Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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September 2019
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Press Release
Entresto improved measures of heart structure and function in HFrEF patients in new Novartis study; additional data complement findings
Results from PROVE-HF trial show significant improvements in measures of cardiac structure and function at six months and one year in heart failure with reduced ejection fraction (HFrEF) patients[1… -
Press Release
Novartis PARAGON-HF trial suggests Entresto® benefit in HFpEF patients but narrowly misses primary endpoint
Entresto (sacubitril/valsartan) reduced the composite of total (first and recurrent) heart failure hospitalizations and cardiovascular death although narrowly missed statistical significance (p = 0.…
August 2019
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Key Release
Novartis ofatumumab demonstrates superiority versus Aubagio® in two head-to-head Phase III multiple sclerosis studies
In ASCLEPIOS I and II, ofatumumab (OMB157) met primary endpoints to reduce the annualized relapse rate over Aubagio®* (teriflunomide) in patients with relapsing forms of MS (RMS)[1] Key secondary… -
Press Release
Novartis to present new Entresto HFpEF and HFrEF data at ESC Congress 2019
PARAGON-HF trial will provide Entresto® (sacubitril/valsartan) Phase III full results in heart failure with preserved ejection fraction (HFpEF)[1] New PROVE-HF and EVALUATE-HF studies will… -
Press Release
AveXis Statement on Changes to Senior Leadership Team
AveXis announces Page Bouchard, DVM has been appointed Senior Vice President of Research and Chief Scientific Officer, effective August 5, 2019. Dr. Bouchard is a 27-year industry veteran with… -
Press Release
Sandoz will appeal District Court of New Jersey ruling in biosimilar Erelzi® (etanercept-szzs) US patent case
Sandoz to appeal court ruling to United States Court of Appeals for the Federal Circuit Ruling prevents launch of important, affordable treatment option for US patients affected by chronic… -
Press Release
Novartis stands behind Zolgensma® (onasemnogene abeparvovec-xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy
Basel, August 6, 2019 – Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma® (onasemnogene abeparvovec-xioi). First and…
July 2019
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Press Release
Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials
In MONALEESA-3, Kisqali plus fulvestrant achieved statistically significant improvement in overall survival in post-menopausal women in first- and second-line setting Kisqali is the only CDK4/6… -
Key Release
Novartis provides update on Phase III PARAGON-HF trial in heart failure patients with preserved ejection fraction (HFpEF)
PARAGON study narrowly misses statistical significance on the primary endpoint; overall safety profile confirmed Totality of evidence suggests potential clinically important benefit; results will… -
Press Release
Novartis receives positive CHMP opinion for Lucentis® treatment in preterm infants with retinopathy of prematurity (ROP), a disease causing visual impairment and blindness
Lucentis (ranibizumab), if approved in the EU for this indication, will be the first and only pharmacological therapy for ROP in these vulnerable infants Positive opinion is based on the landmark… -
Press Release
AveXis Statement on Access to Zolgensma® (onasemnogene abeparvovec-xioi)
The FDA's May 2019 approval of Zolgensma ®, a gene therapy for spinal muscular atrophy (SMA) in pediatric patients less than 2 years of age, marked an important milestone within the SMA community.… -
Press Release
Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis
Integrated Phase I/lll study for proposed biosimilar denosumab to confirm matching efficacy, safety and immunogenicity with reference medicine[1] Osteoporosis accounts for 8.9m bone fractures…