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Hot Stocks
Y-mAbs Therapeutics announces data for DANYELZA » 09:28
06/04/21
06/04
09:28
06/04/21
09:28
YMAB

Y-mAbs Therapeutics

$33.55 /

-0.65 (-1.90%)

Y-mAbs Therapeutics…

Y-mAbs Therapeutics announced that Dr. Jaume Mora, M.D., Ph.D. from SJD Barcelona Children's Hospital will present frontline data for DANYELZA and GM-CSF for consolidation of high-risk neuroblastoma patients in complete remission at the American Society of Clinical Oncology Virtual Annual Meeting on June 4, 2021 Patients received five cycles of DANYELZA and GM-CSF in a compassionate use setting for consolidation of HR-NB in first or subsequent complete remission. DANYELZA was administered in an outpatient setting on days 1, 3 and 5 at 9.0 mg/kg/cycle in combination with GM-CSF, and treatment cycles were repeated every four weeks. From June 2017 to November 2020, a total of 73 patients were treated: 55 patients in first CR and 18 patients in second or more CR. The three-year event free survival for patients in first CR was 74% and 19% for second or later CR. The three-year overall survival for the patients in first CR was 92% and 66% for second or later CR patients. Dr. Mora reported two-year EFS and OR at the Company's R&D Day in December 2020 and those data have been maintained for the three-year follow up.

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YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

05/07/21 BofA
Y-mAbs Therapeutics upgraded to Buy from Neutral at BofA
04/23/21 Cowen
Y-mAbs Therapeutics transferred with Outperform at Cowen
04/21/21 Wedbush
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush
03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

Hot Stocks
Y-mAbs Therapeutics announces presentation of Phase 1 data for omburtamab » 09:05
06/04/21
06/04
09:05
06/04/21
09:05
YMAB

Y-mAbs Therapeutics

$33.55 /

-0.65 (-1.90%)

Y-mAbs Therapeutics…

Y-mAbs Therapeutics announced that Dr. Mark Souweidane, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine will present interim phase 1 dose-escalation data for omburtamab for diffuse intrinsic pontine glioma at the American Society of Clinical Oncology Virtual Annual Meeting on June 4, 2021 The phase 1 dose-escalation study with administration via convection enhanced delivery, showed that dosing of omburtamab radiolabeled with 8 mCi of 124-Iodine appeared to be well-tolerated and provided distribution volume to potentially cover tumor volumes of up to 20 cm3. The median overall survival of all 46 patients in the study increased by three to four months as compared to the historical control group. The study will continue dose escalation for both infused volume and dose. Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.

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YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

05/07/21 BofA
Y-mAbs Therapeutics upgraded to Buy from Neutral at BofA
04/23/21 Cowen
Y-mAbs Therapeutics transferred with Outperform at Cowen
04/21/21 Wedbush
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush
03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

YMAB Y-mAbs Therapeutics
$33.55 /

-0.65 (-1.90%)

Hot Stocks
Y-mAbs in pact with Adium for DANYELZA, Omburtamab Latin American distribution » 16:11
05/19/21
05/19
16:11
05/19/21
16:11
YMAB

Y-mAbs Therapeutics

$33.42 /

-0.9 (-2.62%)

Y-mAbs Therapeutics…

Y-mAbs Therapeutics announced that it has entered into an exclusive distribution agreement with Adium Pharma S.A. to be the exclusive distributor in Latin America of the Company's antibodies, DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. DANYELZA or naxitamab-gqgk, 40mg/10mL was approved by the U.S. Food and Drug Administration on November 25 and is indicated, in combination with granulocyte-macrophage colony-stimulating factor for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. The distribution agreement includes the territories of Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, and certain Caribbean islands. Under the terms of the agreement, Adium will employ its sales and marketing expertise to distribute DANYELZA and omburtamab, if approved, in the territory. In addition, Adium will submit registration files on behalf of the Company in certain parts of the territory. All other unpartnered geographies worldwide remain with the Company. Financial details were not disclosed."We are very pleased to enter this distribution agreement with Adium, a company with a commercial presence in 18 countries and a sustained oncology and rare disease business. We hope to leverage Adium's footprint in Latin America to make DANYELZA and omburtamab, if approved, available to children with unmet medical needs," said Thomas Gad, founder, Chairman and President at Y-mAbs.

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YMAB Y-mAbs Therapeutics
$33.42 /

-0.9 (-2.62%)

YMAB Y-mAbs Therapeutics
$33.42 /

-0.9 (-2.62%)

05/07/21 BofA
Y-mAbs Therapeutics upgraded to Buy from Neutral at BofA
04/23/21 Cowen
Y-mAbs Therapeutics transferred with Outperform at Cowen
04/21/21 Wedbush
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush
03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
YMAB Y-mAbs Therapeutics
$33.42 /

-0.9 (-2.62%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$33.42 /

-0.9 (-2.62%)

YMAB Y-mAbs Therapeutics
$33.42 /

-0.9 (-2.62%)

Over a month ago
Hot Stocks
Y-mAbs Therapeutics announces research update on SADA technology » 09:08
05/13/21
05/13
09:08
05/13/21
09:08
YMAB

Y-mAbs Therapeutics

$31.57 /

-0.92 (-2.83%)

Y-mAbs Therapeutics…

Y-mAbs Therapeutics announced that Nai-Kong V. Cheung, MD, PhD, Enid A. Haupt Endowed Chair, Pediatric Oncology, Memorial Sloan Kettering Cancer Center will present a research update on the Company's SADA technology platform at PEGS Boston Virtual Conference on May 13, 2021 at 1:20 p.m. Eastern Time. The SADA technology was licensed by the Company from MSK and the Massachusetts Institute of Technology. Dr. Cheung's presentation will focus on cancer therapeutics failing in development because of dose-limiting toxicities or subtherapeutic dosing as a consequence of insufficient therapeutic index. The two step SADA technology uses unique pharmacokinetics to potentially improve the TI. When applied to pre-targeted radioimmunotherapy, the bispecific SADA antibodies visualize tumors with high precision using PET and has been shown to ablate aggressive solid tumors using both beta and alpha emitters such as 177Lu or 225Ac, potentially without significant toxicity to bone marrow, liver, kidney, or CNS. Furthermore, the modularity of the SADA platform might allow easy adaptation to different tumor targets and a variety of payloads. Researchers at MSK, including Dr. Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology and Y-mAbs.

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YMAB Y-mAbs Therapeutics
$31.57 /

-0.92 (-2.83%)

YMAB Y-mAbs Therapeutics
$31.57 /

-0.92 (-2.83%)

05/07/21 BofA
Y-mAbs Therapeutics upgraded to Buy from Neutral at BofA
04/23/21 Cowen
Y-mAbs Therapeutics transferred with Outperform at Cowen
04/21/21 Wedbush
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush
03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
YMAB Y-mAbs Therapeutics
$31.57 /

-0.92 (-2.83%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$31.57 /

-0.92 (-2.83%)

YMAB Y-mAbs Therapeutics
$31.57 /

-0.92 (-2.83%)

Upgrade
Y-mAbs Therapeutics upgraded to Buy from Neutral at BofA » 11:57
05/07/21
05/07
11:57
05/07/21
11:57
YMAB

Y-mAbs Therapeutics

$32.50 /

+3.98 (+13.96%)

BofA analyst Alec…

BofA analyst Alec Stranahan upgraded Y-mAbs Therapeutics to Buy from Neutral with an unchanged price target of $56 after Danyelza beat expectations during its first quarter of launch. While the company didn't give formal full-year sales guidance, management expressed confidence in an ability to build sales in Q2 and going forward, said Stranahan, who views the early stages of the launch, paired with news of competitor Unituxin withdrawing its sBLA plans, as "a best case scenario for Y-mAbs." In addition to raising his 2021/2022 sales expectations, the analyst expressed "growing confidence" in the company's early pipeline.

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YMAB Y-mAbs Therapeutics
$32.50 /

+3.98 (+13.96%)

YMAB Y-mAbs Therapeutics
$32.50 /

+3.98 (+13.96%)

04/23/21 Cowen
Y-mAbs Therapeutics transferred with Outperform at Cowen
04/21/21 Wedbush
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush
03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
YMAB Y-mAbs Therapeutics
$32.50 /

+3.98 (+13.96%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$32.50 /

+3.98 (+13.96%)

YMAB Y-mAbs Therapeutics
$32.50 /

+3.98 (+13.96%)

Earnings
Y-mAbs Therapeutics reports Q1 EPS 80c, consensus (19c) » 16:17
05/06/21
05/06
16:17
05/06/21
16:17
YMAB

Y-mAbs Therapeutics

$28.72 /

+0.5 (+1.77%)

Reports Q1 revenue…

Reports Q1 revenue $5.38M, consensus $44.47M. We are very pleased with our first quarter 2021 financial results, as we have been commercializing DANYELZA throughout the U.S. since the beginning of February and we are very pleased with our progress to date. In addition, we successfully completed a follow-on offering with gross proceeds of approximately $115 million and netted another $62 million from closing the sale of our Priority Review Voucher, after sharing the total sales price of $105 million with MSK pursuant to the terms of our license agreement. With a cash balance of $252 million, we believe we are well positioned to advance our pipeline in the coming years," stated Thomas Gad, founder, Chairman and President.Dr. Claus Moller, Chief Executive Officer, continued, "We successfully submitted the European Marketing Authorization Application for omburtamab to the European Medicines Agency in April. In parallel, we are making good progress in the clinic and have continued to advance the earlier stage programs in our pipeline, including GPA33-SADA, where we reported radioactivity uptake with a tumor to blood ratio of 122 in a mouse model. We are planning for the first SADA IND later this year and target an IND for GPA33-SADA in 2022." Y-mAbs reported net income of $33.4 million, or $0.80 per basic share or $0.75 per diluted share, for the quarter ended March 31, 2021, compared to a net loss of $26.2 million, or ($0.66) per basic and diluted share, reported for the quarter ended March 31, 2020. The increased net income was caused by the DANYELZA revenues and the recording of the net proceeds from monetization of the DANYELZA Priority Review Voucher.

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YMAB Y-mAbs Therapeutics
$28.72 /

+0.5 (+1.77%)

YMAB Y-mAbs Therapeutics
$28.72 /

+0.5 (+1.77%)

04/23/21 Cowen
Y-mAbs Therapeutics transferred with Outperform at Cowen
04/21/21 Wedbush
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush
03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
03/01/21 H.C. Wainwright
Y-mAbs Therapeutics price target raised to $70 from $65 at H.C. Wainwright
YMAB Y-mAbs Therapeutics
$28.72 /

+0.5 (+1.77%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$28.72 /

+0.5 (+1.77%)

YMAB Y-mAbs Therapeutics
$28.72 /

+0.5 (+1.77%)

Hot Stocks
Y-mAbs submits Omburtamab MAA to European Medicines Agency » 16:07
04/27/21
04/27
16:07
04/27/21
16:07
YMAB

Y-mAbs Therapeutics

$28.10 /

-0.06 (-0.21%)

Y-mAbs Therapeutics…

Y-mAbs Therapeutics announced that the Company has submitted its Marketing Authorization Application to the European Medicines Agency for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. Omburtamab is an investigational, monoclonal antibody that targets B7-H3 and is radiolabeled before intraventricular central nervous system administration. B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. "We believe omburtamab is on track to potentially become the first EMA approved targeted therapy for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma," said Thomas Gad, founder, Chairman and President at Y-mAbs. "With this submission to EMA, Y-mAbs is continuing to advance the omburtamab program to potentially provide access to this innovative therapy to pediatric patients globally as quickly as possible." In addition, Y-mAbs recently concluded a Type B meeting with the U.S. Food and Drug Administration regarding omburtamab and the Company continues to be in close dialog with the FDA and maintains its aim of resubmitting the Biologics License Application to the FDA late in the second quarter or in the third quarter of 2021. Dr. Claus Moller, the Company's Chief Executive Officer, continued, "We are excited to submit the MAA for omburtamab, and very pleased about the progress we are making. We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma. We also are continuing to work closely with the FDA to resubmit the omburtamab BLA."

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YMAB Y-mAbs Therapeutics
$28.10 /

-0.06 (-0.21%)

YMAB Y-mAbs Therapeutics
$28.10 /

-0.06 (-0.21%)

04/23/21 Cowen
Y-mAbs Therapeutics transferred with Outperform at Cowen
04/21/21 Wedbush
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush
03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
03/01/21 H.C. Wainwright
Y-mAbs Therapeutics price target raised to $70 from $65 at H.C. Wainwright
YMAB Y-mAbs Therapeutics
$28.10 /

-0.06 (-0.21%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$28.10 /

-0.06 (-0.21%)

YMAB Y-mAbs Therapeutics
$28.10 /

-0.06 (-0.21%)

Recommendations
Y-mAbs Therapeutics transferred with Outperform at Cowen » 06:23
04/23/21
04/23
06:23
04/23/21
06:23
YMAB

Y-mAbs Therapeutics

$27.03 /

+0.3 (+1.12%)

Cowen analyst Joseph…

Cowen analyst Joseph Thome took over coverage of Y-mAbs Therapeutics and kept an Outperform rating on the shares.

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YMAB Y-mAbs Therapeutics
$27.03 /

+0.3 (+1.12%)

YMAB Y-mAbs Therapeutics
$27.03 /

+0.3 (+1.12%)

04/21/21 Wedbush
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush
03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
03/01/21 H.C. Wainwright
Y-mAbs Therapeutics price target raised to $70 from $65 at H.C. Wainwright
01/15/21 BofA
BofA cuts Y-mAbs Therapeutics to Neutral with near-term catalysts played out
YMAB Y-mAbs Therapeutics
$27.03 /

+0.3 (+1.12%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$27.03 /

+0.3 (+1.12%)

YMAB Y-mAbs Therapeutics
$27.03 /

+0.3 (+1.12%)

Recommendations
Y-mAbs Therapeutics price target lowered to $52 from $67 at Wedbush » 08:43
04/21/21
04/21
08:43
04/21/21
08:43
YMAB

Y-mAbs Therapeutics

$26.00 /

+0.435 (+1.70%)

Wedbush analyst David…

Wedbush analyst David Nierengarten lowered the firm's price target on Y-mAbs Therapeutics to $52 from $67 and keeps an Outperform rating on the shares. The analyst notes that Y-mAbs reiterated guidance to re-submit the BLA for its B7-H3-targeting radiopharmaceutical omburtamab in Q2/Q3 2021 after a Type B meeting with the FDA and discussing expectations after the company received a Refusal to File letter from the FDA last year. The BLA submission for omburtamab has been a struggle, but Y-mAbshas shown encouraging levels of efficacy with omburt in pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma including a 40% ORR and Nierengarten expects the FDA to eventually approve it.

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YMAB Y-mAbs Therapeutics
$26.00 /

+0.435 (+1.70%)

YMAB Y-mAbs Therapeutics
$26.00 /

+0.435 (+1.70%)

03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
03/01/21 H.C. Wainwright
Y-mAbs Therapeutics price target raised to $70 from $65 at H.C. Wainwright
01/15/21 BofA
BofA cuts Y-mAbs Therapeutics to Neutral with near-term catalysts played out
01/15/21 BofA
Y-mAbs Therapeutics downgraded to Neutral from Buy at BofA
YMAB Y-mAbs Therapeutics
$26.00 /

+0.435 (+1.70%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$26.00 /

+0.435 (+1.70%)

YMAB Y-mAbs Therapeutics
$26.00 /

+0.435 (+1.70%)

Hot Stocks
Y-mAbs receives requests from FDA for additional data on omburtamab » 09:04
04/20/21
04/20
09:04
04/20/21
09:04
YMAB

Y-mAbs Therapeutics

$25.47 /

-0.72 (-2.75%)

Y-mAbs Therapeutics…

Y-mAbs Therapeutics announced a regulatory update for omburtamab, which is an investigational, monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system administration. B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. Y-mAbs recently concluded a Type B meeting with the U.S. Food and Drug Administration regarding omburtamab and received requests from the FDA for additional data concerning the granularity of data from our identified historical control groups. In order to agree on a statistical analysis plan, this additional granularity data is being collected and we anticipate submitting it to the FDA by the end of April. An additional Type B meeting has been scheduled for June 1, 2021 to discuss the SAP based on review of the additional data. The company continues to be in close dialog with the FDA and maintains an aim of resubmitting the Biologics License Application for omburtamab late in the second quarter or in the third quarter of 2021.

ShowHide Related Items >><<
YMAB Y-mAbs Therapeutics
$25.47 /

-0.72 (-2.75%)

YMAB Y-mAbs Therapeutics
$25.47 /

-0.72 (-2.75%)

03/22/21 JPMorgan
Y-mAbs Therapeutics assumed with an Overweight at JPMorgan
03/01/21 H.C. Wainwright
Y-mAbs Therapeutics price target raised to $70 from $65 at H.C. Wainwright
01/15/21 BofA
BofA cuts Y-mAbs Therapeutics to Neutral with near-term catalysts played out
01/15/21 BofA
Y-mAbs Therapeutics downgraded to Neutral from Buy at BofA
YMAB Y-mAbs Therapeutics
$25.47 /

-0.72 (-2.75%)

  • 18
    Feb
YMAB Y-mAbs Therapeutics
$25.47 /

-0.72 (-2.75%)

YMAB Y-mAbs Therapeutics
$25.47 /

-0.72 (-2.75%)

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