2023 Guidance and Q3 Earnings
Changes since Q2 2023
Changes on pipeline
New to Phase I
3915393
-
· TG2 inhibitor, pulmonary fibrosis
4524101 - DNA polymerase theta inhibitor, breast cancer
Achieved pipeline catalysts
Regulatory decisions
Arexvy - Adjuvanted recombinant protein, RSV older adults
Apretude - Pre-exposure prophylaxis (PrEP)
Vocabria - HIV, combination with rilpivirine long-acting injection
Jemperli - RUBY, DMMR/MSI-H IL endometrial cancer
Ojjaara (momelotinib) – MOMENTUM, myelofibrosis
Removed from Phase I
2904545 - Recombinant protein, adjuvanted, C. difficile
4074386 Anti-LAG-3 antibody, cancer
-
3745417-STING agonist, cancer
Regulatory submissions & acceptances
Nucala CRSWNP
1
momelotinib - SIMPLIFY-1 & MOMENTUM, myelofibrosis
Infectious diseases
HIV (ViiV)
Respiratory/Immunology
Oncology
Opportunity driven
JP
22N55
EU
CN
US
US
JP
JP
22.
Progressed to Phase II
4382276-mRNA, seasonal flu
4396687 mRNA, COVID-19
3993129 - Adjuvanted recombinant subunit, cytomegalovirus
3739937 - Maturation inhibitor, HIV
4004280 Capsid protein inhibitor, HIV
4011499 - Capsid protein inhibitor, HIV
1070806 Anti-IL18 antibody, atopic dermatitis
4527226 (AL-101) - Anti-sortilin antibody, Alzheimer's disease
Other events
Arexvy - 50-59 YoA - Positive phase III data readout
bepirovirsen - B-TOGETHER phase llb data, AASLD abstract
Shingrix - Positive phase III data (China)
Positive CHMP opinion
tebipenem - FDA SPA agreement for phase III PIVOT-PO study
Jemperli - RUBY, DMMR/MSI-H IL endometrial cancer -
Jemperli - RUBY part 1 OS overall population, IL endometrial cancer
-
Positive phase III data
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