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BioNTech (Nasdaq: BNTX) and OncoC4 reported that selective Treg modulator gotistobart (BNT316/ONC-392) showed a clinically meaningful overall survival benefit versus docetaxel in the non-pivotal stage of the global Phase 3 PRESERVE-003 trial in previously treated metastatic squamous NSCLC.

At a 14.5-month median follow-up, median OS with gotistobart was not reached versus 10 months with docetaxel; 12-month OS was 63.1% vs 30.3%. Hazard ratio for death was 0.46 (95% CI 0.25–0.84) with nominal p=0.0102. Safety remained manageable; grade ≥3 TRAEs were 42.2% vs 48.8%.

ALX Oncology (NASDAQ: ALXO) reported positive Phase 2 investigator‑sponsored data for evorpacept combined with rituximab and lenalidomide (R2) in untreated indolent B‑cell non‑Hodgkin lymphoma presented at ASH 2025.

In 24 frontline patients (14 follicular, 10 marginal zone), the regimen met its primary objective: 92% complete response (CR), 8% partial response, 100% overall response rate, one‑year PFS 91% and one‑year OS 100%. Investigators reported the combination was well tolerated; MRD evaluation and longer follow‑up were noted as next steps.

Innovent (NUVB) announced that seven of its innovative medicines were included in China’s updated 2025 National Reimbursement Drug List (NRDL), effective January 1, 2026. The inclusions cover oncology, cardiovascular/metabolic, autoimmune and ophthalmology indications, and include a new TYVYT indication (sintilimab plus fruquintinib for advanced pMMR endometrial cancer) and first-time listing of SYCUME (teprotumumab) for moderate-to-severe thyroid eye disease. Other newly listed medicines include limertinib, fulzerasib (Dupert), taletrectinib (DOVBLERON), selpercatinib (Retsevmo) and pirtobrutinib (Jaypirca).

The company says NRDL inclusion will expand patient access and improve affordability across multiple high-need disease areas in China.

Prime Medicine (Nasdaq: PRME) announced publication in the New England Journal of Medicine of Phase 1/2 data for PM359, its investigational autologous HSC product for p47phox chronic granulomatous disease (CGD), with results also presented at the 67th ASH Annual Meeting (Dec 6-9, 2025).

Two patients showed rapid neutrophil and platelet engraftment, achieving 69% and 83% DHR+ neutrophils by Day 30 (above a 20% clinical threshold), durable NADPH oxidase activity, early clinical benefit (cessation of mesalamine in Patient 1; marked fecal calprotectin reduction and symptom improvement in Patient 2), and no clinically significant adverse events attributed to PM359; observed toxicities were consistent with busulfan-based conditioning.

Genmab (Nasdaq: GMAB) reported pivotal Phase 3 EPCORE FL-1 results showing fixed-duration EPKINLY (epcoritamab-bysp) + rituximab and lenalidomide (R2) significantly reduced disease progression or death versus R2 alone (HR 0.21, 79% risk reduction; 95% CI: 0.14–0.31; p<0.0001) in relapsed/refractory follicular lymphoma.

Key efficacy: ORR 95% vs 79% (p<0.0001); CR 83% vs 50%; 12-month DOR 89% vs 49%. Safety: Grade 3–4 TEAEs 90.1% vs 67.6%, with higher neutropenia (68.7% vs 42.0%) and infections (33.3% vs 15.1%). In November 2025 the FDA approved EPKINLY+R2 for R/R FL after ≥1 prior systemic therapy.

Molecular Partners (NASDAQ: MOLN) presented updated Phase 1/2a data for tetra-specific T-cell engager MP0533 in relapsed/refractory AML at ASH on December 7, 2025. As of the September 1, 2025 cut-off, 54 patients received MP0533 and 8 of 48 evaluable patients responded (5 composite complete responses and 3 MLFS). Densified and higher-frequency dosing (cohorts 8–9) was tolerable, increased serum exposure in cycle 1, and showed preliminary antitumor activity. Responses clustered in patients with <20% bone marrow blasts at baseline. Cohort 10 is ongoing with data expected in 2026.

Fulcrum Therapeutics (Nasdaq: FULC) reported positive initial results from the 20 mg cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease on Dec 6, 2025. At Week 6 (n=12) mean absolute fetal hemoglobin (HbF) rose from 7.1% to 16.9% (+9.9%), with 7 of 12 patients (58%) reaching ≥20% HbF. Among six patients reaching Week 12, mean fold induction exceeded 3.75x versus 2.4x in the 12 mg cohort. Markers of hemolysis and anemia improved (LDH -37%, indirect bilirubin -37%, reticulocytes -33%), mean hemoglobin +0.8 g/dL, and no treatment-related serious adverse events were reported.

Incyte (Nasdaq:INCY) announced the U.S. FDA granted Breakthrough Therapy designation to INCA033989, a first‑in‑class mutCALR‑targeted monoclonal antibody, for treatment of essential thrombocythemia (ET) patients with a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.

The designation was supported by early Phase 1 data showing INCA033989 was well‑tolerated and produced rapid, durable platelet normalization; updated Phase 1 data and new myelofibrosis results will be presented at ASH 2025 on December 8. Incyte plans to seek regulator alignment and begin a Phase 3 program in mid‑2026 to evaluate patients with all CALR mutation types.

Key context: CALR mutations occur in ~25% of ET patients and Type 1 deletions represent ~55% of CALR mutations.

Arcellx (NASDAQ: ACLX) reported updated pivotal Phase 2 iMMagine-1 results for anitocabtagene autoleucel (anito-cel) in 117 relapsed/refractory multiple myeloma patients with a median follow-up of 15.9 months (data cutoff Oct 7, 2025).

Key efficacy: ORR 96%, CR/sCR 74%, ≥VGPR 88%; MRD negativity 95% (91/96) and sustained MRD negativity >6 months 83% (54/65) at 10-5 sensitivity. Timepoint survival: 12‑month PFS/OS 82.1%/94.0%, 18‑month PFS/OS 67.4%/88.0%, 24‑month PFS/OS 61.7%/83.0%.

Safety: no delayed or non‑ICANS neurotoxicities observed to date (all patients dosed ≥12 months). Company reiterates planned 2026 commercial launch. Data presented at ASH on December 6, 2025.