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Vertex Pharmaceuticals ($VRTX) reported positive mid-stage results from three different triple combination regimens in cystic fibrosis (CF) patients suffering from one F508del mutation and one minimal function mutation. The data from the Phase 2 study showed mean absolute improvements in lung function of 9.7% and 12.0% as measured by percent predicted forced expiratory volume in one second (ppFEV1) in the regimens containing VX-152 and VX-440, respectively. Preliminary data also showed mean absolute improvements in ppFEV1 of 7.3% and 9.5% when VX-152 or VX-440 were added to tezacaftor and ivacaftor in CF patients with two copies of the F508del mutation.
The company stock reacted positively to the news and shot up over 25 percent in the after hour trading session. The stock has gained over 79 percent in this year so far while its 12 months gain stands at 46 percent.

T2 Biosystems Inc. ($TTOO) shot up as the company announced receiving the CE mark certification for its T2Baccteria Panel performed in its T2Dx instrument. The panel is currently available for research use only. It detects specific species of bacteria in whole blood samples in as little as 3.5 hours. It also does not require a blood culture. The company is currently in the final stages of completing the FDA pivotal trial for filing a 510(k) application to the FDA.
The company stock gained over 12 percent in its previous trading session, trimming its Year to Date losses to 43 percent.

 

uniQure NV ($QURE) announced receiving a patent from the USPTO regarding a component of insect cell-based AAV manufacturing technology. The company said that the new patent will help boost its IP portfolio related to large-scale, highly reproducible manufacturing of AAV in insect cells.

Prana Biotech ($PRAN) announced inking a research deal with Takeda Pharmaceuticals for investigating the ability of PBT434 to mitigate gastrointestinal dysfunction (constipation, lowered colon motility, inflammation) in mouse models.

Gilead Sciences’ ($GILD) announced receiving the FDA approval for its single tablet Vosevi for retreating chronic hepatitis C virus (HCV) infection in adults with genotype 1,2,3,4,5 or 6 who have been previously treated with an NS5A inhibitor-containing regimen. The treatment is also available to patients with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

Mallinckrodt ($MNK) announced that the FDA has designated its StrataGraft regenerative skin tissue a Regenerative Medicine Advanced Therapy (RMAT), qualifying it for accelerated review. StrataGraft is currently being assessed in a Phase 3 clinical trial for the treatment of complex skin defects due to thermal burns, specifically, deep partial thickness burns.

 

Cogentix Medical ($CGNT) announced inking a new deal with Prompela, a Monaco based firm. The deal involves an exclusive licensing agreement for launching a line of endo-urology products in the U.S. Cogentix expects the product to generate more than $2.5 million in sales next year.

VolitionRx signed an agreement with the Great Lakes New England Clinical Validation Center to collaborate in a study of asymptomatic people aimed at validating a panel of biomarkers, including Volition's Nu.Q Colorectal Cancer Screening Test, to support U.S. regulatory approval. Volition America will contribute up to $3 million towards the study. The amount is payable over a period of three years.

Brokerage Action Company Rating Price Target
Barclays PLC Reiterates Charles River Laboratories International (CRL)
Hold $102.00
Barclays PLC Reiterates Quest Diagnostics Incorporated (DGX)
Hold $110.00
Barclays PLC Reiterates Illumina (ILMN)
Hold $150.00

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