MRK’s Keytruda Scores Another FDA Nod, NBIX Disappoints, SBPH Achieves It

Today’s Daily Dose brings you news about FDA approval of Merck’s Keytruda for yet another indication; Neurocrine’s disappointing phase II study of Ingrezza in Tourette syndrome; Spring Bank’s results from phase 2a segment of its ACHIEVE trial and Syndax’ public offering.

Read on…

Achaogen Inc.’s (AKAO) lead product candidate Plazomicin, being developed for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae, has been granted Breakthrough Therapy designation by the FDA.

The Company intends to submit its New Drug Application for Plazomicin in the second half of 2017.

In other news, Achaogen announced that it has commenced an underwritten public offering of up to 5 million shares of its common stock.

AKAO closed Tuesday’s trading at $26.08, up 3.57%.

Merck’s (MRK) blockbuster immunotherapy drug, Keytruda, has scored another FDA approval – this time for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

The above indication has been approved under accelerated approval program. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Keytruda has already received FDA approval for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.

The drug brought home sales of $1.40 billion in 2016, up 148% compared to 2015.

In related news, the Company announced that its Supplemental Biologics License Application for KEYTRUDA for treatment of recurrent or advanced gastric or gastroesophageal…

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