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19.05.2017 05:08:18

Gainers & Losers Of May 18: ACHN, IMGN, GTHX, ELGX, NLNK...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of May 18, 2017.

GAINERS

1. Aradigm Corporation (ARDM)

Gained 29.53% to close Thursday's trading (May 18) at $1.25.

News: No news

Recent event:

The Company held pre-NDA meetings with FDA in December 2016 and March 2017 to discuss phase III studies of its drug candidate Linhaliq for the treatment of non-cystic fibrosis bronchiectasis.

2. Achillion Pharmaceuticals (ACHN)

Gained 16.67% to close Thursday's trading at $4.41.

News: The Company's stock has been upgraded by Leerink Partners to Outperform from Market Perform, and its price target has been raised to $6.00 from $4.00.

Near-term catalyst:

-- Results from the Company's phase IIb study investigating the efficacy, safety and pharmacokinetics of different treatment regimens of AL-335, odalasvir, and simeprevir in treatment-naive and treatment-experienced subjects with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6 infection, with and without cirrhosis, dubbed OMEGA-1, are anticipated during the second half of 2017.

Achillion has an exclusive worldwide collaboration with Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson (JNJ) that was signed in May 2015, for the treatment of chronic hepatitis C viral infection.

3. ImmunoGen Inc. (IMGN)

Gained 14.16% to close Thursday's trading at $5.40.

News: The Company announced encouraging new clinical data of Mirvetuximab Soravtansine in ovarian cancer. The data are to be presented at 2017 ASCO Annual Meeting on June 3, 2017.

The pooled data from 131 ovarian cancer patients treated in multiple Mirvetuximab soravtansine phase 1 cohorts demonstrate clinically meaningful activity in the patient population eligible for the ongoing Phase 3 registration trial, dubbed FORWARD I.

Initial data from phase 1b/2 trial of Mirvetuximab soravtansine in combination with Avastin, carboplatin, Doxil or Keytruda in ovarian cancer, dubbed FORWARD II, have indicated favorable safety and efficacy profile in multiple combinations, the Company noted.

4. G1 THERAPEUTICS INC. (GTHX)

Gained 10.67% to close Thursday's trading at $16.60.

News: No news

Recent event: The Company made its debut on the NASDAQ on May 17, 2017, offering its shares at a price of $15.00 each.

The Company has 3 drug candidates in its pipeline namely, Trilaciclib, G1T38 and G1T48.

A phase II study of Trilaciclib for the treatment of triple-negative breast cancer and a phase 1b/2a study of G1T38 for the treatment of ER+, HER2- breast cancer are underway. G1T48 is currently in IND-enabling studies, and is on track for Phase 1 clinical development in the fourth quarter of 2017.

5. Cascadian Therapeutics Inc. (CASC)

Gained 8.92% to close Thursday's trading at $4.76.

News: No news

Recent event: On May 9, 2017, the Company reported financial results for the first quarter ended March 31, 2017.

Net loss attributable to common stockholders in Q1, 2017 narrowed to $12.4 million or $0.30 per share from $12.9 million or $0.81 per share in Q1, 2016 due to a decrease in general and administrative expenses. No revenue was generated in the two quarters.

The Company had cash of $136.1 million as of March 31, 2017.

On May 8, 2017, the Company filed a Form S-3 shelf registration statement, which relates to the possible resale, from time to time, by Growth Equity Opportunities Fund IV, LLC and its affiliates of up to 1,818,000 shares of the Company's common stock.

6. Ovid Therapeutics Inc. (OVID)

Gained 8.89% to close Thursday's trading at $14.95.

News: The Company will be presenting preclinical data on TAK-935/OV935, a potent and highly selective cholesterol 24-hydroxylase inhibitor in development for the treatment of rare epileptic encephalopathies, on May 19, 2017 at the Antiepileptic Drug and Device (AEDD) Trials XIV Conference.

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.

LOSERS

1. Endologix Inc. (ELGX)

Lost 36.70% to close Thursday's trading at $4.26.

News: The FDA has asked the Company to conduct a confirmatory clinical trial in order for its Nellix Endovascular Aneurysm Sealing System to be approved.

The Company anticipates beginning patient enrollment in the fourth quarter of this year with potential FDA PMA approval in 2020. Earlier, it was expected that the Nellix device could be approved in the second quarter of 2018.

2. NewLink Genetics Corp. (NLNK)

Lost 9.07% to close Thursday's trading at $14.64.

News: The Company announced initial results from the Phase 1b portion of a Phase 1b/randomized Phase 2a trial of Indoximod in combination with chemotherapeutic agents, idarubicin and cytarabine, for patients with newly diagnosed Acute Myeloid Leukemia.

According to the trial results, the combination treatment with Indoximod and conventional remission induction and consolidation therapy was well tolerated without adding significant toxicity. Five of 6 (83%) evaluable patients treated with Indoximod (600 mg or 1000 mg) achieved complete remission, with no evidence of minimal residual disease.

3. Vital Therapies Inc. (VTL)

Lost 8.77% to close Thursday's trading at $2.60.

News: No news

Near-term catalysts:

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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