San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO), a bio­technology com­pany devel­op­ing novel on­col­ogy and drug-delivery ther­a­pies, to­day an­nounced that its col­lab­o­rator Janssen Biotech, Inc. (Janssen) has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion for the sub­cu­tane­ous de­livery of DAR­ZA­LEX® (dara­tu­mu­mab) for patients with mul­ti­ple myeloma.

"Janssen's BLA sub­mission for sub­cu­tane­ous DAR­ZA­LEX® rep­re­sents an im­por­tant devel­op­ment for our ENHANZE® drug de­livery tech­nology business," said Dr. Helen Torley, pres­i­dent and chief exec­u­tive of­fi­cer. "We are delighted that an ap­­prov­al of the sub­cu­tane­ous for­mu­la­tion may soon …

• BLA sub­mitted to U.S. FDA for sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab
• Submission based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) an­nounced to­day that its licensing part­ner, Janssen Biotech, Inc., has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for the use of the sub­cu­tane­ous (SubQ) for­mu­la­tion of dara­tu­mu­mab in mul­ti­ple myeloma indi­ca­tions where the in­tra­venous for­mu­la­tion of dara­tu­mu­mab is cur­rently approved. In August 2012, Genmab granted Janssen an ex­clu­sive world­wide license to de­vel­op, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab.

“Should this sub­mission lead to an ap­­prov­al, it would provide patients …

Paris, France (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for review the Biologics License Application (BLA) for isatuximab for the treat­ment of patients with re­lapsed / re­frac­tory multiple myeloma (RRMM). The target action date for the FDA de­ci­sion is April 30, 2020. Isatuximab is an inves­ti­ga­tional mono­clonal anti­body that targets a specific epitope on the CD38 re­cep­tor of a plasma cell.

The BLA is based on pos­i­tive results from ICARIA-MM, an open-label pivotal Phase 3 clin­i­cal trial of isatuximab in patients with RRMM. ICARIA-MM is the first pos­i­tive ran­dom­ized …

Topline data from the ran­dom­ized Phase II GRIFFIN study in trans­plant eli­gible, newly diag­nosed patients with multiple myeloma treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone met the study’s pri­mary end­point with a higher per­cent­age of stringent com­plete response in the dara­tu­mu­mab arm as com­pared with patients who received lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone alone

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that topline data from the Phase II GRIFFIN (MMY2004) study of newly diag­nosed patients with multiple myeloma eli­gible for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plan­ta­tion (ASCT), who were treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone (VRd), met its pri­mary end­point, demonstrating a higher per­cent­age of stringent com­plete responses (sCR) than patients who received VRd alone. Specifically, the topline data showed that 42.4% of patients treated with dara­tu­mu­mab in com­bi­na­tion with VRd achieved a sCR, com­pared to 32.0% …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• Approval based on Phase III MAIA study

Copenhagen, Denmark (Press Release); June 27, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Application (sBLA) for this indi­ca­tion was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., under the Real-Time Oncology Review (RTOR) pilot pro­gram. …

• Genmab signs agree­ment with Janssen Biotech, Inc. to col­lab­o­rate exclusively on next-generation CD38 anti­body prod­uct, HexaBody®-CD38, incorporating Genmab’s pro­pri­e­tary HexaBody tech­nology
• New agree­ment builds on Genmab’s suc­cess­ful DARZALEX® col­lab­o­ration with Janssen
• Next-generation HexaBody-CD38 could poten­tially add to the DARZALEX multiple myeloma fran­chise and expand the poten­tial of CD38-targeted ther­a­pies in further indi­ca­tions

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copen­hagen: GEN) announced today it has entered into an exclusive world­wide license and option agree­ment with Janssen Biotech, Inc. (Janssen) to develop and com­mer­cial­ize HexaBody-CD38, a next-generation human CD38 mono­clonal anti­body prod­uct incorporating Genmab’s pro­pri­e­tary HexaBody tech­nology. Under the terms of the agree­ment, Genmab will col­lab­o­rate exclusively with Janssen on HexaBody-CD38, with Genmab funding research and devel­op­ment activities until completion of clin­i­cal proof of concept studies in multiple myeloma and diffuse large B-cell lym­phoma. Based on the …

• U.S. FDA grants Priority Review for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant
• September 26, 2019 PDUFA date

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) granted a Priority Review for the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen), in March 2019. Priority Review is a …