ADCT and Swedish Orphan Biovitrum announced the CHMP of the EMA has adopted a positive opinion recommending the marketing authorization of ZYNLONTA (loncastuximab tesirine) for the treatment of relapsed or refractory DLBCL. The positive opinion from the CHMP is now referred to EC for an approval decision.
Immunogen announced findings from an analysis of patient-reported outcomes with mirvetuximab soravtansine vs chemotherapy in the randomized Phase 3 FORWARD I study in platinum-resistant ovarian cancer. The Company also announced population PK and ER analyses across multiple clinical trials evaluating mirvetuximab monotherapy in FRα-positive OVCA. The findings will be highlighted in three posters at ESMO.
Mersana announced that FDA has granted Fast Track designation to XMT-1660 for the treatment of adult patients with advanced or metastatic TNBC. XMT-1660 is a B7-H4-directed Dolasynthen antibody drug conjugate.
Seagen and Merck announced results from the Phase 1b/2 EV-103 trial (KEYNOTE-869) Cohort K investigating Padcev (enfortumab vedotin-ejfv) in combination with Keytruda and Padcev alone as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy. For the combination, results demonstrated a 64.5% confirmed ORR per RECIST v1.1 by BICR, the primary endpoint of Cohort K, with 10.5% of patients experiencing a complete response and 53.9% of patients experiencing a partial response.
The short interest of Alkermes increased in September by 14% to 8,734,973 on September 15, compared to 7,677,528 on August 15.
The short interest of ImmunityBio increased in September by 15% to 21,773,741 on September 15, compared to 18,945,501 on August 15.
Nektar announced data presentations from two Phase 1b, proof-of-concept studies of rezpegaldesleukin (NKTR-358) in patients with atopic dermatitis and plaque psoriasis at the 2022 EADV Congress. Rezpegaldesleukin is a selective Treg inducing IL-2 conjugate. Dose-dependent improvements in key efficacy measures were observed for an additional 36 weeks following the 12-week treatment period.
The short interest of Xencor increased in September by 21% to 3,533,016 on September 15, compared to 2,908,577 on August 15.
Allogene’s management was present at the Jefferies Cell and Genetic Medicine Summit.
The short interest of Autolus decreased in September by 7% to 1,080,681 on September 15, compared to 1,166,186 on August 15.
The short interest of Bellicum decreased in September by 35% to 64,967 on September 15, compared to 99,199 on August 15. Separately, Bellicum participated in the H.C. Wainwright 24th Annual Global Investment Conference.
The short interest of Mustang increased in September by 28% to 732,114 on September 15, compared to 570,875 on August 15. Separately, Mustang participated in the H.C. Wainwright 24th Annual Global Investment Conference and in Cantor Cell & Gene Conference.
Arcus announced that the Compensation Committee of the Company’s Board of Directors granted seven new employees options to purchase a total of 14,700 shares of the company’s common stock.
Immutep provided a clinical development update for its LAG-3 antigen-presenting cell activator product candidate, eftilagimod alpha. Encouraging Phase 2 data supports broad therapeutic potential of eftilagimod alpha in NSCLC, HNSCC and metastatic breast cancer. Data from TACTI-002 support the potential of this IO-IO combination to not only offer a chemotherapy-free option for a broad range of NSCLC patients but also expand the potential market opportunities of current immune checkpoint approaches.
Clovis submitted sNDA with FDA and a Type II variation with EMA for approval of Rubraca as first-line maintenance treatment for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy. The data from Phase 3 ATHENA trial demonstrated that Rubraca as first-line maintenance treatment significantly improved investigator-assessed PFS compared to placebo.