reports
- Jacob Mekhael
- Thomas Vranken
Sequana Medical FDA approval for alfapump
Sequana receives a nice Christmas present this year as it obtained PMA approval from the FDA for its alfapump system in the treatment of r/r ascites due to liver cirrhosis, ahead of the guided 1Q25 timeline. We see the approval as an important derisking event for the company, which will enable the company to address a market opportunity of $ >2bn (mgmt. estimates) in the US. The commercialisation intends to specifically target 90 liver transplant centres and is expected to launch in 2H25. We not...
- Hilde Van Boxstael
- Thomas Vranken
- Wim Lewi
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Sharad Kumar S.P
- Wim Lewi
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Sharad Kumar S.P
- Wim Lewi
- Guy Sips
- Jacob Mekhael
- Thibault Leneeuw
- Thomas Vranken
- Kristof Samoy
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Sequana Medical FIRST LOOK: Convertible loan broadened with additional...
Sequana has expanded its existing € 6.1m convertible loan announced on September 30, 2024 with an additional € 1.0m from existing investors. Same terms apply for the additional cash, as it provides a bit more leeway into the expected PMA approval for the alfapump (expected 1Q25).
- Jacob Mekhael
Sequana Medical € 6m convertible and debt restructuring extend runway ...
Sequana reported 1H24 results and announced a new convertible loan of € 3.05m (additional tranche of € 3.05m), extending its runway into 1Q25. The company is exploring separating the DSR and alfapump businesses into Hive-Downs to solve for the lack of synergy between programs. Additionally, Sequana restructured its debt with Kreos, PMV, Belfius, and Sensinnovat. Responses to the FDA 90 Day letter will submitted on 1 October, and alfapump PMA approval continues to be expected by 1Q25.
- Jacob Mekhael
- Thomas Vranken
- Wim Hoste
- Jacob Mekhael
- Michiel Declercq
- Thomas Vranken
Life Sciences Conference 26.09.2024
This conference booklet is your guide to our Life Sciences Conference set to take place on Thursday, 26 September 2024 at our historic building at Grand Place in Brussels. This event offers the possibility to have one-on-one meetings and/or join pitch sessions with the following companies and their top management: Public: AUTOLUS | GALAPAGOS | HYLORIS | INVENTIVA | MAAT PHARMA | ONWARD MEDICAL | SEQUANA MEDICAL | UCB | ZEALAND PHARMA Private: CONFO TX | MRM HEALTH | PANTERA | SKYLINE DX
- Jacob Mekhael
- Thomas Vranken
- Jacob Mekhael
Sequana Medical Presents alfapump QOL benefit in liver ascites at EASL
Sequana will present previously reported outcomes from a matched cohort analysis of the POSEIDON study and NACSELD3 registry showing a quality of life benefit with comparable safety for the alfapump vs. standard of care (paracentesis) in liver ascites, at EASL being held 5-8 June. We believe the data continues to support the alfapump's positioning and look forward to PMA approval expected in 1Q25, and subsequent US commercial launch in 2H25. We reiterate our BUY rating and € 6 TP.
- Hilde Van Boxstael
- Jacob Mekhael
- Michiel Declercq
- Thibault Leneeuw
- Wim Lewi
- Jacob Mekhael
Sequana Medical FIRST LOOK: 100 day meeting shifts alfapump PMA approv...
Sequana announced the agreed outcome of the day 100 meeting with the FDA following receipt of the day 90 letter in relation to the PMA submission for the alfapump in liver ascites. The FDA requested additional work related to non-clinical aspects, and Sequana now expects FDA approval before end of 1Q25 (previously 3Q24). While the shift in the timing for PMA approval (1Q25 vs. 3Q24) is not ideal, timeline for US commercial launch remains unchanged (2H25). We note that the FDA was satisfied with ...
- Hilde Van Boxstael
- Wim Lewi
- Laura Roba
Sequana Medical - Update on FDA approval
Sequana Medical announced the outcome from the Day 100 meeting with the FDA. The positive news is that the FDA did not have any additional clinical questions, which partially de-risks the approval. Some non-clinical questions remain to be answered. Management indicates that those are manageable and should be completed by end of September 2024.The company will exclude its DirectLink software from the PMA submission for the time being. Instead of being sent automatically to the doctors, the alfap...
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Couvreur
- Wim Lewi
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Sharad Kumar S.P
- Thibault Leneeuw
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
Sequana Medical FIRST LOOK: FY23 update comes with 90-day FDA letter f...
Sequana reported FY23 results with a cash position of € 2.6m (YE22: € 18.9m), which together with the € 3m convertible loan in February 2024 and € 11.5m equity placement in March 2024, provides a cash runway to end of 3Q24. The company is evaluating the feedback received last night in the 90-day letter from the FDA. Given the short timeframe, management is unable to provide more details on the FDA comments, and will update the market in due course. The company has a day-100 meeting scheduled wit...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Thomas Couvreur
- Wim Lewi
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