MGNX Soars On INCY Deal, CDTX Strides Ahead, NUVA Entices, ACHC In Poor Health

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 25, 2017.

GAINERS

1. MacroGenics Inc. (MGNX)

Gained 17.36% to close Wednesday's (Oct.25) trading at $19.00.

News: The Company has licensed its proprietary anti-PD-1 monoclonal antibody drug candidate MGA012 to Incyte Corp. (INCY).

Incyte will pay MacroGenics an upfront payment of $150 million in return for the worldwide rights to develop and commercialize MGA012 in all indications.

MGA012 is under a phase I study in patients with advanced solid tumors.

2. Sierra Oncology Inc. (SRRA)

Gained 12.63% to close Wednesday's trading at $2.14.

News: The Company announced the appointment of Andrew Allen to its Board of Directors, effective October 23, 2017.

Andrew Allen is a co-founder of Gritstone Oncology and serves as its President, Chief Executive Officer and a member of its Board of Directors. He was a Co-Founder of Clovis Oncology (CLVS) where he served as Executive Vice President of Clinical and Preclinical Development and Chief Medical Officer, leading the in-licensing and global development of Rubraca, a PARP inhibitor approved for treatment of ovarian cancer. Prior to that, he was Chief Medical Officer at Pharmion Corporation, which was sold to Celgene Corporation for $2.9 billion following the global development of Vidaza for the treatment of myelodysplastic syndromes and Thalomid for the front-line treatment of multiple myeloma in Europe.

Prior to Pharmion assignment, Allen served in clinical development leadership roles at Chiron Corporation and Abbott Laboratories, and worked at McKinsey & Company.

Pipeline:

The Company's lead drug candidate is SRA737, currently being investigated in two phase I clinical trials in patients with advanced cancer. Another compound SRA141 is undergoing preclinical development.

Near-term catalyst:

Preliminary update from phase I clinical trials of SRA737 is expected in early 2018.

3. Cidara Therapeutics Inc. (CDTX)

Gained 11.46% to close Wednesday's trading at $8.75.

News: No news

Near-term catalyst:

-- A phase II trial of CD101 IV in candidemia, dubbed STRIVE, is ongoing. This study is comparing the safety and efficacy of CD101 IV to standard-of-care therapy, Caspofungin with an optional step-down to oral Fluconazole. The top line data from the STRIVE study are anticipated this quarter (Q4, 2017).

4. Accuray Inc. (ARAY)

Gained 11.39% to close Wednesday's trading at $4.40.

News: The Company reported a narrower loss and higher revenue for the first quarter of fiscal 2018.

Net loss was $9.4 million, or $0.11 per share, for the first quarter of fiscal 2018, compared to a net loss of $9.9 million, or $0.12 per share, for the first quarter of fiscal 2017. Total revenue for the fiscal 2018 first quarter was $91.0 million compared to $86.5 million in the prior fiscal year first quarter.

5. Adamas Pharmaceuticals Inc. (ADMS)

Gained 9.49% to close Wednesday's trading at $19.85.

News: The FDA has recognized seven-years of orphan drug exclusivity for the Company's approved drug GOCOVRI.

GOCOVRI received FDA approval in August of this year for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

The Company expects GOCOVRI's orphan drug exclusivity to be additionally recognized in a future update of the Orange Book. Upon such update, Adamas will receive $65 million in funding from HealthCare Royalty Partners, as part of the $100 million royalty-backed note the company signed in May 2017.

6. NuVasive Inc. (NUVA)

Gained 9.49% to close Wednesday's trading at $19.85.

News: The Company will showcase its latest spine technology innovation at the North American Spine Society (NASS) Annual Meeting held October 25-28, 2017 in Orlando, Florida.

Recent event:

-- On October 24, 2017, the Company reported Q3, 2017 financial results.

On a non-GAAP basis, the Company's net income rose to $26.7 million or $0.52 per share from $21.1 million or $0.40 per share for the third quarter 2016. The third quarter 2017 total revenue increased to $247.4 million from $239.6 million in the comparable year-ago quarter.

The Company also announced that its Board of Directors approved a share repurchase program authorizing the purchase of up to $100 million of its common stock over a three-year period commencing October 25, 2017.

7. Novan Inc. (NOVN)

Gained 6.91% to close Wednesday's trading at $6.19. This is the second straight day of gain for the stock.

News: No news

Pipeline:

The Company's pipeline includes:

-- SB206, which is under phase II trial for genital warts; under phase I study for Molluscum and under phase I study for HPV -associated STIs. -- NVN3100, which is under pre-clinical testing for anal neoplasia and cervical neoplasia. -- SB414, which is under phase I study for psoriasis, and under preclinical testing for atopic dermatitis. -- SB204, under late-stage development for acne, and under phase II study for Onychomycosis Tinea Pedis.

LOSERS

1. Acadia Healthcare Co. Inc. (ACHC)

Lost 25.93% to close Wednesday's trading at $32.68.

News: The Company reported lack-luster revenue for the third quarter ended September 30, 2017 and trimmed its earnings and revenue outlook for full year 2017.

Revenue for the recent third quarter was $716.71 million, down from $734.67 million reported in the third quarter of 2016. Net income attributable to Acadia stockholders was $45.6 million or $0.52 per diluted share, for the third quarter of 2017 compared with a net loss attributable to Acadia stockholders of $117.8 million, or $1.36 per diluted share, for the third quarter of 2016.

Looking ahead, the Company now expects revenue for 2017 to be in a range of $2.82 billion to $2.83 billion range from its prior outlook range of $2.85 billion to $2.87 billion.

Adjusted EPS for 2017 is now expected to range between $2.23 and $2.25, down from its prior EPS forecast of $2.42 to $2.47.

2. Akcea Therapeutics Inc. (AKCA)

Lost 10.01% to close Wednesday's trading at $17.44.

News: No news

Recent event:

-- On August 31, 2017, the Company submitted a New Drug Application to the FDA for Volanesorsen, an investigational medicine for the treatment of familial chylomicronemia syndrome (FCS).

Volanesorsen is co-developed by Akcea and Ionis Pharmaceuticals Inc. (IONS)

Upcoming event:

The Company is scheduled to discuss its third quarter 2017 financial results on November 6, 2017.

3. uniQure N.V. (QURE)

Lost 9.48% to close Wednesday's trading at $17.00.

News: The Company has priced its underwritten public offering of 5 million of its ordinary shares at a public offering price of $18.25 each.

To know more about uniQure, please visit our Company Spotlight column.

4. Mesoblast Limited (MESO)

Lost 8.33% to close Wednesday's trading at $5.72.

News: No news

Near-term catalysts:

-- A Phase 3 trial using MSC-100-IV in children with steroid refractory acute Graft-versus-host disease (GVHD) is expected to complete enrollment with top-line data readout expected in 2H CY17. -- A Phase 3 trial using MPC-06-ID in patients with chronic low back pain is expected to complete enrollment in Q4 CY17. -- A Phase 2b trial using MPC-150-IM in 159 end-stage CHF (congestive heart failure) patients with a LVAD completed enrollment last month, with top-line results expected in Q1 CY18. -- A Phase 3 trial using MPC-150-IM in patients with Class II/III CHF is continuing to enrol through FY18, with full enrollment expected to occur in 2H CY18.