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Gainers & Losers Of Mar.16: MCRB, PLSE, OCUL, PTCT, TROV...

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 16, 2017.

GAINERS

1. Seres Therapeutics Inc. (MCRB)

Gained 37.11% to close Thursday's (Mar.16) trading at $12.71.

News: The Company plans to initiate a new phase II study of SER-109 in patients with multiply recurrent Clostridium Difficile infection that, as agreed to by the FDA, may qualify as a pivotal study. The new study is nicknamed ECOSPOR III.

Last July, the company announced that its phase II trial of SER-109 for the prevention of multiply recurrent Clostridium Difficile infection, dubbed ECOSPOR, did not achieve the primary efficacy endpoint.

2. Cancer Genetics Inc. (CGIX)

Gained 16.28% to close Thursday's trading at $2.50.

News: No news:

Anticipated event: The Company will release its financial results for the fourth quarter and full year ended December 31, 2016, on Thursday, March 23, 2017.

Cancer Genetics' revenue was $6.8 million in the third quarter of 2016, an increase of 68% over the year-ago comparable quarter. For Q4, 2016, analysts polled by Thomson Reuters are expecting revenue of $7.1 million.

3. Agile Therapeutics Inc. (AGRX)

Gained 13.98% to close Thursday's trading at $2.69.

News: No news

Near-term catalyst:

The Company plans to resubmit its NDA for its once-weekly contraceptive patch Twirla in the first half of 2017. Twirla was turned down by the FDA in 2013.

4. Galectin Therapeutics Inc. (GALT)

Gained 13.90% to close Thursday's trading at $2.13.

News: No news

Recent event: On March 14th, the Company had announced that its investigational drug GR-MD-02 demonstrated clinically significant effect in a small, investigator-initiated study that had enrolled three adult patients with severe atopic dermatitis.

5. Pulse Biosciences Inc. (PLSE)

Gained 13.17% to close Thursday's trading at $24.84.

News: No news

Recent event:

The Company submitted a 510(k) to the FDA for its PulseTx System for a general indication for soft tissue ablation on March 14th.

The PulseTx System is based on the Company's proprietary technology called Nano-Pulse Stimulation, or NPS, and it marks Pulse Bio's first FDA 510(k) submission.

Near term catalyst:

The company expects to initiate the first NPS pilot study in immuno-oncology this year.

Pulse Bio featuredin our Company Spotlight column on February 17, 2017 when it was trading around $12.30.

6. Ocular Therapeutix Inc. (OCUL)

Gained 12.13% to close Thursday's trading at $9.98.

News: The Company announced positive results of a patient experience study of DEXTENZA 0.4 mg for intracanalicular use.

DEXTENZA 0.4 mg for intracanalicular use for the treatment of ocular pain occurring after ophthalmic surgery is under FDA review, with a decision expected on July 19, 2017.

According to the patient experience study of DEXTENZA, all patients reported that the intracanalicular insert was comfortable - with 96% feeling that the insert was extremely or very convenient compared to topical eye drops on a tapered schedule. The highest level of overall product satisfaction was reported by 92% patients, with 88% saying they would request the insert if they were to undergo cataract surgery again.

7. Syros Pharmaceuticals Inc. (SYRS)

Gained 11.37% to close Thursday's trading at $16.65, continuing its rally for the second straight day.

News: No news

Near-term catalyst:

The Company will present new data on the following three programs at the American Association for Cancer Research (AACR) Annual Meeting on April 3, 2017.
-- SY-1425, under phase II study, in defined subsets of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients
-- SY-1365 that is on track to begin a phase 1 trial in the first half of this year in transcriptionally driven solid tumors
-- CDK12/13 inhibitor program, under pre-clinical testing.

LOSERS

1. TrovaGene Inc. (TROV)

Lost 25.71% to close Thursday's trading at $1.30.

News: The Company reported Q4 and full-year 2016 financial results.

The net loss for Q4, 2016 widened to $8.5 million or $0.34 per share from $7.4 million or $0.26 per share in the year-ago quarter.

As of December 31, 2016, Trovagene had cash, cash equivalents and short-term investments of approximately $37.9 million.

2. CareDx Inc (CDNA)

Lost 25.58% to close Thursday's trading at $1.60.

News: The Company reported preliminary financial results for the fourth quarter and year ended December 31, 2016.

Preliminary revenue ranges for the fourth quarter and full-year of 2016 were $10.6 million to $10.9 million and $40.4 million to $40.7 million, respectively, both of which are below analysts' consensus estimate.

Analysts polled by Thomson Reuters expect the company to report revenue of $11.78 million for Q4, 2016 and $41.64 million for full-year 2016.

For the full year 2017, the Company expects revenue to be in the range of $45 million to $50 million while analysts expect $52.26 million.

3. PTC Therapeutics Inc. (PTCT)

Lost 18.90% to close Thursday's trading at $8.84.

News: The Company has agreed to acquire all rights to Emflaza, the first treatment approved in the United States for all Duchenne muscular dystrophy (DMD) patients five years and older, regardless of their genetic mutation, from privately-held Marathon Pharmaceuticals LLC.

As part of the agreement, PTC Therapeutics will pay Marathon Pharmaceuticals $75 million in cash plus $65 million in Company stock. Marathon is also entitled to receive payments from PTC based on annual net sales of Emflaza beginning in 2018, which PTC expects will range as a percentage of net sales between the low to mid-20s on a blended average basis. In addition, Marathon has the opportunity to receive a single $50 million sales-based milestone.

The news didn't go down well with investors because Marathon has been accused of setting a very high price of $89,000 for the DMD drug. The active ingredient in Emflaza is deflazacort (a corticosteroid), which according to reports is available in Europe at a price of $1,200. Accused of overpricing, Marathon has delayed the launch of Emflaza, which was approved by the FDA on February 9, 2017.

Marathon's pricing practises werequestioned in 2014 too.

So, has PTC overpaid Marathon?

4. Inovio Pharmaceuticals Inc. (INO)

Lost 9.61% to close Thursday's trading at $6.21.

News: The Company reported Q4 and full-year 2016 financial results.

The net loss attributable to common stockholders for the quarter was $26.2 million or $0.35 per share on total revenue of $8.5 million. This compared with a net loss attributable to common stockholders of $18.0 million or $0.25 per share and total revenue of $5.9 million in the year-ago quarter.

Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.30 per share and revenue of $8.51 million. So, that means Inovio's bottom line and revenue for Q4, 2016 fell shy of analysts' estimate.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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