European Medicines Agency (EMA)
The CHMP endorsed the following positive opinions (initial approval or indication extension) in their October 2025 Session:
- Brinsupri (brensocatib, Insmed) in non-cystic-fibrosis bronchiectasis in adults. CHMP October highlights
- Wayrilz (rilzabrutinib, Sanofi) Rin immune thrombocytopenia in refractory adults (orphan condition). CHMP October highlights
- Breyanzi, Cejemly, Gazyvaro, Libtayo, Paxlovid, Pyrukynd, Tremfya, Scemblix — all received positive recommendations for indication extension. CHMP October highlights
- Rezurock (belumosudil, Sanofi Winthrop) in chronic GVHD after ≥ 2 lines received a negative opinion. CHMP October highlights
- Other CHMP updates consisted of the following: Hydrocortisone Aguettant — application withdrawn (BPD in preterm infants) and Oxbryta (voxelotor): suspension maintained for public-health reasons.
The PRAC, in their 27-30 October session, endorsed a DHPC reinforcing Tranexamic acid injections IV-only use with stronger warnings and distinct packaging to prevent intrathecal or epidural errors. PRAC October highlights
US Food and Drug Administration (FDA)
The FDA approved the following drugs in October 2025:
- Zepzelca (lurbinectedin) + atezolizumab (± hyaluronidase-tqjs) — maintenance therapy for extensive-stage SCLC without progression after induction. FDA approval
- Libtayo (cemiplimab-rwlc) — adjuvant treatment of high-risk cutaneous SCC after surgery + RT (adults). FDA approval
- Blenrep (belantamab mafodotin-blmf) + bortezomib + dexamethasone — relapsed/refractory multiple myeloma after ≥ 2 prior lines. FDA approval
- Revuforj (revumenib) — R/R AML with susceptible NPM1 mutation (≥ 1 year, no alternatives). FDA approval
- Lynkuet (elinzanetant) — vasomotor symptoms due to menopause (first dual NK1/NK3 antagonist). Bayer press release
The FDA issues the following updates in Prescribing information for Tranexamic acid injection: boxed warning and label changes to prevent inadvertent neuraxial administration → FDA safety update Oct 21. FDA communication
New data from clinical trials (Phase 2, Phase 3)
Here are the recent updates on Phase 2 and Phase 3 clinical trials:
- Gazyva/Gazyvaro (obinutuzumab) — Roche — Idiopathic nephrotic syndrome (2–25 yrs), INShore Phase 3 → positive; sustained remission vs MMF. Press release
- Cosentyx (secukinumab) — Novartis — Polymyalgia rheumatica, Phase 3 → positive; primary & secondary endpoints met. Press release
- Rinvoq (upadacitinib) — AbbVie — Vitiligo (adults/adolescents), two Phase 3 → positive; T-VASI50 and F-VASI75 at week 48 met. Press release
- Encaleret — BridgeBio — ADH1, CALIBRATE Phase 3 → positive; all primary and key secondaries met. Press release
- BBP-418 (ribitol prodrug) — BridgeBio — LGMD2I/R9, FORTIFY Phase 3 (interim) → positive; interim endpoints achieved. Press release
- Denifanstat — Sagimet — Moderate-to-severe acne, Phase 3 → positive; all endpoints met. Press release
- mRNA-1647 (CMV vaccine) — Moderna — Congenital CMV prevention, Phase 3 → negative; primary endpoint not met; program discontinued for congenital setting, continues in transplant study. Blog post
- Latozinemab (AL001) — Alector / GSK — FTD-GRN, INFRONT-3 Phase 3 → negative; co-primary missed; OLE and continuation studies stopped. Press release
Development Program Updates — October 2025
Moderna — mRNA-1647 (CMV vaccine) → program discontinued for congenital CMV after Phase 3 failure; continues Phase 2 in BMT setting. Blog post
Alector — Latozinemab (AL001) for FTD-GRN → OLE and continuation studies terminated; ~49 % workforce reduction and R&D leadership changes. Press release
Development Program Updates — October 2025
October marked a strong rebound in biopharma dealmaking, with 4 M&A transactions totaling an estimated ~USD 26 billion and 8 financing rounds raising approximately USD 2.4 billion across Europe and the United States.
Activity centered on RNA therapeutics, ADC platforms, and immunology, underscoring investor confidence in clinically validated and scalable technologies.
Development Program Updates — October 2025
Total: 4 deals | Combined value: ≈ USD 26 billion
- Novartis ↔ Avidity Biosciences (NASDAQ: RNA) — USD 12 billion, all-cash. Novartis expanded its RNA franchise by acquiring Avidity and its AOC™ platform for genetic neuromuscular disorders (DM1, FSHD, DMD). Press release
- Ipsen ↔ ImCheck Therapeutics — EUR 350 million upfront + up to EUR 1 billion in milestones. The deal strengthens Ipsen’s oncology pipeline via ImCheck’s BTN3A antibody ICT01 (Phase 1/2 EVICTION trial in AML). Press release
- Eli Lilly ↔ Adverum Biotechnologies (NASDAQ: ADVM) — Up to USD 12.47 per share (USD 3.56 cash + CVR up to USD 8.91). Adds Ixo-vec, an intravitreal AAV gene therapy for wet AMD, to Lilly’s ophthalmology portfolio. Press release
- Roche ↔ 89bio (NASDAQ: ETNB) — USD 14.50 per share + CVR up to USD 6.00 per share. Roche closed its tender offer for 89bio, securing pegozafermin (FGF21) for MASH and SHTG (Phase 3). Press release
Development Program Updates — October 2025
- Tubulis — EUR 308 million (≈ USD 361 million) Series C. Led by Venrock Healthcare Capital Partners with Wellington Management and Ascenta Capital. Advances lead ADC TUB-040 and expands the company’s platform. Press release
- Adcytherix — EUR 105 million Series A. Investors: Bpifrance (lead), Kurma, Andera, Angelini Ventures, Surveyor Capital (Citadel), aMoon and others. Funds early development of ADCX-020, a next-generation ADC.
- Press release
- Hemab Therapeutics — USD 157 million Series C. Led by Sofinnova Partners to advance sutacimig toward registration and HMB-002 for VWD. Press release
- Electra Therapeutics — USD 183 million Series C. Co-led by EQT Life Sciences and Nextech with new investors Sanofi, HBM, Mubadala. Funds ELA026 (anti-SIRP, sHLH) and ELA822 (immunology). Press release
- Summit Therapeutics (NASDAQ: SMMT) — USD 500 million private placement. 26.68 M shares @ USD 18.74 to finance late-stage programs for ivonescimab (PD-1/VEGF bispecific). Press release
- Kailera Therapeutics — USD 600 million Series B. Led by Bain Capital Private Equity; supports global Phase 3 program of KAI-9531 for obesity. Press release
- Trogenix — GBP 70 million (≈ USD 95 million) Series A. Funds the Odysseus® precision-oncology platform for treatment-resistant cancers. Press release
- NanoPhoria Bioscience — EUR 83.5 million Series A Advances NP-MP1 for heart failure and its nano-in-micro delivery platform. Press release
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