reports
- Jacob Mekhael
Autolus FIRST LOOK: 3Q24 update focusses on Aucatzyl's launch in r/r a...
Yesterday before US market opens, Autolus reported 3Q24 results with a cash position of $657.1m (YE23: $239.9m), sufficient to drive Aucatzyl's (obe-cel, CD19 CAR-T) launch in r/r adult ALL, and advance the company's pipeline towards pivotal autoimmune data (KBCSe 2028). The focus of the 3Q24 update was Aucatzyl's upcoming launch, and we expect the large safety differentiation vs. Tecartus to be a key factor for adoption. In parallel, we look forward to initial autoimmune data in 1Q25, which has...
- Jacob Mekhael
- Michiel Declercq
- Thibault Leneeuw
- Thomas Couvreur
- Wim Lewi
Autolus Therapeutics Reports Third Quarter 2024 Financial Results and ...
Autolus Therapeutics Reports Third Quarter 2024 Financial Results and Business Updates AUCATZYL® (obecabtagene autoleucel) approved by US FDA on November 8, ahead of target PDUFA date of November 16; US commercial launch initiatedBLA approval triggers $30m milestone payment to Autolus from Blackstone Marketing authorizations for obe-cel under review with both the MHRA EMAMatthias Will M.D. appointed as Chief Development Officer, effective September 30, 2024Conference call to be held today at 08:30 am EDT/13:30 pm BST: conference call participants should pre-register using the link at the bo...
- Jacob Mekhael
Autolus Christmas came early! CAR-T hits the road with FDA approval in...
Our life sciences top pick Autolus secured FDA approval for Aucatzyl (obe-cel, CD19 CAR-T) in r/r adult B-ALL ahead of the scheduled PDUFA date of 16 November. In our view Aucatzyl has a best in class safety profile, and the absence of a requirement for a REMS program from the FDA provides further validation of its differentiated safety. Based on KOL feedback, Aucatzyl's safety profile will be a key driver for adoption, and we think no REMS will give this a further boost! We look forward to the ...
Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene...
Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy)Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALLConference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 08, 2024 (GLOB...
MaaT Pharma présentera une mise à jour des données issues de son progr...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT : MAAT - la « Société »), société de biotechnologies en stade clinique avancé, leader dans le développement de Microbiome Ecosystem TherapiesTM (MET)1 visant à améliorer la survie des patients atteints de cancers grâce à la modulation du système immunitaire, annonce que les données mises à jour issues du programme d'accès compassionnel (Early Access Program ou EAP) en Europe portant sur 154 patients atteints de la maladie du greffon contre l’hôte gastro-intestinale (GI-aGvH) réfractaire aux stéroïdes (SR) ou dépendante aux stéroïdes ...
MaaT Pharma to Present Updates from Early Access Program at the 2024 A...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced that updated results from its Early Access Program of MaaT013 in 154 patients with steroid-refractory (SR) or dependent (SD) gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD) have been selected for poster presentation at the . GI-aGvHD is a major cause of morbidity and mortality following allogene...
- Guy Sips
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Thibault Leneeuw
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
ASH abstracts Autolus, Galapagos, MaaT
The abstracts for presentations at ASH (7-10 December) became available yesterday during the day (here). While we may have to wait until the actual conference for the latest datasets, here in this note are some key takeaways for our coverage including updates from Autolus (digging deeper into the obe-cel dataset), Galapagos (more CAR-T data and pre-clinical data on TCR-T) and MaaT (early access program in aGvHD):
Galapagos to Present Results of Pioneering Innovation in Cancer Cell T...
Galapagos to Present Results of Pioneering Innovation in Cancer Cell Therapy at ASH 2024 New Phase 1/2 data support the potential of our CAR T-cell therapy candidates, GLPG5101 and GLPG5201, in addressing unmet needs for patients with poor prognoses. Our innovative decentralized cell therapy manufacturing platform delivers fresh, fit cells within a median vein-to-vein time of seven days, with potentially encouraging patient outcomes. Three abstracts, including one oral presentation for GLPG5101 in relapsed/refractory non-Hodgkin lymphoma, and a company showcase, will spotlight our cutting-e...
Galapagos presenteert resultaten van baanbrekende innovatie in kankerc...
Galapagos presenteert resultaten van baanbrekende innovatie in kankerceltherapie op ASH 2024 Nieuwe fase 1/2 resultaten ondersteunen het potentieel van onze CAR T-celtherapiekandidaten, GLPG5101 en GLPG5201, om tegemoet te komen aan de onvervulde behoeften bij patiënten met een slechte prognose. Ons innovatieve gedecentraliseerde celtherapieproductieplatform levert verse, fitte cellen binnen een mediane vein-to-vein tijd van zeven dagen, met een bemoedigende impact op de resultaten voor patiënten. Drie abstracts, waaronder een mondelinge presentatie voor GLPG5101 bij recidief/refractair non...
MaaT Pharma publie ses résultats financiers pour le troisième trimestr...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT : MAAT - la « Société »), société de biotechnologies en stade clinique avancé, leader dans le développement de Microbiome Ecosystem TherapiesTM (MET)1 visant à améliorer la survie des patients atteints de cancers grâce à la modulation du système immunitaire, annonce aujourd'hui un point sur ses activités et la publication de sa trésorerie et de son chiffre d’affaires jusqu'au 30 septembre 2024. Faits cliniques marquants MaaT013 Hémato-oncologie : En , MaaT Pharma a annoncé que les lots de MaaT013 étaient produits et prêts à êtr...
MaaT Pharma Provides Third Quarter 2024 Business and Financial Results...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today provided a business update and reported its cash position and revenue as of September 30, 2024. Pipeline highlights MaaT013 In hemato-oncology: In , MaaT Pharma announced that MaaT013 batches were ready for distribution for clinical supply in the US and that MaaT Pharma advanced the readiness phase for th...
Autolus Therapeutics to Present Clinical Data Updates at the American ...
Autolus Therapeutics to Present Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2024 in One Oral Presentation and Three Poster Presentations LONDON, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, announces the online publication of four abstracts submitted to the American Society of Hematology (ASH) Annual Meeting, to be held from December 7-10, 2024, in San Diego. “The FELIX study’s rich data set continues to provide importan...
- Jacob Mekhael
- Emira Sagaama
- Michael B. Schäfer
SOP SOPRA STERIA GROUP SA
TFI TELEVISION FRANCAISE 1 SA
VETO VETOQUINOL SA
LSS LECTRA SA
EBRO EBRO FOODS SA
MBB MBB INDUSTRIES SE
G24 SCOUT24 AG
ELIS ELIS SA
MAREL MAREL HF.
AIXA AIXTRON SE
ATS AT & S AUSTRIA TECHNOLOGIE & SYSTEMTECHNIK AKTIENGESELLSCHAFT
ROYAL VOPAK NV
DLG DE'LONGHI S.P.A.
FDR FLUIDRA S.A.
MELE MELEXIS NV
SPIE SPIE SA
GLPG GALAPAGOS NV
IDR INDRA SISTEMAS S.A. CLASS A
UNI UNICAJA BANCO S.A.
DUFN DUFRY AG
RUI RUBIS SCA
ALD ALD SA
BFSA BEFESA SA
VOS VOSSLOH AG
WAVE WAVESTONE SA
CLA CLARANOVA SE
ZEL PHARMA MAR SA
AML ASTON MARTIN LAGONDA GLOBAL HOLDINGS
TE TECHNIP ENERGIES NV
FPE3 FUCHS PETROLUB SE
STM STABILUS SE
FLOW FLOW TRADERS LTD
PLX PLUXEE NV
- Emira Sagaama
- Michael B. Schäfer
SOP SOPRA STERIA GROUP SA
TFI TELEVISION FRANCAISE 1 SA
VETO VETOQUINOL SA
LSS LECTRA SA
EBRO EBRO FOODS SA
MBB MBB INDUSTRIES SE
G24 SCOUT24 AG
ELIS ELIS SA
MAREL MAREL HF.
AIXA AIXTRON SE
ATS AT & S AUSTRIA TECHNOLOGIE & SYSTEMTECHNIK AKTIENGESELLSCHAFT
ROYAL VOPAK NV
DLG DE'LONGHI S.P.A.
FDR FLUIDRA S.A.
MELE MELEXIS NV
SPIE SPIE SA
GLPG GALAPAGOS NV
IDR INDRA SISTEMAS S.A. CLASS A
UNI UNICAJA BANCO S.A.
DUFN DUFRY AG
RUI RUBIS SCA
ALD ALD SA
BFSA BEFESA SA
VOS VOSSLOH AG
WAVE WAVESTONE SA
CLA CLARANOVA SE
ZEL PHARMA MAR SA
AML ASTON MARTIN LAGONDA GLOBAL HOLDINGS
TE TECHNIP ENERGIES NV
FPE3 FUCHS PETROLUB SE
STM STABILUS SE
FLOW FLOW TRADERS LTD
PLX PLUXEE NV
- Damien Choplain
- Martial Descoutures
Galapagos : Sharp ramp-up in R&D costs
>A sharp ramp-up in R&D costs - Galapagos reported yesterday its Q3 earnings after the closure of the US market. Revenues stood at € 60m vs € 70m forecast. These revenues come mainly from the booking of its agreement over 10 years with Gilead. In terms of costs, opex ramp up very sharply in the first 9M of the year.The R&D business is developing as expected following the progress in clinical programs, but costs are proving far higher than forecasts with a s...
- Jacob Mekhael
Galapagos Uneventful 9M24 results, new cell therapy data at ASH
Galapagos reported uneventful 9M24 results with a cash position of € 3.3b, and reiterated its FY24 cash burn guidance of € 370-410m (including BD). In the pipeline, we most look forward to new data from the phase 1/2 ATALANTA-1 and EUPLAGIA-1 CAR-T studies at ASH in December 2024, and are keen to see the solid outcomes observed to date confirmed in a larger set of patients and with longer follow up. In addition, the company plans to present pre-clinical data for uza-cel (TCR-T), and we hope to g...
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Thomas Couvreur
- Wim Hoste
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