Aronex Pharmaceuticals Inc initiated with an Outperform at Oppenheimer. Oppenheimer analyst Kevin DeGeeter started coverage of Aronex Pharmaceuticals Inc with an Outperform rating and $20 price target. The analyst cited the expectation for positive Oraxol Phase III breast cancer data in Q3, proprietary survey results suggesting potential for meaningful uptake of KX2-391 for treatment of actinic keratosis, and strength of the company’s commercial channel for specialty oncology products and opportunity for operating leverage. DeGeeter views Aronex Pharmaceuticals Inc’s Orascovery oral chemotherapy platform as offering potential for important efficacy and tolerability benefits compared to traditional IV chemotherapy, and views partnering as providing important catalysts over the next 12-24 months.
Thursday, May 2, 2019
Dicerna submits updated IND application for DCR-PHXC
Dicerna Pharmaceuticals announced the submission of an updated investigational new drug, or IND, application to the FDA for DCR-PHXC, the Company’s lead GalXC product candidate for the treatment of all forms of primary hyperoxaluria, or PH. The update reflects agreement on the primary endpoint for the PHYOX 2 pivotal clinical trial, which is enrolling patients with PH type 1, or PH1, and PH type 2, or PH2, and alignment with the FDA regarding the path to full approval for the treatment of patients with PH1, as conveyed during a recent FDA Type A meeting. The Company will continue its ongoing dialogue with the FDA regarding endpoints for studies involving patients with PH2 and PH3, as part of the PHYOX clinical development program for DCR-PHXC.
Rocket Pharma presents preclinical data of RP-A501 for Danon disease
Rocket Pharmaceuticals presents preclinical data of RP-A501 at the American Society of Gene and Cell Therapy 2019 Annual Meeting in Washington, D.C. RP-A501 is the Company’s adeno-associated viral vector-based gene therapy for the treatment of Danon disease. The data is included in an oral presentation by Annahita Keravala, Ph.D., Associate Vice President, AAV Platform, entitled, “Systemic Delivery of AAV9.LAMP2B for the Treatment of Danon Disease: Toxicology Studies in Mice and Cynomolgus Monkeys.” Investigational New Drug application-enabling toxicology studies were conducted in wild-type mice and non-human primates. Three dose levels were tested in mice, including 3X10 13 vg/kg, 1X10 14 vg/kg, and 3X10 14 vg/kg. The highest dose level from the murine study, 3X10 14 vg/kg, was tested in non-human primates. No dose-related adverse events were observed at all tested doses in both mice and non-human primates. Vector genomes, mRNA and protein expression were widely distributed across key tissues with high levels of transduction, transcription and translation detected in the heart, skeletal muscle, diaphragm and liver. The ASGCT presentation also highlights previously reported preclinical efficacy data of RP-A501 in LAMP-2 knockout mice which showed dose-dependent improvements and restoration of cardiac function, with responses observed in both older and younger KO mice.
U.S. Physical Therapy reports adjusted EPS 39c, consensus 60c
Reports Q1 revenue $, consensus $116.05M. Same store revenues for de novo and acquired clinics open for one year or more increased 4.7% in the most recent quarter. Visits increased 3.6% for de novo and acquired clinics open for one year or more while the same store net rate increased 1.0%. CEO Chris Reading said, “Despite a historically long and difficult winter our dedicated team of partners, clinicians and support staff got us started off on the right foot for 2019. Cost control coupled with good volume helped to create some meaningful margin improvement in all aspects of our business. With our recently announced industrial injury prevention acquisition coupled with continued opportunity, internally and externally, we look forward to a good year ahead.”
Abbott receives WHO prequalification approval for HIV test
Abbott’s m-PIMA HIV-1/2 VL, the world’s first point-of-care viral load diagnostic test, has received the World Health Organization’s Prequalification approval. The test received CE Mark in December 2018. Viral load testing is the gold standard for monitoring ART treatment failure.
Teva sees free cash flow stronger in second half of 2019
Sees FY19 free cash flow $1.6B-$2B. Comments from Q1 earnings conference call.
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