MediWound Ltd. (MDWD) has seen a decline of 18.92% in the aftermarket. However, the last trading session closed at $2.59 with a decrease of 5.82%.
Pediatric Label Extension – What’s up?
On 18th November 2021, MDWD reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given the Company good scientific advice on the pediatric label modification for NexoBrid. The Company plans to file a pediatric label authorization form in the first half of 2022, based on the input.
So what?
The company is overjoyed to have gained cooperation and favorable advice from the CHMP on the regulatory process. Having a non-surgical alternative for these badly burnt young kids will be a huge improvement over the present surgical standard.
NexoBrid has seen significant growth in Europe, and our marketing team and sales partner are excited to extend the market and continue to enhance the standard of care with the prospective pediatric label extension.
Third Quarter 2021 Results by MDWD – How’s the quarter?
MDWD announced third quarter 2021 results on 16th November 2021. According to the report issues, the overall revenue was $6.4 million, compared to $6.6 million in the same period of 2020. Moreover, the first nine months of 2021 had total revenues of $18.3 million, 21% more than $15.1 million at the same time of 2020. Furthermore, the firm has $13.9 million in cash and short-term investments.
The Company achieved clarity on a route forward for resubmitting its NexoBrid Biologics License Application (BLA). Last but not least, the company also released positive top-line findings for eschar eradication of severe heat burns in phase III pediatric research.
Now what?
MDWD is happy with the success it has achieved across the portfolio this quarter. The company managed to gain regulatory clarity on the NexoBrid BLA resubmission pathway, and it keeps making substantial progress in EscharEx’s clinical development programs.
Moreover, as the company moves close to the year and looks ahead to 2022, they remain positive about its initiatives. Lastly, MDWD is excited to keep the momentum going as they work toward their strategic goals.
Second Quarter 2021 Financial Results by MDWD
MDWD reported second-quarter 2021 results on 10th August 2021. In the second quarter of 2021, total revenues were $6.1 million, 50% more than the same period in 2020. Moreover, the firm has $17.2 million in cash and short-term investments.
Interim review for the EscharEx U.S. phase II adaptive design trial found no modifications to the study. However, the complete study enrolment is scheduled by the end of 2021, with data readout in the first part of 2022.
