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NEWS

Merck and Eisai Present P-III (LITESPARK-011) Trial Data on Welireg + Lenvima in Advanced Renal Cell Carcinoma (RCC) at ASCO GU 2026

Shots: Merck & Eisai has reported the P-III (LITESPARK-011) trial data assessing Welireg (belzutifan; 120mg, PO, QD) + Lenvima (lenvatinib; 20mg, PO, QD) vs cabozantinib in 747 pts with advanced RCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy At mFU of 29mos., trial met its 1EP of improved PFS by 30% (mPFS: 14.8 vs…
March 3, 2026

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Gyre Therapeutics to Acquire Cullgen for ~$300M

Shots: Gyre has entered into an agreement to acquire Cullgen in an all-stock transaction valued at ~$300M, making it a wholly owned subsidiary upon deal completion in Q2’26 Following the acquisition’s close, the combined company will operate as a fully integrated biopharma organization with US & China capabilities across discovery, manufacturing, & commercialization, addressing inflammatory…
March 3, 2026

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Roche
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Roche Reports P-III (FENhance 1) Trial Data on Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Shots: Roche has reported P-III (FENhance 1) trial results in RMS pts, randomized to either fenebrutinib (PO, BID) with PBO-matched to teriflunomide or teriflunomide (PO, QD) with PBO matched to fenebrutinib Trial met its 1EP, reducing ARR by 51% over ≥96wks., consistent with the P-III (FENhance 2) study showing 59% reduction, while 2EPs showed significant…
March 3, 2026

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NEWS

Pfizer, Merck and Astellas Report P-III (KEYNOTE-B15) Trial Findings on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed Keytruda + Padcev (IV), followed by surgery & then Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts Trial showed 47% reduction in the risk of tumor recurrence, progression, or death, with an estimated 79.4% pts event-free at 2yrs. vs 66.2% with SoC, plus the combination…
March 2, 2026

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NEWS

Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia

Shots: FDA granted accelerated approval to Yuviwel (navepegritide, QW) to increase linear growth in children (≥2yrs.) with achondroplasia & open epiphyses; commercially available by Q2’26 Approval was based on extensive clinical data, incl. 3 PBO-controlled trials plus up to 3yrs. of OLE data, with the pivotal ApproaCH results published in JAMA Pediatrics Continued approval may…
March 2, 2026

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Merck new
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Merck Presents P-III (LITESPARK-022) Trial Data on Keytruda + Welireg in Clear Cell Renal Cell Carcinoma (RCC) at ASCO GU 2026

Shots: Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy At 28.4mos. mFU, the trial showed improved DFS (1EP), reducing the risk of disease recurrence or death by 28%, with mDFS…
March 2, 2026

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NEWS

X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome

Shots: The CHMP has recommended approval of Xolremdi, under exceptional circumstances, for the treatment of WHIM syndrome, with EC’s decision expected in Q2’26 Opinion was backed by the global P-III (4WHIM) trial assessing Xolremdi vs PBO in 31 pts (≥12yrs.) with WHIM syndrome, which showed improved absolute lymphocyte counts, absolute neutrophil counts, & fewer infections,…
March 2, 2026

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Ipsen Pharmaceuticals
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Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

Shots: The CHMP has recommended conditional approval of Ojemda monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy Opinion was based on the ongoing P-II (FIREFLY-1) trial assessing Ojemda (QW, PO) in 137 relapsed or refractory BRAF-altered pLGG…
March 2, 2026

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