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PTI Faces Busy December, CYTK Displays Fortitude, LENS Losing Sharpness?

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 29, 2017.

GAINERS

1. Proteostasis Therapeutics Inc. (PTI)

Gained 32.14% to close Wednesday's trading at $2.59.

News: No news

Pipeline:

The Company's drug candidates include PTI-428, PTI-801 and PTI-808 for cystic fibrosis.

Clinical trials & near-term catalysts:

-- A 28-day phase II clinical trial of PTI-428 in cystic fibrosis patients receiving Vertex Pharmaceuticals' Orkambi as their background therapy is underway. Preliminary data from this cohort are expected this quarter.
-- A 14-day phase II study of PTI-428 in cystic fibrosis patients on Vertex Pharmaceuticals' Kalydeco is also ongoing. Preliminary data from this study are anticipated in the first quarter of 2018.
-- A 14-day phase I study of PTI-801 in cystic fibrosis patients on Orkambi background therapy is underway. Initial data from this study are expected in the fourth quarter of 2017.
-- A phase I study of PTI-808 in healthy volunteers is ongoing, and initial safety, tolerability and PK data are anticipated this quarter.

2. InflaRx N.V. (IFRX)

Gained 8.95% to close Wednesday's trading at $20.70. This is the fourth straight day of gain for the stock.

News: No news

Recent event:

-- The Company went public on the NASDAQ Global Select Market on November 8, 2017, offering its shares at a price of $15.00 each.

Pipeline:

The Company's lead compound is IFX-1, under phase II clinical trial in patients suffering from moderate to severe Hidradenitis Suppurativa (HS), a painful, chronic and debilitating inflammatory skin disease. Positive top line data from an exploratory Phase IIa trial of IFX-1 in Hidradenitis Suppurativa were reported in September of 2017.

Near-term catalyst:

-- Initiation of an international, multi-center, randomized, placebo-controlled Phase IIb trial in Hidradenitis Suppurativa is being planned.

3. Cytokinetics Incorporated (CYTK)

Gained 8.28% to close Wednesday's trading at $7.85.

News: No news

Recent event:

-- On November 21, 2017, the Company announced that its phase III clinical trial of Tirasemtiv in patients with amyotrophic lateral sclerosis, dubbed VITALITY-ALS, did not meet the study goals. The news sent the stock plunging 25.68% to $8.25 that day.

Clinical trials & near-term catalysts:

With Tirasemtiv biting the dust, the next compound on which Cytokinetics has pinned its hopes on is CK-2127107.

-- A phase Ib crossover study to assess the effect of CK-2127107 on measures of physical function in elderly adults with limited mobility is ongoing. This study is being conducted by Astellas, in collaboration with Cytokinetics.
-- A phase II clinical trial of CK-2127107 in patients with amyotrophic lateral sclerosis, dubbed FORTITUDE-ALS, is ongoing.
-- A phase II clinical trial of CK-2127107 in patients with spinal muscular atrophy (SMA) is ongoing, and enrollment in Cohort 2 of the study is expected to be completed this year.
-- Data from phase II clinical trial of CK-2127107 in patients with SMA are expected in Q1 2018.
-- A phase II study of CK-2127107 in patients with chronic obstructive pulmonary disease is underway.
-- A phase Ib clinical trial of CK-2127107 in adults with limited mobility is ongoing.

4. Minerva Neurosciences Inc. (NERV)

Gained 8.04% to close Wednesday's trading at $6.05.

News: No news

Clinical trials & near-term catalysts:

-- Initiate a pivotal phase III trial of MIN-101 to treat negative symptoms in patients diagnosed with schizophrenia in the fourth quarter of 2017. Top-line results from this trial are expected in the first half of 2019.
-- A phase IIb clinical trial of Seltorexant as adjunctive therapy to antidepressants in adult patients with major depressive disorder is underway. Another phase IIb clinical trial of Seltorexant in major depressive disorder is planned for initiation this quarter.
-- A phase IIb trial of Seltorexant in insomnia is also planned for initiation this quarter.
-- Patient recruitment in a phase IIb clinical trial of MIN-117 in major depressive disorder is expected to commence in early 2018.
-- MIN-301 with potential for treating neurodevelopmental and neurodegenerative disorders including and beyond Parkinson's disease is under preclinical testing.

LOSERS

1. Apollo Endosurgery Inc. (APEN)

Lost 12.96% to close Wednesday's trading at $4.70.

News: No news

The Company deals with less invasive medical devices for bariatric and gastrointestinal procedures.

Recent event:

-- On November 27, 2017, the Company received FDA Clearance for OverStitch Sx endoscopic suturing system. It will be introduced in the US and Europe in the first half of 2018.

In the third quarter ended September 30, 2017, the Company's total sales were $16.5 million compared to $15.8 million in the year-ago quarter.

2. Presbia PLC (LENS)

Lost 12.96% to close Wednesday's trading at $4.70.

News: No news

Pipeline:

The Company's lead product candidate is Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision. The Presbia Flexivue Microlens is currently approved for sale in 42 countries around the world.

Near-term catalyst:

-- The Company is planning to make its final submission to the FDA seeking approval of Presbia Flexivue Microlens before the end of 2017 in anticipation of approval in 2018.

3. Arrowhead Pharmaceuticals Inc. (ARWR)

Lost 9% to close Wednesday's trading at $3.54.

News: No news

Pipeline:

ARO-AAT for the treatment of alpha-1 antitrypsin deficiency liver disease; ARO-HBV for the treatment of chronic hepatitis B virus infection, and ARO-APOC3, ARO-ANG3 for the treatment of hypertriglyceridemia are the compounds in the Company's pipeline.

Near-term catalysts:

-- File a Clinical Trial Authorization (CTA) to initiate clinical studies for ARO-AAT in Q1, 2018.
-- File a CTA for ARO-HBV in Q2, 2018
-- File a CTA for ARO-APOC3 and/or ARO-ANG3 by the end of 2018.

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