Mustang Bio receives orphan designation from FDA for MB-102

Mustang Bio announced that the FDA has granted orphan drug designation to MB-102 for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and incurable blood cancer with a median survival of less than 18 months and no standard of care.
https://thefly.com/landingPageNews.php?id=2839953

AbbVie submits NDA to FDA, MAA to EMA for upadacitinib

AbbVie announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration and a marketing authorization application to the European Medicines Agency for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis. The NDA and MAA are supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five Phase 3 studies. In all studies, upadacitinib met all primary and ranked secondary endpoints. The most frequent serious adverse events were infections. Top-line results from these clinical studies were previously announced. Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
https://thefly.com/landingPageNews.php?id=2839969

Astellas Pharma, Pfizer announce Phase 3 ARCHES trial meets primary endpoint

Astellas Pharma (ALPMY) and Pfizer (PFE) announced that the Phase 3 ARCHES trial evaluating XTANDI plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer met its primary endpoint, significantly improving radiographic progression-free survival versus ADT alone. The preliminary safety analysis of the ARCHES trial appears consistent with the safety profile of XTANDI in previous clinical trials in castration-resistant prostate cancer. Detailed results will be submitted for presentation at an upcoming medical congress. XTANDI is currently approved in the U.S. and Japan for the treatment of CRPC and in the EU for the treatment of metastatic and high-risk non-metastatic CRPC. Since its initial approval in 2012, XTANDI has been prescribed to more than 330,000 men worldwide.
https://thefly.com/landingPageNews.php?id=2839977

Sarepta submits NDA for golodirsen to FDA

Sarepta announced that it has completed the submission of its rolling new drug application, or NDA, seeking accelerated approval for golodirsen, a phosphordiamidate morpholino oligimer engineered to treat those patients with Duchenne muscular dystrophy who have genetic mutations subject to skipping exon 53 of the Duchenne gene. The completion of the rolling submission for golodirsen includes data from the 4053-101 study assessing the safety, tolerability, pharmacokinetics and dystrophin expression of golodirsen in 25 boys with confirmed deletions of the DMD gene amenable to exon 53 skipping. The study demonstrated statistically significant results in favor of golodirsen on all biological endpoints, including properly exon-skipped RNA transcript using reverse transcription polymerase chain reaction, increase in quantity of dystrophin expression from baseline using Western blot and increase in dystrophin intensity as measured by immunohistochemistry. If the golodirsen NDA is filed and granted accelerated approval, the company’s ESSENCE study could serve as a post-marketing confirmatory study. ESSENCE, which is under way, is a global, randomized double-blind, placebo-controlled study assessing the safety and efficacy of golodirsen and casimersen, our exon 45 skipping therapy.
https://thefly.com/landingPageNews.php?id=2839987

Assertio Therapeutics submits cosyntropin NDA to FDA

Assertio Therapeutics announced that it has submitted to the FDA a 505 new drug application for its novel injectable formulation of cosyntropin depot with its partner, West Therapeutic Development. The application seeks approval for the use of this product as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency. Cosyntropin depot is an alcohol-free formulation of a synthetic ACTH analogue, a hormone secreted from the pituitary gland that is responsible for the stimulation of the adrenal cortex. Cosyntropin depot is composed of the first 24 of 39 amino acids found in ACTH, which retains the full steroidogenic activity of the natural hormone.
https://thefly.com/landingPageNews.php?id=2840031

Endocyte stockholders approve merger agreement with Novartis

Endocyte (ECYT) announced that Endocyte’s stockholders approved the adoption of the merger agreement pursuant to which Novartis (NVS) will acquire Endocyte for $24 per share, or a total equity value of approximately $2.1B, in cash. Approximately 99.8% of the votes cast at the meeting voted to approve the adoption of the merger agreement, representing approximately 69.5% of Endocyte’s outstanding common stock as of the record date. Subject to the satisfaction of customary closing conditions, the proposed merger is expected to close on or about December 21.
https://thefly.com/landingPageNews.php?id=2840067

Health Insurance Innovations sees FY18 adjusted EPS $2.95-$3.15, consensus $2.52

https://thefly.com/landingPageNews.php?id=2840073