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SESN

Sesen Bio

$1.19

-0.01 (-0.84%)

07:37
12/09/19
12/09
07:37
12/09/19
07:37

Sesen Bio initiates rolling submission of BLA for Vicinium to FDA

Sesen Bio announced that on December 6, the company initiated the submission of its Biologics License Application, or BLA, for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer, or NMIBC, under Rolling Review to the FDA. Vicinium was granted Fast-Track Designation by the FDA in 2018. The company has submitted completed non-clinical and clinical modules, and a partially completed Chemistry, Manufacturing and Controls, or CMC, module. The company anticipates completing the BLA submission with the finalization of the CMC module in 2020. If the FDA accepts the BLA filing, the company plans to request a Priority Review.

SESN Sesen Bio
$1.19

-0.01 (-0.84%)

01/04/19
HCWC
01/04/19
DOWNGRADE
Target $1
HCWC
Neutral
Sesen Bio downgraded to Neutral from Buy at H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth downgraded Sesen Bio to Neutral and lowered his price target for the shares to $1 from $3. While the Phase 3 Vista results "appear decent in isolation," the failure to improve on the Phase 2 results despite a more rigorous treatment schedule introduces additional uncertainties on the regulatory and commercial prospects of Vicinium, Ramakanth tells investors in a research note. The full Vista results are not expected until mid-2019, which could potentially render the stock range-bound until then, says the analyst.
02/06/19
JEFF
02/06/19
INITIATION
Target $3
JEFF
Buy
Sesen Bio assumed with a Buy at Jefferies
Jefferies analyst Chris Howerton assumed coverage of Sesen Bio with a Buy rating and $3 price target. The analyst believes the company's Vicinium will be approvable in 2020 or 2021 with peak U.S. sales potential of $260M in 2034.
06/11/19
HCWC
06/11/19
UPGRADE
Target $3
HCWC
Buy
Sesen Bio upgraded to Buy from Neutral at H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth upgraded Sesen Bio to Buy from Neutral and raised his price target for the shares to $3.00 from $1.00. The company yesterday announced that it has successfully completed a Type B pre-Biologics License Application meeting with FDA for lead product, Vicinium, for the treatment of patients with Bacillus Calmette-Guerin unresponsive, non-muscle invasive bladder cancer, Ramakanth tells investors in a research note. Following this "green light" from the FDA, the analyst believes there is a high likelihood that Vicinium will be approved. He now projects a 90% probability of U.S. approval, up from 60% previously.
08/09/19
LDLW
08/09/19
DOWNGRADE
LDLW
Hold
Sesen Bio downgraded to Hold from Buy at Laidlaw

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