DRNA Soars On NASH Deal, JUNO Transcends Expectations, FMI On Solid Footing

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 2, 2017.

GAINERS

1. Dicerna Pharmaceuticals Inc. (DRNA)

Gained 28.19% to close Thursday's (Nov.2) trading at $7.23.

News: The Company has teamed up with Boehringer Ingelheim to develop novel treatments for chronic liver diseases including nonalcoholic steatohepatitis.

As per the deal terms, Boehringer Ingelheim will pay Dicerna up to $201 million in upfront and success-based development and commercialization milestones, excluding royalties, for an undisclosed target.

2. Juno Therapeutics Inc. (JUNO)

Gained 24.01% to close Thursday's trading at $59.91.

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.

As regards the update on the TRANSCEND trial, the Company noted that dose level 2, the dose in the pivotal cohort, showed a 3 month overall response rate of 80% and a 3 month complete response rate of 73% in the core group. Data support a dose response relationship.

The TRANSCEND pivotal trial is ongoing using dose level 2.

Near-term catalyst:

-- BLA filing of JCAR017 for relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphoma is expected to be completed in the second half of 2018.

3. Foundation Medicine Inc. (FMI)

Gained 19.50% to close Thursday's trading at $50.25.

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

Net loss for the recent third quarter was approximately $32.6 million or $0.90 per share on total revenue of $42.7 million. Analysts expected the Company to incur a loss of $1.10 per share on revenue of $37.99 million.

In the third quarter of 2016, the Company had reported a net loss of $31.3 million or $0.90 per share and total revenue of $29.4 million.

Looking ahead, Foundation expects 2017 revenue to be in the range of $135 million to $145 million. The Company had generated revenue of $116.9 million in 2016.

4. Neurocrine Biosciences Inc. (NBIX)

Gained 19.45% to close Thursday's trading at $72.78.

News: The Company reported better-than-expected third-quarter financial results.

The net loss in the third quarter of 2017 narrowed to $11.1 million or $0.13 per share from $36.9 million or $0.43 loss per share for the same period in 2016. The net product sales from INGREZZA were $45.8 million in the recent third quarter whereas no sales were generated in the comparable year-ago period as the drug was made available for commercial distribution only on May 1, 2017.

Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.49 per share on revenue of $29.86 million in Q3, 2017.

Near-term catalysts:

-- A phase II, proof-of-concept study of NBI-74788 in adult males and females with classic, 21-hydroxylase deficiency Congenital Adrenal Hyperplasia is planned for initiation this month. -- The NDA for Elagolix for the management of endometriosis with associated pain is under priority review by the FDA - with a decision expected in the second quarter of 2018.

Elagolix is being developed by AbbVie, in collaboration with Neurocrine Biosciences.

-- Top-line data from phase IIb trial of INGREZZA in pediatric patients with Tourette syndrome is expected in late 2018.

5. Calithera Biosciences Inc. (CALA)

Gained 19.45% to close Thursday's trading at $72.78.

News: The Company reported Q3, 2017 financial results and provided an overview of its pipeline.

Net loss for the recent third quarter narrowed to $6.07 million or $0.17 per share on collaboration revenue of $7.25 million. Analysts polled by Thomson Reuters were expecting a loss of $0.22 per share and revenue of $4.51 million.

In the third quarter of 2016, the Company had posted a loss of $8.54 million or $0.44 per share and zero collaboration revenue.

LOSERS

1. OraSure Technologies Inc. (OSUR)

Lost 27.66% to close Thursday's trading at $13.76.

News: The Company announced Q3, 2017 financial results.

While net revenues for the third quarter of 2017 grew 31%, net income slumped 7% from the year-ago comparable quarter.

Net income for the third quarter of 2017 was $5.76 million or $0.09 per share down from $6.24 million or $0.11 per share in the third quarter of 2016. Net revenue for the recent third quarter was $42.3 million, up from $32.25 million in the comparable year-ago period.

Analysts polled by Thomson Reuters expected the Company to earn $0.09 per share on revenue of $40.83 million.

2. AMAG Pharmaceuticals Inc. (AMAG)

Lost 19.75% to close Thursday's trading at $12.80.

News: The Company reported financial results for the quarter ended September 30, 2017, and lowered its revenue outlook for the year.

Non-GAAP adjusted EBITDA for the third quarter of 2017 was $56.7 million, down from $76.2 million in the third quarter of 2016. Non-GAAP revenue totaled $155.1 million in the third quarter of 2017, up from $145.8 million in the third quarter of 2016.

Looking ahead, the Company has trimmed its non-GAAP revenue outlook range to $601 million - $633 million from its prior forecast of $630 million to $690 million range.

3. Intellia Therapeutics Inc. (NTLA)

Lost 17.55% to close Thursday's trading at $21.00.

News: The Company has priced its public offering of 6.25 million shares of its common stock at a price of $24.00 each.

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

4. Syros Pharmaceuticals Inc. (SYRS)

Lost 16.79% to close Thursday's trading at $12.64.

News: No news

Pipeline:

The Company's drug candidates are SY-1425, in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, in a Phase 1 clinical trial for patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.

Near-term catalysts:

-- Initial clinical data from phase II clinical trial of SY-1425 are expected to be reported on December 10, 2017. -- Preliminary clinical data from phase I clinical trial of SY-1365 is expected in 2018.

5. Myriad Genetics Inc. (MYGN)

Lost 15.60% to close Thursday's trading at $28.56.

News: The Company's subsidiary, Assurex Health, announced positive results from a trial assessing the impact of GeneSight Psychotropic test.

GeneSight Psychotropic test is a genetic test that helps doctors figure out which depression medications work best for their patients.

According to the trial results, patients receiving the GeneSight test achieved a clinically meaningful and statistically significant improvement in both remission rates and response rates at eight weeks compared to the treatment-as-usual group.

Referring to the clinical trial milestone payment to be made to former stockholders of Assurex, Myriad says that the payment will not be due because this endpoint did not achieve statistical significance in the entire study population.

Myriad acquired Assurex Health last August for $225 million upfront with the potential for $185 million in additional performance-based milestones.

6. Omeros Corp. (OMER)

Lost 13.84% to close Thursday's trading at $13.26.

News: No news

Near-term catalysts:

-- A subset of data from phase II trial of OMS721 for the treatment of glomerulonephropathies will be presented on November 4, 2017. -- The Company is scheduled to report Q3, 2017 financial results on any day between Nov 7, 2017 and Nov 13, 2017.

7. Cellectis SA (ADR) (CLLS)

Lost 12.71% to close Thursday's trading at $25.47. This is the second straight day of loss for the stock.

News: No news

Recent events:

-- On November 1, 2017, the Company reported preliminary results of its phase 1 trial of UCART19 in pediatric patients with high risk relapsed refractory (R/R) CD19+ B-ALL and no therapeutic options.

In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co developed 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.

-- On September 4, 2017, the Company's phase I studies evaluating UCART123 in acute myeloid leukemia and in blastic plasmacytoid dendritic cell neoplasm (BPDCN) were placed on hold by the FDA, following one fatality in the BPDCN clinical trial.