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MGNX

MacroGenics

$9.87

0.19 (1.96%)

15:09
12/09/19
12/09
15:09
12/09/19
15:09

MacroGenics announces updated results from Phase 1/2 study of flotetuzumab

MacroGenics announced updated results from a Phase 1/2 dose expansion study of flotetuzumab, an investigational, bispecific CD123 x CD3 DART molecule in patients with primary induction failure and early relapsed acute myeloid leukemia, or AML. The data were presented in an oral session at the 61st Annual Meeting of the American Society of Hematology, or ASH. In the Phase 1/2 open-label, dose expansion study, 30 patients classified as primary induction failure or early relapsed AML who had received a median of four prior therapies were treated with flotetuzumab at the recommended phase 2 dose of 500 ng/kg/day by continuous infusion. Data were reported as of the cut-off date of November 1, 2019. The study is currently ongoing, with additional patients being enrolled. Responses, including complete remission, CR with partial hematological recovery and CR with incomplete hematological improvement per a modified International Working Group Response Criteria for AML were summarized. Four responders received allogeneic hematopoietic stem cell transplantation as consolidation therapy and remain in remission after 6 to 21 months. The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome that occurred in all 30 patients. However, most CRS events observed were of short duration and mild to moderate in severity, with only one grade 3 event reported in one patient, the company said. "Based on the encouraging data from this study, and pending anticipated discussions with the FDA in the first half of 2020, we are planning for a potential registration-enabling study of flotetuzumab in this high unmet need population of patients with refractory AML, who have limited treatment options," said Scott Koenig, President and CEO of MacroGenics.

  • 09

    Dec

MGNX MacroGenics
$9.87

0.19 (1.96%)

11/20/19
GUGG
11/20/19
INITIATION
GUGG
Neutral
MacroGenics assumed with a Neutral at Guggenheim
Guggenheim analyst Etzer Darout assumed coverage of MacroGenics with a Neutral rating and no price target. The analyst believes the shares are currently fairly valued.
11/21/19
MSCO
11/21/19
DOWNGRADE
Target $6
MSCO
Underweight
MacroGenics downgraded to Underweight from Equal Weight at Morgan Stanley
Morgan Stanley analyst David Lebowitz downgraded MacroGenics to Underweight from Equal Weight with a $6 price target.
11/21/19
MSCO
11/21/19
DOWNGRADE
Target $6
MSCO
Underweight
Morgan Stanley downgrades MacroGenics on limited margetuximab opportunity
As previously reported, Morgan Stanley analyst David Lebowitz downgraded MacroGenics to Underweight from Equal Weight with a price target of $6, down from $17. Based on recent data, he believes that margetuximab might be approvable, but that the drug probably has a limited market opportunity. He basis this view on the second interim survival analysis from the Phase 3 SOPHIA trial which he believes suggests that the drug is unlikely to achieve an overall survival benefit when the final analysis is complete in 2020, Lebowitz explains to investors. Though MacroGenics has an "expansive" R&D program with multiple candidates of interest, Lebowitz said he needs to see "clean data" before gaining more comfort in the pipeline opportunities, he added.
11/21/19
11/21/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. KLA-Tencor (KLAC), Applied Materials (AMAT), and Lam Research (LRCX) were downgraded to Sell from Neutral at UBS. 2. AMD (AMD) downgraded to Market Perform from Outperform at Northland with analyst Gus Richard saying AMD shares are now ahead of the company's fundamentals. 3. Cubic (CUB) downgraded to Neutral from Overweight at JPMorgan with analyst Mark Strouse saying the company reported "mixed" fiscal Q4 results with disappointing EBITDA on stronger than expected revenue. 4. Carnival (CCL) downgraded to Hold from Buy at SunTrust with analyst Charles Scholes citing his analysis of booking trends data, noting that while volumes have improved over the past 8 weeks, the demand is driven by pricing cuts and is targeting mainly the sailings which had been impacted by the September hurricane. 5. MacroGenics (MGNX) downgraded to Underweight from Equal Weight at Morgan Stanley with analyst David Lebowitz saying based on recent data, he believes that margetuximab might be approvable, but that the drug probably has a limited market opportunity. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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