Adial Pharma (ADIL) : 7-month performance,

Sector(s): Healthcare

Industry: Biotechnology

Full Time Employees: 8

http://www.adialpharma.com

Elanco Animal Health (ELAN) reported earnings on Wed 6 Feb 2019 (b/o)

ticker: ELAN

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Elanco Animal Health beats by $0.02, reports revs in-line; reaffirms FY19 EPS, revs guidance

• Reports Q4 (Dec) earnings of $0.29 per share, excluding non-recurring items, $0.02 better than the S&P Capital IQ Consensus of $0.27; revenues rose 6.0% year/year to $799.3 mln vs the $804.07 mln S&P Capital IQ Consensus.
• Gross margin, as a percent of revenue, was 48 percent, an increase of 200 basis points period over period. The gross margin increase was primarily due to favorable product mix and non-recurring costs in 2017 associated with the unwinding of purchase accounting inventory adjustments, partially offset by 200 basis points of unfavorable impact from foreign exchange rates.
• Co reaffirms guidance for FY19, sees EPS of $1.02-1.12, excluding non-recurring items, vs. $1.10 S&P Capital IQ Consensus; sees FY19 revs of $3.1-3.16 bln vs. $3.15 bln S&P Capital IQ Consensus.

MacroGenics (MGNX) announced positive results from SOPHIA

MacroGenics announced positive results from SOPHIA, a Phase 3 clinical study of margetuximab in HER2-positive metastatic breast cancer patients

• The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. Patients in the margetuximab arm experienced a 24% risk reduction in PFS compared to patients in the trastuzumab arm (HR=0.76, p=0.033). Notably, approximately 85% of patients in the study were carriers of the CD16A (Fc?RIIIa) 158F allele, which has been previously associated with diminished clinical response to HERCEPTIN and other antibodies.
• MacroGenics anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the second half of 2019.

A gene mutation that makes an excess of the HER-2 protein is present in about 15% of primary invasive breast cancers, according to UpToDate, an evidence-based medical resource used by clinicians. This particular trial showed longer progression-free survival in patients treated with a combination of margetuximab and chemotherapy compared to those on trastuzumab (brand name Herceptin) and chemotherapy, a standard-of-care treatment. The company also said approximately 85% of patients in the study were carriers of the CD16A 158F allele, a gene variation has been associated with a reduced clinical response to Herceptin and other antibodies. MacroGenics said it plans to submit a biologics license application to the U.S. Food and Drug Administration in the second half of 2019.

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