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ADRO Dumps CRS-207, Another Win For CoolSculpting, FDA Expands GSK's Nucala Use

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Today's Daily Dose brings you news about Aduro's revised pipeline; FDA approval of a new indication for CoolSculpting; Blueprint's stock offering; encouraging preliminary results from Cellectis' CALM and PALL trials; expanded FDA approval for GlaxoSmithKline's Nucala and Omeros' OMIDRIA.

Read on...

Aduro Biotech Inc. (ADRO) has decided to pull the plug on its drug candidate CRS-207, which is under phase II trials in the indications of malignant pleural mesothelioma and gastroesophageal adenocarcinoma.

The decision to discontinue the development of CRS-207 was based on preliminary results from its mesothelioma and ovarian studies, as well as a business and commercial assessment.

Stephen Isaacs, chairman and CEO of Aduro Biotech said, "We will shift our focus and investment toward our STING agonist program, B-select antibodies and personalized neoantigen approach with pLADD. In our STING program in particular, there are several additional clinical trials under consideration to complement our ongoing Phase 1 dose escalation trial of ADU-S100 as well as our combination study with Novartis' PD-1 checkpoint inhibitor, PDR-001".

The Company now expects its current cash balance to be sufficient to fund planned activities for the next three years through 2020.

ADRO closed Tuesday's trading at $8.25, up 5.10%.

Allergan plc's (AGN) CoolSculpting treatment has received FDA clearance to improve lax tissue in the double chin.

CoolSculpting came under Allergan's fold, following the acquisition of ZELTIQ Aesthetics Inc in February of this year.

CoolSculpting is a non-invasive fat reduction procedure, and it received its initial FDA clearance for fat reduction in abdomen as well as flanks (love handles) in September 2010. It received expanded FDA clearance to treat thighs in April 2014 and to treat double chin in September 2015.

The use of CoolSculpting was further expanded to reduce fat around bra straps, on the back and underneath the buttocks, following FDA clearance in April of 2016.

AGN closed Tuesday's trading at $171.87, down 0.52%.

Blueprint Medicines Corp. (BPMC) has offered to sell 3.7 million shares of its common stock to the public at a price of $81.00 each.

The underwriters have a 30-day option to purchase up to an additional 555,555 shares of its common stock at the public offering price. The offering is expected to close on December 15, 2017.

Earlier in the week, the Company reported strong data from its ongoing phase I trial of Avapritinib (BLU-285) in patients with advanced Systemic Mastocytosis, sending the stock soaring to an all-time high of $92.

The Company plans to meet up with global regulatory authorities in the first half of 2018 to obtain input on registration pathways for Avapritinib.

If all goes well as planned, a registration-enabling clinical trial of Avapritinib in patients with advanced SM will be initiated in the first half of 2018 and a dose escalation and proof-of-concept clinical trial of Avapritinib in patients with indolent and smoldering SM will be initiated in the second half of 2018.

BPMC closed Tuesday's trading at $81.98, down 7.18%.

Cellectis (CLLS) and Pfizer Inc. (PFE)/Servier have reported encouraging preliminary results from two phase I studies of UCART19 in adult and pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The data are from two phase I studies namely CALM, which tested UCART19 in adult patients with R/R B-ALL, and PALL, which tested UCART19 in pediatric patients with high-risk R/R B-ALL.

The first-in-human data demonstrated the safety and tolerability of UCART19, resulting in an 83% complete remission rate across the adult and pediatric patient population, noted the Company.

CLLS closed Tuesday's trading at $24.02, down 4.42%.

More than two years after winning the initial FDA approval to treat severe asthma, GlaxoSmithKline plc's (GSK) Nucala has been greenlighted for a second indication - i.e., for the treatment of eosinophilic granulomatosis with polyangiitis for adults in the US.

The expanded approval was based on results from MIRRA study that evaluated the efficacy and safety of 300mg of Nucala administered subcutaneously every four weeks versus placebo as add-on therapy to standard of care (corticosteroids plus or minus immunosuppressants) in 136 patients with relapsing and/or refractory eosinophilic granulomatosis with polyangiitis.

Nucala brought home sales of £223 million for GlaxoSmithKline in the first nine months of 2017 compared to £58 million in the year-ago period.

GSK closed Tuesday's trading at $35.52, up 0.59%.

The FDA has extended the decision date on Pfizer Inc.'s (PFE) supplemental New Drug Application for XELJANZ for adult patients with moderately to severely active ulcerative colitis by three months to June 2018.

The supplemental new drug applications for XELJANZ 5 mg and XELJANZ XR 11 mg for the treatment of adult patients with active psoriatic arthritis are under FDA review, with a decision expected this month.

XELJANZ and XELJANZ XR are already approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

XELJANZ is an immediate release tablet that releases medication into the bloodstream over the course of several hours, and is taken twice daily. XELJANZ XR is an extended release tablet that releases medication into the bloodstream over the course of a day, and is taken only once a day.

The drugs netted sales of $935 million in the first nine months of 2017 and $927 million for full year 2016.

PFE touched a new 52-week high of $36.82 on Tuesday, before closing the day's trading at $36.58, up 1.02%.

The FDA has expanded the approved use of Omeros Corp.'s (OMER) OMIDRIA to include pediatric patients.

OMIDRIA, used during cataract surgery or intraocular lens replacement, prevents intraoperative miosis (pupil constriction) and reduces postoperative pain, and it received the first FDA approval in June 2014.

In the first nine months of 2017, revenues from OMIDRIA sales were $51 million compared to $28.5 million in the year-ago period.

OMER closed Tuesday's trading at $18.90, up 1.12%.

by RTTNews Staff Writer

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