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Jacob Mekhael
  • Jacob Mekhael

mdxhealth Collaboration with Oxford could further validate GPS in pros...

Yesterday before US market opens, mdxhealth announced the next major phase of its collaboration with the University of Oxford: the initiation of Genomic Prostate Score (GPS) testing in the landmark UK ProtecT trial (Prostate Testing for Cancer and Treatment). This study is designed to establish GPS as the first genomic classifier supported by randomised clinical trial evidence in an Active Surveillance cohort, further validating the clinical utility of GPS in predicting prostate cancer progressi...

Jacob Mekhael
  • Jacob Mekhael

Autolus To assess feasibility of Cellares' platform for CAR-T manufact...

Yesterday before US market opens, Autolus announced that it will assess the feasibility of Cellares' Cell Shuttle platform to complement its commercial manufacturing operations at the Nucleus facility in the UK. This evaluation could open the door for Autolus to expand its manufacturing to meet future demand from the larger autoimmune indications, which would likely require more than the 2000 batches per year capacity that the existing Nucleus facility is able to produce. $ 9 TP and BUY maintain...

Jacob Mekhael ... (+2)
  • Jacob Mekhael
  • Livio Luyten
 PRESS RELEASE

Autolus Therapeutics to Evaluate Automated Manufacturing of AUCATZYL® ...

Autolus Therapeutics to Evaluate Automated Manufacturing of AUCATZYL® (obe-cel) on the Cellares Cell Shuttle™ Platform Autolus will evaluate Cellares’ fully automated, high-throughput manufacturing platform in preparation for expansion into new indications SOUTH SAN FRANCISCO, Calif. and LONDON, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, and Cellares Corp, the first Integrated Development and Manufacturing Organization (IDMO),...

 PRESS RELEASE

Mdxhealth and University of Oxford to validate GPS test in largest ran...

Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer IRVINE, CA – January XX, 2026 () – Mdxhealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a leading precision diagnostics company, today announced the next major phase of its collaboration with the University of Oxford: the initiation of Genomic Prostate Score (GPS) testing in the l...

Guy Sips ... (+8)
  • Guy Sips
  • Hilde Van Boxstael
  • Jacob Mekhael
  • Kristof Samoy
  • Livio Luyten
  • Michiel Declercq
  • Thibault Leneeuw
  • Wim Lewi

Morning Notes : BAR BB, COFB BB, FAGR BB, GLPG NA, IBAB BB, DEME BB, N...

: BAR BB, COFB BB, FAGR BB, GLPG NA, IBAB BB, DEME BB, NXFIL NA, ENRGY BB

 PRESS RELEASE

Autolus Therapeutics Presents Updated Clinical Data from the CARLYSLE ...

Autolus Therapeutics Presents Updated Clinical Data from the CARLYSLE Trial in Patients with Severe Refractory Systemic Lupus Erythematosus at the American Society of Hematology (ASH) Annual Meeting 2025 Data show deep, durable responses in the 50 million cell dose level cohort; initial data suggest substantial early improvement in three patients dosed with 100 million cellsAll patients show deep B-cell depletion after infusion, suggesting an immune resetNine patients were evaluable for safety, no ICANS or high-grade CRS were observed LONDON and GAITHERSBURG, Md., Dec. 08, 2025 (GLOBE NE...

 PRESS RELEASE

Autolus Therapeutics Presents Initial Clinical Data in Pediatric r/r B...

Autolus Therapeutics Presents Initial Clinical Data in Pediatric r/r B-ALL Patients and Other Oncology Data at the American Society of Hematology (ASH) Annual Meeting 2025 Obe-cel demonstrates high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%; low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) observed, consistent with obe-cel’s adult safety profile FELIX study data analyses highlight product cell phenotype and level of CAR T persistence at three months as pote...

Hilde Van Boxstael ... (+5)
  • Hilde Van Boxstael
  • Jacob Mekhael
  • Livio Luyten
  • Mathijs Geerts Danau
  • Wim Lewi
Guy Sips ... (+3)
  • Guy Sips
  • Jacob Mekhael
  • Wim Lewi
 PRESS RELEASE

Autolus Therapeutics Appoints Ryan Richardson to Board of Directors

Autolus Therapeutics Appoints Ryan Richardson to Board of Directors LONDON and GAITHERSBURG, Md., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced the appointment of Ryan Richardson to the Company’s Board of Directors. Mr. Richardson brings more than 20 years of strategy and corporate development experience and in the healthcare and investment banking industries to Autolus’ Board. “Autolus has entered a new pha...

Jacob Mekhael
  • Jacob Mekhael

Autolus NICE recommends Aucatzyl for r/r adult B-ALL in England and Wa...

Autolus announced that the National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Aucatzyl (obe-cel, CD19 CAR-T) for use in the National Health Service (NHS) in England and Wales as a treatment option for adult patients (=26 years) with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r B-ALL). Aucatzyl will be available through routine commissioning by the NHS, and Autolus intends to launch the product in England and Wales immi...

Jacob Mekhael ... (+3)
  • Jacob Mekhael
  • Kristof Samoy
  • Thibault Leneeuw
 PRESS RELEASE

NICE Recommends AUCATZYL® (obecabtagene autoleucel) as a Treatment Opt...

NICE Recommends AUCATZYL® (obecabtagene autoleucel) as a Treatment Option for Adult Patients (≥26 years) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)¹ AUCATZYL® will be available through routine commissioning by the UK National Health Service (NHS) LONDON, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the National Institute for Health and Care Excellence (NICE) has pu...

Jacob Mekhael ... (+5)
  • Jacob Mekhael
  • Lynn Hautekeete
  • Thomas Couvreur
  • Wim Hoste
  • Wim Lewi
Jacob Mekhael
  • Jacob Mekhael

Autolus Upping our Aucatzyl sales estimates in r/r ALL

Last week, Autolus reported 3Q25 results. Autolus reported 3Q25 sales of $21.1m, bringing the total for 9M25 to $51m. In our launch preview published in January 2025, we estimated Aucatzyl could generate $43m in FY25 sales vs. $37m CSS estimate. Ours and CSS initial estimates turned out to be conservative given that Aucatzyl generated $51m in 9M25. As such, we increase our Aucatzyl FY25 sales estimate in the US to $72.5m, and increase our peak market share to 50% (from 40%) supported by strong i...

 PRESS RELEASE

Autolus Therapeutics to Participate in the Jefferies Global Healthcare...

Autolus Therapeutics to Participate in the Jefferies Global Healthcare Conference in London LONDON and GAITHERSBURG, Md., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the Company will participate in the Jefferies Global Healthcare Conference in London. Autolus Chief Executive Officer Dr. Christian Itin will present in a Fireside Chat on Tuesday, November 18, 2025 at 7:30am EST / 12:30pm GMT. A webcast of th...

Mathijs Geerts Danau
  • Mathijs Geerts Danau

mdxhealth 3Q25 results continue adj. EBITDA profitability, guidance ma...

Yesterday evening mdxhealth reported 3Q25 results. The company had $ 27.4m in revenue up 18% y/y, with a gross margin of 65.2% representing a 4% improvement. OPEX was essentially flat leading to a second quarter of adj. EBITDA profitability of $ 1m. The company reiterated its FY25 revenue guidance and reported that it will fully focus on integrating the ExoDx acquisition into the business in the 4Q25. Therefore, it will postpone Germline and re-evaluate the opportunity in 2026. We reiterate our ...

Mathijs Geerts Danau
  • Mathijs Geerts Danau

Autolus Launch continues, FY25 beat is within reach

Autolus reported 3Q25 sales of $ 21.1m which came in slightly below CSS expectations of $ 21.9m. However, deferred revenue of $ 7.6m was significantly higher than the previous quarter giving us confidence that FY25 expectations are achievable. Additionally, at ASH 2025 Autolus plans to present longer follow-up in SLE and initial data in pediatric ALL, the topline results indicate a competitive profile against Kymriah. Autolus reiterated its plans to start a pivotal study in LN and a phase 1 in A...

Guy Sips ... (+7)
  • Guy Sips
  • Hilde Van Boxstael
  • Jacob Mekhael
  • Mathijs Geerts Danau
  • Thomas Couvreur
  • Wim Hoste
  • Wim Lewi

Morning Notes : AGN NA, AGFB BB, IVA FP, MDXH BB, MELE BB, SOLB BB, DE...

: AGN NA, AGFB BB, IVA FP, MDXH BB, MELE BB, SOLB BB, DEME BB, AUTL US, ZEAL DC, PHVS US

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