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

(RTTNews) - 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.

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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 junction adenocarcinoma has been granted priority review, with a decision date set for Sept. 22, 2017.

MRK closed Tuesday's trading at $64.55, up 0.80%.

Shares of Neurocrine Biosciences Inc. (NBIX) dropped more than 8% in extended trading on Tuesday, following disappointing results from its phase II study of Ingrezza for treatment of Tourette syndrome in pediatric population.

Tourette syndrome (TS) is a neurological disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations called tics. (Source: NINDS).

The study, dubbed T-Force GREEN, did not meet its primary endpoint of change-from-baseline between the placebo and active groups in the Yale Global Tic Severity Scale (YGTSS) at Week 6 in the intent-to-treat (ITT) population.

Ingrezza received FDA approval in the treatment of adults with tardive dyskinesia as recently as April of this year. Ingrezza is the first drug approved by the FDA for tardive dyskinesia.

Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips.

The results from a phase II study of Ingrezza in adults with Tourette syndrome, which were reported in January, were also disappointing.

The study, dubbed T-Forward , did show a significant improvement in overall symptoms of Tourette syndrome but failed to meet the pre-specified primary endpoint of change-from-baseline in the Yale Global Tic Severity Scale at Week 8.

NBIX closed Tuesday's trading at $53.53, down 0.21%. In after-hours, the stock was down 8.09% to $49.20.

Spring Bank Pharmaceuticals Inc. (SBPH) reported encouraging top-line results from the initial 25mg monotherapy dosing cohort of the Phase 2a segment of its ACHIEVE trial.

The first segment of the ACHIEVE trial is a Phase 2a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by Gilead Sciences Inc's Viread 300 mg for an additional 12 weeks.

The primary endpoints for the Phase 2a trial are safety and antiviral activity, as measured by the change in HBV DNA at week 12 from baseline, with multiple exploratory secondary endpoints.

According to the Company, overall, SB 9200 demonstrated a statistically significant reduction in HBV DNA at week 12 compared to placebo.

The Company has begun enrollment in the second cohort (50 mg) of its phase 2a trial, and top-line results are anticipated in the fourth quarter of 2017.

The Phase 2b segment of the ACHIEVE trial is designed to examine the concomitant use of SB 9200 and Viread in approximately 200 HBV patients.

SBPH closed Tuesday's trading at $12.00, unchanged from the previous day's close.

Shares of Syndax Pharmaceuticals Inc. (SNDX) plunged nearly 6% in extended trading on Tuesday, following a proposed public offering of its common stock.

The Company is planning to offer and sell, subject to market and other conditions, $50 million of its common stock in the underwritten public offering. The underwriters have a 30-day option to purchase up to an additional 15% of the number of shares sold in the public offering.

Last week, the Company reported results from melanoma cohort of its ongoing phase II trial of Entinostat in combination with Merck's KEYTRUDA. The results showed that the addition of Entinostat can result in meaningful responses in patients who have progressed on an anti-PD-1 or anti-PD-1/anti-CTLA-4 regimen like KEYTRUDA, which is an area of very high unmet medical need, according to the Company.

SNDX closed Tuesday's trading at $14.67, up 0.41%. In after-hours, the stock was down 5.93% to $13.80.

TG Therapeutics Inc.'s (TGTX) phase III trial of TG-1101 + TGR-1202 regimen in patients with Chronic Lymphocytic Leukemia, dubbed UNITY-CLL, is expected to complete enrollment by this year end, which is earlier than planned.

The Company expects to report pivotal Overall Response Rate (ORR) data from the trial in the third quarter of 2018.

An independent Data Safety Monitoring Board (DSMB) reviewed updated safety data from more than 270 patients in the trial, and finding no safety concerns, has recommended continuation of enrollment without modification.

TGTX closed Tuesday's trading at $11.95, up 4.37%.