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SAGE Goes Out On A High Note, MRNS Spirited, STAAR Shines, OPK Slumps

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 9, 2017.

GAINERS

1. Otonomy Inc. (OTIC)

Gained 83.04% to close Thursday's (Nov.9) trading at $5.12.

News: The Company reported positive results from the second of its two phase III clinical trials of OTIVIDEX in patients with Ménière's disease, conducted in Europe, dubbed AVERTS-2.

Ménière's disease is a disorder of the inner ear characterized by acute episodes of vertigo, fluctuations in hearing, tinnitus and aural fullness. Currently, there is no approved drug for Ménière's disease.

On August 30, 2017, the Company had announced that the first phase III trial of OTIVIDEX in patients with Ménière's disease, conducted in the U.S., dubbed AVERTS-1, failed to achieve the primary endpoint. The news sent the stock plunging to $3.58 from $20 that day.

2. Sage Therapeutics Inc. (SAGE)

Gained 54.25% to close Thursday's trading at $96.65.

News: The Company announced positive top-line results from its phase III clinical program evaluating Brexanalone (formerly SAGE-547) as a potential treatment for postpartum depression, or PPD, a mood disorder impacting women after childbirth.

This phase III clinical program consisted of separate placebo-controlled trials in severe PPD patients (202B) and in moderate PPD patients (202C), collectively known as the Hummingbird Study.

Both the trials demonstrated a statistically significant mean reduction in the Hamilton Rating Scale for Depression (HAM-D) score compared to placebo at 60 hours. There was also a rapid and durable reduction over 30 days in depressive symptoms in the treatment arm in the two trials.

Near-term catalysts:

-- Top-line data from phase II clinical trial of SAGE-217 in major depressive disorder are expected this quarter.
-- Completion of enrollment for the Phase 2 trial of SAGE-217 in severe PPD is expected in 4Q 2017 with top-line results expected in 1Q 2018.
-- Top line results from Part C of an exploratory phase II clinical trial of SAGE-217 in essential tremor are expected in 4Q 2017.
-- File NDA for Brexanalone in postpartum depression in 2018.

3. Collegium Pharmaceutical Inc. (COLL)

Gained 26.72% to close Thursday's trading at $12.71.

News: The Company reported better-than-expected Q3, 2017 financial results.

Net loss for the third quarter of 2017 narrowed to $13.3 million or $0.45 per share on Xtampza ER product revenue of $12.0 million. Analysts polled by Thomson Reuters were expecting a loss of $0.74 per share on revenue of $5.4 million.

The Company had incurred a net loss of $26.4 million or $1.13 per share on product revenue of $408,000 in the third quarter of 2016.

Cash and cash equivalents totaled $107.6 million as of September 30, 2017.

Recent event:

-- On November 7, 2017, the FDA approved the Company's supplemental New Drug Application seeking to enhance the label for Xtampza ER.

Xtampza ER, a twice-daily, oxycodone medication, received its FDA approval last April for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Now that the sNDA has been approved, comparative OxyContin data and oral human abuse deterrent claim have been added to the Xtampza ER label.

4. Surgery Partners Inc. (SGRY)

Gained 17.07% to close Thursday's trading at $9.60.

News: The Company reported Q3, 2017 results, and presented an optimistic picture of its business for the next year.

For the third quarter of 2017, the Company's net loss was $13.6 million or $0.66 per share compared to $2.3 million or $0.05 per share for the same period last year.
Revenue for the recent third quarter increased 8.4% to $306.3 million from $282.7 million for the third quarter of 2016.

Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.02 per share on revenue of $302.87 million.

Looking ahead to full-year 2017, the Company now expects revenue to be in the range of $1.30 billion to $1.33 billion, down from its prior outlook of $1.34 billion to $1.36 billion range. The continuation of broader industry softness related to residual effects of the hurricanes as well as the ongoing impact of slower volumes and a less favorable payor mix are the reasons for the tapered outlook.

However, given the integration with National Surgical Healthcare, or NSH, progressing as planned, the Company is confident of entering 2018 with a stronger business capable of delivering improved, sustainable long-term financial performance.

Surgery partners acquired NSH from Irving Place Capital for roughly $760 million in May of this year.

5. Marinus Pharmaceuticals Inc. (MRNS)

Gained 14.14% to close Thursday's trading at $7.59.

News: No news; the effect of positive PPD trial results of Sage Therapeutics seem to have rubbed off on Marinus.

Marinus is also developing a drug for severe PPD, and it goes by the name Ganaxolone, which is under phase II testing.

Near-term catalysts:

-- A phase II study of Ganaxolone capsules in women with moderate Postpartum Depression, dubbed Amaryllis, is underway, with data expected in 2018.
-- Enrollment is ongoing in a phase II clinical trial of intravenous (IV) Ganaxolone in women diagnosed with severe PPD. Data from this trial, dubbed Magnolia, are expected in early 2018.
-- A phase II study of Ganaxolone IV in patients with status epilepticus is underway- with data expected next year.

6. STAAR Surgical Co. (STAA)

Gained 13.19% to close Thursday's trading at $15.45.

News: The Company reported better-than-expected Q3, 2017 financial results.

Adjusted net income for the third quarter of 2017 was $1.5 million or $0.04 per diluted share compared with an adjusted net loss of $0.9 million or $0.02 per share for the prior year quarter. Net sales were $23.5 million for the third quarter of 2017, up 17% compared to $20.1 million reported in the prior year quarter.

Analysts polled by Thomson Reuters were expecting a loss of $0.04 per share and revenue of $21.45 million.

Near-term catalysts:

-- Begin pivotal clinical trial of an EDOF optic design to treat Presbyopia on the approved EVO Visian Implantable Collamer Lens platform during Q1, 2018.

7. Infinity Pharmaceuticals Inc. (INFI)

Gained 11.11% to close Thursday's trading at $2.80.

News: A late-breaking abstract reporting clinical and translational data from completed monotherapy dose-escalation component of Phase 1/1b study of IPI-549 in patients with advanced solid tumors is to be presented on November 10, 2017.

8. Endocyte Inc. (ECYT)

Gained 9.28% to close Thursday's trading at $5.18.

News: No news

Near-term catalysts:

-- First patient visit in phase II multi-center TheraP trial of 177Lu-PSMA-617 versus cabazitaxel in 200 metastatic castration-resistant prostate cancer (mCRPC) patients in December 2017.
-- Initiation of US registration trial of 177Lu-PSMA-617 in mCRPC first patient visit in the first half of 2018.
-- Updated results from Peter MacCallum Cancer Center-sponsored 177Lu-PSMA-617 trial in metastatic castration-resistant prostate cancer (mCRPC) patients in the second half of 2018.

9. Kura Oncology Inc. (KURA)

Gained 9.03% to close Thursday's trading at $15.10.

News: No news

Near-term catalysts:

-- Present preliminary results from the ongoing phase II trial of Tipifarnib in chronic myelomonocytic leukemia at the American Society of Hematology Annual Meeting in December 2017.
-- Present updated results from phase II trial of Tipifarnib in HRAS mutant head and neck squamous cell carcinomas at the Multidisciplinary Head and Neck Cancers Symposium in February 2018.
-- Report additional data from phase II trials of Tipifarnib in peripheral T-cell lymphoma, chronic myelomonocytic leukemia and myelodysplastic syndromes in 2018.

10. Iovance Biotherapeutics Inc. (IOVA)

Gained 8.65% to close Thursday's trading at $7.85.

News: The Company announced early efficacy and safety data from Cohort 2 of the ongoing phase II trial of its drug candidate LN-144 in metastatic melanoma trial.

The data based on nine patients in Cohort 2 of the trial showed a disease control rate of 78%, including three partial responses and a fourth awaiting confirmation.
Also in the pipeline is C-145-04, which is under phase II trial in cervical cancer.

LOSERS

1. Inovio Pharmaceuticals Inc. (INO)

Lost 16.89% to close Thursday's trading at $4.43.

News: The Company reported wider loss and lower revenue for the third quarter of 2017.

The net loss attributable to common stockholders for the recent third quarter widened to $34.1 million or $0.39 per share from $20.8 million or $0.28 per share in the comparable year-ago quarter.

Total revenue for the third quarter of 2017 declined to $2.6 million from $12.5 million for the same period in 2016 due to lower revenues recognized due to the nearing of successful completion of our DARPA Ebola grant.

2. Opko Health Inc. (OPK)

Lost 16.05% to close Thursday's trading at $5.41.

News: The Company reported a wider loss on lower revenue for the third quarter of 2017.

Net loss for the recent third quarter widened to $46.04 million or $0.08 per share from $15.0 million or $0.03 per share in the year-ago quarter. Similarly revenues declined to $263.5 million in the third quarter of 2017 from $298 million in the comparable year-ago quarter.

Near-term catalysts:

-- Initiate a phase 2b dose ranging study of OPK88004 to treat men with benign prostatic hypertrophy in Q4 2017.
-- Initiate a phase 2b dose escalation study OPK88003 for type 2 diabetes and obesity in early 2018.
-- Plans are now being finalized to begin a single dose Phase 2a trial of OPK88002 to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis.

3. Akebia Therapeutics Inc. (AKBA)

Lost 12.57% to close Thursday's trading at $15.10.

Near-term catalysts:

-- Data from phase II study of Vadadustat in dialysis-dependent patients are expected by year end.
-- A phase III study to further evaluate a three-times-weekly dosing regimen for vadadustat, dubbed TRILO2GY later this year.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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