Redeye returns with an update on Ascelia after the Q2 report, which contained few surprises.
* Type A meeting with the FDA scheduled for September 9 * Implementing cost-saving measures * Conf call at 10am CET Recent and upcoming rele...
Redeye returns with an update following the CRL and additional consideration, where we lower the likelihood of approval, include an assumed ...
* CRL questions SPARKLE endpoint analysis; re-read rejected *Ascelia disputes both points; expresses confidence * Type A meeting next; outco...
Redeye comments on the publication of the Complete Response Letter and Ascelia's subsequent press release.
Redeye comments on the disappointing news that Ascelia has received a CRL from the FDA for Orviglance.
* Additional clinical data and product documentation requested * Urgent FDA meeting to discuss next steps * Very low visibility: Valuation s...
Redeye comments on Ascelia's Q1 report and recent development in the company.
* Orviglance data accepted for presentation at high-quality congress * Cash runway into 2027 * Fair value range updated: SEK 2.
Redeye gives a short comment on the directed issue in Ascelia.
Redeye returns with an update following Ascelia Pharma's Q4 update, which contained no material surprises.
* PDUFA action date for Orviglance in July * Cash runway into Q4'26 * Fair value range updated: SEK 2.
Redeye gives a short comment on the news that the FDA has accepted Ascelia’s NDA application for Orviglance for review.
Redeye returns with an update following Ascelia Pharma's Q3 update, which contained no surprises.
* An NDA for Orviglance submitted to the FDA * Patience for a partner deal * Fair value range updated: SEK 2.
Yesterday evening, it was announced that Ascelia had raised around SEK30m in a directed share issue - we see this as a sign of strength and ...
Ascelia has now submitted Orviglance to the FDA. The next step is to start the initial filing review process with an FDA confirmation within...
* A quarter centred on preparations * Orviglance FDA submission around the corner * Fair value range updated: SEK 2.
Ascelia’s two most important value drivers are the US submission, which is now de-risked, and Ascelia is expecting a submission in early Sep...
* Stable financials * Orviglance FDA submission in early September * Neutral share price reaction expected Stable financials Operating cash ...
Ascelia is progressing with the Orviglance application, and the company is about to complete the electronic configuration of the file.
After the warrant contribution, Ascelia Pharma is well funded for 2025 with some SEK 80m net cash, which is enough for securing a partner ah...
The FDA submission is progressing toward the finish line, as illustrated by the more precise expected time of submission by the first half o...
Orviglance FDA submission during the summer Good cost control Conf call at 10:00 CEST Recent relevant events In mid'March '25, Ascelia comm...
Alternative MRI contrast agent for frail cancer patients Ph 3 finished and ready for FDA filing Initiating coverage, fair value range of SEK...
FDA's final minutes confirm that Orviglance is on track for NDA submission by mid-2025.
After the recent rights issue, Ascelia has SEK 75.
Q4 is a reminder that Ascelia ticked some essential boxes during 2024, including completing a successful phase 3 study and securing growth c...
After the recent rights issue, Ascelia has SEK 95.
The preliminary result is 100% support and a gross proceed of SEK 105m.
Ascelia’s Q2 confirmed a contained OPEX base. With support from the recent SPARKLE success and the ongoing secured part of the rights issue,...
Ascelia’s actual 21 result is minor compared with the recent SPARKLE success and the ongoing SEK 105m funding where SEK 70m is secured.
Ascelia proceeds with a rights issue of units to secure growth capital to be able to finalize and submit the NDA application for for the pro...
Ascelia’s Q1 result was minor compared to the recent SPARKLE success.
Ascelia’s actual Q1 result is a very minor event compared with the recent SPARKLE success.
Positiva topline-data Ascelia presenterade under föregående vecka topline-data från fas III-studien SPARKLE (n=85).
Ascelia has just concluded a call providing a commercial road-map following the positive SPARKLE results.
Ascelia achieved the vital objective to secure a re-reader evaluation of SPARKLE by May 2024.
Orviglance meets the primary endpoint in the SPARKLE study with a p-value of
Ascelia's confirmation yesterday that the three professional external readers has completed the image reading process reduces the risk of de...
Q4 – allt under kontroll Ascelias rapport för det fjärde kvartalet innehöll inga överraskningar.
Ascelia’s priority is to secure a re-reader evaluation of SPARKLE by May 2024.
A SEK 20m to SEK 35m financing based with the financial partner Formue Nord Fokus A/S eases the financial pressure ahead of the SPARKLE resu...
The initiation of the SPARKLE reading process reduces the risk of a delayed read-out by May 2024.
Realistiskt att nå SPARKLE-resultat med nuvarande kassa Ascelia levererade en Q3-rapport som var enligt våra förväntningar.
Ascelia's priority is to secure a re-reader evaluation of SPARKLE by May 2024.
the main point is that Ascelia is on track for a re-evaluation on SPARKLE in May 2024 and the cash run rate is stretched beyond Q2 2024.
Ascelias priority is to secure a re-reader evaluation of SPARKLE by May 2024.
Inga överraskningar i rapporten Ascelias rapport för det andra kvartalet innehöll inga överraskningar.
The FDA feedback later this year will be very important.
Planerar för ny datautläsning Ascelia meddelade under måndagskvällen att de planerar att genomföra en ny utläsning av MRI-bilderna i sin fas...
The required revaluation of a certain number of patients showed a high level of variability and this intra-reader inconsistency will require...
The ordinary required revaluation of a certain number of patients showed a high level of variability.
Sommarens höjdpunkt i biotech-Sverige Sommarens stora händelse på den svenska biotechscenen är resultaten från SPARKLE-studien med Ascelias ...
Based on earlier studies, we use a LOA of 85%. If the headline results due by mid-2023 are favorable, we expect Ascelia to complete the Clin...
Kvartalsrapport i linje med våra förväntningar Ascelia presenterade under gårdagen en Q1-rapport som var i linje med våra förväntningar.
The main points is that Ascelia reminds investors that Last Patient Last Visit (LPLV) was completed in March and that Ascelia reminas on tra...
Ascelia is preparing and planning for the launch, and the activities are now expected to shift gear as the pivotal SPARKLE study is fully re...
Q4 – fullt fokus på patientrekrytering Ascelia levererade under fredagen en rapport i linje med våra förväntningar.
Ascelia’s leading SPARKLE study has recruited 71 (out of 80) patients, as announced earlier, and the study is on track for completion by the...
Ascelia announced that 65 patients has now completed the SPARKLE study.
Ändrad omfattning av SPARKLE-studien Ascelia meddelade under förgående vecka att de planerar att stänga fas III-studien med Orviglance med 8...
Bolaget uppdaterar tidsplanen samt minskar antalet deltagare i SPARKLE-studien.
Ascelia's pivotal SPARKLE study will not be completed with 80 patients (earlier up to 200) and we can expect completion by February-March (e...
Q3-rapporten Ascelia presenterade i fredags sin Q3-rapport.
Ascelia is reporting progress towards pivotal results with contained operational costs and cashflow.
Målsättningarna för helåret kvarstår och en FDA-ansökan närmar sig allt mer.
Q2-rapport Ascelias Q2-rapport innehöll inga överraskningar och var i linje med våra förväntningar.
