In February 2021, Oncopeptides’ drug candidate for relapsed or refractory multiple myeloma, Pepaxto®, was approved by the FDA for use in the USA. This marked an astonishing accomplishment for a small Swedish biotech company, but also the start of significant regulatory hurdles.
In March the same year, Pepaxto was commercially available and the first patients received treatment. The drug was well received however, only a few months later, the FDA issued a safety alert regarding Pepaxto, after the presentation of phase 3 data, which ultimately led to a voluntary withdrawal of the product in October. This forced the company to make some tough decisions, close business operations, dismantle the organization, and refocus on R&D.
At the moment, Oncopeptides has rescinded the withdrawal of Pepaxto in the USA and is awaiting a CHMP recommendation regarding a marketing authorization in Europe in Q2.
To learn about how Oncopeptides managed the extraordinary challenges it faced, don’t miss the chance to hear Jakob Lindberg, CEO of Oncopeptides, in an exclusive webcast conversation with Carolin Wiken, partner at Paues Åberg Communications. Topics that will be addressed include:
- How to communicate clinical data and regulatory setbacks
- How to staff your organization in different stages of development
- How to finance your operations
- How to manage the stakeholder frustrations
When: June 1, 2022, 8:30 – 9:30 am CEST
Link to webcast: https://financialhearings.com/event/44387
For more information, please contact: email@example.com