resultater slÄr aldri feil

Det sees i Ultimovacs (shortere forsĂžker smarte handler) men blir knust av gode resultater. At noen kanskje forsĂžker Ă„ stagge kurs for Ă„ tjene penger i short innen biotekverden hvor pasienter er avhengig av risikokapital for Ă„ fremme nye lĂžsninger er en STOR uting.

Hvis Janus eller andre forsÞker seg med short i Photocure hÄper jeg det blir en blemme av de sjeldne

2 Likes

Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, “APL-1706 is currently the only approved optical imaging for assisting in the diagnosis and surgery of bladder cancer worldwide. The data presented at the SIU conference further validates the tremendous clinical value of APL-1706. We believe that this innovative drug will bring significant benefits to bladder cancer patients in the local market. We will actively advance the related regulatory submissions in China, expediting its market entry to benefit more patients as soon as possible.”

5 Likes

We believe that this innovative drug will bring significant benefits to bladder cancer patients in the local market. We will actively advance the related regulatory submissions in China, expediting its market entry to benefit more patients as soon as possible.”

7 Likes

Litt uheldig at Ultimovacs slapp resultater i dag, mye “sidelined money” som kunne gĂ„tt inn i Pho, som gikk inn i Ulti. Kan se ut som norske biotek fans er all in nĂ„ :wink:

1 Like

Markedet sender kursen ned
vrient Ä forstÄ seg pÄ dette. Ikke bra nok til Ä danke ut hvitt lys? Markedet er redd for samme situasjon som i USA?

Beklager, skjÞnner ikke hvilken planet du er pÄ.
Markedet sender akkurat nÄ verdiene opp. Og like gjerne ender kursen langt opp allerede i dag. Hva er riktig kurs skjer plutselig og gjerne over tid. Ville noen lÞftet Þyenbryn om kursen i dag var over 100kr?

« .expediting its market entry to benefit more patients as soon as possible.”

1 Like

image

Denne gjengen er pÄ SIU sammen med alle verdens urologer, klart vi skal kraftig opp den kommende tiden.

3 Likes

Sorry bare skjĂžnte ikke hvorfor ikke markedsreaksjonen ble en annen. Kursen var hĂžyere rett fĂžr enn rett etter

Trenger ikke beklage. Og det stemmer ikke. Kursen var ikke hÞyere rett fÞr. Etter melding i dag har kursen vÊrt oppe i 59,8 og dagen er ung. Og kanskje er fremtiden ikke sÄ vÊrst likevel? @Bingo123 det er vel ikke hverdagskost i norsk biotek at det snakkes om expediting its market entry?

Resultatene er kjent og blir sikkert diskutert av aktĂžrer i innlegget over. Stor interesse for selskapet i dag, se omsetning mot markedsverdi. Ultimovacs bykser og Photocure opp ca 30% siste mnd. Det er jo en start og positiv trend?

Alt annet likt, enkelt Ă„ se lysere pĂ„ femtiden med Asieris sine fremlagte resultater i meldingen og underbygges av deres kommentar om expediting its market entry to benefit more patients as soon as possible.”

2 Likes

PÄ tide med nye analyser fra meglerhusene? For Ä fÄ ett riktig bilde av potensialet til Photocure burde de ogsÄ ta Cevira med i betraktningen. :face_with_raised_eyebrow:

3 Likes