Thu, May 19, 3:38 PM
- IPO Merus B.V. (Pending: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)
Wed, May 11, 12:18 AM
Tue, May 10, 11:54 AM
Fri, Apr. 1, 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.
Wed, Mar. 9, 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)
Wed, Feb. 17, 12:09 PM
Wed, Jan. 20, 3:39 PM
- Tomorrow is the FDA's action date (PDUFA) for its review of Novartis' (NVS -0.2%) supplemental New Drug Application (sNDA) seeking clearance of Arzerra (ofatumumab) for the maintenance treatment of chronic lymphocytic leukemia (CLL) patients who have relapsed.
- Arzerra is currently cleared in the U.S. to treat CLL patients who have not responded to fludarabine and alemtuzumab (Sanofi's LEMTRADA) and, in combination with chlorambucil, for treatment-naive CLL patients for whom fludarabine-based therapy is inappropriate.
- Novartis, by way of GlaxoSmithKline (GSK -0.6%) is commercializing ofatumumab via a collaboration agreement with Danish biotech Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY).
- Ofatumumab is a monoclonal antibody that binds to CD20, an antigen found on the surface of CLL cells and normal B lymphocytes.
- Previously: FDA tags Genmab's ofatumumab for Priority Review for maintenance therapy for CLL (Sept. 20, 2015)
- Previously: Novartis files Arzerra sBLA for expanded use in chronic lymphocytic leukemia (July 22, 2015)
- Update: Approval issued yesterday.
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.
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.
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.
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.
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. 9, 2015, 2:03 PM
- Janssen Biotech (JNJ +0.9%) finishes the rolling submission of its Biologics License Application (BLA) for Breakthrough Therapy-designated daratumumab for the treatment of multiple myeloma patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. The application includes a request for Priority Review. If granted, it will shorten the review clock to six months.
- The completion of the filing triggers a $15M milestone payment to antibody discoverer Genmab (OTCPK:GMXAY) (OTC:GNMSF). In August 2012, Genmab granted Janssen an exclusive global license to develop, manufacture and commercialize the product.
- Daratumumab is an investigational human IgG1k monoclonal antibody that binds to the transmembrane ectoenzyme CD38, found on the surface of multiple myeloma cells. Once bound, it induces rapid tumor cell death.
Apr. 17, 2014, 4:23 PM
- The FDA approves Glaxo (GSK) and Genmab's (GNMSF) monoclonal antibody Arzerra (ofatumumab) as a first-line therapy for patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
- "Arzerra is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab," says Jan de Winkel, Ph.D., Genmab's CEO.
- In the Phase 3 COMPLEMENT 1 clinical trial the ofatumumab plus chlorambucil group's progression-free survival (PFS) was 22.4 months compared to 13.1 months for the chlorambucil alone group.
May 29, 2013, 3:28 PM
GlaxoSmithKline (GSK -3%) says a combination of ARZERRA and chlorambucil has met its primary endpoint of improving progression free survival times (versus treatment with chlorambucil alone) in a pivotal Phase 3 trial with partner Genmab (GNMSF.PK). No unexpected safety issues were encountered. (PR)| May 29, 2013, 3:28 PM
Aug. 30, 2012, 8:16 AM
J&J (JNJ) unit Janssen Biotech buys the global licensing rights to cancer agent daratumumab from Danish biotech Genmab in a deal that could eventually be worth over $1.1B. Janssen is paying $55M upfront and will make further payments following the achievement of development, regulatory and sales milestones. J&J is also investing $80M in Genmab in return for a 10.7% stake. (PR)| Aug. 30, 2012, 8:16 AM