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MGNX

MacroGenics

$20.25

0.83 (4.27%)

16:40
01/23/18
01/23
16:40
01/23/18
16:40

MacroGenics completes interim futility analysis of the Phase 3 SOPHIA trial

MacroGenicsannounced completion of a pre-planned interim futility analysis of the Phase 3 SOPHIA trial. This randomized, multi-center clinical study compares margetuximab plus chemotherapy to trastuzumab plus chemotherapy in subjects with metastatic breast cancer. Based on results from the futility analysis, an independent data safety monitoring committeehas recommended that the SOPHIA study continue as planned without modification. This analysis was based on a pre-specified assessment of progression-free survival as determined by independent central review. The futility analysis did not allow for early stopping due to efficacy. MacroGenics also announced today that the U.S. FDA has granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy. Fast Track designation is designed to facilitate the development and expedite the review of new therapies for serious conditions and unmet medical needs. With Fast Track designation, early and frequent communications between the FDA and the sponsor are encouraged to help enable rapid development of the candidate molecule."We are encouraged with the DSMC's determination that there were no safety concerns and that the analysis of PFS data support continuation of the Phase 3 SOPHIA trial. Recruitment of patients into the SOPHIA study is progressing well. We remain on track to complete enrollment by the end of 2018 and we look forward to sharing top-line results after the trial has read out in 2019," commented Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Also, we are very pleased to receive Fast Track designation for margetuximab, as this may potentially expedite future regulatory interactions on this product candidate. Furthermore, the gastric cancer data recently presented at ASCO GI for margetuximab in combination with anti-PD-1 may provide additional opportunities to address unmet medical needs in other HER2+ indications." About the SOPHIA Study MacroGenics continues to enroll patients in the pivotal Phase 3 SOPHIA clinical study of margetuximab at approximately 200 trial sites across North America, Europe and Asia. The 530-patient study is designed to evaluate the efficacy of margetuximab plus chemotherapy compared to that of trastuzumab plus chemotherapy in relapsed/refractory HER2-positive metastatic breast cancer patients. This registration study has sequential primary endpoints, which include PFS and overall survival.

MGNX MacroGenics
$20.25

0.83 (4.27%)

03/30/17
RAJA
03/30/17
INITIATION
Target $26
RAJA
Outperform
MacroGenics initiated with an Outperform at Raymond James
Raymond James analyst Reni Benjamin initiated MacroGenics with an Outperform and a $26 price target saying it is a unique "marquee" player in the bispecific antibody space. The analyst believes the value of MacroGenics' DART platform, the newsflow from multiple trials, the potential to sign additional global marquee partners, and a cash position of $245M represent an unique opportunity.
08/31/17
NOMU
08/31/17
NO CHANGE
Target $41
NOMU
Buy
MacroGenics abstract shows initial signs of efficacy, says Nomura Instinet
Nomura Instinet analyst Christopher Marai says last night's ESMO abstract for MacroGenics' flotetuzumab indicated initial signs of efficacy and good tolerability. The analyst is encouraged that no maximum tolerated dose/schedule was defined. He has a Buy rating on MacroGenics with a $41 price target.
09/01/17
RHCO
09/01/17
NO CHANGE
RHCO
MacroGenics outlook remains upbeat despite J&J decision, says SunTrust
SunTrust analyst Peter Lawson says that Johnson &Johnson's decision to return duvortuxizumab, the CD19xCD3 T cell redirecting bispecific antibody, to MacroGenics is negative for MacroGenics. However, he does not believe that the decision reflects on MacroGenics' platform. He blames the decision on the neurotoxicity side effects of the drug and increased competition in the space. Lawson reiterates a $26 price target and a Buy rating on MacroGenics.
10/25/17
LEER
10/25/17
NO CHANGE
LEER
Outperform
MacroGenics MGA012 license to Incyte 'logical deal,' says Leerink
Leerink analyst Michael Schmidt notes that MacroGenics (MGNX) and Incyte (INCY) announced that the two companies have entered into an exclusive global collaboration and license agreement for the former's MGA012, an antiPD1 antibody currently in Phase I clinical development. This analyst says that the deal reinforces his view that MacroGenics' R&D engine and broad pipeline provide for a rich set of development and business development opportunities not currently reflected in the stock. He reiterates an Outperform rating on MacroGenics' shares.

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