<a id="bm-comp-9525cde2-3a90-4877-8d8f-01a629c6e53a" name="bm-comp-9525cde2-3a90-4877-8d8f-01a629c6e53a" class="BMCustomAnchor"></a><table><tr><td bm-component-id="9525cde2-3a90-4877-8d8f-01a629c6e53a" style="vertical-align: top; width:100.000000%;"><ul><li>Type A meeting with the FDA scheduled for September 9</li><li>Implementing cost-saving measures</li><li><a data-bm-trackable="false" href="https://ascelia-pharma.events.inderes.com/q2-report-2026/register" target="_blank">Conf call</a> at 10am CET</li></ul></td></tr></table><a id="bm-comp-86b1ffa7-61f0-49cd-994a-30ce1340f4f7" name="bm-comp-86b1ffa7-61f0-49cd-994a-30ce1340f4f7" class="BMCustomAnchor"></a><table><tr><td bm-component-id="86b1ffa7-61f0-49cd-994a-30ce1340f4f7" style="vertical-align: top; width:100.000000%;"><h3 class="bm-h3">Recent and upcoming relevant events</h3><p>Following the July 2, 2026 Complete Response Letter for Orviglance, which cited concerns over the SPARKLE re-read (potential reader bias and a T1-only scoring scope) alongside small product documentation questions, Ascelia disputed both clinical grounds while acknowledging the product quality points, and moved to request an expedited Type A meeting. The FDA has now accepted that request and scheduled the meeting for September 9, 2026. Ahead of it, Ascelia has submitted a briefing package addressing each CRL topic, confirming it has aligned with and implemented the FDA's product quality recommendations, and defending the scientific rationale for the SPARKLE re-read, including reader training and the use of T1-weighted imaging as the basis for assessing lesion visualisation. Management reiterates confidence in the overall data package, with an update expected once official meeting minutes are received following the September 9 meeting (issued within 30 days, i.e. by mid-September).</p><h3 class="bm-h3">Implementing cost-saving measures</h3><p>Operating cash flow was SEK -14m (SEK -16m in Q1'26), as opex decreased 30% q-o-q. Following a directed share issue of gross SEK 20m in the quarter, cash and cash equivalents came in at SEK 34m (SEK 38m in Q1'26). After quarter's end, Ascelia has implemented cost-saving measures including the departure of the CFO to provide flexibility for supporting activities related to the CRL, which is stated to extend the cash runway into Q2'27.</p><h3 class="bm-h3">Conference call at 10am</h3><p>Ascelia will host a <a data-bm-trackable="false" href="https://ascelia-pharma.events.inderes.com/q2-report-2026/register" target="_blank">conference call</a> at 10am CET today.</p></td></tr></table>
Ascelia Pharma - Still alive: Fighting to reverse the FDA setback
20 augusti 2026