NEW YORK, NY / ACCESSWIRE / July 31, 2018 / Biotech stocks Progenics and ARCA biopharma were both soaring on Monday. While ARCA had no news to explain its 40% climb, shares of Progenics soared higher after announcing that the FDA has approved the New Drug Application for AZEDRA .
Progenics Pharmaceuticals, Inc. shares closed up 8.49% on about 1.7 million shares traded yesterday. The company announced that the FDA has approved the New Drug Application for AZEDRA ( iobenguane I 131) 555 MBq/mL injection for intravenous use. AZEDRA is a radiotherapeutic that is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. It is the first and only therapy that has been approved for this indication. The trial's lead investigator, Dr. Daniel Pryma stated, " AZEDRA is a true breakthrough in treating pheochromocytoma and paraganglioma delivering an effective anticancer therapy to these tumors . With this innovative, rationally designed treatment, we finally have a therapeutic option that helps address patients' needs." CEO of Progenics, Mark Baker, said, "As the first FDA approved therapy for unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy, AZEDRA provides a new treatment option for physicians and their patients. AZEDRA has been shown to decrease the need for blood pressure medication and reduce tumor size in some patients. We are extremely grateful to the patients, their families and the investigators who participated in AZEDRA's clinical development program. We also thank those who have contributed to the development of AZEDRA over many years." The press release also stated that AZEDRA can cause serious side effects including risk from radiation exposure, bone marrow problems and other cancers (myelosuppression and secondary malignancies), thyroid problems (hypothyroidism), elevations in blood pressure, kidney problems (renal toxicity), respiratory problems (pneumonitis), pregnancy warning (embryo-fetal toxicity), and fertility problems.
ARCA biopharma, Inc. shares closed up nearly 41% on Monday with roughly 5 million shares traded. The company had no news or catalyst to explain the unusual activity. It was about two months ago that the biopharma company had announced data from the GENETIC-AF clinical trial at the European Society of Cardiology Heart Failure 2018 World Congress in May. Per the company's press release, in the overall study population of heart failure patients who were at high risk for recurrent atrial fibrillation (AF), pharmacogenetic guided GencaroTM did not reduce AF/AFL/ACM recurrence compared to the active comparator TOPROL-XL. However, in U.S. patients (48% of the entire cohort), a trend for potential benefit in favor of Gencaro (approximately 30% risk reduction over TOPROL-XL), was observed for the primary endpoint of all-cause mortality (ACM) or time to recurrence of AF or atrial flutter (AFL). Chairman of the Steering Committee, Dr. William T. Abraham, commented, "With additional analysis of the trial data, and taking into consideration recent studies in animal models of AF, it is likely that AF-HFrEF phenotypic differences are responsible for the heterogeneity in treatment response observed. These Phase 2B data support and provide guidance for potential additional development of Gencaro as a treatment for atrial fibrillation in patients with heart failure, an indication for which there are currently no FDA approved therapeutics."
Our Actionable Research on Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) and ARCA biopharma, Inc. (NASDAQ: ABIO) can be downloaded free of charge at Research Driven Investing.
Research Driven Investing
We are committed to providing relevant and actionable information for the self-directed investor. Our research is reputed for being a leader in trusted, in-depth analysis vital for informed strategic trading decisions. The nimble investor can leverage our analysis and collective expertise to execute a disciplined approach to stock selection.
RDInvesting has not been compensated; directly or indirectly; for producing or publishing this document.
Disclaimer: This article is written by an independent contributor of RDInvesting.com and Nadia Noorani, a CFA® charter holder, has provided necessary guidance in preparing the document templates. RDInvesting.com is neither a registered broker-dealer nor a registered investment advisor. For more information please read our full disclaimer at www.rdinvesting.com/disclaimer.
For any questions, inquiries, or comments reach out to us directly at: