OSUR Turns Heads, MRSN To Report Data By Year-end, CYTK Loses Vitality

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 21, 2017.

GAINERS

1. OraSure Technologies Inc. (OSUR)

Gained 18.55% to close Tuesday's (Nov.21) trading at $16.55.

News: The Company has entered into a $143 million agreement for the supply of its Oragene Dx devices to a leading consumer genomics customer. The agreement provides for the supply of product over several years with minimum annual purchases by the customer.

Oragene Dx is the first and only FDA 510(k) cleared saliva DNA collection and stabilization device.

2. BioScrip Inc. (BIOS)

Gained 14.09% to close Tuesday's trading at $2.51.

News: No news

Recent event:

-- On November 2, 2017, the Company reported third quarter 2017 financial results.

The net loss from continuing operations in the recent third quarter was $12.4 million or $0.12 per share on net revenue of $198.7 million. This compared with a net loss from continuing operations of $11.1 million or $0.12 per share and revenue of $224 million in the prior year quarter.

Looking ahead to full year 2017, the Company expects revenue to be in the range of $805.0 million to $810.0 million.

3. AC Immune SA (ACIU)

Gained 13.11% to close Tuesday's trading at $11.73.

News: No news

Pipeline:

The Company's lead product candidate is Crenezumab, out-licensed to Genentech, under phase III testing for the treatment and prevention of Alzheimer's disease including the first-ever Alzheimer's disease prevention trial.

Next in the pipeline is ACI-24, a liposomal therapeutic anti-Abeta vaccine, wholly owned by AC Immune, and it is under phase 1/2a clinical study in patients with mild to moderate Alzheimer's disease.

The other clinical candidates include ACI-35, outlicensed to Janssen Pharmaceuticals, under phase 1b study in patients with mild to moderate Alzheimer's disease, and RO7105705, outlicensed to Genentech, under phase II study in people with prodromal-to-mild Alzheimer's disease.

4. GW Pharmaceuticals plc (GWPH)

Gained 11.13% to close Tuesday's trading at $127.54.

News: The Company announced that new results from completed phase III trials of Epidiolex in Lennox-Gastaut syndrome and Dravet syndrome will be presented at the American Epilepsy Society (AES) Annual Meeting, December 1-5, 2017, in Washington D.C.

Recent event:

-- On October 30, 2017, the Company completed its New Drug Application submission to the FDA for Epidiolex in the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome.

5. Mersana Therapeutics Inc. (MRSN)

Gained 9.96% to close Tuesday's trading at $18.54.

News: No news

Recent event:

-- The Company went public on the NASDAQ Global Select Market on June 28, 2017 at an offering price of 15.00 per share.

Near-term catalysts:

-- Interim safety results from phase I trial of lead oncology drug candidate XMT-1522 in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC) and gastric cancer are expected around the end of this year. -- Begin phase I dose escalation study of XMT-1536, a potential first-in-class Dolaflexin ADC targeting NaPi2b-expressing tumors, in early 2018.

LOSERS

1. Acasti Pharma Inc. (ACST)

Lost 32.58% to close Tuesday's trading at $2.09. Pullback after yesterday's (Nov.20) gain of over 140%.

News: No news

Recent event:

-- On November 20, 2017, the Company announced that development and commercialization discussions related to its drug candidate CaPre are progressing with a leading China pharmaceutical partner. The news sent the stock soaring over 140% yesterday.

If the discussions result in signing of a definitive agreement, Acasti would receive an upfront payment of US$8 million upon signing, plus potential additional regulatory and commercial milestone payments in excess of US$125 million, and tiered double-digit royalties on net sales.

2. Cytokinetics Incorporated (CYTK)

Lost 25.68% to close Tuesday's trading at $8.25.

News: The Company's phase III clinical trial of Tirasemtiv in patients with amyotrophic lateral sclerosis did not meet the study goals.

The trial, dubbed VITALITY-ALS, did not meet the primary endpoint of change from baseline in slow vital capacity (SVC) which was evaluated at 24 weeks or any of the secondary endpoints in the trial which were evaluated at 48 weeks.

3. NantHealth Inc. (NH)

Lost 9.74% to close Tuesday's trading at $3.15.

News: No news

Recent event:

-- On November 9, 2017, the Company reported financial results for its third quarter ended September 30, 2017.

Net loss was $42.4 million or $0.37 per share compared with $36.9 million, or $0.30 per share for 2016 third quarter. Total net revenue in the recent third quarter increased to $21.8 million from $20.7 million in the comparable year-ago quarter.

4. Novelion Therapeutics Inc. (NVLN)

Lost 9.60% to close Tuesday's trading at $4.52.

News : District Judge William Young has rejected Aegerion Pharmaceuticals' amended criminal plea agreement which was negotiated with the United States Department of Justice (DOJ).

The plea agreement is regarding a settlement of the ongoing investigations into Aegerion's sales activities and disclosures related to JUXTAPID capsules, an adjunct therapy to treat homozygous familial hypercholesterolemia (HoFH).

Aegerion Pharmaceuticals is an indirect subsidiary of Novelion.

5. Enanta Pharmaceuticals Inc. (ENTA)

Lost 8.17% to close Tuesday's trading at $45.65.

News: No news

Near-term catalysts:

-- Initiate a phase II study of EDP-305 in primary biliary cholangitis by the end of 2017. -- Initiate a phase I study of EDP-938 for respiratory syncytial virus by the end of 2017.

6. Ocular Therapeutix Inc. (OCUL)

Lost 8.12% to close Tuesday's trading at $4.30.

News: No news

Near-term catalysts:

-- Meet with the FDA in early 2018 to review plans to resubmit its NDA for DEXTENZA for the treatment of post-surgical ocular pain. --Resubmit its NDA for DEXTENZA in the first half of 2018. --A phase III clinical trial for OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension is underway - with topline efficacy data expected in the second half of 2018. -- A pilot human clinical trial with an intracameral product candidate, OTX-TIC, which is a bioresorbable travoprost-containing hydrogel depot delivered via a fine-gauge needle injection for patients who have moderate to severe glaucoma, initiated in Q3, 2017, is underway. -- Advance OTX-TKI into phase I testing outside the United States in the first half of 2018.

7. Global Blood Therapeutics Inc. (GBT)

Lost 6.81% to close Tuesday's trading at $38.30.

News: No news

Near-term catalysts:

-- Provide an interim update on the ongoing HOPE-KIDS 1 Study at the upcoming American Society of Hematology Annual Meeting in December.

HOPE-KIDS 1 Study is a phase IIa trial of Voxelotor in pediatric patients with sickle cell disease.

-- Announce top-line data for HOPE Study in the first half of 2019.

HOPE is a phase III trial evaluating Voxelotor for the treatment of sickle cell disease.