Novartis Ag (NVS) announced that together with Molecular Partners it has begun clinical trial EMPATHY.
The EMPATHY trial is a Phase 2 and 3 study to examine the use of its novel DARPin therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. The trial will research the safety and efficacy of ensovibep in early-stage COVID-19 patients, to prevent worsening symptoms and hospitalization.
Novartis will conduct the clinical trial program for ensovibep, while Molecular Partners will be the sponsor of the studies. (See Novartis stock analysis on TipRanks)
In March, Molecular Partners posted positive results from the initial Phase 1 trial conducted with healthy volunteers.
Novartis may seek accelerated approval via the FDA’s Emergency Use Authorization (EUA) if the trial results are satisfactory.
The study intends to enroll 2,100 patients in total, with 400 patients to be enrolled into Phase 2, followed by 1700 patients in Phase 3.
The study will be conducted on adults with a positive SARS-CoV-2 antigen test and who are experiencing at least two pre-determined mild/moderate symptoms of COVID-19 within 7 days of their diagnosis.
Phase 2 results are expected in August 2021 while the outcome from the Phase 3 study is expected in H1 2022.
Novartis’ Group Head of Corporate Affairs and Global Health, Dr. Lutz Hegemann commented, “Today, with Molecular Partners, we’re announcing an important next step in the development of ensovibep, which holds promise to respond to breakthrough disease and new variants in the future. We are hopeful the results of this clinical trial program will provide a reliable treatment option for patients with COVID-19.”
On April 19, UBS analyst Laura Sutcliffe maintained a Buy rating and increased the price target from CHF 95 to CHF 96 ($106.86). This implies approximately 20% upside potential over the next 12 months.
Overall, the stock has a Moderate Buy consensus rating with 3 Buys, 1 Hold, and 1 Sell. The average analyst price target of $104.70 implies 17.4% upside potential from current levels.
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