GNMSF
Genmab A/S  |  Grey Market
52wk high:185.00
52wk low:94.74
EPS:1.83
PE (ttm):101.08
Div Rate (ttm):-
Yield (ttm):-
Market Cap:$11.15B
Volume:
  • Dec. 20, 2016, 11:56 AM
    • Janssen Biotech's Japanese subsidiary Janssen Pharmaceutical K.K. (JNJ -0.3%) submits a marketing application in Japan seeking approval of DARZALEX (daratumumab) for the treatment of adults with relapsed/refractory multiple myeloma. The filing triggers a $10M milestone payment to licensor Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY).
    • Genmab ups its 2016 guidance to include the milestone payment (KK millions): Revenue: 1,720- 1,770 from 1,650 - 1,700; operating income: 895 - 945 from 825 - 875.
    • Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms. It is being exclusively developed by Janssen Biotech.
    Dec. 20, 2016, 11:56 AM | 1 Comment
  • Nov. 11, 2016, 9:30 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending the use of Novartis' (NYSE:NVS) Arzerra (ofatumumab), in combination with the chemo agents fludarabine and cyclophosphamide, for the treatment of adult patients with relapsed chronic lymphocytic leukemia (CLL).
    • The original European indication specifies the use of Arzerra, in combination with the chemo agents chlorambucil or bendamustine, in treatment-naive CLL patients who cannot be treated with fludarabine and in CLL patients who do not respond to fludarabine and alemtuzumab [Sanofi's (NYSE:SNY) LEMTRADA].
    • A final decision from the European Commission usually takes ~60 days.
    • Novartis is developing ofatumumab under a collaboration with Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY).
    Nov. 11, 2016, 9:30 AM | 1 Comment
  • Aug. 31, 2016, 6:57 AM
    • The FDA approves Novartis' (NYSE:NVS) ARZERRA (ofatumumab), in combination with the chemo agents fludarabine and cyclophosphamide, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).
    • ARZERRA was previously approved for the treatment of CLL patients who have not responded to fludarabine and Sanofi's (NYSE:SNY) LEMTRADA (alemtuzumab), in treatment-naive CLL patients not treated with fludarabine and maintenance treatment of CLL in partial/complete responders treated with at least two prior lines of therapy.
    • Ofatumumab is a monoclonal antibody that binds to CD20, an antigen found on the surface of CLL cells and normal B lymphocytes.
    • ARZERRA is being commercialized under a collaboration with Danish biotech Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY).
    Aug. 31, 2016, 6:57 AM | 2 Comments
  • Aug. 9, 2016, 11:31 AM
    • Genmab (OTC:GNMSF): Q2 EPS of DKK2.72 beats by DKK1.17.
    • Revenue of DKK353.83M (+103.5% Y/Y) beats by DKK142.15M.
    • Press Release
    Aug. 9, 2016, 11:31 AM
  • May 19, 2016, 3:38 PM
    • IPO Merus N.V. (NASDAQ:MRUS) is holding its ground on its debut day. Shares are up 5% from the issue price of $10 on modest turnover of 868K shares.
    • The Netherlands-based company develops immuno-oncology-focused bispecific antibody therapeutics based on its technology platform called Biclonics. A bispecific antibody has the ability to bind to two or more targets simultaneously. Its lead product candidate is MCLA-128, in Phase 1/2 development in Europe for the treatment of various solid tumors, including breast, colorectal and ovarian cancers. Other pipeline candidates are MCLA-117 for blood cancers, MCLA-158 for colorectal cancer, MCLA-134 for solid tumors and MCLA-145 for solid tumors.
    • 2015 Financials (€M): Revenue: 2.0 (+51.7%); Operating Expenses: 25.0 (+33.7%); Net Loss: (23.2) (-33.2%); CF Ops: (23.0) (-57.9%).
    • Related tickers: (AMGN -1.5%)(MGNX +1.2%)(JNJ -0.7%)(AFMD +0.3%)(PIRS -7%)(OTC:GNMSF)
    May 19, 2016, 3:38 PM
  • May 11, 2016, 12:18 AM
    • Genmab A/S (OTC:GNMSF): Q1 EPS of -DKK0.19
    • Revenue of DKK170.17M (+59.4% Y/Y)
    May 11, 2016, 12:18 AM
  • May 10, 2016, 11:54 AM
    • Genmab A/S (OTC:GNMSF): Q1 Revenue of DKK170M (+59.2% Y/Y) beats by DKK32.7M.
    May 10, 2016, 11:54 AM
  • Apr. 1, 2016, 1:22 PM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending conditional approval of Janssen Biotech's (JNJ +0.3%) DARZALEX (daratumumab) for the treatment of adult patients with relapsed/refractory multiple myeloma whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and whose disease has progressed on the last therapy.
    • Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
    • Janssen licensed daratumumab from Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY) in August 2012. The FDA approved it in November 2015.
    • A final decision from the European Commission usually takes ~60 days.
    Apr. 1, 2016, 1:22 PM | 1 Comment
  • Mar. 9, 2016, 3:58 PM
    • Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY) earns a $5M milestone from Johnson & Johnson's (JNJ +0.3%) Janssen Biotech triggered by progress in the ongoing Phase 2 clinical trial assessing Orphan Drug-tagged daratumumab as monotherapy in three different types of non-Hodgkin lymphoma (NHL): diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL). The milestone was specific to progress in the FL arm.  Genmab earned the first milestone, also $5M, in December.
    • Daratumumab, branded as DARZALEX, is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms. The FDA approved DARZALEX in mid-November 2015 for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.
    • The companies inked a global license and development deal for daratumumab in August 2012.
    • Previously: Genmab earns $5M milestone from Janssen for progress in mid-stage study of daratumumab (Dec. 9, 2015)
    Mar. 9, 2016, 3:58 PM | 7 Comments
  • Feb. 17, 2016, 12:09 PM
    • Genmab A/S (OTC:GNMSF): FY15 EPS of DKK 12.56.
    • Revenue of DKK 1.13B (+32.9% Y/Y).
    Feb. 17, 2016, 12:09 PM
  • Jan. 20, 2016, 3:39 PM
    Jan. 20, 2016, 3:39 PM | 6 Comments
  • Dec. 9, 2015, 12:14 PM
    • Copenhagen, Denmark-based Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY) earns a $5M milestone payment from Janssen Biotech (JNJ +0.1%) triggered by progress in the ongoing Phase 2 clinical trial evaluating Orphan Drug-tagged daratumumab (DARZALEX) in three types of non-Hodgkin lymphoma (diffuse large B-cell (DLBCL), follicular and mantle cell). The milestone is related to the study's progress in patients with DLBCL.
    • The primary endpoint of the study is the Overall Response Rate (ORR), defined as the proportion of participants who achieve either a complete or partial response. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is April 2019. The estimated study completion date is September 2019.
    • Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of multiple myeloma cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
    • The FDA approved DARZALEX in mid-November for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.
    • The companies inked a global license and development deal for daratumumab in August 2012.
    Dec. 9, 2015, 12:14 PM
  • Oct. 5, 2015, 11:54 AM
    • Genmab A/S (OTC:GNMSF) (OTCPK:GMXAY) earns a $3M milestone payment from collaboration partner Janssen Biotech (JNJ +0.3%) triggered by its pre-clinical progress on a DuoBody product candidate targeting cancer.
    • Janssen has optioned 11 programs out of a total of 20 under its collaboration with Genmab. Janssen is one of five commercial partnerships Genmab has established for its DuoBody technology.
    • Under the companies' original agreement that was inked in July 2012, Janssen has the right to use the DuoBody technology for up to 10 programs across a range of diseases. In addition to an upfront fee of $3.5M, Genmab is eligible to receive up to ~$175M in milestones and license payments. Under the terms of a contract amendment signed in December 2013, Janssen may work on an additional 10 programs. In addition to a $2M upfront fee, Genmab could potentially earn up to $191M in milestone and license payments for each additional program that Janssen commercializes.
    • DuoBody is an innovative platform for the discovery and development of bispecific antibodies (they bind to two sites instead of just one) that could potentially improve antibody therapy across a range of diseases.
    Oct. 5, 2015, 11:54 AM
  • Sep. 20, 2015, 8:27 PM
    • The FDA designates Genmab A/S's (OTC:GNMSF) (OTCPK:GMXAY) ofatumumab for Priority Review for the maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL). The PDUFA date is January 21, 2016. The supplemental Biologics License Application (sBLA) was submitted by licensee Novartis (NYSE:NVS) via its acquisition of GlaxoSmithKline's (NYSE:GSK) oncology business.
    • The data supporting the application was generated in the Phase 3 PROLONG study which evaluated ofatumumab maintenance therapy compared to no further treatment in CLL patients who experienced a complete or partial response after second or third line treatment.
    • The FDA approved ofatumumab, branded as Arzerra, for treatment-naive CLL patients who are not being treated with the chemo agent fludarabine in April 2014.
    • Priority Review status shortens the review clock to six months versus the normal 10 months.
    Sep. 20, 2015, 8:27 PM | 2 Comments
  • Aug. 14, 2015, 8:04 AM
    • Copenhagen, Denmark-based Genmab A/S (OTC:GNMSF) (OTCPK:GMXAY) inks an agreement with Novo Nordisk (NYSE:NVO) that grants Novo commercial licenses to use Genmab's DuoBody technology platform to create and develop bispecific antibody candidates for two non-cancer therapeutic programs.
    • Under the terms of the agreement, Genmab will receive an upfront payment of $2M, regulatory and sales milestones of up to $250M for each exclusive license ($200M if non-exclusive) and single-digit royalties on commercial sales.
    • Bispecific antibodies bind to two different sites (epitopes) on the same or different targets, thereby improving their efficacy in inactivating disease targets.
    Aug. 14, 2015, 8:04 AM
  • Jul. 22, 2015, 11:43 AM
    • Novartis (NVS -1.4%) submits a supplemental Biologics License Application (sBLA) to the FDA seeking approval for Arzerra (ofatumumab) for the maintenance treatment of patients with relapsed chronic lymphocytic leukemia (CLL). It is currently cleared, in combination with chlorambucil, for treatment-naive CLL patients who are not candidates for fludarabine or who are refractory to fludarabine and alemtuzumab.
    • Ofatumumab is a human monoclonal antibody that binds to CD20, an antigen found on the surface of CLL cells and normal B lymphocytes. It was approved by the FDA in April 2014 and by the European Commission in July 2014.
    • Novartis is developing ofatumumab for cancer indications as part of its acquisition of GlaxoSmithKline's (GSK -1%) oncology business. GSK will continue to develop and commercialize it for autoimmune indications. The antibody was discovered by Danish biotech Genmab A/S (OTC:GNMSF) (OTCPK:GMXAY).
    Jul. 22, 2015, 11:43 AM