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YMAB

Y-mAbs Therapeutics

$22.72

0.85 (3.89%)

09:06
07/08/19
07/08
09:06
07/08/19
09:06

Y-mAbs plans to submit clinical/safety, non-clinical portions of BLA in November

Y-mAbs Therapeutics announced that it has completed a Type B Pre-Biologics License Application meeting with the U.S. Food and Drug Administration regarding a potential pathway for FDA approval of naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma. At the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission. The Company expects to submit the Clinical/Safety portion and the non-Clinical portion of the BLA in November 2019. For the CMC portion, the Company believes it will have sufficient data from the process performance qualification batches to complete the CMC portion in early 2020. However, Y-mAbs is still investigating possibilities for accelerating the submission of the CMC portion, and hope to comply with the FDA requirements at an earlier time. Under naxitamab's breakthrough therapy designation, the compound qualifies for a Rolling BLA, which enables individual modules of the application to be submitted by the Company and reviewed by the FDA on a rolling basis, rather than waiting for all sections to be completed before submission. The rolling application process will provide the Company with the opportunity for ongoing communications with the FDA, and, during this rolling process, the Company anticipates that it will be able to address any substantial matters raised by the FDA. Based on the previously announced efficacy data from Study 12-230 in relapsed/refractory high-risk neuroblastoma patients at Memorial Sloan Kettering Cancer Center, the FDA determined that efficacy data from all 37 patients of the Company's multicenter Study 201 would not be required for the BLA filing. The FDA advised the Company that the available data for the first group of patients treated outside MSK in Study 201 would be sufficient for the BLA filing. The first group consists of 24 patients, of which 11 were evaluable prior to the pre-BLA meeting and showed an overall response rate of 73%, including 55% complete responses, as assessed by the investigators. The Company intends to announce the complete dataset for Study 201 once the data becomes available.

  • 09

    Sep

YMAB Y-mAbs Therapeutics
$22.72

0.85 (3.89%)

10/16/18
ADAM
10/16/18
INITIATION
Target $30
ADAM
Buy
Y-mAbs Therapeutics initiated with a Buy at Canaccord
Canaccord analyst Arlinda Lee initiated Y-mAbs Therapeutics with a Buy rating citing its staggered and deep pipeline including two late stage clinical drug candidates. The analyst sees top-line data from the company's pivotal Study 201 of naxitamab and an initiation of Study 17-251 of naxitamab + chemo in refractory NB in 2018 as near-term catalysts. Lee has a $30 price target on Y-mAbs Therapeutics shares.
10/16/18
COWN
10/16/18
INITIATION
COWN
Outperform
Y-mAbs Therapeutics initiated with an Outperform at Cowen
Cowen analyst Boris Peaker initiated Y-mAbs Therapeutics with an Outperform rating. He noted the company has two pivotal stage drugs for rare pediatric cancers. He believes the assets are highly de-risked and offer high barriers for potential competitors. Peaker has not established a price target yet.
04/01/19
HCWC
04/01/19
INITIATION
Target $36
HCWC
Buy
Y-mAbs Therapeutics initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju started Y-mAbs Therapeutics with a Buy rating and $36 price target. The company has a "highly differentiated business model," focusing on rare, hitherto difficult-to-treat pediatric cancers with next-generation monoclonal antibody therapeutics, Selvaraju tells investors in a research note. He believes the company's is a platform "possesses multiple advantages."
06/10/19
HCWC
06/10/19
NO CHANGE
Target $40
HCWC
Buy
Y-mAbs Therapeutics price target raised to $40 from $36 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Y-mAbs Therapeutics to $40 from $36 saying he's encouraged by omburtamab's efficacy in diffuse intrinsic pontine glioma. Further, he believes the drug's efficacy results may improve in later-stage trials. The analyst reiterates a Buy rating on Y-mAbs.

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