ABBVIE

AbbVie's Elahere (mirvetuximab soravtansine) receives European Commission approval for treating platinum-resistant ovarian cancer, becoming the first FRα-directed ADC in the EU for this indication. The approval is based on the MIRASOL study, showing Elahere reduced tumor progression risk by 35% and improved overall survival.

Aldeyra Therapeutics announces FDA acceptance for review of reproxalap NDA for dry eye disease, with a PDUFA date of April 2, 2025. The company expands its option agreement with AbbVie, which includes potential milestone payments up to $300 million. Reproxalap is a first-in-class small-molecule modulator of RASP, studied in over 2,500 patients with no significant safety concerns.

The European Commission has authorized mirvetuximab soravtansine (Elahere) for treating FRα-positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, based on MIRASOL trial data showing a 35% reduction in disease progression or death risk. This makes it the first FRα-directed antibody-drug conjugate approved in the EU, Iceland, Liechtenstein, Norway, and Northern Ireland. The FDA also granted regular approval in March 2024.

FDA accepted Aldeyra Therapeutics' resubmitted NDA for reproxalap, a dry eye disease treatment, with a PDUFA date of April 2, 2025. Reproxalap, a first-in-class RASP modulator, showed efficacy in reducing ocular discomfort in a phase 3 trial. The drug has been studied in over 2,500 patients with mild adverse events. Aldeyra also conducted a phase 3 trial for reproxalap in allergic conjunctivitis, showing decreased ocular symptoms and redness.

T.C.-F.Y. advises and speaks for Gilead Sciences. G.L.-H.W. advises AstraZeneca, Gilead Sciences, GlaxoSmithKline, Janssen, Virion Biotherapeutics, speaks for Abbott, AbbVie, Ascletis, Bristol-Myers Squibb, Echosens, Ferring, Gilead Sciences, GlaxoSmithKline, Janssen, Roche, and received a research grant from Gilead Sciences.

Aldeyra Therapeutics' resubmitted NDA for topical ocular reproxalap, targeting dry eye disease, was accepted by the FDA with a PDUFA date of April 2, 2025. The company expanded its option agreement with AbbVie, which could pay Aldeyra $100 million upfront, less $6 million in option fees, and up to $300 million in milestone payments. If the option is exercised, AbbVie would share 60% of U.S. profits and losses, with Aldeyra receiving 40%.

AbbVie's ELAHERE received EC marketing authorization for platinum-resistant ovarian cancer, targeting FRα-positive patients. The approval, supported by MIRASOL Phase 3 trial data, offers a 35% reduction in tumor progression risk and a 33% reduction in death risk. Roche's VENTANA FOLR1 RxDx Assay also received CE Mark approval to identify eligible patients.

Halozyme proposes to acquire Evotec for €11.00 per share, creating a leading global pharma services company with capabilities in drug discovery, biologic manufacturing, and drug delivery technologies, diversifying and scaling Halozyme's revenue and EBITDA into the next decade. The all-cash transaction would be funded by cash on hand and new debt, with expected net leverage less than 2x two years post-close.

AbbVie's $10.1 billion acquisition of ImmunoGen secures EU approval for Elahere, the first drug for FRα-positive, platinum-resistant ovarian cancer. Elahere, an ADC, was approved in the US in 2022 and received full FDA approval in March. The EU approval ends a 10-year treatment hiatus and shows improved overall survival compared to chemotherapy. The MIRASOL trial supports these findings, with a 33% reduction in death risk and 35% improvement in progression-free survival. Rivals include Eisai's farletuzumab ecteribulin, but Elahere is expected to dominate, with potential sales of $2.8 billion by 2029.

The European Commission has approved AbbVie’s Elahere for treating FRα-positive, platinum-resistant ovarian cancer, offering a 35% reduction in disease progression risk compared to standard chemotherapy. This marks the first new treatment in a decade for this condition in the EU, with potential revenue of $1.98bn by 2030.