BioMed Nexus Daily Updates

Your essential biotech, medtech, and pharma recap — no noise, just what matters.

🔮 What To Watch Today

  • How Johnson & Johnson positions its newly acquired RiPTAC platform and prostate program from Halda

  • The payer and oncology-community reaction to Poherdy, the first interchangeable biosimilar to Perjeta

  • Continued fallout from the NIH grant-termination findings, which disrupted 3.5 percent of NIH-funded trials

Overview: Oncology M&A, biosimilar competition, and the stability of U.S. research infrastructure defined today’s narrative.

🚀 Top Stories

  • J&J acquires Halda for about $3.05B
    The deal brings in Halda’s RiPTAC targeted cell-death platform and lead prostate cancer candidate, extending J&J’s precision oncology depth. 👉 Read more

  • FDA approves Poherdy, first interchangeable Perjeta biosimilar
    Developed by Henlius and Organon, Poherdy becomes the first interchangeable biosimilar to Perjeta in HER2-positive breast cancer, initiating the next phase of HER2 pricing pressure. 👉 Read more

  • Nuvalent hits pivotal bar with neladalkib in ALK+ NSCLC
    The ALK inhibitor delivered durable responses in previously treated patients, with many lasting ≥12 months, strengthening Nuvalent’s case as a next-generation TKI contender. 👉 Read more

Overview: Oncology produced the day’s largest deal, its highest-value biosimilar approval, and one of Q4’s most impactful pivotal readouts.

🎗️ Oncology & Rare Disease

  • Halda deal signals rising interest in non-ADC targeted cell-death platforms
    RiPTACs attract attention for their precision and potential resistance advantages. 👉 Read more

  • Artios raises $115M to advance DNA damage response (DDR) programs
    The round supports alnodesertib and SLFN11-directed assets as DDR continues drawing sustained capital. 👉 Read more

  • Captain T Cell secures ~€20M to advance next-generation TCR-T
    Funding and grants move its autologous and allogeneic solid-tumor programs into and toward first-in-human studies. 👉 Read more

Overview: Capital stayed concentrated in differentiated, mechanism-rich oncology—DDR, TCR-T, and RiPTACs.

🔬 Clinical & Research Updates

  • CAR T enters autoimmune disease with new UCI lupus trial
    A formal step toward translating early academic remission data into a structured clinical program. 👉 Read more

  • Silo Pharma preparing PTSD IND
    SPC-15 advances with Allucent support as CNS and trauma-related indications expand their development footprint. 👉 Read more

  • Cincinnati Children’s expands cell and gene therapy (CGT) infrastructure
    The planned facility boosts trial capacity and translational manufacturing. 👉 Read more

Overview: Advanced therapies widened beyond oncology into autoimmune and neuropsychiatric indications.

🏢 Corporate Developments

  • J&J’s $3.05B Halda acquisition strengthens its oncology pipeline
    A mid-range M&A asset that reinforces big pharma’s emphasis on targeted mechanisms. 👉 Read more

  • Synchron raises $200M to accelerate its BCI neurotech platform
    The round supports commercial runway for its minimally invasive brain–computer interface system and positions Synchron alongside robotics and AI-enabled medtech growth stories. 👉 Read more

  • Bambusa completes Series A-2 to push bispecific I&I assets
    Funds IND-enabling work for BBT003/004. 👉 Read more

  • Invivyd raises ~$125M; TELA Bio completes $13M offering
    Both reinforce the constructive backdrop for targeted capital raises. 👉 Read more

Overview: Oncology M&A, neurotech financing, and bispecific biologics set the tone across corporate activity.

🌍 Policy & Public Health

  • NIH grant cuts disrupted 383 trials and more than 74,000 participants
    A JAMA analysis highlighted $1.81B in terminated funding and disproportionate impacts in infectious disease and prevention. 👉 Read more

  • EU IVDR’s burden continues to slow diagnostic innovation
    Industry leaders warn the regulation is elongating timelines and raising costs. 👉 Read more

  • FDA clarifies device QMSR future expectations
    Aligns CGMP with ISO 13485 and defines implications for 2026 and beyond. 👉 Read more

Overview: Policy delivered both structural risk (NIH instability) and operational complexity (EU IVDR, US QMSR).

  • Oncology dominated with a combined $3.05B buyout + $115M DDR + ~€20M TCR-T

  • First interchangeable Perjeta biosimilar expands HER2 competition

  • Neurotech and robotics momentum reinforced by Synchron’s $200M raise

  • AI-biotech and medtech-packaging forecasts show infrastructure acceleration

  • NIH funding volatility emerges as a real operational risk

  • M&A today: $3.05B

  • Oncology financings: $115M + ~€20M

  • NIH disruption: 383 trials, >74,000 participants, $1.81B in terminated grants

📅 Today’s Calendar

  • Sell-side coverage of Halda–J&J and Poherdy

  • Continued readthrough from Nuvalent’s pivotal data

  • Device updates around Arctx Cool Catheter and Modular’s Pivot study setup

📉 Market Snapshot (Nov 17 Close)

  • XBI: ~114.8 (+0.7%)

  • IBB: ~165.3 (+0.6%)

  • Tone: Constructive on oncology M&A and pivotal data, with NIH instability creating a new macro overhang.

We’ll be back tomorrow with more updates. Got a tip? Just reply.

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