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SGEN

Seattle Genetics

$61.88

-2.64 (-4.09%)

08:04
06/20/17
06/20
08:04
06/20/17
08:04

Seattle Genetics submits supplemental BLA to FDA for ADCETRIS

Seattle Genetics announced that it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration based on data from the phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials of ADCETRIS in patients with cutaneous T-cell lymphoma. ADCETRIS is currently not approved for the treatment of CTCL. In November 2016, based on preliminary analysis of ALCANZA, the FDA granted ADCETRIS Breakthrough Therapy Designation for the treatment of patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma who require systemic therapy and have received one prior systemic therapy. These represent the most common subtypes of CTCL. Based on discussions with the FDA following the BTD, additional data from investigator-sponsored phase 2 trials have been incorporated into the supplemental BLA to support the potential for a broader label in CTCL. The supplemental BLA is primarily based on positive results from a phase 3 trial called ALCANZA that were presented at the 58th American Society of Hematology annual meeting in December 2016 and published in the Lancet in June. Results from the ALCANZA trial in 128 CTCL patients requiring systemic therapy included: The trial achieved its primary endpoint with the ADCETRIS treatment arm demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months versus the control arm as assessed by an independent review facility. ORR4, as assessed by Global Response Score, was 56.3% in the ADCETRIS arm compared to 12.5% in the control arm. Key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in the burden of symptoms during treatment, were all highly statistically significant in favor of the ADCETRIS arm. The safety profile associated with ADCETRIS from the ALCANZA trial was generally consistent with the existing prescribing information. The most common adverse events of any grade include: peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, alopecia, pruritis, pyrexia, decreased appetite and hypertriglyceridemia.

SGEN Seattle Genetics
$61.88

-2.64 (-4.09%)

03/15/17
OPCO
03/15/17
INITIATION
OPCO
Perform
Seattle Genetics initiated with a Perform at Oppenheimer
Oppenheimer analyst Leah Rush Cann initiated Seattle Genetics with a Perform rating, expecting Seattle Genetics will continue to develop its commercial drug, Adcetris, which is already approved for Hodgkin lymphoma.
05/05/17
05/05/17
UPGRADE

Outperform
Immunomedics upgraded at Wells Fargo after Seattle Genetics deal terminated
As previously reported, Wells Fargo analyst Jim Birchenough upgraded Immunomedics (IMMU) to Outperform from Market Perform, stating that he is impressed at how quickly the new board moved to secure financing needed to advance IMMU132 and to put in place new management. With improved leadership, a better cash position and the Seattle Genetics (SGEN) deal terminated, Birchenough expects Immunomedics to secure "more appropriate" partnership terms for its "competitive asset for solid tumors," he tells investors. He increased his price target range for Immunomedics shares to $10-$11.50 from $5-$6.
06/19/17
PIPR
06/19/17
NO CHANGE
Target $48
PIPR
Neutral
Seattle Genetics price target lowered to $48 from $57 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff lowered his price target for Seattle Genetics to $48 after the company announced the discontinuation of the Phase III Cascade trial in acute myeloid leukemia. The analyst views the news as a negative surprise and removed SGN-CD33A from his model. He keeps a Neutral rating on Seattle Genetics. The stock in early trading is down 9%, or $5.62, to $58.90.
06/20/17
LEER
06/20/17
NO CHANGE
Target $66
LEER
Outperform
Seattle Genetics price target lowered to $66 from $74 at Leerink
Leerink analyst Michael Schmidt lowered his price target for Seattle Genetics to $66 after the company discontinued SGN-CD33A in front-line, elderly acute myeloid leukemia patients. The news increases the importance of positive Adcetris ECHELON-1 trial in front-line Hodgkin lymphoma later this year, which will be critical for the company to accelerate top-line growth, Schmidt tells investors in a research note. He keeps an Outperform rating on Seattle Genetics.

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