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TTOO Catches Investors' Eyes, SIEN Shaping Up, AGTC Slips Into Red

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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 13, 2017.

GAINERS

1. T2 Biosystems Inc. (TTOO)

Gained 20.64% to close Wednesday's (Sep.13) trading at $6.78. This is the third 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.

2. Sientra Inc. (SIEN)

Gained 19.32% to close Wednesday's trading at $15.01.

News: No news

Recent event:

Sientra, a medical aesthetics company, announced financial results for the second quarter ended June 30, 2017 on August 9, 2017.

Net loss for the recent second quarter widened to $20.4 million or $1.07 per share on net sales of $8.2 million. This compared with a net loss of $10.2 million or $.56 per share and net sales of $6.2 million in the year-ago quarter.

Near-term catalyst:

The Company expects FDA approval of its new manufacturing facility by the end of 2017.

3. Loxo Oncology Inc. (LOXO)

Gained 15.28% to close Wednesday's trading at $86.59.

News: The Company is expected to present initial clinical data of two patients enrolled in Phase 1 clinical trial of LOXO-292 as a single agent in patients with advanced solid tumors on October 18, 2017.

Near-term catalyst:

-- Submit NDA for Larotrectinib for the treatment of solid tumors with NTRK-fusion proteins in late 2017 or early 2018.

4. Synlogic Inc. (SYBX)

Gained 15.14% to close Wednesday's trading at $20.15.

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 commenced trading on the NASDAQ Capital Market under the ticker symbol "SYBX" that day.

5. Apollo Endosurgery Inc. (APEN)

Gained 13.61% to close Wednesday's trading at $4.34.

News: No news

Recent event:

On August 10, 2017, the FDA alerted health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.

Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery.

The following were the clarifications provided by the Company pertaining to the FDA's alert.

ORBERA, which assists adult patients suffering from obesity with a body mass index of 30 to 40 in losing and maintaining weight, was approved by the FDA in August of 2015. "Since its approval, there have been 5 reported deaths of patients who had received the ORBERA intragastric balloon in four different countries, and they were all self reported by the Company. The incident rate remains less than 0.01% and there have been no product liability-related claims in connection with the five cases".

6. Blueprint Medicines Corp. (BPMC)

Gained 9.12% to close Wednesday's trading at $52.78.

News: No news

Pipeline:

The Company's clinical drug candidates include BLU-554 in phase I trial in patients with advanced hepatocellular carcinoma; BLU-285, being evaluated in the indications of Gastrointestinal Stromal Tumors and Systemic Mastocytosis, and BLU-667 for patients with non-small cell lung cancer, medullary thyroid cancer and other advanced solid tumors that harbor a RET alteration, all of which are under phase I testing.

Near-term catalysts:

-- Initiate a global, pivotal Phase 3 clinical trial of BLU-285 in third line patients with KIT-driven Gastrointestinal Stromal Tumors in the first half of 2018.
-- Provide updated data from phase I clinical trial of BLU-285 in patients with advanced systemic mastocytosis by the end of 2017.

7. Syros Pharmaceuticals Inc. (SYRS)

Gained 7.81% to close Wednesday's trading at $16.70.

News: No news

Pipeline:

The Company's lead 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 in the fourth quarter of 2017.
-- Preliminary clinical data from phase I clinical trial of SY-1365 are expected in 2018.

LOSERS

1. Applied Genetic Technologies Corporation (AGTC)

Lost 17.17% to close Wednesday's trading at $4.10.

News: The Company reported financial results for the quarter and fiscal year ended June 30, 2017.

Net loss for the fourth quarter of 2017 was $3.2 million or $0.18 per share compared to a net income of $2.73 million or $0.15 per share in the year-ago quarter. Revenue for the recent fourth quarter dropped to $8.34 million from $12.11 million in the comparable year-ago period.

2. Aileron Therapeutics Inc. (ALRN)

Lost 11.33% to close Wednesday's trading at $11.90.

News: No news

Recent event:

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. Advaxis Inc. (ADXS)

Lost 11.68% to close Wednesday's trading at $4.84. This is the second straight day of loss for the stock.

News: No news

Recent event:

On September 11, 2017, 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.

4. NewLink Genetics Corp. (NLNK)

Lost 8.53% to close Wednesday's trading at $13.73.

News: No news

Recent event:

On September 7, 2017, the Company reported encouraging updated data from its phase II trial of investigational drug Indoximod plus Merck & Co.'s Keytruda in advanced melanoma, sending its shares up over 74% that day.

Near-term catalyst:

-- Initiation of a pivotal trial of Indoximod in combination with PD-1 checkpoint blockade for patients with advanced melanoma in the coming months.

5. Sage Therapeutics Inc. (SAGE)

Lost 7.77% to close Wednesday's trading at $70.46. This is the second straight day of loss for the stock.

News: No news

Recent event:

On September 12, 2017, the Company announced that its phase III study of Brexanolone in the treatment of 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.

6. Epizyme Inc. (EPZM)

Lost 6.73% to close Wednesday's trading at $15.95.

News: The Company announced that it intends to offer and sell $120 million of shares of its common stock in an underwritten public offering.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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