11.07.2017 04:02:32

Gainers & Losers Of July 10: KMPH, DOVA, AGLE, LMAT, OCUL...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 10, 2017.

GAINERS

1. KemPharm Inc. (KMPH)

Gained 11.94% to close Monday's (July 10) trading at $3.75.

News: No news

Near-term catalysts:

-- Initiate development of KP484, a new super-extended release (SER) d-MPH being designed for the treatment of ADHD, and file an Investigational New Drug application for KP484 as early as the third quarter of 2017. -- Initiate pivotal efficacy trial of KP415 for the treatment of ADHD in the second half of this year. -- Human clinical trials of KP201/IR for the short-term treatment of acute pain are anticipated to commence in 1H 2017 - with final intranasal human abuse liability (HAL) study data expected in the second half of this year. -- NDA submission for KP415 for the treatment of ADHD is planned for 2018.

2. Dova Pharmaceuticals Inc. (DOVA)

Gained 9.14% to close Monday's trading at $27.47.

News: No news

Recent event:

The Company made its trading debut on the NASDAQ Global Market on June 29, 2017 at an opening price of $19.25, about 13% higher than the IPO price of $17.

Pipeline:

The Company's lead product candidate is Avatrombopag for the treatment for thrombocytopenia in patients with chronic liver disease (CLD). The compound was tested in two pivotal clinical trials, ADAPT 1 and ADAPT 2, in which all primary and secondary endpoints were met with high statistical significance.

Near-term catalyst:

The Company expects to file an NDA for Avatrombopag in the third quarter of 2017.

3. Aeglea Biotherapeutics Inc. (AGLE)

Gained 7.52% to close Monday's trading at $3.64.

News: The Company has appointed James Wooldridge, M.D. to the position of chief medical officer.

Pipeline:

Aeglea is currently recruiting patients for its ongoing phase 1/2 trial of AEB1102 for the treatment of Arginase 1 Deficiency. Two phase I trials of AEB1102 in cancer patients with advanced solid tumors and with hematological malignancies are underway.

4. Omeros Corp. (OMER)

Gained 7.54% to close Monday's trading at $20.55.

News: No news

Pipeline:

The Company is preparing for its Phase 3 clinical trial of OMS721 in IgA nephropathy, and is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy.

OMS721 is also being evaluated in a Phase 3 clinical program for atypical hemolytic uremic syndrome and in a Phase 2 clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy.

The Company has one marketed drug OMIDRIA that was launched in the U.S. in the second quarter of 2015 for use during cataract surgery or IOL replacement. In the European Union, the drug is approved for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

LOSERS

1. LeMaitre Vascular Inc. (LMAT)

Lost 12.66% to close Monday's trading at $27.94.

News: Michael Wijas, who served as Vice President, Sales, The Americas, of LeMaitre Vascular resigned, effective July 7, 2017.

The Company has initiated a search for a replacement. In the interim, the North American sales management team will report to George W. LeMaitre, Chairman and Chief Executive Officer of the Company.

Two brokerages - Canaccord Genuity and Benchmark - on Monday downgraded the stock to "Hold" from "Buy".

To know more about LMAT, visit our Company Spotlight column

2. Cara Therapeutics Inc. (CARA)

Lost 10.35% to close Monday's trading at $12.21, extending its loss for the fourth trading day.

News: No news

Recent event:

The Company reported disappointing results from its phase IIb trial of CR845 in patients with osteoarthritis of the knee or hip after the market close on June 29, 2017. The news sent the stock plunging as low as 40% to $15.25 the following day (on June 30, 2017).

3. Ocular Therapeutix Inc. (OCUL)

Lost 8.85% to close Monday's trading at $6.49.

News: The Company has submitted details of a manufacturing equipment change as an amendment to the NDA resubmission for DEXTENZA, and has sought to extend the current decision date of July 19, 2017.

Dextenza, proposed for treatment of ocular inflammation and pain following cataract surgery, is under FDA review. The U.S. regulatory agency had refused to approve Dextenza last July, raising concerns pertaining to manufacturing process and controls.

4. Anika Therapeutics Inc. (ANIK)

Lost 7.75% to close Monday's trading at $45.71.

News: No news

Recent event:

A SEC filing made on July 6, 2017, reveals that Charles Sherwood, the Company's CEO, sold 5,965 shares on July 3rd in multiple trades ranging from $50.00 to $50.02, and sold another 8,236 shares on July 5th in multiple trades ranging from $50.00 to $50.25.

Near-term catalyst:

The Company President and Chief Executive Officer, Charles H. Sherwood, is slated to make a presentation at the Singular Research Summer Solstice Conference on Thursday, July 13, 2017.

5. Ovid Therapeutics Inc. (OVID)

Lost 7.42% to close Monday's trading at $8.99.

News: No news

Recent event:

On June 13, 2017, the Company reported first quarter 2017 financial results.

The Q1, 2017 net loss widened to $34.2 million or $3.48 per share from $3.7 million or $0.37 per share in the year-ago quarter.

As of March 31, 2017, Ovid had cash of $44.2 million.

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.

Pipeline:

The lead 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.

Near-term catalysts:

-- The company expects top line data from the STARS trial to be available in 2018. -- The top line data from the phase I trial evaluating OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome are expected to be available in the second half of 2017.

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Aktien in diesem Artikel

Anika Therapeutics Inc. 16,20 0,00% Anika Therapeutics Inc.
Cara Therapeutics Inc 0,28 -0,29% Cara Therapeutics Inc
LeMaitre Vascular incShs 101,00 0,00% LeMaitre Vascular incShs
Ocular Therapeutix Inc 8,57 2,39% Ocular Therapeutix Inc
Omeros Corp 11,03 9,32% Omeros Corp
Ovid Therapeutics Inc Registered Shs 1,01 0,00% Ovid Therapeutics Inc Registered Shs