-=Spectrum Pharma (SPPI) reported earnings on Thur 9 Aug 2018 (a/h)

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.

=Incyte (INCY) and Merck (MRK) : failed key Phase 3 melanoma study

• Biotech stocks (XBI) lower after important immune-oncology combo data (Incyte's IDO inhibitor plus Merck's Keytruda) fails in key Phase 3 melanoma study:  NLNK (IDO inhibitor peer) -37.57%,  INCY -18.23%,  NKTR -9.84%,  JNCE -10.20%,  LABU -5.14%,  FPRX -3.84%,  ONCS -3.72%,  SAGE -2.21%,  SGEN -1.81%,  BLUE -4.85%,  PBYI-1.85%,  SPPI -2.46%,  CRVS -9.17%,  TSRO +0.37%,  BMRN -2.01%, GLYC-2.03%, MRK-1.19% 
• IBB -1.99%,  XBI -1.78%

Incyte announces that the External Data Monitoring Committee determined that the Phase 3 ECHO-301/KEYNOTE-252 study did not meet the primary endpoint 

The co and Merck (MRK) announced that an external Data Monitoring Committee review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte's epacadostat in combination with Merck's KEYTRUDA in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy.

• The study's second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA.

Incyte and Merck will inform investigators of the results and work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

This week's biggest % winners & losers : Oct. 16 - 20, 2017 (wk 42)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: SPPI (19.32 +44.61%), CRBP (7.75 +13.97%), CYH (6.44 +11.61%), THC (14.66 +11.48%), TXMD (5.11 +11.46%)
• Materials: VHI (3.36 +14.68%)
• Industrials: GWW (207.81 +14.78%), SALT (8.2 +13.1%),
• Consumer Discretionary: SKX (33.99 +39.59%), ASNA (2 +12.36%), EXPR (6.62 +12.2%), BOOT (8.3 +11.71%), SCSS (33.99 +10.97%)
• Information Technology: TEAM (50.01 +26.16%), SYNT (24.22 +24.88%), NPTN (5.46 +15.43%), CREE (33.82 +15.17%), ADBE (175.46 +13.99%)
• Energy: CLD (4.58 +25.14%)
• Utilities: TERP (13.56 +13%)

This week's top 20 % losers

• Healthcare: ARDX (5.55 -23.71%), MNKD (4.13 -21.85%), TRVN (1.76 -19.63%), CELG (121.4 -11.04%)
• Materials: KLDX (3.22 -16.15%), HMY (1.66 -11.7%)
• Industrials: UAL (59.9 -11.35%)
• Consumer Discretionary: TACO (12.65 -16.61%), CTRP (48.43 -12.25%)
• Information Technology: SNCR (11.43 -19.22%), BMI (43.8 -14.79%), BHE (30.5 -14.08%), NCR (33.05 -11.96%), AAOI (41.41 -11.91%), MTSI (36.99 -11.06%)
• Financials: VIRT (14.3 -16.13%)
• Energy: KEG (10.58 -14.75%), FMSA (3.88 -14.73%), SPN (8.85 -12.98%)
• Consumer Staples: SVU (15.03 -25.59%)

Long trade : SPPI +40% (10/17)

  

** monthly **

Spectrum Pharma reports new data for Poziotinib; demonstrates evidence of significant antitumor activity

• Co announced the oral presentation of interim data from a Phase 2 clinical study evaluating poziotinib in EGFR Exon 20 Mutant Non-Small-Cell Lung Cancer
• Poziotinib demonstrates evidence of significant antitumor activity in NSCLC patients with EGFR exon 20 insertion mutations, with interim data showing an Objective Response Rate of 73%.
• Evidence of central nervous system activity in a patient with CNS metastasis and another with leptomeningeal disease.
• On October 18th at 8:30 a.m. EDT/5:30 a.m. PDT, the Company will hold a conference call with Dr. John Heymach, from The University of Texas MD Anderson Cancer Center to discuss the study results.

Long trade : SPPI +35% (10/17)

• 9/27:  #15; vol. 2.1 M

** daily **

** monthly **

=========
bot 9/27;  day after (9/28):

 

Spectrum Pharma (SPPI) reported earnings on Mon 14 November 2016 (b/o)

** charts after earnings **

  

Spectrum Pharma beats by $0.10, beats on revs :

• Reports Q3 (Sep) loss of $0.07 per share, $0.10 better than the single analyst estimate of ($0.17); revenues rose 16.8% year/year to $33.4 mln vs the $28.43 mln Capital IQ Consensus. Product sales in the third quarter included: FUSILEV (levoleucovorin) net sales of $4.9 million, FOLOTYN (pralatrexate injection) net sales of $11.3 million, ZEVALIN (ibritumomab tiuxetan) net sales of $2.6 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.9 million.

SPPI — NR