Company Update (NASDAQ:HZNP): Horizon Pharma PLC and Fox Chase Cancer Center Temple Health Initiate Phase 1 Study

Horizon Pharma PLC (NASDAQ:HZNP), a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced that it, in collaboration with Fox Chase Cancer Center Temple Health, has initiated a Phase 1 clinical study to evaluate ACTIMMUNE (interferon gamma-1b) in combination with nivolumab in advanced solid tumors.

“We are eager to explore the safety and efficacy of ACTIMMUNE in combination with nivolumab in multiple, difficult-to-treat cancers that are often inoperable or have become unresponsive to standard therapies,” said Jeffrey W. Sherman, M.D., FACP, executive vice president, research and development and chief medical officer, Horizon Pharma plc. “Through this study, we hope to find that the addition of ACTIMMUNE to PD-1 inhibitors, like nivolumab, could potentially lead to better patient outcomes and inform our strategy for future ACTIMMUNE indications to pursue in Phase 2 trials.”

The Phase 1, open label study will evaluate the combination of ACTIMMUNE and nivolumab in patients with advanced solid tumors who have progressed on at least one prior systemic therapy, which may include prior immunotherapy. Patients will be treated with a one week induction phase of ACTIMMUNE (starting dose 50 mcg/m2subcutaneously), followed by a combination phase with ACTIMMUNE and nivolumab (3 mg/kg intravenously) for three cycles, followed by a single-agent phase of nivolumab alone for up to one year.

“Nivolumab and other PD-1 inhibitors have demonstrated clinical benefit in multiple trials across many advanced solid tumor types,” said Elizabeth R. Plimack, MD, MS, associate professor of medical oncology, and director of Genitourinary Clinical Research at Fox Chase. “However, some patients benefit from these therapies while others do not. Based on work from Fox Chase and other laboratories, we have strong evidence to suggest that ACTIMMUNE may increase the proportion of patients for whom nivolumab is effective. We are excited to test this hypothesis as part of this Phase 1 clinical trial.”

The study will primarily assess the safety and tolerability of the combination of ACTIMMUNE and nivolumab. Secondary objectives, including overall response rate, progression free survival and overall survival, will also be assessed, as will various correlative analyses. Initial accrual will occur using a modified 6+6 design, and if endpoints for safety (using dose-limiting toxicity criteria) are met, expansion cohorts in renal cell carcinoma (kidney cancer) and urothelial carcinoma (bladder cancer) are planned for up to 15 patients per cohort. (Original Source)

Shares of Horizon Pharma closed last Friday at $18.99, down $1.41 or -6.91%. HZNP has a 1-year high of $39.49 and a 1-year low of $12.16. The stock’s 50-day moving average is $19.35 and its 200-day moving average is $27.15.

On the ratings front, Horizon has been the subject of a number of recent research reports. In a report issued on December 3, Morgan Stanley analyst David Risinger assigned a Sell rating on HZNP, with a price target of $23, which implies an upside of 21.1% from current levels. Separately, on November 23, Jefferies Co.’s David Steinberg assigned a Buy rating to the stock and has a price target of $32.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, David Risinger and David Steinberg have a total average return of 3.2% and 14.9% respectively. Risinger has a success rate of 64.0% and is ranked #1019 out of 3618 analysts, while Steinberg has a success rate of 52.8% and is ranked #298.

Overall, one research analyst has rated the stock with a Sell rating, one research analyst has assigned a Hold rating and 6 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 $36.00 which is 89.6% above where the stock closed last Friday.

Horizon Pharma PLC is a specialty pharmaceutical company. The Company’s product portfolio consists of ACTIMMUNE, DUEXIS, PENNSAID 2% and RAYOS/LODOTRA, which addresses the unmet therapeutic needs in arthritis, pain, inflammatory and/or orphan diseases.


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