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Protalix BioTherapeutics, IncNYSEMKT
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  • Fri, Dec. 2, 10:14 AM
    • Thinly traded nano cap Protalix BioTherapeutics (PLX -33.2%) slumps on almost a 4x surge in volume in early trading in response to the company's announcement of an exchange of convertible debt in a private placement.
    • The agreement, announced after the close yesterday, calls for the exchange of $54.1M aggregate principal amount of the company's outstanding 4.50% Senior Convertible Notes due 2018 for $40.2M of newly issued 7.50% Senior Secured Convertible Notes due 2021.
    • Concurrently, it has agreed to sell $22.5M of the 2021 Notes to qualified investors. Both transactions should close by December 7.
    • The 2021 Notes will be secured by perfected liens on Protalix's material assets. The 7.50% interest will be paid semi-annually and, in certain circumstances, the company may elect to pay up to 1.25% of the interest in shares of common stock. The Notes will mature on November 15, 2021.
    • The initial conversion rate will be 1,176.4706 common shares per $1,000 principal amount of the Notes (~$0.85 per share).
    • Net proceeds will fund clinical trials, R&D, working capital and general corporate purposes.
    | Fri, Dec. 2, 10:14 AM | 3 Comments
  • Wed, Nov. 30, 8:36 AM
    • The first patient has been enrolled in Protalix BioTherapeutics' (NYSEMKT:PLX) Phase 2 clinical trial assessing OPRX-106 in ulcerative colitis (UC). Initial data should be available in the second half of next year.
    • The open-label two-arm study will enroll 20 subjects with mild-to-moderate UC. Participants will be randomized to receive a daily oral dose of either 2 mg or 8 mg of OPRX-106 for eight weeks. The primary endpoint is safety. Secondary endpoints include clinical response.
    • If successful, OPRX-106 will be the first oral enzyme treatment for UC. It is a plant-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain. It is based on the company's ProCellEx platform.
    | Wed, Nov. 30, 8:36 AM
  • Wed, Nov. 9, 8:05 AM
    • Protalix BioTherapeutics (NYSEMKT:PLX): Q3 EPS of -$0.07 beats by $0.03.
    • Revenue of $4.67M (+248.5% Y/Y) beats by $2.97M.
    • Press Release
    | Wed, Nov. 9, 8:05 AM
  • Mon, Aug. 8, 4:56 PM
    • Protalix BioTherapeutics (NYSEMKT:PLX): Q2 EPS of -$0.11 misses by $0.03.
    • Revenue of $1.77M (+32.1% Y/Y)
    • Press Release
    | Mon, Aug. 8, 4:56 PM
  • Thu, Jul. 7, 10:38 AM
    • The first patient has been dosed in a Phase 2 clinical trial assessing Protalix BioTherapeutics' (PLX +1.6%) AIR DNase (formerly PRX-110) for the treatment of cystic fibrosis (CF). The 28-day switch-over study involves 15 CF patients previously treated with Roche's (OTCQX:RHHBY) Pulmozyme (dornase alfa). The primary endpoint is the change from baseline in lung function as measured by forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). Top-line data should be available around year end.
    • According to the company, AIR DNase is a proprietary plant cell-expressed recombinant form of a human enzyme called deoxyribonuclease 1 (DNase 1) that cleaves extracellular DNA and thins the thick mucus that accumulates in the lungs of CF sufferers. It is designed to be more effective than Pulmozyme by being more resistant to actin inhibition, which restricts DNase I activity. Actin is a protein that plays a role in a wide range of cellular processes.
    | Thu, Jul. 7, 10:38 AM
  • Mon, May 9, 7:16 AM
    • Protalix BioTherapeutics (NYSEMKT:PLX): Q1 EPS of -$0.09 misses by $0.01.
    • Revenue of $0.7M (-58.8% Y/Y) misses by $0.4M.
    | Mon, May 9, 7:16 AM
  • Fri, Apr. 8, 11:05 AM
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    | Fri, Apr. 8, 11:05 AM | 9 Comments
  • Tue, Mar. 8, 1:44 PM
    • Protalix BioTherapeutics (NYSEMKT:PLX): FY15 EPS of -$0.29.
    • Revenue of $4.36M (+23.9% Y/Y).
    | Tue, Mar. 8, 1:44 PM
  • Thu, Mar. 3, 10:22 AM
    • Interim data from a Phase 1/2 dose-ranging study showed Protalix BioTherapeutics' (PLX +6%) PRX-102 reduced the levels of a key fat in the kidneys of Fabry disease patients. The results will be presented today at the Lysosomal Disease Network 12th Annual WORLDSymposium 2016 in San Diego, CA.
    • The study enrolled 18 treatment-naive Fabry patients across three dosing cohorts (0.2 mg/kg, 1.0 mg/kg and 2.0 mg/kg). Subjects received an IV infusion of PRX-102 every two weeks. Efficacy was assessed at Months 6 and 12.
    • Results from kidney biopsies in the 0.2 mg/kg and 1.0 mg/kg cohorts showed a mean reduction of a fat called Gb3 was 75.5% and 86.5%, respectively. No data were provided for the 2.0 mg/kg cohort. Gb3 or globotriaosylceramide, accumulates in the brain, heart and kidneys of Fabry sufferers. Cardiovascular disease and kidney failure are the leading causes of death in Fabry patients.
    • Additional data showed consistent cardiac and renal function from baseline to Month 6 and 12 in both the 0.2 mg/kg and 1.0 mg/kg dosage groups.
    • PRX-102 is chemically modified version of a recombinant therapeutic enzyme called alpha-galactosidase A.
    • Fabry disease is an inherited disorder caused by mutations in the gene that codes for alpha-galactosidase A. It is characterized by the buildup of Gb3 in the body's cells.
    • The company plans to initiate two Phase 3 studies that will support an NDA filing. The first should commence in Q2.
    • Previously: Protalix Bio to initiate two late-stage studies of lead product candidate in Fabry disease in early 2016 (Nov. 16, 2015)
    | Thu, Mar. 3, 10:22 AM | 1 Comment
  • Dec. 10, 2015, 2:59 AM
    • New Ebola cases have surfaced in Liberia, the worst hit of all Ebola-affected nations, suggesting that the fight against the disease could take months, or even years, to fully eliminate.
    • Recent scientific studies and case reports indicate the Ebola virus can persist in survivors' bodily fluids months longer than previously thought.
    • Liberia has already been declared Ebola-free (42 days pass without a new episode of hemorrhagic fever) twice this year, only to see new cases appear.
    • Previously: Sierra Leone declared free of Ebola (Nov. 08 2015)
    • Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, OTCQB:GOVX, SRPT, CMRX, PLX, NSPH, LAKE, APT, VSR, SMED
    | Dec. 10, 2015, 2:59 AM | 15 Comments
  • Nov. 16, 2015, 1:18 PM
    • Based on feedback from the FDA at an End-of-Phase 2 meeting, Protalix BioTherapeutics (PLX +3.8%) intends to proceed with two Phase 3 trials assessing lead product candidate PRX-102 for the treatment of Fabry disease, an inherited disorder characterized by the buildup of a type of fat in the body's cells.
    • One trial will be a randomized, multicenter, placebo-controlled study assessing the 1 mg/kg dose of PRX-102 in treatment-naive Fabry patients. The company believes that a small sample size will be sufficient to achieve statistical significance with a study duration of only six months. The primary endpoint will be the effect on gastrointestinal symptoms.
    • The other trial will be a head-to-head superiority study comparing PRX-102 to Sanofi's (SNY -0.3%) Fabrazyme (agalsidase beta). The primary endpoint will be an improvement in eGFR (estimated Glomerular Filtration Rate), a measure of kidney function/damage.
    • The company believes that no additional non-clinical studies are required to support a Biologics License Application (BLA). More details on the design of the trials will be provided after the study protocols have been approved.
    • Both trials should commence in early 2016.
    • PRX-102 is chemically modified version of a recombinant therapeutic enzyme called alpha-Galactosidase-A protein.
    | Nov. 16, 2015, 1:18 PM
  • Nov. 9, 2015, 5:40 PM
    • Protalix BioTherapeutics (NYSEMKT:PLX): Q3 EPS of -$0.04 beats by $0.04.
    • Revenue of $4.3M (+79.2% Y/Y) misses by $0.7M.
    | Nov. 9, 2015, 5:40 PM
  • Oct. 19, 2015, 10:46 AM
    • 12-month data from a Phase 1/2 clinical trial assessing Protalix BioTherapeutics' (PLX) PRX-102 in patients with Fabry disease showed positive responses in two key metrics. The three-arm dose-ranging study evaluated 0.2 mg/kg, 1 mg/kg and 2 mg/kg infusions of PRX-102 administered every two weeks for one year in 18 treatment-naive subjects.
    • Patients receiving the lowest dose of 0.2 mg/kg showed stable kidney function as measured by estimated Glomerular filtration rate (eGFR). Fabry sufferers are characterized by a deterioration in eGFR over time.
    • Patients in the 0.2 mg/kg arm also showed continuous and durable reductions in lyso-Gb3 levels of up to almost 62%. Lyso-Gb3, a biomarker, dramatically increases and accumulates in the plasma of Fabry patients. In addition, they showed a continuous reduction and durable improvement in Mainz Severity Score Index (MSSI), a tool used to evaluate Fabry disease status.
    • The company has scheduled an end-of-Phase 2 meeting with the FDA for November. A Phase 3 study is on tap for early 2016.
    • PRX-102 is chemically modified version of a recombinant therapeutic enzyme called alpha-Galactosidase-A protein.
    | Oct. 19, 2015, 10:46 AM | 4 Comments
  • Oct. 13, 2015, 9:16 AM
    | Oct. 13, 2015, 9:16 AM | 2 Comments
  • Sep. 9, 2015, 9:17 AM
    | Sep. 9, 2015, 9:17 AM | 6 Comments
  • Aug. 10, 2015, 5:19 PM
    • Protalix BioTherapeutics (NYSEMKT:PLX): Q2 EPS of -$0.05 beats by $0.03.
    • Revenue of $3.8M (+57.0% Y/Y) misses by $2.6M.
    | Aug. 10, 2015, 5:19 PM | 3 Comments