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MGNX

MacroGenics

$15.10

-0.11 (-0.72%)

16:06
07/17/19
07/17
16:06
07/17/19
16:06

MacroGenics provides update on flotetuzumab program

MacroGenics announced that it plans to advance the development of flotetuzumab, its investigational bispecific CD123 x CD3 Dart molecule, in patients with primary refractory acute myeloid leukemia, or AML. MacroGenics has enrolled 50 patients at the recommended Phase 2 dose, or RP2D, in the Phase 1 monotherapy study, including 30 patients with primary refractory AML. The updated clinical data from this study will be submitted for presentation at the American Society for Hematology, or ASH. MacroGenics plans to meet with the FDA in Q3 to discuss future development of flotetuzumab, and to define a potential registration path for this molecule as monotherapy. In parallel, MacroGenics plans to initiate a study in relapsed or refractory AML patients combining flotetuzumab with MGA012, a proprietary anti-PD-1 antibody, as a potential means to both broaden and lengthen the duration of response of AML patients on flotetuzumab. The combination is supported by a scientific rationale based on data previously reported by MacroGenics. The company is positioned to begin to enroll patients imminently. MacroGenics and Laboratoires Servier will terminate their collaboration and license agreement, with an effective date of January 15, 2020, unless sooner agreed to by the parties. As a result, MacroGenics will regain full global rights to develop and commercialize flotetuzumab. MacroGenics entered into an agreement with Servier in September 2012 to develop and commercialize flotetuzumab and other earlier stage Dart molecules, in all regions other than North America, Japan, South Korea and India. Servier recently informed MacroGenics of its intention to terminate the agreement.

  • 09

    Sep

MGNX MacroGenics
$15.10

-0.11 (-0.72%)

05/16/19
STFL
05/16/19
NO CHANGE
STFL
Buy
MacroGenics' SOPHIA trial data 'very encouraging,' says Stifel
Stifel analyst Stephen Willey said he believes the magnitude of the median progression free survival and overall survival benefits observed in MacroGenics' Phase 3 SOPHIA trial in margetuximab-treated patients - particularly in those carrying the CD16A-158F polymorphism - is "very encouraging" and eliminates the overhang of a "statistically-significant but potentially not clinically-meaningful" scenario. Feedback from knowledge leader physicians also suggests a product label potentially restricted to CD16A-158F patients does not pose a barrier to adoption, Willey tells investors. The analyst, who said he is incrementally more positive on the prospects of a PFS-based approval, even in the absence of mature overall survival data, keeps a Buy rating on MacroGenics shares, which are up 15% in pre-market trading.
05/16/19
FBCO
05/16/19
NO CHANGE
Target $29
FBCO
Outperform
MacroGenics SOPHIA abstract leaves more questions than answers, says Credit Suisse
Commenting on MacroGenics' Phase 3 SOPHIA trial, Credit Suisse analyst Michael Morabito says that physician experts with whom he has been consulting were hoping for a benefit of at least 2 months compared to Herceptin, which they would consider practice changing in this third-line setting of patients who progressed on Herceptin/Perjeta/Kadcyla. With the net benefit for margetuximab coming in at only 0.9 months, the analyst would expect the shares could see increased pressure on this data. He reiterates an Outperform rating and $29 price target on the shares.
06/04/19
STFL
06/04/19
NO CHANGE
STFL
Stifel 'gut reaction' to margetuximab data aligns with 19% selloff
Stifel analyst Stephen Willey says his "gut reaction" to today's more-detailed Sophia data appears to align with how the stock is trading post this morning's presentation. Shares of MacroGenics are down 19%, or $3.55, to $15.17 in midday trading. The analyst found the overall survival data of margetuximab the most disappointing. He had hoped the large absolute median OS benefit in low-affinity CD16A-158 patients favoring margetuximab would offset some of the concern around the clinical relevance of the progression free survival benefit. Unfortunately, however, this benefit appears to be less compelling when viewed in the context of the full Kaplan-Meier curve, Willey tells investors in a research note titled "First Take on SOPHIA Data Presentation - Don't Expect OS to Pick Up the PFS Slack." The analyst continues to believe the Sophia data represents an approvable data set, but he admits the addressable market opportunity is "likely now amplified following today's presentation." The continued perception of margetuximab as an overhang could serve to keep near-term enthusiasm in MacroGenics shares "muted," says Willey. He keeps a Buy rating on the shares.
06/05/19
STFL
06/05/19
NO CHANGE
Target $29
STFL
Buy
MacroGenics price target lowered to $29 from $36 at Stifel
Stephen analyst Kevin Willey lowered his price target for MacroGenics to $29 from $36, saying he expects maturing overall survival data from Sophia to command "meaningful" regulatory and commercial importance given what is likely to remain perceived to be a progression free survival benefit of uncertain clinical relevance. Willey tells investors in a research note that he is now less optimistic directionally-supportive OS data will manifest over time in the intent-to-treat patient population and has "minimal" confidence the early numerical OS separation favoring margetuximab in CD16A-158F patients will prove durable. He maintains a Buy rating.

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T

AT&T

$37.82

0.03 (0.08%)

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HBO Max to stream Studio Ghibli films, Reuters says »

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T

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T

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BDN

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BDN

Brandywine Realty

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BDN

Brandywine Realty

$14.68

0.13 (0.89%)

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GIL

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BDN

Brandywine Realty

$14.68

0.13 (0.89%)

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  • 18

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BDN

Brandywine Realty

$14.68

0.13 (0.89%)

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