Hematology Today—November 17, 2025

LucidQuest

1 day ago

This week’s hematology news brings you the most important developments, regulatory updates, and industry breakthroughs across biopharma.

In Today’s Newsletter

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💊 Blenrep reimbursement recommendations from Canada’s Drug Agency [1] [Canada • 13 Nov 2025]

https://myeloma.ca/2025/11/14/cda-recommends-public-reimbursement-of-blenrep-a-step-forward-for-canadians-living-with-myeloma/
Context: Health Canada approval Jul 2025; only anti-BCMA ADC in myeloma; community-center administration feasible.
Key point: CDA recommended reimburse-with-conditions for belantamab mafodotin combos in RRMM, supported by DREAMM-7/8 (endpoints not specified).
Implication: May influence prescriber choice and payer reviews pending full data.

🧠 CHARM advances CHM-029, a pan-menin inhibitor for AML [2] [UK • 13 Nov 2025]

https://charmtx.com/charm-therapeutics-advances-a-next-generation-menin-inhibitor-as-its-first-clinical-candidate-for-acute-myeloid-leukaemia/
Context: AI discovery via DragonFold; preclinical dose-dependent tumor regression in wild-type and mutant menin models.
Key point: CHM-029 nominated to overcome resistance mutations; first-in-human expected Q2 2026.
Implication: Signals pipeline investment and modality expansion.

🧪 Moleculin MIRACLE Phase 2B/3 AML study recruitment update [3] [US • 13 Nov 2025]

https://moleculin.com/moleculin-reports-60-of-first-45-subjects-in-pivotal-miracle-phase-3-aml-trial-consented/
Context: Global randomized double-blind adaptive trial of Annamycin + HiDAC vs HiDAC; blinded activity within expected range.
Key point: 60% of first 45-subject unblinding cohort consented as of 04 Nov 2025; first 45 treatments planned to complete Q1 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

✅ FDA clears TELLOMAK 3 confirmatory Phase 3 for lacutamab in CTCL [4] [US • 10 Nov 2025]

https://www.innate-pharma.com/media/all-press-releases/innate-pharma-announces-fda-clearance-proceed-tellomak-3-confirmatory-phase-3-trial-lacutamab-ctcl
Context: Open-label randomized cohorts in Sézary syndrome and Mycosis fungoides; comparators romidepsin or mogamulizumab; PFS by blinded central review.
Key point: FDA completed protocol review with no further comments, allowing the Phase 3 to proceed; potential accelerated approval in SS once underway.
Implication: May influence prescriber choice and payer reviews pending full data.

🧡 RMAT designation for March Bio’s MB-105 CD5 CAR-T [5] [US • 11 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/11/3185372/0/en/March-Biosciences-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-MB-105-in-Relapsed-Refractory-CD5-Positive-T-Cell-Lymphoma.html
Context: Phase 2 multicenter trial ongoing; early run-in shows activity with manageable safety (details not specified).
Key point: FDA granted RMAT to MB-105 for R/R CD5-positive T-cell lymphoma.
Implication: May influence prescriber choice and payer reviews pending full data.

🍁 Quebec first to reimburse Ojjaara for MF with anemia [6]

https://ca.gsk.com/en-ca/media/press-releases/quebec-becomes-the-first-province-to-publicly-reimburse-ojjaara-for-the-treatment-of-myelofibrosis-in-adults-who-have-moderate-to-severe-anemia/
Context: Health Canada approval Nov 2024; positive CDA-AMC and INESSS recommendations earlier in 2025.
Key point: RAMQ will fund momelotinib for newly diagnosed and previously treated MF with moderate–severe anemia; only Canadian therapy addressing spleen, symptoms, and anemia.
Implication: May expand screening, initiation, and follow-up at scale.

🎬 AbbVie launches “Second Winds” film on living with CLL [7] [US • 14 Nov 2025]

https://news.abbvie.com/2025-11-14-AbbVie-Partners-with-Award-Winning-Filmmaker-on-Film-About-the-Dynamic-and-Resilient-Lives-of-Those-Living-with-Blood-Cancer
Context: Premiered 13 Nov in Los Angeles; available on LA Times Studios Short Docs and AbbVie YouTube, wider streaming Dec 2025.
Key point: Documentary highlights three individuals’ CLL journeys and resilience.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🩸 Metagenomi MGX-001 shows FVIII restoration in NHPs (Hemophilia A) [8] [US • 11 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/11/3185757/0/en/Metagenomi-Presents-New-Preclinical-Data-from-MGX-001-Hemophilia-A-Program-Supporting-Advancement-into-Clinical-Development.html
Context: AAV + LNP genome-editing approach; dose-dependent FVIII activity; transient LFT elevations only at highest LNP dose.
Key point: Preclinical data support therapeutically relevant FVIII activity and advancement toward IND/CTA in 4Q 2026.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧯 First approval for Grifols/Biotest fibrinogen concentrate in Germany [9] [EU • 13 Nov 2025]

https://www.grifols.com/en/view-news/-/news/grifols-biotest-receives-first-regulatory-approval-for-its-fibrinogen-concentrate
Context: Prufibry approved for congenital and acquired fibrinogen deficiency; Austria and Spain expected to follow in 2026.
Key point: Paul-Ehrlich-Institut granted marketing authorization; adult and pediatric use in surgery or trauma-related bleeding.
Implication: Introduces competition that may affect pricing and formulary access.

🧷 City Therapeutics submits MHRA CTA for FXI RNAi anticoagulant [10] [UK • 10 Nov 2025]

https://www.citytx.com/news/city-therapeutics-announces-submission-of-clinical-trial-application-for-city-fxi-an-investigational-rnai-therapeutic-for-the-treatment-of-thromboembolic-diseases
Context: Preclinical data show potency, durability, specificity; FXI knockdown aims to reduce thrombosis with lower bleeding risk.
Key point: CTA filed to initiate Phase 1 in early 2026, with initial human data targeted for late 2026.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Expanding RRMM access, including community-center delivery, could reduce treatment burden in Canada [1][6].
AML pipeline momentum spans resistance-proof targeted agents and chemo-backbone innovation [2][3].
CTCL programs progress toward potential accelerated pathways in an orphan setting [4][5].
Hemostasis innovations cover editing, replacement, and anticoagulation, broadening options across bleeding and thrombosis [8][9][10].

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FAQ

What did CDA recommend for Blenrep in Canada?

CDA issued reimburse-with-conditions recommendations for belantamab mafodotin combinations in RRMM, referencing DREAMM-7/8. Endpoints are not specified in the source [1].

How is CHM-029 positioned versus first-generation menin inhibitors?

It is designed to retain potency against known resistance mutations and showed preclinical dose-dependent tumor regression. First-in-human is planned for Q2 2026 [2].

What is the status of Moleculin’s MIRACLE trial?

As of 04 Nov 2025, 60% of subjects for the first 45-patient unblinding cohort have consented, with completion of treatment for those 45 planned in Q1 2026 [3].

What did FDA clear for lacutamab?

FDA cleared the TELLOMAK 3 confirmatory Phase 3 protocol in CTCL, with a potential accelerated approval path in Sézary syndrome once the study is underway [4].

What does RMAT mean for MB-105?

RMAT provides enhanced FDA interactions and expedited review options based on early clinical evidence in R/R CD5-positive T-cell lymphoma [5].

Where is Ojjaara now reimbursed in Canada?

Quebec is the first province to fund momelotinib for MF with moderate–severe anemia, following prior federal approval and positive recommendations [6].

Entities / Keywords

Belantamab mafodotin, Blenrep, BCMA ADC; CHM-029, menin inhibitor, CHARM Therapeutics; Annamycin, naxtarubicin, MIRACLE trial, Moleculin; Lacutamab, KIR3DL2, CTCL, TELLOMAK 3, Innate Pharma; MB-105, CD5 CAR-T, March Biosciences; Momelotinib, Ojjaara, myelofibrosis, GSK; CLL awareness film, AbbVie; MGX-001, FVIII, Hemophilia A, Metagenomi; Prufibry, fibrinogen concentrate, Grifols, Biotest; CITY-FXI, FXI RNAi, City Therapeutics.