Busy Year Awaits FLKS, Mark Your Calendar For BPMC Data, CLLS Loses Steam

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 1, 2017.

GAINERS

Flex Pharma Inc. (FLKS)

Gained 13.43% to close Wednesday's (Nov.1st) trading at $3.04.

News: No news

Near-term catalysts:

-- A U.S. phase II trial evaluating FLX-787 in patients with Charcot-Marie-Tooth, who suffer from painful, debilitating cramps, dubbed COMMIT, is underway. Topline results from this study are expected in the middle of 2018. -- A U.S. phase II trial of FLX-787 in patients with motor neuron disease, focused on amyotrophic lateral sclerosis, who suffer from painful, debilitating cramps, dubbed COMMEND, was initiated in August of this year. Top-line results from this study are expected in the middle of 2018. -- Data readout from an exploratory phase II spasticity study of FLX-787 in multiple sclerosis in Australia anticipated in 2018. -- Data readout from phase 1/2a renal dialysis cramping studies of FLX-787 expected in 2018. -- Data readout from phase 1/2a Dysphagia (swallowing)/tongue fasciculations studies of FLX-787 in Amyotrophic Lateral Sclerosis expected next year.

2. Aileron Therapeutics Inc. (ALRN)

Gained 9.55% to close Wednesday's trading at $13.19.

News: No news

Aileron's common stock made its debut on the NASDAQ Global Market on June 29, 2017 at an offering price of $15.00 per share.

Pipeline:

The Company's lead product candidate is ALRN-6924. Multiple clinical studies of ALRN-6924 are underway, including a Phase 1 All-comers trial in advanced solid tumors or lymphomas, a Phase 2a trial in peripheral T-cell lymphoma (PTCL), a Phase 1 trial in acute myeloid leukemia (AML) and advanced myelodysplastic syndrome (MDS) as a monotherapy, and a Phase 1b trial in AML/MDS in combination with cytosine arabinoside (Ara-C).

Near-term catalysts:

-- Interim data from the ongoing trials are expected to be reported during the first half of 2018.

3. Blueprint Medicines Corporation (BPMC)

Gained 8.10% to close Wednesday's trading at $71.80.

News: Data published in Science Translational Medicine highlight the potential of the Company's drug candidate BLU-285, a potent and highly selective KIT and PDGFRa inhibitor, to address unmet patient needs in gastrointestinal stromal tumors (GIST) and systemic mastocytosis.

Near-term catalysts:

BLU-285 is in two ongoing phase I clinical trials in patients with advanced gastrointestinal stromal tumors and patients with advanced systemic mastocytosis.

-- The updated results from the ongoing Phase 1 clinical trial of BLU-285 in patients with advanced GIST are expected to be presented on November 10, 2017. -- Updated data from ongoing phase 1 clinical trial of BLU-285 n patients with advanced SM are expected to be presented by the end of 2017. -- Initiate an additional cohort in the ongoing phase I trial of BLU-554 in Hepatocellular Carcinoma in the first quarter of 2018.

4. Adamas Pharmaceuticals Inc. (ADMS)

Gained 7.95% to close Wednesday's trading at $26.62.

News: No news

Recent events:

--A 13G filing dated October 27, 2017 revealed that hedge-fund billionaire Steve Cohen's Point72 Asset Management has a 5.1% stake in Adamas. -- On August 24, 2017, the Company received approval for GOCOVRI, the first and only medication for the treatment of Dyskinesia in Parkinson's disease patients.

GOCOVRI, with a list price is $28,500/year or $2,375/month, is expected to be available this quarter, and formally launched with the full deployment of Adamas' sales force in January 2018.

Near-term catalyst:

-- The Company is slated to report third quarter 2017 financial results on Thursday, November 2, 2017 after market close.

5. Juno Therapeutics Inc. (JUNO)

Gained 7.57% to close Wednesday's trading at $48.31.

News: The Company reported stellar Q3, 2017 financial results, crushing analysts' estimates. Updated data from its phase I study of JCAR017 in patients with relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphoma, dubbed TRANSCEND, were also detailed.

For the third quarter of 2017, non-GAAP net loss was $76.3 million or $0.73 per share on revenue of $44.8 million. Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.79 per share and revenue of $16.03 million.

The Company had incurred a non-GAAP net loss of $58.3 million or $0.57 per share on revenue of $20.8 million in the third quarter of 2016.

In the TRANSCEND study, at dose level 2, the 3 month overall response rate was 80% and 3 month complete response rate was 73% in the core group.

LOSERS

1. Intellia Therapeutics Inc. (NTLA)

Lost 18.16% to close Wednesday's trading at $25.47.

Intellia is a genome editing company focused on developing curative therapeutics using CRISPR technology.

News: The Company has commenced an underwritten public offering of $150 million of its common stock. The underwriters will be granted a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering.

2. aTyr Pharma Inc. (LIFE)

Lost 16.67% to close Wednesday's trading at $4.00.

News: The Company has announced leadership transition.

John Mendlein, President and Chief Executive Officer will step down, handing over the baton to Sanjay Shukla, who joined the Company as Chief Medical Officer in March 2016.

The out-going CEO will continue to serve on the Board of Directors of aTyr Pharma.

3. Cellectis SA (ADR) (CLLS)

Lost 16.65% to close Wednesday's trading at $29.18.

News: Preliminary results of a Phase 1 trial of UCART19 in pediatric patients with high risk relapsed refractory (R/R) CD19+ B-ALL and no therapeutic options were reported.

In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being codeveloped by Servier and Pfizer.

As of 24 June 2017, 5 children (3 males and 2 females), including two infant leukaemias, aged between 8 months and 16.4 years had been enrolled and treated in the trial.

Preliminary results of the trial reveal no unexpected toxicities. GvHD, which was mild and self-limiting, lymphodepletion-related viral complications and persisting neutropenia are some of the toxicities encountered in the trial. One subject died in remission from transplant related complications, noted the Company.

4. Surgery Partners Inc. (SGRY)

Lost 16.22% to close Wednesday's trading at $7.75.

News: The Company announced preliminary financial results for the third quarter ended September 30, 2017.

Loss before income taxes for the third quarter of 2017 is expected to be approximately $21.9 million compared to income of $12.6 million in the third quarter of 2016. Revenues for the third quarter of 2017 are expected to be roughly $306.3 million compared to $282.7 million in the year-ago quarter.

The impact of Hurricanes Harvey and Irma are blamed for the poor results. The third quarter 2017 results are slated to be reported after the market close on Wednesday, November 8, 2017.

5. Momenta Pharmaceuticals Inc. (MNTA)

Lost 12.58% to close Wednesday's trading at $12.32.

News: The Company reported disappointing product revenue for Q3, 2017.

The product revenue from sales of Glatopa 20 mg, the first generic version of Teva's Copaxone, was $10.9 million in Q3, 2017 compared to $23.3 million for the same period in 2016. The net loss for the recent third quarter widened to $33.2 million or $0.44 per from $17.5 million or $0.26 per share for the same period in 2016.