Gilead Sciences, Inc. (NASDAQ:GILD) announced top-line results from two Phase 3 clinical trials (SIMPLIFY 1 and 2) evaluating momelotinib, an investigational inhibitor of Janus kinase (JAK) compared to ruxolitinib or best alternative therapy (BAT) in patients with myelofibrosis. The SIMPLIFY-1 study achieved its pre-specified primary endpoint of non-inferiority to ruxolitinib for splenic response rate at Week 24 (SRR24), defined as the percentage of patients experiencing a ≥ 35 percent reduction in spleen volume (momelotinib: 26.5%; ruxolitinib: 29.0%; 95 percent CI: -11.2% to +5.6%; p=0.011).
Non-inferiority was not achieved for the key secondary endpoint of response rate in total symptom score (TSS). Greater improvements in all three pre-specified anemia-related secondary endpoints (proportion of patients who are transfusion independent, or transfusion dependent and transfusion rate) were observed in patients receiving momelotinib compared to ruxolitinib. However, because the TSS response rate did not meet the non-inferiority test, formal sequential statistical testing was not undertaken for these three additional anemia secondary endpoints.
During 24 weeks of treatment in SIMPLIFY-1, the most frequent adverse events in patients receiving momelotinib were thrombocytopenia, diarrhea, headache, dizziness and nausea; the most frequent adverse events in patients receiving ruxolitinib were anemia, thrombocytopenia, diarrhea, headache and dizziness. Ten percent of patients receiving momelotinib reported peripheral neuropathy (any grade) compared to five percent of ruxolitinib-treated patients. There was no Grade ≥3 peripheral neuropathy in momelotinib-treated patients and one case in ruxolitinib-treated patients during 24 weeks of treatment.
SIMPLIFY-2 did not achieve its primary endpoint of superiority of momelotinib compared to BAT in patients previously treated with ruxolitinib in SRR24 (momelotinib: 6.7%; BAT: 5.8%; 95 percent CI: -8.9% to +10.2%; p=0.90). Eighty-eight percent of patients randomized to the BAT arm continued to receive ruxolitinib; the remainder of patients received chemotherapy, interferon, corticosteroids, other therapies or some combination thereof. Differences in favor of momelotinib were observed for the pre-specified secondary endpoints of TSS and one of the three anemia-related endpoints (transfusion independence), however, formal sequential statistical testing was not undertaken because the primary superiority endpoint was not achieved.
“The results from both the SIMPLIFY-1 and SIMPLIFY-2 studies indicate that momelotinib provides some treatment benefit, including benefit on anemia-related endpoints,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “We plan to discuss these results with regulatory authorities to determine the next steps.”
Detailed results from both studies will be submitted for presentation at upcoming scientific conferences.
Momelotinib is an investigational therapy and has not been proven safe or efficacious. (Original Source)
Shares of Gilead Sciences closed today at $76.00, down $0.35 or -0.46%. The stock’s 50-day moving average is $75.71 and its 200-day moving average is $81.15.
On the ratings front, GILD stock has been the subject of a number of recent research reports. In a report released yesterday, Leerink Swann analyst Geoff Porges reiterated a Hold rating on GILD, with a price target of $89, which represents a potential upside of 17% from where the stock is currently trading. Separately, on November 14, Stifel Nicolaus’ Katherine Breedis initiated coverage with a Buy rating on the stock and has a price target of $100.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Geoff Porges and Katherine Breedis have a yearly average return of 0.8% and 9.4% respectively. Porges has a success rate of 43% and is ranked #1993 out of 4223 analysts, while Breedis has a success rate of 80% and is ranked #1815.
Overall, 5 research analysts have assigned a Hold rating and 12 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $99.00 which is 30% above where the stock opened today.