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Parkinson's Drug Hits Shelves, Major Event Awaits ABIO In Mar, FDA Nod For NVRO

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Today's Daily Dose brings you news about Acceleron's phase II facioscapulohumeral dystrophy trial; Adamas' commercial launch of the first and only FDA-approved medication for the treatment of Dyskinesia in Parkinson's disease patients; ARCA's major upcoming event; Dexcom's preliminary Q4 results and 2018 outlook; Infinity Pharma's near-term catalysts, and FDA approval of Nevro's Spinal Cord Stimulation (SCS) System.

Read on...

Acceleron Pharma Inc.'s (XLRN) first two cohorts in Part 1 of its phase II clinical trial with ACE-083 in patients with facioscapulohumeral dystrophy (FSHD) have yielded positive preliminary results.

FSHD is a rare genetic muscle disorder that results in progressive focal muscle loss and weakness.

According to the Company, treatment of FSHD patients with ACE-083 demonstrated positive safety and tolerability along with unprecedented mean increases in total muscle volume of over 12% in the two distinct muscles evaluated - tibialis anterior and biceps brachii muscle.

The tibialis anterior (TA), which is located in the lower leg, is associated with the ability to lift the front of the foot when taking a step. Over 70% of FSHD patients experience tibialis anterior weakness over the course of their disease, which can lead to general decreased mobility and an increased frequency of falling.

The biceps brachii (BB), which is located in the upper arm, is a major muscle responsible for the ability to lift the lower arm. A majority of FSHD patients experience biceps brachii weakness early in their disease, which leads to the inability to lift objects or perform other important daily activities without assistance.

The Company plans to initiate Part 2 of the ACE-083 FSHD Phase II trial during the second quarter of 2018.

XLRN closed Monday's trading at $42.02, down 0.21%.

Adamas Pharmaceuticals Inc. (ADMS) has launched GOCOVRI, the first and only FDA-approved medication for the treatment of Dyskinesia in Parkinson's disease patients, in the U.S.

GOCOVRI received the U.S. regulatory nod in August 2017, and it enjoys seven years of orphan drug exclusivity. The drug has been available for physician and patient use since October 2017.

GOCOVRI's list price is $28,500/year or $2,375/month.

ADMS closed Monday's trading at $32.15, down 5.52%.

ARCA biopharma Inc. (ABIO) has completed patient follow-up for its GENETIC-AF trial.

GENETIC-AF is a phase 2B double-blind, clinical superiority trial comparing the safety and efficacy of ARCA bio's investigational drug Gencaro to an approved drug TOPROL-XL for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF).

The Company expects to report top-line data from the GENETIC-AF trial in March 2018.

ABIO closed Monday's trading at $1.65, up 10%.

Correction: An earlier version of this article incorrectly mentioned the status of GENETIC-AF trial as phase 2B/3 instead of phase 2B.

bluebird bio Inc. (BLUE) announced that it has issued an additional 277,109 shares of common stock at the public offering price of $185 per share, pursuant to the partial exercise of the underwriters' over-allotment option related to its previously announced public offering.

With the exercise of the over-allotment option, the total number of shares sold by bluebird bio in the public offering was 3.52 million, and gross proceeds of the offering were approximately $651.3 million.

BLUE closed Monday's trading at $170.10, down 2.80%.

DexCom Inc. (DXCM) has reported preliminary, unaudited revenue for the fourth quarter and full year 2017.

For the fourth quarter, the Company's preliminary revenue is $218 million, an increase of 27% over the fourth quarter of 2016, and well above analysts' estimate of $212.9 million.

For fiscal 2017, total preliminary, unaudited revenue is expected to be approximately $715 million, an increase of 25% over 2016. Analysts polled by Thomson Reuters were expecting revenue of $710.45 million.

Fueled by continued strength in sensor volumes, international revenue and the expansion of its worldwide patient base, DexCom currently anticipates total revenue of approximately $830 to $850 million in 2018. Wall Street analysts are expecting revenue of $853.06 million in 2018.

DexCom is slated to report its audited full fourth quarter and fiscal 2017 financial results on February 27, 2018 after the close of market.

DXCM closed Monday's trading at $55.44, up 4.09%.

Infinity Pharmaceuticals Inc. (INFI) has a couple of events to watch out for this year related to its Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in advanced solid tumors.

The Phase1/1b monotherapy expansion component of the study is fully enrolled, and the combination dose escalation component of the study has been completed.

The near-term catalysts are:

-- Report data from the monotherapy expansion component of the study in the second quarter of 2018.
-- Report data from the combination dose-escalation component of the study in the second quarter of 2018.
-- Report initial data from the combination expansion component of the study in the second quarter of 2018.
-- Report additional data from the combination expansion component, with more mature clinical and translational data, including insights from paired tumor biopsies, in the second half of 2018.

INFI closed Monday's trading at $1.98, down 10.18%.

Nevro Corp. (NVRO) has received FDA approval for its next-generation Senza II Spinal Cord Stimulation (SCS) System delivering HF10 therapy, a non-opioid treatment option, to alleviate pain.

The Senza II system offers the superior outcomes and clinical advantages of HF10 therapy through a smaller and more refined footprint while maintaining the performance and durability of the current Implantable Pulse Generator (IPG).

NVRO closed Monday's trading at $81.33, up 14.40%.

pSivida Corp. (PSDV) has submitted its New Drug Application to the FDA for Durasert three-year treatment for posterior segment uveitis.

Posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is believed to be a leading cause of blindness in the developed and developing countries.

After an NDA is submitted, the FDA has 60 days to decide whether to file it so it can be reviewed.

PSDV closed Monday's trading at $1.10, down 1.79%.

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