• DARZALEX (dara­tu­mu­mab) receives European con­di­tional mar­ket­ing authori­za­tion for heavily pre-treated or double refractory multiple myeloma
• First CD38 mono­clonal anti­body approved in Europe

Copenhagen, Denmark; May 23, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the European Com­mis­sion (EC) has granted a con­di­tional mar­ket­ing authori­za­tion for first-in-class CD38 anti­body DARZALEX® (dara­tu­mu­mab). The con­di­tional approval is for the use of DARZALEX® as mono­therapy for the treat­ment of adult patients with re­lapsed and refractory multiple myeloma, whose prior ther­apy in­cluded a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent and who have dem­onstrated disease pro­gres­sion on the last ther­apy. The EC approval follows a pos­i­tive opinion issued …

• Phase III POLLUX study of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma met the pri­mary end­point at a pre-planned interim analysis
• Independent Data Monitoring Committee rec­om­mends unblinding the data
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Phase III POLLUX study (MMY3003) of dara­tu­mu­mab in combi­na­tion with lena­lido­mide and dexa­meth­a­sone versus lena­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52), p < 0.0001). Patients who received treat­ment with dara­tumu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone had a 63% …

First and only immunostimulatory anti­body approved in the Euro­pean Union for mul­ti­ple myeloma

Accelerated assess­ment and ap­prov­al based on long-term data from ELOQUENT-2, which eval­u­ated Empliciti in com­bi­na­tion with Revlimid® (lena­lido­mide) and dexa­meth­a­sone (Rd)

ELOQUENT-2 dem­onstrated the Empliciti com­bi­na­tion de­liv­ered a 53% rel­a­tive im­prove­ment in pro­gres­sion-free sur­vival vs. Rd alone at three years (23% vs. 15%)

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) an­nounced to­day that the Euro­pean Com­mis­sion has approved Empliciti™ (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy with Revlimid® (lena­lido­mide) and dexa­meth­a­sone in patients who have re­ceived at least one prior ther­apy. Empliciti is now the first and only immunostimulatory anti­body approved for mul­ti­ple myeloma in the Euro­pean Union (EU).

The ap­prov­al is based on data from the ran­dom­ized, open-label, Phase 3 ELOQUENT-2 study, which eval­u­ated Empliciti in …

Pivotal TOURMALINE-MM1 Results Demonstrated that the Addition of Oral Ixazomib to Lena­lido­mide and Dexamethasone Significantly Extended Progression-Free Survival, with Limited Additional Toxicity in Patients with Relapsed/Refractory Multiple Myeloma

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that results from the inter­na­tional, ran­dom­ized, double-blind, placebo-controlled TOURMALINE-MM1 Phase 3 clin­i­cal study, eval­u­ating once-weekly oral NINLARO® (ixazomib) capsules plus lena­lido­mide and dexa­meth­a­sone versus placebo plus lena­lido­mide-dexamethasone in patients with re­lapsed and/or refractory multiple myeloma, have been published in the prestigious New England Journal of Medicine (NEJM). NINLARO was recently approved by the U.S. Food and Drug Admin­istra­tion (FDA), based on the pivotal TOURMALINE-MM1 data, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of …

• Oral plenary session presentation on dara­tu­mu­mab Phase III Castor study data
• Trial in progress poster presentation from Phase I study of sub­cu­tane­ous dara­tu­mu­mab

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that two dara­tu­mu­mab abstracts have been accepted for presentation at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3 — 7. The titles of the abstracts are avail­able on the ASCO website at www.asco.org via ASCO's iPlanner. With the exception of the dara­tu­mu­mab Phase III Castor study data, which has been designated as a late breaking abstract by ASCO, the full abstracts are scheduled to be …

Lund, Sweden (Press Release) – BioInvent Inter­na­tional (BINV) announced today that patient recruitment into the trial can now start in the upcoming clin­i­cal Phase II study with the anti­body BI-505 in patients with multiple myeloma, as nec­es­sary regu­la­tory approvals have been obtained. The first patient is ex­pec­ted to be dosed in May.

Multiple myeloma is a bone marrow cancer which affects more than 120,000 people globally every year [1]. Initial treat­ment is often successful, but unfortunately, most patients will relapse and in 2015, nearly 90,000 patients died as a result of the …

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (NASDAQ:CLRB) ("Cellectar" or the “company”) today announced the pricing of an underwritten public offering of common stock, or pre-funded warrants in lieu thereof, at a price of $2.13 per share and asso­ci­ated traditional warrants, for gross proceeds of approx­i­mately $7.0 million, prior to deducting underwriting discounts, commissions and offering expenses payable by the com­pany.

For each share or pre-funded warrant purchased, an in­­vestor will receive a five-year traditional warrant exercisable for one share of our common stock, at an exercise price of $3.04 per …