Kite Reports Fourth Quarter and Full Year 2016 Financial Results

Strong Execution Across Clinical Development, Pipeline, Manufacturing and Pre-Commercial Activities in 2016
On Track to Complete Rolling Biologics License Application to the U.S. Food and Drug Administration for Axicabtagene Ciloleucel by End of First Quarter 2017
Potential U.S. Approval and Launch of Axicabtagene Ciloleucel Expected in 2017
Conference Call to Be Held Today at 9:00 AM Eastern Time
 
SANTA MONICA, Calif. --  Kite Pharma, Inc. (Nasdaq:KITE) today provided a corporate update and reported fourth quarter and full-year 2016 financial results for the period ended December 31, 2016.
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aTyr Pharma Receives U.S. FDA Orphan Drug Designation for the Treatment of Limb Girdle Muscular Dystrophy with Resolaris ™

SAN DIEGO, Feb. 28, 2017  -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product candidate Resolaris™ was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy (LGMD) patients.
 
"Receiving Orphan Drug Designation for the treatment of all types of LGMD patients with Resolaris is an important step in our overall process of bringing our first Physiocrine-based product candidate to the market to treat patients," said John Mendlein, CEO of aTyr Pharma. "This designation follows our recently granted Fast Track designation and our promising signals of clinical activity in a LGMD sub-type (LGMD2B). We are excited to continue the development of Resolaris to treat patients with rare myopathies with an immune component who currently have limited or no therapeutic treatment options."
Read more: aTyr Pharma Inc ( LIFE )

Cellectar Biosciences Provides Phase I Trial Update of CLR 131 in Multiple Myeloma: Median Progression-Free Survival Extends to 133 Days, Median Overall Survival Reaches 17.7 Months

MADISON, Wis., Feb. 27, 2017 -- Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused clinical stage biotechnology company, today provides an update of its Phase I clinical study of CLR 131 in patients with relapsed or refractory multiple myeloma following the previously announced successful completion of its third cohort and initiation of Cohort 4 at a 31.25 mCi/m2 dose.
 
The objectives of the multi-center, open label, Phase I dose escalation study include the characterization of the safety and tolerability of CLR 131 administered as a single dose, 30-minute infusion in patients with relapsed or refractory multiple myeloma, and the establishment of a recommended efficacious dose for Phase II, both with and without dexamethasone, as well as an assessment of therapeutic activity.
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Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Glucophage ® XR

TORONTO, Feb. 24, 2017 -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I)  ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received final approval from the U.S. Food and Drug Administration ("FDA") for the Company's abbreviated new drug application ("ANDA") for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths.  The Company's newly approved product is a generic equivalent for the corresponding strengths of the branded product Glucophage® XR sold in the United States by Bristol-Myers Squibb.
Read more: Intellipharmaceutics International ( IPCI / I )

Cempra ’s Fusidic Acid Achieves Primary Endpoint in Phase 3 Study of ABSSSI

—Fusidic acid met primary endpoint and secondary efficacy endpoints—
—Fusidic acid well tolerated in the study—
 
CHAPEL HILL, N.C., Feb. 24, 2017 -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for the acute care and community settings to meet critical medical needs in the treatment of infectious diseases, today announced positive topline results from a phase 3 study of oral fusidic acid in 716 patients with acute bacterial skin and skin structure infections (ABSSSI). Fusidic acid was well tolerated in the study and achieved the primary endpoint, demonstrating non-inferiority (NI) (10% NI margin) of oral fusidic acid compared to oral linezolid for early clinical response (ECR) in the intent to treat (ITT) patient population.
Read more: Cempra Inc ( CEMP )

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