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IOVA

Iovance Biotherapeutics

$9.46

-0.34 (-3.47%)

08:29
11/06/18
11/06
08:29
11/06/18
08:29

Iovance says new cohort of 80-100 patients in C-144-01 will be enrolled

Iovance Biotherapeutics said this morning in a press release, "As previously reported, an End of Phase 2 meeting with the FDA was held. During this meeting, the FDA acknowledged the potential acceptability of a single-arm cohort for registration. FDA has further acknowledged that conduct of a randomized Phase 3 trial may not be feasible in its intended population of advanced melanoma patients who have been treated with at least one systemic therapy including a PD-1 blocking antibody and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor and is not required for initial registration of lifileucel. Literature suggests that available care for these patients offers approximately 10% ORR. A new cohort of 80-100 patients in C-144-01 will be enrolled with a prospective definition of the primary endpoint of ORR to be read out by a Blinded Independent Review Committee to support registration of lifileucel. This new cohort, which the company refers to as Cohort 4, will be initiated in early 2019 and is expected to be fully enrolled by late 2019/early 2020. BLA submission to FDA is expected in the second half of 2020."

  • 06

    Nov

IOVA Iovance Biotherapeutics
$9.46

-0.34 (-3.47%)

10/12/18
HCWC
10/12/18
NO CHANGE
HCWC
Iovance Biotherapeutics price target raised to $26 from $22 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on Iovance Biotherapeutics and raised his price target on shares to $26 from $22, following the outcome of the end-of-Phase 2 meeting with the FDA regarding lead candidate LN-144. Pantginis called the interactions with the FDA "successful," and believes that Iovance will "further pursue its discussion with the agency in order to find the best path forward for LN-144 followed by assets across multiple indications." Additionally, the analyst reiterated his belief that Iovance is a compelling takeout candidate, and added that the company's cash resources provide strong leverage in any discussions.
10/12/18
OPCO
10/12/18
NO CHANGE
Target $25
OPCO
Outperform
Iovance Biotherapeutics price target raised to $25 from $22 at Oppenheimer
Oppenheimer analyst Mark Breidenbach reiterated an Outperform rating on Iovance Biotherapeutics and raised his price target to $25 from $22 citing recent positive clinical updates for its tumor infiltrating lymphocyte product for melanoma and the outcome of discussions with the FDA regarding the regulatory pathway forward.
09/25/18
COWN
09/25/18
NO CHANGE
COWN
Outperform
Iovance Biotherapeutics weakness a buying opportunity, says Cowen
Cowen analyst Boris Peaker said the recent weakness in Iovance is a buying opportunity. The analyst noted the company's results from the Moffitt-run study of TILS in NSCLC were deemed mild and somewhat disappointing. He believes the data has no read-through to the ongoing melanoma trial, making the weakness an attractive entry point. Peaker reiterated his Outperform rating on Iovance shares.
09/13/18
JEFF
09/13/18
NO CHANGE
Target $31
JEFF
Buy
Feedback on Moffitt TIL study appears positive, says Jefferies
Jefferies analyst Biren Amin hosted a call with an oncologist at Moffitt Cancer Center to review the initial data from this first non-small cell lung cancer tumor infiltrating lymphocytes study. The doctor highlighted the large unmet need in NSCLC patients who failed to respond to anti-PD-1 therapy and feels the 100% disease control rate achieved in the first eight refractory patients to nivo is promising, Amin tells investors in a research note. Further, the oncologist believes the limited duration of response could improve in a second NSCLC study incorporating key "biomarkers," the analyst points out. Amin believes Iovance Biotherapeutics could incorporate some of these key learnings into its two Phase I/II NSCLC studies. The analyst keeps a Buy rating on Iovance with a $31 price target.

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CLF

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TGT

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$69.29

-7.84 (-10.16%)

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Best Buy

$64.05

1.86 (2.99%)

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LB

L Brands

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$NSD

NASDAQ Market Internals

$0.00

(0.00%)

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$NYE

NYSE Market Internals

$0.00

(0.00%)

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BSX

Boston Scientific

$34.13

-1.16 (-3.29%)

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AMAT

Applied Materials

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FB

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EGRX

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SDRL

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EROS

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LB

L Brands

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  • 20

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SCO

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