Programs Directory

BioNTech SE

Pumitamig (BNT327 / PM8002 / BMS-986545) is an investigational PD-L1 × VEGF-A bispecific antibody being co-developed by BioNTech and Bristol Myers Squibb after BioNTech acquired Biotheus, the original developer. The asset is designed to combine checkpoint inhibition with anti-angiogenic activity in a single molecule, aiming to restore anti-tumor T-cell activity while blocking VEGF-driven tumor vascular support. This places pumitamig in the same broad strategic class as ivonescimab and makes it an important test of whether dual IO/VEGF blockade can become a new oncology backbone. BioNTech/BMS are pursuing the drug across multiple solid tumors, including TNBC, SCLC, NSCLC, HCC, and glioblastoma, with Phase 3 trials such as ROSETTA Breast-01 and first-line extensive-stage SCLC studies now central to the program.

Revolution Medicines, Inc.

Daraxonrasib (RMC-6236) is Revolution Medicines' investigational oral RAS(ON) multi-selective inhibitor, targeting the active GTP-bound state of RAS across multiple oncogenic variants including G12D, G12V, and G12R. The program was validated in April 2026 when RASolute 302 — the Phase 3 registrational trial in previously treated metastatic PDAC — delivered median OS of 13.2 versus 6.7 months against chemotherapy (HR 0.40; p<0.0001), meeting both coprimary PFS and OS endpoints. Full data will be presented at ASCO 2026 plenary session LBA5. FDA Breakthrough Therapy designation granted; NDA submission planned under the Commissioner's National Priority Voucher pathway. RASolute 303 (NCT07491445) is the first-line expansion: a global, randomized, three-arm Phase 3 comparing daraxonrasib monotherapy, daraxonrasib plus gemcitabine/nab-paclitaxel followed by daraxonrasib maintenance, versus gemcitabine/nab-paclitaxel alone in approximately 900 previously untreated metastatic PDAC patients, enrolled regardless of RAS genotype. Coprimary endpoints PFS and OS. Enrollment opened April 2026; readout several years away. No efficacy data. The central prediction question is how much of RASolute 302's extraordinary effect size survives the move into first line against a substantially stronger chemotherapy comparator.

AstraZeneca

Datopotamab deruxtecan (Dato-DXd; Datroway) is AstraZeneca and Daiichi Sankyo's TROP2-directed antibody-drug conjugate (ADC), delivering a topoisomerase I inhibitor payload via a cleavable linker with a high drug-to-antibody ratio designed to maximize tumor cell killing while limiting systemic toxicity. Datroway received FDA approval in January 2025 for previously treated locally advanced or metastatic nonsquamous NSCLC without actionable genomic alterations, establishing its first commercial foothold in lung cancer. The AVANZAR trial (NCT05687266) is the pivotal first-line expansion: a global, randomized, open-label Phase 3 comparing Dato-DXd plus durvalumab plus carboplatin versus pembrolizumab plus platinum-based chemotherapy in locally advanced or metastatic NSCLC without actionable genomic alterations, with co-primary endpoints of PFS and OS evaluated in both the TROP2 biomarker-positive nonsquamous population and the broader nonsquamous ITT population. The central prediction question is whether TROP2-directed ADC activity combined with PD-L1 blockade can displace pembrolizumab plus chemotherapy as the first-line standard of care, and whether any benefit is broad across the nonsquamous population or concentrated in TROP2-high expressers. PFS data is anticipated in 2026; OS readout is expected 2027-2028.

AstraZeneca

PD-L1 + CTLA-4 + TACE + lenvatinib quad combination in intermediate-stage HCC. EMERALD-3 cohort 1 toplined PFS positive April 2026. ASCO 2026 late-breaker LBA4000. Triplet arm did not hit.

Pfizer

BCMA × CD3 bispecific. FDA approved in R/R MM. MagnetisMM-5 Phase 3 (elranatamab ± daratumumab vs DPd) ongoing for earlier-line expansion.

Johnson & Johnson

AR inhibitor in perioperative locally advanced prostate cancer + ADT vs ADT + surgery. PROTEUS Phase 3 at ASCO 2026 plenary LBA1. No efficacy data previously disclosed — pure prediction event. If positive, expands Erleada to earlier-stage disease.

Jacobio Pharma

KRAS G12C inhibitor with promising Phase 2 data. Competing vs sotorasib and adagrasib.

Daiichi Sankyo / MSD

B7-H3-directed ADC with strong SCLC signal. IDeate-Lung Phase 3 trials ongoing.

Genentech / Roche

PI3Kα inhibitor. FDA approved. INAVO120 OS analysis at ASCO 2025 confirmed significant OS improvement in PIK3CA-mutant HR+/HER2- breast cancer.

Summit Therapeutics / Akeso

PD-1 × VEGF bispecific antibody. HARMONi-3 (NCT05899608) is the pivotal global Phase 3: ivonescimab + chemo vs pembrolizumab + chemo in 1L metastatic NSCLC (all-comers, no EGFR/ALK exclusions). Co-primary endpoints OS and PFS. Enrollment target 1,080 patients across squamous and nonsquamous histologies; enrollment status ongoing. Readout timing not formally guided by Summit — PFS event-driven readout estimated H2 2026 based on trial design and April 2026 DSMB interim signal; OS interim timing TBD per statistical analysis plan. This is a materially harder trial than prior HARMONi readouts. The comparator is pembrolizumab + chemo — the entrenched global standard of care — rather than placebo or tislelizumab. That raises the efficacy bar considerably and makes directional prediction genuinely uncertain, which is why this is an active prediction event. No efficacy data disclosed. An April 2026 DSMB interim review recommended the study continue as planned — the community is actively debating whether this reflects a routine safety/futility check or a more meaningful efficacy interim with an unfavorable HR. For context: HARMONi (EGFR-mutant, 2L, vs placebo + chemo) and HARMONi-6 (1L squamous, vs tislelizumab + chemo) have already read out positively in China. BLA for HARMONi filed January 2026; PDUFA Q4 2026. HARMONi-6 OS data scheduled for ASCO 2026 plenary.

Bristol-Myers Squibb

CELMoD agent (cereblon E3 ligase modulator) developed as a next-generation successor to lenalidomide and pomalidomide, with enhanced cereblon binding designed to drive deeper tumor cell killing and immune activation. SUCCESSOR-2 (NCT05552976) is the pivotal Phase 3: mezigdomide + carfilzomib + dexamethasone (MeziKd) versus carfilzomib + dexamethasone (Kd) in relapsed/refractory multiple myeloma, targeting patients with prior lenalidomide and anti-CD38 exposure; primary endpoint PFS, key secondaries OS, ORR, MRD negativity, and HRQoL. A parallel study, SUCCESSOR-1, evaluates a bortezomib-based mezigdomide triplet in a complementary RRMM population. In March 2026, BMS announced SUCCESSOR-2 met its primary PFS endpoint — mezigdomide's first positive Phase 3 result and the second Phase 3 win for the CELMoD program overall — but no efficacy data have been disclosed; PFS HR, median PFS, and subgroup results remain unreported ahead of a planned medical conference presentation. Active prediction events are the magnitude of the PFS benefit and the OS trajectory, with MRD negativity data, if disclosed, representing an additional signal of response depth in this population.

Incyte / MorphoSys

Anti-CD19 MAb + lenalidomide + R-CHOP vs R-CHOP in 1L DLBCL. FRONTMIND Phase 3 toplined positive January 2026 — primary EFS endpoint hit, details not disclosed. Full data at ASCO 2026 late-breaker LBA7000 (June 1). Key prediction events: EFS hazard ratio magnitude and whether OS shows early separation. If confirmed, would establish tafasitamab in frontline DLBCL; currently only approved in R/R setting.

Ono Pharmaceutical Co., Ltd.

ONO-4578 is an oral, selective EP4 antagonist developed by Ono Pharmaceutical that blocks PGE2-mediated immunosuppression to potentiate PD-1 inhibition. The ONO-4578-08 trial (NCT06256328) is a randomized, double-blind, placebo-controlled Phase 2 study evaluating ONO-4578 plus nivolumab and chemotherapy as first-line treatment for patients with HER2-negative unresectable advanced or recurrent gastric/gastroesophageal junction cancer. The trial enrolled approximately 210 patients across 63 sites in Japan, South Korea, and Taiwan. The primary endpoint of PFS was met, with ONO-4578 demonstrating statistically significant improvement over the placebo plus nivolumab and chemotherapy comparator. Full results, including secondary endpoints, are being presented at ASCO 2026 (Abstract #4007, June 1).

Eli Lilly

Next-generation KRAS G12C inhibitor. SUNRAY-01 Phase 3 vs SOC in 1L KRAS G12C+ NSCLC. Best-in-class potential.

Daiichi Sankyo / Merck

HER3-directed ADC. HERTHENA-Lung02 Phase 3 met PFS primary endpoint vs chemo in EGFR-mutant NSCLC post-TKI. OS data pending. FDA submission discussions ongoing.

Daiichi Sankyo

Raludotatug deruxtecan (R-DXd; DS-6000a) is a CDH6-directed antibody-drug conjugate (ADC) developed jointly by Daiichi Sankyo and Merck, delivering a topoisomerase I inhibitor DXd payload to cadherin-6 expressing tumor cells via a cleavable linker with a drug-to-antibody ratio of 8. CDH6 is overexpressed in multiple solid tumors including ovarian cancer, renal cell carcinoma, and certain gastrointestinal cancers, positioning R-DXd as a potential first-in-class CDH6-directed therapeutic. The pivotal study is REJOICE-Ovarian01 (NCT06161025), a global Phase 2/3 randomized trial in platinum-resistant high-grade ovarian, primary peritoneal, or fallopian tube cancer, where Phase 2 dose-optimization data presented at ESMO 2025 demonstrated an ORR of 50.5% with a manageable safety profile, supporting progression into the Phase 3 portion comparing R-DXd against investigator's choice of chemotherapy with PFS and OS as the key efficacy endpoints. FDA Breakthrough Therapy designation has been granted for CDH6-expressing platinum-resistant ovarian cancer previously treated with bevacizumab, establishing a clear regulatory pathway ahead of the Phase 3 readout.You said: Now I need three paragraphs under these three topics; Analyst Commentary

Eli Lilly

Selective RET inhibitor. LIBRETTO-432 Phase 3 adjuvant RET fusion+ NSCLC — primary endpoint met. EFS HR 0.172 (95% CI 0.058–0.509; p=0.0003) in stage II–IIIA; 2-year EFS 91.5% vs 61.1% placebo. Full data presented ASCO 2026 plenary LBA3. OS immature; crossover permitted at recurrence.

MSD / Kelun-Biotech

Next-generation TROP2 ADC. OptiTROP-Breast trials head-to-head vs sacituzumab govitecan.

Astellas Pharma Global Development, Inc.

ASP3082 / setidegrasib is Astellas’s investigational KRAS G12D-targeted protein degrader, positioned as a precision oncology asset for tumors driven by one of the most common and historically difficult KRAS mutations. The development program suggests Astellas is not treating ASP3082 as a narrow exploratory molecule, but as a potential multi-tumor KRAS G12D franchise, with studies spanning pancreatic cancer, NSCLC, biomarker/resistance work, and combination strategies. Its most important near-term strategic trial is the Phase 3 first-line metastatic PDAC study combining ASP3082 with intensive chemotherapy backbones, where the key question is whether selective KRAS G12D degradation can improve survival on top of modern standard treatment. This also defines the competitive contrast with Revolution Medicines’ daraxonrasib: daraxonrasib is a broad oral RAS(ON) inhibitor with strong data in previously treated PDAC, while ASP3082 is more targeted, mutation-specific, and likely needs to win through G12D precision, depth of pathway suppression, combination efficacy, and earlier-line positioning.

Pfizer

PARP inhibitor in metastatic castration-sensitive prostate cancer without HRR biomarker selection. TALAPRO-3 toplined positive March 2026. ASCO 2026 late-breaker LBA5007.

Amgen

DLL3 × CD3 bispecific T-cell engager. FDA approved for 2L SCLC. DeLLphi-304 Phase 3 confirmatory trial met OS primary endpoint April 2025 — full approval expected.

AbbVie

c-Met directed ADC. LUMINOSITY Phase 2 and TeliMET Phase 3 trials in EGFR-wild type NSCLC.

Vir Biotechnology, Inc. / Astellas

VIR-5500 by Vir Biotechnology, Inc.. PHASE1 trial in Hormone-refractory Prostate Cancer.

AstraZeneca

PD-1 × CTLA-4 bispecific. KEYVIBE Phase 3 trials in 1L NSCLC ongoing.

Exelixis

Next-gen MET/VEGFR2 inhibitor. STELLAR-303 (RCC) and STELLAR-007 (mCRPC) Phase 3 readouts to watch.

Merck (MSD)

ROR1-directed ADC. waveLINE-010 Phase 3 (1L DLBCL, ZV + R-CHP vs R-CHOP) enrolling globally. Phase 2 showed 100% CR rate at RP2D.

Boehringer Ingelheim

Selective HER2 TKI. FDA accelerated approval August 2025 (2L) and February 2026 (1L). Beamion LUNG-2 Phase 3 (1L HER2-mutant NSCLC vs SoC) is the confirmatory trial; enrollment complete. OS readout is the key remaining catalyst.

Vera Therapeutics

Dual BAFF/APRIL inhibitor. ORIGIN-3 Phase 3 met primary endpoint (46% proteinuria reduction vs placebo, p<0.0001). BLA filed Nov 2025. FDA decision expected 2026. First dual BAFF/APRIL inhibitor in IgAN.

argenx

FcRn antagonist. Approved in AChR-Ab+ gMG. ADAPT SERON Phase 3 in seronegative gMG hit primary endpoint. sBLA Priority Review; PDUFA May 10, 2026. First therapy for seronegative gMG.

Novartis

Complement factor B inhibitor. APPLAUSE-IgAN Phase 3 showing proteinuria reduction. FDA approved in PNH. IgAN approval anticipated.

Travere Therapeutics

Dual endothelin/angiotensin receptor antagonist. FDA approved in IgAN. PROTECT Phase 3 confirmatory eGFR data ongoing.

Novartis

Anti-APRIL monoclonal antibody. BEYOND Phase 3 ongoing. Attacks IgAN upstream at galactose-deficient IgA1 production.

Novartis / Ionis

Antisense oligonucleotide reducing Lp(a) by ~80%. Lp(a)HORIZON Phase 3 cardiovascular outcomes trial with 8,325 patients. Data expected H1 2026 — first outcomes trial to test the Lp(a) lowering hypothesis.

Eli Lilly

Anti-amyloid antibody targeting plaque-specific pyroglutamate form. FDA approved July 2024. Post-marketing studies and prevention trials ongoing. Note: shares AHEAD NCT with lecanemab — Lilly-sponsored Phase 4 studies tracked separately.

Bristol Myers Squibb

Selective M4 muscarinic receptor positive allosteric modulator. Novel MoA. Phase 2 EMPOWER positive. Phase 3 ongoing.

GH Research

Inhaled 5-MeO-DMT. INVOKE-2 Phase 2b positive. Ultra-short duration (~30 min). Phase 3 KANNA program initiated. Otsuka strategic interest.

Eisai / Biogen

Anti-amyloid antibody. FDA approved. AHEAD 3-45 Phase 3 prevention trial ongoing in pre-symptomatic AD. Subcutaneous maintenance dosing approved Aug 2025. Rolling sBLA for induction dosing initiated.

Mind Medicine (MindMed)

LSD tartrate ODT. Phase 2b positive in GAD. Phase 3 Panorama (NCT06741228, US + Europe) and Voyage Phase 3 both enrolling. First LSD-based Phase 3 program in history.

COMPASS Pathways

COMP006 Phase 3 hit primary endpoint February 2026 — two doses of 25mg vs 1mg showed -3.8 MADRS difference (p<0.001). Both COMP005 and COMP006 now positive. NDA filing planned Q4 2026. First classic psychedelic with consistent Phase 3 data.

Sarepta Therapeutics

Gene therapy delivering micro-dystrophin. FDA approved under accelerated approval. EMBARK confirmatory trial ongoing.

Italfarmaco / Chiesi

HDAC inhibitor. FDA approved February 2024. First small molecule for all DMD genotypes. Post-marketing studies ongoing.

Dicerna / Novo Nordisk

RNAi targeting LDHA in primary hyperoxaluria. FDA approved. Competing with lumasiran. Confirmatory PHYOX data ongoing.