Vitrolife

Hansa Biopharma

Xvivo Perfusion

Moberg Pharma

Cantargia

CellaVision

Calliditas Therapeutics

While we find the feedback from PDCO undoubtedly positive, we do not find it surprising given the large unmet medical need in this patient population and the reliant stance previously seen from regulatory agencies.
The most important takeaways from today&#39;s news are that, given successful completion of the agreed PIP, Calliditas has de-risked its regulatory pathway to market further, and additionally prolonged its market exclusivity with two years in the EMA region (a total of 12 years from the date of a potential approval).
We will elaborate more on this in a subsequent update on the company. Our current base case amounts to SEK 90, with a bull- and bear case of SEK 165 and 35, respectively.