The following are some of today’s top gainers in the pharma/biotech sector.
1. Bioblast Pharma Ltd. (ORPN)
Bioblast is a clinical-stage, orphan disease-focused biotechnology company.
Gained 31.30% to close Tuesday’s (Feb.19) trading at $1.51.
News: The Company announced the sale of its Trehalose clinical development programs to Seelos Therapeutics Inc. (SEEL) for an unconditional payment of $3.5 million and a contingent payment of up to additional $17 million plus royalties.
The Trehalose clinical development programs include the advanced phase 2 clinical program of Trehalose to treat Oculopharyngeal Muscular Dystrophy (OPMD).
2. CHF Solutions Inc. (CHFS)
CHF Solutions is a medical device company focused on commercializing Aquadex FlexFlow system for aquapheresis therapy.
Aquadex FlexFlow system is indicated for ultrafiltration to reduce fluid overload in patients when diuretics fail. The device is FDA 510(k) market cleared and CE marked.
Gained 19.40% to close Tuesday’s trading at $12.00.
News: The Company has initiated a distribution agreement in the Brazilian market with Bragenix LTDA for the Aquadex FlexFlow system.
The agreement expands CHF Solutions’ worldwide sales outreach into South America by entering the largest market in the region.
3. MediciNova Inc. (MNOV)
MediciNova is a biopharmaceutical company developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs.
Gained 16.64% to close Tuesday’s trading at $8.90.
News: No news
The Company’s core programs include:
— MN-001, which has successfully completed phase II trial in NASH, and is under phase II development in idiopathic Pulmonary Fibrosis (IPF).
— MN-166 (ibudilast), which is under phase 2/3 trial in degenerative cervical myelopathy, all set to enter phase III study in amyotrophic lateral sclerosis, successfully completed phase IIb trial in relapsing multiple sclerosis, under phase II trial for the treatment of methamphetamine addiction, under phase I/II study for the treatment of recurrent glioblastoma, among others.
— MN-221 (bedoradrine), which has completed phase II trial for the treatment of acute exacerbations of asthma treated in the emergency room. The Company is working to identify a partner for financial support before further clinical development of MN-221 is commenced.
4. AgeX Therapeutics Inc. (AGE)
AgeX Therapeutics is focused on the development and commercialization of novel therapeutics targeting human aging.
Gained 14.56% to close Tuesday’s trading at $4.80.
News: No news
AGEX-BAT1 for Type 2 diabetes; AGEX-VASC1 for metabolic imbalances in aging; AGEX-iTR1547 for the treatment of congestive heart failure; and Renelon designed to promote scarless tissue repair, all under preclinical testing.
5. INSYS Therapeutics Inc. (INSY)
INSYS is involved in the development, manufacture, and commercialization of pharmaceutical cannabinoids and spray technology.
Gained 13.51% to close Tuesday’s trading at $5.63.
News: No news
Clinical Trials & Near-term Catalysts:
— A phase II trial of Cannabidiol oral solution in childhood absence epilepsy is ongoing. Data read-out from this trial is expected in Q1, 2019.
— A phase II trial of Cannabidiol oral solution in Prader-Willi syndrome is underway. Data read-out from this trial is expected in Q4, 2019.
— A phase III trial of Cannabidiol oral solution in infantile spasms is ongoing.
— File NDA for Epinephrine nasal spray product in Anaphylaxis in Q4, 2019.
— Report results from nonclinical juvenile toxicity study related to Naloxone in early March of 2019.
— File NDA for Naloxone nasal spray for opioid overdose in Q1, 2019.
6. CorMedix Inc. (CRMD)
CorMedix is a biopharmaceutical company developing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.
Gained 12.43% to close Tuesday’s trading at $1.90.
News: No news
The lead product candidate Neutrolin, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, is under phase III development for patients undergoing chronic hemodialysis.
The phase III trial of Neutrolin, dubbed LOCK-IT-100, demonstrated efficacy last July. The topline results of the full data set of LOCK-IT-100 were announced on January 30, 2019.
At a recently held meeting, the FDA agreed that the Company could request consideration of Neutrolin for approval under the LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) pathway.
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