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Novartis’ Kisqali extends survival in second late-stage breast cancer study

Results from a second Phase 3 clinical, MONALEESA-3, evaluating Novartis’ (NVS +0.6%) CDK4/6 inhibitor Kisqali (ribociclib), combined with fulvestrant [AstraZeneca’s Faslodex], in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced/metastatic breast cancer showed a statistically significant improvement in overall survival (OS) compared to fulvestrant alone in first-line and second-line settings.

Complete results will be presented at an upcoming medical conference and submitted to global regulatory authorities.

Another Phase 3, MONALEESA-7, also met the OS endpoint.

The FDA first approved Kisqali in March 2017.

https://seekingalpha.com/news/3484335-novartis-kisqali-extends-survival-second-late-stage-breast-cancer-study

Eloxx Pharma on go with mid-stage study of ELX-02 in CF; shares ahead 6%

Thinly traded micro cap Eloxx Pharmaceuticals (ELOX +5.6%) announces that the FDA has signed off on its IND for a Phase 2 clinical trial evaluating lead candidate ELX-02 in cystic fibrosis (CF) patients with a nonsense mutation called G542X on one or both alleles. Nonsense mutations occur in ~10% of CF patients.

The U.S. Cystic Fibrosis Foundation has endorsed the protocol as well.

ELX-02 is a eukaryotic ribosomal selective glycoside, a compound that modulates the ribosome, a part of the cell that plays a major role in protein production. It is designed to increase the read-through activity in patients with nonsense mutations, enabling the production of enough full-length protein to restore biochemical activity. CF is caused by the absence of or dysfunction in a protein called CFTR resulting from mutations in the gene that encodes the protein.

https://seekingalpha.com/news/3484465-eloxx-pharma-go-mid-stage-study-elxminus-02-cf-shares-ahead-6-percent