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Gainers & Losers Of June 1: XBIT, CBMG, COLL, NEOT, MACK...

June1 060117

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

GAINERS

1. XBiotech Inc. (XBIT)

Gained 26.59% to close Thursday's (June 1) trading at $9.33.

News: The Company will be presenting data from its European Phase III Study of advanced colorectal cancer patients treated with Hutruo (MABp1)on June 3, 2017.

In the Phase III study, 82% of all patients that received at least one dose of Hutruo, long referred to as Xilonix, did complete the 8 week treatment regimen. According to the Company, 40% of patients that received treatment with the antibody therapy achieved the primary endpoint, nearly double compared to placebo.

The patients who achieved the primary endpoint of the study had substantially improved survival outcomes, with a median survival of 11.7 months versus 5.7 months for those that did not. Other key findings include RECIST assessment of tumor progression, where radiographic evidence of stable disease was more than three-fold better in the patients who achieved the primary endpoint, noted the Company.

The Company has been pursuing approval of Hutruo for colorectal cancer in the European Union. In April of this year, questioning the validity of the phase III results, the European Medicines Agency rendered a negative "trend" vote after meeting with the Company. A negative trend vote means it is unlikely that a positive Committee for Medicinal Products for Human Use (CHMP) opinion related to the Company's MAA will be attained.

In the presentation to be made on June 3, 2017, the Company will drive home the point that the phase III study data is a proof to show that in an advanced cancer population, the use of the combination of patient-reported symptoms and radiography used as the primary endpoint to measure disease modifying anti-tumor therapies is a logical surrogate to assess new anti-cancer agents in chemorefractory patients.

2. Cellular Biomedicine Group Inc. (CBMG)

Gained 24.22% to close Thursday's trading at $7.95.

News: The Company has announced a new stock repurchase program, which is designed to return value to its stockholders.

The buyback program authorizes the Company to repurchase up to $10 million in common shares.

3. Minerva Neurosciences Inc. (NERV)

Gained 21.21% to close Thursday's trading at $10.00.

News: Minerva announces amended agreement for MIN-202 in insomnia

Under the amended agreement, Minerva will gain global strategic control of the development of MIN-202 to treat insomnia, and Janssen will forego its right to royalties on MIN-202 insomnia sales in Minerva territories.

Minerva will retain its current rights to MIN-202 as adjunctive therapy for major depressive disorder (MDD), which include an exclusive license in the European Union, Switzerland, Liechtenstein, Iceland and Norway, with royalties payable by Minerva to Janssen, and royalties on sales payable by Janssen to Minerva elsewhere worldwide.

Janssen will make an upfront payment of $30 million, $20 million at the start of a Phase 3 insomnia trial for MIN-202 and $20 million when 50% of the patients are enrolled in the trial.

A payment of $13 million due from Minerva for Phase 2 development of MIN-202 will be waived by Janssen. All Minerva stock currently owned by held by an affiliate of Janssen, totaling approximately 3.9 million shares and representing about 10% of total Minerva shares outstanding, will be repurchased by Minerva at par value of $.0001 per share or roughly $389 in total.

In January 2016, Minerva announced top line results from a Phase IIa clinical trial of MIN-202 for the treatment of insomnia disorder. In March 2016, the Company reported top line results from a Phase Ib clinical trial in MDD with MIN-202.

4. T2 Biosystems Inc. (TTOO)

Gained 12.39% to close Thursday's trading at $3.72.

News: Study published in the Journal of Clinical Microbiology highlights detection of Lyme Disease-causing bacteria in blood using T2 Biosystems' T2MR technology.

The research demonstrates that T2MR is able to detect Lyme disease-causing bacteria in clinical samples and was found to be highly sensitive with extremely low levels of detection.

The Company expects to complete pre-clinical studies for the T2MR-powered T2Lyme Panel in 2017, which is expected to lead to a clinical trial for FDA submission in 2018, in partnership with Canon U.S.A.

5. Collegium Pharmaceutical Inc. (COLL)

Gained 11.45% to close Thursday's trading at $9.16.

The Company currently has one marketed product Xtampza ER, an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA for the management of pain.

News: One of the largest managed care organizations has added Xtampza ER to its Medicare Part D formularies.

Michael Heffernan, Collegium's CEO said, " With this formulary addition, Xtampza ER is now covered for over 40% of Medicare Part D lives and over 90% of commercial lives".

6. Alder Biopharmaceuticals Inc. (ALDR)

Gained 10.71% to close Thursday's trading at $17.05.

News: No news

Near-term catalysts:

-- The top-line data read out from the Company's first phase III study of ALD403 in patients with chronic migraine, known as PROMISE 1, is expected this month (June, 2017).
-- The top line results from the second phase III study of ALD403 in patients with chronic migraine, dubbed PROMISE 2, are expected in the first half of 2018.
-- The submission of the company's Biologics License Application for ALD403 to the FDA is planned for the second half of 2018.

7. Proteostasis Therapeutics Inc. (PTI)

Gained 10.61% to close Thursday's trading at $4.38.

News: No news

Near-term catalysts:

-- Preliminary phase I data from at least 8 cystic fibrosis subjects from a cohort of stable Orkambi patients dosed with PTI-428 for 7 days followed by a 7-day follow-up period are expected to be reported in this quarter (Q2, 2017).
-- Data from the 28-day dosing cohort in phase I clinical trial of PTI-428 are expected in the second half of 2017.

8. Otonomy Inc. (OTIC)

Gained 9.80% to close Thursday's trading at $13.45.

News: No news

Near-term catalysts:

-- Top-line results from U.S. phase III trial of OTIVIDEX in patients with Ménière's disease, dubbed AVERTS-1, expected in the third quarter of 2017.
-- Top-line results from European phase III trial of OTIVIDEX in patients with Ménière's disease, dubbed AVERTS-2, expected by the end of 2017.

9. Syros Pharmaceuticals Inc. (SYRS)

Gained 9% to close Thursday's trading at $17.44.

The Company has two lead product candidates - SY-1425 for genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) under phase II testing, and SY-1365 for certain solid tumors, under phase I testing.

News: No news

Near-term catalyst:

-- Initial clinical data from the ongoing Phase 2 clinical trial of SY-1425 are anticipated in the fall of 2017.

LOSERS

1. Neothetics Inc. (NEOT)

Lost 17.46% to close Thursday's trading at $2.01.

News: No news

Near-term catalyst

A phase II proof of concept trial of LIPO-202 for reduction of submental fat is underway, and top-line results from this study are expected in June.

2. Merrimack Pharmaceuticals Inc. (MACK)

Lost 10.19% to close Thursday's trading at $1.63.

News: This is the fifth straight loss for the stock ever since the Company announced management changes on May 25, 2017.

Yasir Al-Wakeel will resign as the Company's Chief Financial Officer and Head of Corporate Development, effective June 9, 2017 to pursue other business interests.

3. Nabriva Therapeutics AG (NBRV)

Lost 10.48% to close Thursday's trading at $9.40.

News: No news

Near-term catalysts:

-- Top-line data from 1st phase III trial of Lefamulin (IV/oral) in patients with moderate to severe community-acquired bacterial pneumonia, dubbed LEAP 1, expected to be reported in Q3, 2017.
-- Top-line data from 2nd phase III trial of Lefamulin (IV/oral) in patients with moderate to severe community-acquired bacterial pneumonia, dubbed LEAP 2, expected to be reported in Q1, 2018.

4. Ovid Therapeutics Inc. (OVID)

Lost 8.39% to close Thursday's trading at $11.68.

News: No news

Recent event: The Company made its debut on the NASDAQ Global Select Market on May 5, 2017, offering its shares at a price of $15.00 each.

The most advanced clinical drug candidate of the Company is OV101, a potential treatment for Angelman syndrome and Fragile X syndrome.

A phase II clinical trial of OV101 in adults with Angelman syndrome, dubbed STARS, and a phase I trial of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome are underway.

5. Vital Therapies Inc. (VTL)

Lost 5.66% to close Thursday's trading at $2.50.

News: No news

Near-term catalyst:

-- The top line data from a phase III study of ELAD System in subjects with severe alcoholic hepatitis, dubbed VTL-308, are anticipated around mid-2018.

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