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AXON Throws In The Towel On Nelotanserin, MNLO On Watch, VYGR Sails Ahead

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Today's Daily Dose brings you news about Axovant's disappointing phase II trial in REM sleep behavior disorder; progress in Axsome Therapeutics' ADVANCE-1 study of Alzheimer's; Menlo Therapeutics' promising results from phase II trial of Serlopitant in pruritus associated with psoriasis, and Ra Pharma's generalized myasthenia gravis study results.

Read on...

Axovant Sciences' (AXON) investigational drug Nelotanserin for the treatment of REM sleep behavior disorder in patients with Lewy body dementia has failed in a phase II trial, sending the shares down over 27%.

The study failed to meet the primary efficacy endpoint of reduction in frequency of REM sleep behavior disorder events as measured by sleep laboratory video assessment.
The Company has decided to discontinue the clinical development of Nelotanserin.

AXON closed Monday's trading at $1.24, down 27.49%.

An independent data monitoring committee has recommended continuation of Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of AXS-05 in agitation associated with Alzheimer's disease, dubbed ADVANCE-1.

In the study, about 435 patients were to be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 5 weeks.

Additionally, the IDMC recommended no further randomization of subjects to the bupropion treatment arm of the study. The IDMC did not indicate that there were any safety concerns in the study. Axsome intends to follow the IDMC's recommendations.

AXSM closed Monday's trading at $3.39, up 14.92%.

Constellation Pharmaceuticals Inc. (CNST) has initiated the phase II portion of its ProSTAR study, an ongoing Phase 1b/2 clinical trial of CPI-1205 in patients with metastatic castration-resistant prostate cancer (mCRPC).

The phase II portion will evaluate CPI-1205 in combination with enzalutamide versus enzalutamide alone. Constellation has also decided to expand the Phase 2 portion of the study by adding an arm evaluating CPI-1205 in combination with abiraterone in the second-line setting.

The Company continues to expect to determine proof of concept for CPI-1205 in mid-2019.

CNST closed Monday's trading at $5.80, down 3.17%.

Denali Therapeutics Inc. (DNLI) has initiated dosing in a Phase 1b clinical study of DNL201 in patients with Parkinson's disease.

The study is designed to enroll 30 patients who will be randomized to receive either a low dose of DNL201, a high dose of DNL201, or placebo. Data readout from this study is expected during Q4 2019.

DNLI closed Monday's trading at $20.23, up 3.37%.

Jazz Pharmaceuticals plc's (JAZZ) Board of Directors has authorized a $400 million increase in the company's share repurchase program, which the company intends to use over time based on market conditions and other factors.

Prior to this increased authorization, the Board of Directors had authorized $620 million under the company's share repurchase program, of which $194 million had been utilized through September 30, 2018. Since that date, the company has utilized the remainder of that prior authorization.

The Company's Solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea, is under FDA review, with a decision expected on December 20, 2018.

JAZZ closed Monday's trading at $139.65, down 1.08%.

Menlo Therapeutics Inc.'s (MNLO) phase II clinical trial of Serlopitant for the treatment of pruritus associated with psoriasis has successfully met its primary endpoint, showing a statistically significant reduction in pruritus.

In the trial, 33% of patients treated with Serlopitant 5 mg daily achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 8 compared to baseline compared to 21% of patients treated with placebo.

The Company plans to have an End of Phase 2 Meeting with the FDA in the first half of 2019 and begin its phase III program for pruritus associated with psoriasis in 2019.

MNLO closed Monday's trading at $5.51, down 2.82%.

Pfenex Inc. (PFNX) has submitted its New Drug Application to the FDA seeking approval of PF708 for the treatment of osteoporosis. The approval is being sought under 505(b)(2) regulatory pathway, and references Eli Lilly's (LLY) Forteo as the Reference Listed Drug.

Lilly's Forteo generated global sales of $1.7 billion in 2017.

PFNX closed Monday's trading at $3.83, up 10.06%.

Shares of Ra Pharmaceuticals Inc. (RARX) touched a new 52-week high of $19.75 in intraday trading on Monday, following positive top-line results from its phase II clinical trial evaluating Zilucoplan for the treatment of generalized myasthenia gravis.

In the phase II study, Zilucoplan dosed at 0.3 mg/kg subcutaneously daily achieved clinically meaningful and statistically significant reductions in both Quantitative Myasthenia Gravis (QMG) score and the MG Activities of Daily Living (MG-ADL) score.

Based on the promising data, Ra Pharma plans to engage with FDA in the first half of 2019 regarding the design of a Phase 3 clinical trial evaluating the 0.3 mg/kg dose of Zilucoplan versus placebo in patients with generalized myasthenia gravis.

In other news, the Company announced that it intends to offer and sell, subject to market and other conditions, $100 million of its common stock in an underwritten public offering. Ra Pharma expects to grant the underwriters a 30-day option to purchase up to $15 million of additional shares of its common stock.

RARX closed Monday's trading at $17.62, up 7.05%. In after-hours, the stock was down 3.46% to $17.01.

Voyager Therapeutics Inc. (VYGR) has dosed the first patient in RESTORE-1, a Phase 2 trial evaluating the safety and efficacy of VY-AADC for the treatment of Parkinson's disease in patients with motor fluctuations that are refractory to medical management.

VYGR closed Monday's trading at $11.04, up 2.89%.

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