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TTOO Rallies For 2nd Day, SAGE's STATUS Flops, ICPT Warns Of Ocaliva Overdosing

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of September 12, 2017.

GAINERS

1. Synlogic Inc. (SYBX)

Gained 22.63% to close Tuesday's (Sep.12) trading at $17.50.

News: No news

Pipeline:

The Company's lead product candidate is SYNB1020 for Hyperammonemia including Urea Cycle Disorder and Hepatic Encephalopathy. A healthy volunteer study with SYNB1020 was initiated in June 2017. Another investigational product in the pipeline is SYNB1618 for Phenylketonuria, and is under preclinical testing.

Recent event:

Synlogic completed its merger with Mirna Therapeutics to become NASDAQ listed company on August 28, 2017, and commence trading on the NASDAQ Capital Market under the ticker symbol "SYBX" that day.

2. MannKind Corp. (MNKD)

Gained 9.31% to close Tuesday's trading at $2.23.

News: No news

Recent events:

-- On August 7, 2017, the Company reported Q2, 2017 financial results.

The net loss for the second quarter of 2017 was $35.3 million or $0.35 per share on total net revenue of $2.2 million. This compared with a net loss of $30.0 million or $0.33 per share on nil revenue in the year-ago quarter.

-- On September 5, 2017, the Company announced that it has fully relocated its corporate headquarters to a 12,596-square-foot location in the Westlake Landmark office park in Westlake Village, California.

3. Aileron Therapeutics Inc. (ALRN)

Gained 8.40% to close Tuesday's trading at $13.42.

News: No news

Recent event:

Aileron's common stock made its debut on the NASDAQ Global Market on June 29, 2017 $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.

4. T2 Biosystems Inc. (TTOO)

Gained 8.29% to close Tuesday's trading at $5.62. This is the second straight day of gain for the stock.

News: No news

Recent event:

On September 11, 2017, the Company announced that it has filed a 510(k) premarket submission for the T2Bacteria Panel with the FDA.

The T2Bacteria Panel is designed to run on the FDA-cleared T2Dx Instrument. The T2Bacteria Panel, once FDA cleared, combined with the commercially available T2Candida Panel is designed to be the first comprehensive rapid diagnostic solution on the market that identifies pathogens associated with sepsis within hours instead of days, potentially enabling 95% of patients with bloodstream infections to receive targeted therapy within 8 hours of blood draw.

TTOO was trading around $2.96 when we alerted our premium subscribers to this stock on August 8, 2017.

5. Minerva Neurosciences Inc. (NERV)

Gained 8.03% to close Tuesday's trading at $7.40.

News: The Company announced the appointment of Jay B. Saoud as senior vice president, head of research and development.

Near-term catalysts:

-- Initiation of a phase III trial with MIN-101 for schizophrenia in the second half of 2017.
-- Initiation of a phase 2b trial with MIN-202 for major depressive disorder in the second half of 2017.
-- Initiation of a phase 2b trial with MIN-202 for insomnia disorder in the second half of 2017.
-- Initiation of Phase 2b trial with MIN-117 for major depressive disorder in the second half of 2017.
-- Completion of pre-clinical development and subsequent initiation of clinical development with MIN-301 for Parkinson's disease in the second half of 2017.

6. XOMA Corp. (XOMA)

Gained 7.81% to close Tuesday's trading at $19.05.

News: The Company has earned a $3 million milestone payment related to the clinical advancement of an anti-botulism product candidate the Company licensed to Nanotherapeutics Inc. in 2015.

If the product candidate advances from its current stage of development to production and stockpiling by governmental agencies, XOMA is eligible to receive a 15% royalty on net sales.

LOSERS

1. Advaxis Inc. (ADXS)

Lost 19.88% to close Tuesday's trading at $5.48.

News: The Company reported financial results for the third quarter ended July 31, 2017.

Net loss for the recent third quarter widened to $70.1 million or $1.74 per share from $51.8 million or $1.52 per share for the same period in 2016, largely due to increased research and development (R&D) expenses.

The Company ended Q3, 2017 with cash, cash equivalents and investments of $89.4 million.

2. Sage Therapeutics Inc. (SAGE)

Lost 13.69% to close Tuesday's trading at $76.40.

News: The Company's phase III study of Brexanolone in the treatment super-refractory status epilepticus, dubbed STATUS, did not achieve its primary endpoint.

The study did not meet the primary endpoint, comparing success in weaning of third-line agents and resolution of potentially life-threatening status epilepticus with Brexanolone vs. placebo when added to standard-of-care.

3. Intercept Pharmaceuticals Inc. (ICPT)

Lost 13.54% to close Tuesday's trading at $98.12.

News: The Company has issued a letter warning physicians against overdosing patients with Ocaliva, its treatment for primary biliary cholangitis.

The letter dated September 8, 2017, sent to health care providers, cautions that liver injury, liver decompensation, liver failure, and death have been reported in patients with moderate to severe hepatic impairment when Ocaliva was dosed more frequently than recommended in labeling for such patients.

Ocaliva was granted accelerated approval by the FDA last May, and was commercially launched in the United States in June 2016. The drug netted sales of $18.2 million last year.

4. ImmunoGen Inc. (IMGN)

Lost 10.60% to close Tuesday's trading at $6.75.

News: No news

Near-term catalysts:

-- A phase III registration trial of Mirvetuximab soravtansine in women with folate receptor alpha (FRa)-positive ovarian cancer is underway.
-- File an investigational new drug application for IMGN632 to treat a range of hematological malignancies in the third quarter of 2017.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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