FDA 캘린더

ARROWHEAD PHARMACEUTICALS, INC.ARWR

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$7.46-7.0%

30일 · 10/09

ARO-MAPTsiRNA

Early Alzheimer's diseaseAROMAPT-SC-1001NCT07221344

Tau (MAPT) / MAPT mRNA

임상 데이터중간 임상 데이터2026/10/14

AROMAPT-SC-1001 · Interim Results from ARO-MAPT Phase 1/2a Study

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$62.54-24.4%

30일 · 10/09

Opus Genetics, Inc.IRD

OPGx-001AAV gene therapy

LCA5-associated inherited retinal disease (registered Phase 1/2)Children with LCA5

Functional LCA5 gene

임상 데이터1/2상 데이터2026/10/14Retina in Rio

Near Normalization of Cone Sensitivity

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$4.63-23.7%

30일 · 10/09

Verastem, Inc.VSTM

VS-7375

advanced KRAS G12D-mutated solid tumors / second-line advanced or metastatic pancreatic ductal carcinoma / first-line metastatic pancreatic ductal adenocarcinoma combination development / second- or third-line advanced KRAS G12D-mutated non-small cell lung cancer / first-line advanced non-small cell lung cancer / second-line or later metastatic colorectal cancer / first-line metastatic colorectal cancer combination development

KRAS G12D

임상 데이터1/2상 데이터2026/10/14

to present initial efficacy and updated safety and tolerability data

enGene Therapeutics Inc.ENGN

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$8.24+8.1%

30일 · 10/09

Detalimogene voraplasmid (EG-70)non-viral gene therapy

Non-muscle-invasive bladder cancer (NMIBC)LEGEND · high-risk, BCG-unresponsive NMIBC patients with CIS · surfactant cohortNCT04752722

RIG-I

임상 데이터전임상 웨비나 · 코호트 등록 계획2026/10/15

LEGEND · Webinar on surfactant plus detalimogene preclinical data and cohort enrollment guidance

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$1.77+0.0%

30일 · 10/09

Pharming Group N.V.PHAR

Joenja® (leniolisib)small molecule

Primary immunodeficiencies with immune dysregulationleniolisib Phase 2 · 13 subjects with genetically defined PIDs · dose escalation

PI3Kδ

임상 데이터2상 데이터 · 추가2026/10/14 - 17ESID 2026

leniolisib Phase 2 · Additional data will be presented

EUPRAXIA PHARMACEUTICALS INC.EPRX

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$9.73-9.9%

30일 · 10/09

EP-104GI

Eosinophilic esophagitis (EoE)RESOLVE · dose escalation

—

임상 데이터Conference presentation2026/10/18UEG Week 2026

RESOLVE · Moderated Poster

EUPRAXIA PHARMACEUTICALS INC.EPRX

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$7.46-7.0%

30일 · 10/09

EP-104GI

Eosinophilic esophagitis (EoE)RESOLVE · dose escalation

—

임상 데이터Conference presentation2026/10/19UEG Week 2026

RESOLVE · Oral Abstract Session

Achieve Life Sciences, Inc.ACHV

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$7.46-7.0%

30일 · 10/09

Cytisinicline

E-cigarette/vaping cessation / Cigarette smoking cessationORCA-OL · adults who previously participated in the ORCA-2, ORCA-3 or ORCA-V1 trials and were actively smoking cigarettes and/or vaping daily

α4β2 nicotinic acetylcholine receptor / 5-HT3 receptor

임상 데이터2상 데이터2026/10/20CHEST 2026

시험 상세

ORCA-OL · new data evaluating the efficacy of 52 weeks of cytisinicline treatment for cigarette smoking and e-cigarette cessation will be presented

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$7.34+0.8%

30일 · 10/09

Shattuck Labs, Inc.STTK

SL-846bispecific antibody

Non-human primates (IND-enabling GLP toxicology)SL-846 IND-enabling GLP toxicology study · non-human primates

DR3 / IL-23R

임상 데이터전임상 데이터2026/10/17 - 20UEG Week

시험 상세

SL-846 IND-enabling GLP toxicology study · Preclinical data for SL-846, including safety, pharmacokinetics, and receptor occupancy from the ongoing GLP toxicology study

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$5.66-8.0%

30일 · 10/09

Biohaven Ltd.BHVN

BHV-1530antibody-drug conjugate

Advanced solid tumorsBHV-1530 Phase 1NCT06874335

FGFR3

임상 데이터1상 데이터2026/10/23ESMO

BHV-1530 Phase 1 · new Phase 1 data planned for ESMO

PERSPECTIVE THERAPEUTICS, INC.CATX

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$12.13-5.2%

30일 · 10/09

VMT-α-NETpeptide radiopharmaceutical

SSTR2-positive neuroendocrine tumorsNCT05636618 · Cohorts 1–3NCT05636618

SSTR2

임상 데이터1/2상 데이터2026/10/23European Society of Medical Oncology (ESMO) Congress 2026

NCT05636618 · Cohort level safety and efficacy results

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$2.66-4.0%

30일 · 10/09

EIK1003

Advanced solid tumors, including breast, ovarian, prostate and pancreatic cancerNCT06253130 · Participants with advanced solid tumors; Cohort 1B includes patients with advanced prostate cancer · Cohorts 1A, 1B and 1CNCT06253130

PARP1

임상 데이터1/2상 데이터2026/10/23ESMO Congress 2026

NCT06253130 · will present clinical data from its ongoing Phase 1/2 trial of EIK1003

출처 모두 보기 (3)

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$7.55-18.0%

30일 · 10/09

EIK1004

Advanced solid tumors with or without brain metastasesNCT06907043 · Patients with ovarian, breast, prostate, and pancreatic cancersNCT06907043

PARP1

임상 데이터1/2상 데이터 · 최초2026/10/23ESMO Congress 2026

NCT06907043 · will also present, for the first time, data from an ongoing Phase 1/2 trial

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$7.55-18.0%

30일 · 10/09

EIK1005

Advanced solid tumors including MSI-H tumorsNCT07262619 · Participants with advanced solid tumorsNCT07262619

WRN

임상 데이터1/2상 데이터2026/10/23ESMO Congress 2026

NCT07262619 · Preliminary safety, tolerability and pharmacokinetic data for EIK1005 will be presented

ORIC PHARMACEUTICALS, INC.ORIC

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$7.55-18.0%

30일 · 10/09

Rinzimetostat (ORIC-944)small molecule

Metastatic castration-resistant prostate cancer previously treated with abirateroneHimalayas-1 · mCRPC patients previously treated with abiraterone acetate

EED / PRC2

임상 데이터Conference presentation2026/10/23global · ESMO Congress 2026

Himalayas-1 · A Global Phase 3 Study in mCRPC Patients Previously Treated With Abiraterone Acetate (Himalayas-1)

COMPASS THERAPEUTICS, INC.CMPX

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$12.25+1.5%

30일 · 10/09

CTX-009bispecific antibody

second-line unresectable advanced, metastatic or recurrent biliary tract cancerCOMPANION-002 · previously treated patients with advanced biliary tract cancer

DLL4 / VEGF-A

임상 데이터2/3상 데이터2026/10/24ESMO Congress

COMPANION-002 · will highlight the results of the randomized, controlled Phase 2/3 COMPANION-002 clinical trial

NovaBridge BiosciencesNBP

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$1.05-49.0%

30일 · 10/09

Givastomigbispecific antibody

Advanced or metastatic solid tumors; gastroesophageal adenocarcinoma, pancreatic ductal adenocarcinoma and biliary tract cancer cohortsgivastomig Phase 1b · patients with first-line gastric cancer · dose expansion

CLDN18.2 × 4-1BB

임상 데이터1상 데이터2026/10/25European Society for Medical Oncology (ESMO) Congress 2026

givastomig Phase 1b · Poster presentation of Phase 1b combination dose expansion data

Summit Therapeutics Inc.SMMT

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$1.41-16.9%

30일 · 10/09

ivonescimab (SMT112)bispecific antibody

first-line treatment of patients with advanced biliary tract cancerHARMONi-GI1 · patients with advanced biliary tract cancer

PD-1 / VEGF

임상 데이터파트너 주도: Akeso, Inc. · China · 예상 3상 데이터2026/10/25China · ESMO 2026

시험 상세

HARMONi-GI1 · data from the Phase III HARMONi-GI1 trial, conducted in China and sponsored by Akeso, Inc., featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab, will be featured

ALNYLAM PHARMACEUTICALS, INC.ALNY

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현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$17.35+2.1%

30일 · 10/09

ALN-HTT02RNAi therapeutic

Huntington's disease

HTT

임상 데이터Conference presentation2026/10/26

Up next…

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$231.37-6.5%

30일 · 10/09

EIK1001

Stage 4 non-small cell lung cancerTeLuRide-005 · Patients with NSCLCNCT06246110

TLR7 / TLR8

임상 데이터2상 데이터2026/10/26ESMO Congress 2026

TeLuRide-005 · will present comprehensive updated data from TeLuRide-005

ORIC PHARMACEUTICALS, INC.ORIC

출처 모두 보기 (7)

현재 단계

비임상IND1상2상3상허가 신청승인

주가 · 30일

$7.55-18.0%

30일 · 10/09

Enozertinib (ORIC-114)small molecule

NSCLC with EGFR atypical mutationsEnozertinib Phase 1b · treatment-naive metastatic NSCLC with EGFR atypical mutationsNCT05315700

EGFR / HER2

임상 데이터1상 데이터2026/10/26ESMO Congress 2026

시험 상세

Enozertinib Phase 1b · Enozertinib (ORIC-114), a Brain Penetrant, Highly Selective EGFR Inhibitor, in Treatment-Naive Metastatic NSCLC with EGFR Atypical Mutations