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CBAY Walks The Talk, MYND Explodes, NITE Sparkles, NVLN Awaits CHMP Opinion

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The following are some of today's top gainers in the pharma/biotech sector.

1. Aptevo Therapeutics Inc. (APVO)

Gained 15.55% to close Wednesday's (Apr.11) trading at $3.79.

News: No news

You can find more about APVO in our premium stock report. Our premium subscribers were alerted to the stock on November 6, 2017, when it was trading around $2.83. The stock had touched a high of $4.85 on January 3, 2018.

Near-term Catalysts:

-- Submit an IND application for APVO436 in acute myeloid leukemia in Q2 2018.
-- Complete enrollment of Phase 1 dosing cohorts in APVO414 clinical trial in metastatic castration resistant prostate cancer in Q3 2018.
-- Report preliminary data from phase II trial of Otlertuzumab in peripheral T-cell lymphoma in Q4 2018.
-- Submit an IND for APVO210 in Autoimmune/Inflammatory Diseases in Q4 2018.
-- Report preliminary APVO414 phase I dose escalation clinical data in Q4 2018.

2. Fate Therapeutics Inc. (FATE)

Gained 13.82% to close Wednesday's trading at $11.45.

News: No news

Pipeline:

-- FATE-NK100, under phase I study, for refractory / relapsed acute myeloid leukemia, dubbed VOYAGE.
-- FATE-NK100, under phase I study, for recurrent ovarian cancer, dubbed APOLLO.
-- FATE-NK100, under phase I study, for advanced solid tumors, dubbed DIMENSION.
-- ProTmune, for the prevention of graft-versus-host disease, under a phase II clinical trial.

3. Novelion Therapeutics Inc. (NVLN)

Gained 12.57% to close Wednesday's trading at $4.12.

News: No news

Recent event:

-- On March 15, 2018, the Company announced financial results for the fourth quarter and full year ended December 31, 2017, and provided an overview of recent business activities.

On a pro forma basis, net loss in the fourth quarter of 2017 shrunk to $3.3 million or $0.18 per share from $20.1 million or $1.50 per share for the same period in 2016.

GAAP total net revenues from product sales of JUXTAPID and MYALEPT for the fourth quarter of 2017 were $38.9 million, up from $13.6 million in the year-ago quarter.

Near-term Catalysts:

-- The opinion of the European Medicines Agency's Committee for Medicinal Products for Human related to metreleptin (marketed as MYALEPT in the U.S.) is expected this quarter (Q2, 2018).
-- The European Commission's approval decision on metreleptin is scheduled for mid-2018.

The Company is seeking approval of metreleptin as replacement therapy to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in a subset of patients with partial lipodystrophy (PL).

In the U.S., metreleptin, under brand name MYALEPT, is indicated to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It was approved by the FDA in 2014.

4. Homology Medicines Inc. (FIXX)

Gained 11.40% to close Wednesday's trading at $18.86.

News: No news

Homology Medicines is focused on developing therapies for rare genetic diseases through its proprietary gene editing and gene therapy platform.

Recent events:

-- On April 3, 2018, the Company closed its initial public offering of 10.35 million shares of common stock at a public offering price of $16.00 each.
-- On March 28, 2018, the Company began trading on the Nasdaq Global Select Market under the ticker symbol "FIXX."

Pipeline & Near-term Catalysts:

The lead development program is HMI-102, an AAVHSC-mediated gene therapy treatment for adults with the rare disease phenylketonuria.

A phase I/II trial of HMI-102 is expected to be initiated in 2019.

5. CymaBay Therapeutics Inc. (CBAY)

Gained 11.35% to close Wednesday's trading at $13.44.

News: The Company announced positive new 12-week and 26-week results from its ongoing phase II study of Seladelpar in patients with primary biliary cholangitis at the International Liver Congress 2018.

Seladelpar maintains potent anti-cholestatic and anti-inflammatory activity and appears safe and well tolerated, with no drug-induced pruritus, through 26 weeks of treatment, according to the Company.

Near-term Catalysts:

-- A phase II study of Seladelpar in Non-alcoholic Steatohepatitis is expected to be initiated in the first half of 2018.
-- A phase III study of Seladelpar in Primary Biliary Cholangitis is expected to be initiated in the second half of 2018.
-- The 52-week data from the phase II study of Seladelpar in Primary Biliary Cholangitis is expected in the second half of 2018.

6. MYnd Analytics Inc. (MYND)

Gained 10.71% to close Wednesday's trading at $1.51.

News: No news

MYnd is a predictive analytics company that has developed a decision support tool to help physicians reduce trial and error treatment in mental health and provide more personalized care to patients.

Recent events:

-- On March 29, 2018, the Company completed a private placement for gross proceeds of $2.1 million.
-- Last November, the Company acquired revenue-generating Arcadian Telepsychiatry Services which is anticipated to generate rapid growth and benefits from cross-selling going forward.
-- The Company ended the fiscal year-end on September 30, 2017 with no long-term debt and over $5 million cash.

7. Nightstar Therapeutics plc (NITE)

Gained 9.80% to close Wednesday's trading at $14.68.

News: No news

Recent event:

-- On September 28, 2017, the Company made its debut on The NASDAQ Global Select Market, offering its American Depositary Shares at a price of $14.00 per ADS.

Nightstar is a clinical-stage gene therapy company developing treatments for rare inherited retinal diseases.

Clinical Trials & Near-term Catalysts:

-- The lead product candidate is NSR-REP1 for choroideremia, which is under phase III development. The trial, dubbed STAR, is expected to enroll approximately 140 patients across 18 clinical sites in the United States, Europe, Canada and South America.
-- NSR-RPGR for the treatment of patients with X-linked retinitis pigmentosa, is under phase I/II clinical trial. The initial data on safety and tolerability from the dose escalation cohorts of this trial is expected to be available towards the end of 2018.

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