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TiGenix ($TIG) stock touched its 52 weeks high of $16.10 in its Tuesday trading session as the company announced receiving positive feedback from the U.S. Food and Drug Administration (FDA) on an improved protocol for its global Phase III trial for the treatment of complex perianal fistulas in Crohn's disease patients. Pursuant to its meeting with FDA earlier this year, the company has been given an improved protocol for the global Phase III trial of Cx601. 
The FDA has agreed to accept fewer patients than originally planned in the study, and has endorsed a broader target population that will ultimately facilitate the recruitment process.  the study will now benefit from an expedited recruitment process that should lead to shorter timelines, an earlier filing, and the possibility of an earlier approval in the U.S.

EnteroMedics Inc. ($ETRM) announced net loss for its fourth quarter. The company suffered $2.65 per share loss while its total loss stood at $4.4 million. EnteroMedics reported that it generated $141,900 worth of revenue during the period. Its adjusted revenue stood at $142,000. For the entire year, the company reported that its loss narrowed to $23.4 million, or $37.53 per share. Its revenue for the year was pegged at $787,000.
EnteroMedics stock dipped more than 92 percent in the past 12 months. However, it has shown strong recovery this year so far as it gained 220 percent. The stock is expected to keep up the momentum in the near future.

 

Alere Inc. ($ALR) announced that its Alere™ i RSV test has been granted Clinical Laboratory Improvement Amendments) waiver by the U.S. Food and Drug Administration (FDA) for the detection of RSV (respiratory syncytial virus) infection in children and adults. With CLIA waiver, the Alere i RSV test will be available in physician offices, hospital emergency rooms and walk-in clinics throughout the United States. The test was cleared for marketing by the FDA in August 2016. it is the first molecular test that can be used at the point-of-care to detect RSV in 13 minutes or less.
Eli Lilly ($LLY) reported head-to-head 24-week data comparing the efficacy and safety of Taltz and Stelara for the treatment of moderate-to-severe plaque psoriasis. The company said that the treatment demonstrated superior efficacy at 24 weeks compared to patients treated with Stelara®* (ustekinumab). At 24 weeks, patients treated with Taltz achieved significantly higher response rates compared to patients treated with Stelara, including 83 percent of patients who achieved Psoriasis Area Severity Index (PASI) 90, compared to 59 percent of patients who achieved PASI 90 after treatment with Stelara.

Kura Oncology Inc. ($KURA) announced updated results from the ongoing, Phase 2 trial of tipifarnib . The company said that, as of February 28, 2017, the two patients with HRAS mutant SCCHN with objective responses remain on study and are currently at treatment cycle 19 and cycle 12. Among the five patients with HRAS mutant salivary gland cancer, although no objective responses were observed, three patients experienced disease stabilization and were on study for 9, 10 and 14 cycles. The drug was generally well tolerated with adverse events consistent with its known safety profile.

 

Revance Therapeutics Inc. ($RVNC) reported that it has completed  patient enrollment in two pivotal trials of the company’s SAKURA Phase 3 program for its investigational drug candidate DaxibotulinumtoxinA for Injection (RT002) for the treatment of moderate to severe glabellar lines in adults.  The company’s Phase 3 program is comprised of two pivotal trials evaluating the efficacy, safety and duration of RT002, as well as a long-term safety trial. It will continue to enroll patients for long-term safety trial.

Vermillion ($VRML) announced that its associate company ASPiRA LABs has attained out-of-state provider status with Medi-Cal, California's Medicaid program, for OVA1®/Multivariate Index Assay. With this development, OVA1 is now available to over 12 million Medi-Cal beneficiaries, representing approximately a third of the covered lives in California.

 

Avinger Inc. ($AVGR) announced its fourth quarter and full year results. The company earned $4.7 million in revenue for the fourth quarter, up 64 percent on year over year basis. It also announced positive two-year clinical data from the pivotal VISION study of the Company’s Lumivascular technology during the same quarter. Avinger suffered $12 million in loss from operations during the quarter. Its full year revenue stood at $19.2 million, up 79 percent from 2015.

Almost Family Inc. ($AFAM) announced its fourth quarter and full year results. The company’s net service revenue stood at $153.4 million while its adjusted EPS was reported at $0.59 for the quarter. For the entire year, the net service revenue was reported at $623.5 million while adjusted EPS stood at $2.38.

Brokerage
Action
Company
Rating
Price Target
Wells Fargo & Co
Initiates
Bellicum Pharmaceuticals (BLCM)
Outperform

BMO Capital Markets
Reiterates
Rigel Pharmaceuticals (RIGL)
Outperform
$4.00

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