Spectrum Pharma misses by $0.03, misses on revs; reaffirms FY18 revs guidance
- Reports Q2 (Jun) loss of $0.21 per share, excluding non-recurring items, $0.03 worse than the Capital IQ Consensus of ($0.18); revenues fell 29.5% year/year to $24.17 mln vs the $27.58 mln Capital IQ Consensus.
- Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations:
- Updated data from the MD Anderson Phase 2 trial in non-small cell lung cancer with exon 20 mutations will be presented at the World Conference on Lung Cancer in Toronto on September 24. Updated data will include EGFR and HER2 patients with exon 20 mutations. The abstract will be released online on September 5.
- Spectrum recently had a meeting with the FDA regarding poziotinib to gain clarity on the regulatory pathway. Based on that conversation, Spectrum views the current poziotinib phase 2 study as the pivotal registrational trial needed for the Agency's review.
Data published in Nature Medicine from the first 11 NSCLC
- ROLONTIS (eflapegrastim), a novel long-acting GCSF:
- Spectrum plans to conduct a pre-BLA meeting in the third quarter to ensure alignment with the FDA in preparation for a planned BLA filing in the fourth quarter of 2018.
- Co reaffirms guidance for FY18, sees FY18 revs of $95-115 mln vs. $109.45 mln Capital IQ Consensus Estimate.
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