Shares of Pieris Pharmaceuticals Inc. (PIRS) were up 6.22% in early trading today at $3.76. Pieris Pharmaceuticals dipped 4.12% or $0.14 as shares closed at $3.54 last session. PIRS stock traded between $3.39 and $3.56 during the day. There were 1.84 million shares exchanged, below the company’s average daily volume of 11.94 million.
The PIRS stock has rallied 8.26% over the past 12 months, and it has increased 2.02% over the last one week. PIRS stock price has increased by 27.34% over the past six months, and by 41.60% over the past three months. With federal authorities giving orphan drug status to one of its drugs, PIRS stock has been rising.
PIRS has received approval for what?
Pieris develops medicines utilizing the latest approaches in protein engineering combined with deep expertise in molecular mechanisms behind the disease. The medicines from PIRS produce superior outcomes for patients by driving local biology. Among the pipeline products of PIRS are inhalable Anticalin proteins to treat respiratory disorders and locally-activated bispecifics to target immune-related diseases. Anticalin proteins, the proprietary property of PIRS, are a class of therapeutics that have been validated clinically and through partnerships with leading pharmaceutical companies.
Cinrebafusp alfa (PRS-343) received the medical designation of an orphan drug from the US Food and Drug Administration (FDA), announced Pieris.
- This bispecific treatment will target both gastric cancers with HER2-high and HER2-low expression.
- It is poignant that PIRS cinrebafusp alfa has been granted orphan drug designation because of the significant unmet medical needs associated with gastric cancer.
- Furthermore, the study reaffirms PIRS’ conviction that the program needs to be implemented while setting high success goals to help patients with limited options in treatment.
- Later this summer, PIRS plans to begin the second phase of the cinrebafusp alfa trial.
- FDA grants orphan drug designation to drugs that target conditions that affect 200,000 or fewer US patients each year.
- Cinrebafusp alfa’s Orphan Drug Designation will provide development as well as commercial incentives to PIRS.
- PIRS will enjoy assistance from FDA for the design of clinical trials, tax credits for qualified clinical trials as well as waivers of application fees as part of this designation.
- Additionally, it will grant PIRS a seven-year market exclusivity following FDA approval for the development and commercialization of cinrebafusp alfa.
PIRS’ further plans:
Pieris (PIRS) is actively pursuing a phase 2 study of cinrebafusp alfa following the positive phase 1 results, which indicate that the therapy is a single agent with a mechanism of action related to 4-1BB. For that phase, PIRS will combine cinrebafusp alfa with ramucirumab and paclitaxel for treating HER2-high expression gastric cancer and tucatinib for treating HER2-low expression gastric cancer.