Latest Ascelia Pharma News & Updates

See the latest news and media coverage for Ascelia Pharma. We track all announcements, press releases, and industry mentions in real time, all in one place.

Ascelia Pharma

Biotech company focused on orphan oncology drugs

ascelia.com

Headquarters: Malmö, Sweden
Founded year: 2000
Company type: Public company
Number of employees: 14–50
Industry: Pharmaceuticals

Last updated October 11

Latest news about Ascelia Pharma

In short: Ascelia Pharma received an FDA Complete Response Letter requiring a new Orviglance study and pivoted toward Europe.

Company announcements

October 11 Ascelia Pharma

Ascelia Pharma updates on Orviglance after Type A meeting with FDA

FDA requires additional evidence but accepts analysis of existing data. The company focuses on Europe and partnerships.

August 17 Ascelia Pharma

Ascelia Pharma publishes Q2 2026 financial and regulatory updates

The company received an FDA Complete Response Letter for Orviglance and scheduled a follow-up meeting. Executive changes and targeted cost reductions support liquidity during the review phase.

July 3 Ascelia Pharma

Ascelia Pharma receives FDA Complete Response Letter for Orviglance NDA

The FDA requests additional clinical data and product documentation. Ascelia will seek a Type A meeting to find an expedited path forward.

May 11 Ascelia Pharma

Ascelia Pharma approaches FDA decision for Orviglance

The company reports reduced loss and strengthens cash ahead of partnership discussions. Orviglance's NDA is reviewed with decision on July 3, 2026.

Media coverage

October 11 Dagens industri

FDA demands new study from Ascelia Pharma after collapse

Ascelia Pharma collapsed last summer after a rejection of an NDA application to the US Food and Drug Administration FDA. They demand a new study, which the company...

August 20 Investing.com

Despite FDA setback: Ascelia Pharma stock rises by 8.2%

Since no forecasts for EPS or revenue were available, there is no direct comparison with analyst expectations. The reported operating loss of 12 million SEK indicates...

August 19 Zone Bourse

Ascelia Pharma AB (publ) publishes its results for the second quarter and the first half ended June 30, 2026

Ascelia Pharma AB has communicated its financial results for the second quarter and the first half ended June 30, 2026. For the second quarter...

August 19 Økonomisk Ugebrev

Ascelia Pharma: Investors fumble in the dark until FDA meeting minutes

It was the worst possible outcome for Ascelia Pharma and its investors, when the FDA over the summer gave a negative answer to the application...

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