MaaT Pharma Positive DSMB safety analysis for MaaT033 phase 2 in allo-...

MaaT announced the positive outcome of a key DSMB safety interim analysis for the phase 2b trial (PHOEBUS), which compares the efficacy and safety of MaaT033 (microbiome therapy, oral capsule) to placebo in patients undergoing an allogeneic hematopoietic stem cell transplantation (allo-HSCT). We are encouraged by the DSMB outcome, particularly in the context that allo-HSCT is a high risk patient population, and see this as supportive of MaaT033´s good safety profile. We note that MaaT033 is next...

MaaT Pharma To present preclinical data on MaaT034 at AACR

MaaT will present new non-clinical data on MaaT034 (donor independent microbiome therapy) at the American Association for Cancer Research (AACR) conference, taking place on 25-30 April. The results demonstrate MaaT034's potential as a combination therapy to improve responses to checkpoint inhibitors in solid tumours. Being co-cultured means MaaT034 is donor-independent, which offers the scale required for the larger solid tumour market. Initial data from the phase 2 placebo-controlled trial of l...

Morning Notes : COLR BB, FLOB BB, KIN BB, MAAT FP, ONWD BB

: COLR BB, FLOB BB, KIN BB, MAAT FP, ONWD BB

Morning Notes : ELI BB, IVA FP, MONT BB, SOF BB, TESB BB, UMI BB, VGP ...

: ELI BB, IVA FP, MONT BB, SOF BB, TESB BB, UMI BB, VGP BB, MAAT FP, DEME BB, ONWD BB, EXO NA

MaaT Pharma FIRST LOOK: FY24 results extend runway with € 13m private ...

MaaT reported FY24 results with the key item being the private placement of € 13m supported by existing shareholders. This extends the company's runway into October 2025 (previously into 2Q25) and provides sufficient funding to reach a number of milestones including MAA submission for MaaT013 to the EMA (June 2025), and enables the company to make progress with its regulatory interactions with the FDA to clarify the route to market in the US. On the pipeline front, we continue to look forward to...

Benelux Morning Notes

Arcadis: Short-term uncertainty, long-term continues to look attractive. Coverage change. Results Calendar

Alfen/Specific qualities for a specific audience/BUY (previously Hold)

Alfen's 4Q24 results were broadly in line with our expectations, but with the new medium-term objectives as well as the more specific 2025 guidance undershooting our below consensus expectations. We therefore cut our 2025-26 revenue estimates by 11% and 14% and our EBITDA estimates by 28% and 24% respectively. Management did bite the bullet and provided more cautious end market growth prospects for the different business segments. Equally importantly, several cost actions were taken that should ...

MaaT Pharma FIRST LOOK: Positive DSMB review for lead product MaaT013 ...

MaaT announced that the independent data safety monitoring board (DSMB) completed its final safety assessment of the pivotal phase 3 (ARES) trial of MaaT013 in 3L aGvHD, which was in line with previous evaluations confirming the favourable benefit/risk ratio of the product. As a reminder, MaaT013 met its primary endpoint in the phase 3 (ARES) trial, and results presented in January 2025 demonstrated a 28 day GI-ORR of 62%, which came in above expectations. Looking ahead, we look forward to the r...

Morning Notes : GIMB BB, UCB BB, MAAT FP, BTLS BB

: GIMB BB, UCB BB, MAAT FP, BTLS BB

MaaT Pharma MaaT013 PIP approval clears path for MAA submission in Jun...

MaaT announced that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved the pediatric investigation plan (PIP) for MaaT013 for the treatment of acute Graft-versus-Host Disease (aGvHD). The approval of the pediatric investigation plan (PIP) for MaaT013 in aGvHD is a positive step for the company as an approved PIP is a prerequisite for filing a marketing authorization application (MAA). As such, MaaT is on track to submit the MAA for MaaT013 in Europe in June 2025, which m...

Morning Notes : ADYEN NA, AGFB BB, BFIT NA, IMMO BB, TINC BB, ALFEN NA...

: ADYEN NA, AGFB BB, BFIT NA, IMMO BB, TINC BB, ALFEN NA, ZEAL DC

Alfen: Michelle Lesh steps down as CCO

This morning, Alfen announced that Michelle Lesh, who has served as Alfen's CCO since 2021, has decided to step down from her role, effective 31st March 2025. Over the past four years, Michelle was instrumental in leading Alfen’s commercial and business development efforts across all three of its b

Morning Notes : GREEN BB, TINC BB, ALFEN NA

: GREEN BB, TINC BB, ALFEN NA

Alfen Between a rock and a hard place

In this note, we analyse Alfen's recent financial performance and future outlook. Despite being undervalued based on fundamentals, Alfen faces significant challenges. The company must navigate a delicate balance: they can't afford to set overly optimistic targets and risk missing them, but setting targets too low could undermine investor confidence. We lower our revenue and margin estimates based on the current market conditions. Consequently, our DCF based target price decreases from € 24 to € ...

Alfen: FY24 results, disappointing outlook

Yesterday, Alfen published FY24 revenues (down 3.3% YoY at EUR487.6m) broadly in line with consensus and BGe expectations (respectively EUR483.0m and EUR485.2m). Gross margin, however, came in at 23.7% (-6.3ppt vs. 30.0% in FY23) and was affected by significant one-off items whereas adjusted EBITDA

ODDO BHF Small & MIDCAP MORNING NEWS – 02/13/2025