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Gainers & Losers Of The Day: DFFN, ETRM, GNVC, EGRX, ADHD...

Jan9 Pharma 010917

The following are the biotech stocks that made their way onto the Day's Gainers & Losers' list of January 9, 2017.

1. Diffusion Pharmaceuticals Inc. (DFFN)

Gained 176.70% to close Monday's trading at $5.70.

News: No news

Anticipated event:

The company's lead investigational drug is Trans Sodium Crocetinate or TCS, which is being investigated to enhance the efficacy of radiation and chemotherapy.

TSC is designed to work by safely re-oxygenating oxygen deprived (hypoxic) tissue. Hypoxia is an especially critical obstacle in the treatment of cardiovascular and respiratory diseases, as well as in cancer.

A phase II study of TCS in Glioblastoma produced encouraging results - with overall survival increasing by 37% at 2 years. An end of phase II meeting with the FDA was held in May 2015 and the company was informed that a single phase III study could serve as the basis for approval.

Diffusion Pharma expects to begin enrollment in the phase III study of TSC in Glioblastoma in the first half of this year.

The company's shares were uplisted from OTC to the NASDAQ on November 9, 2016.

2. EnteroMedics Inc. (ETRM)

Gained 92.60% to close Monday's trading at $17.70.

News: No news

EnteroMedics shares have been on a tear since the January 5th announcement about the availability of its VBLOC neurometabolic therapy for the treatment of obesity at two additional institutes - which brings the total number of institutes to have implanted the therapy to 13.

The stock has gained an impressive 345% in just the last three trading days.

ETRM has undergone 3 reverse stock splits - a 1-for-6 reverse split on July 12, 2010; 1-for-15 reverse stock split on January 7, 2016 and a 1-for-70 reverse stock split on December 28, 2016.

3. ARIAD Pharmaceuticals (ARIA)

Gained 72.85% to close Monday's trading at $23.75.

News: ARIAD is all set to be acquired by Japan's Takeda Pharmaceutical Company Ltd.

Takeda Pharma is acquiring ARIAD Pharma for $24.00 per share in cash, which equates to a total enterprise value of approximately $5.2 billion. The purchase price per share represents a premium of approximately 75 percent over ARIAD's closing price of $13.74 on January 6, 2017.

The transaction is expected to close by the end of February 2017, subject to customary conditions.

4. GenVec Inc. (GNVC)

Gained 35.79% to close Monday's trading at $4.97.

News: No news

GenVec's lead product candidate is CGF166, which is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders.

Last week, the company entered into an exclusive option agreement with Washington University in St. Louis to license intellectual property and technology related to gene editing and pulmonary endothelial cell targeting.

5. Viking Therapeutics Inc. (VKTX)

Gained 34.13% to close Monday's trading at $1.69.

News: No news

Near-term catalysts:

The company's lead investigational drug is VK5211 in phase II testing in patients recovering from non-elective hip fracture surgery. This trial is expected to be completed in Q2, 2017.

A phase II clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease is underway - and this study is also scheduled for completion in Q2, 2017.

6. CTI BioPharma Corp. (CTIC)

Gained 20.42% to close Monday's trading at $5.78.

News : The company announced positive progress on its lead programs in addition to key business priorities for 2017.

As previously announced on January 5, 2017, Pacritinib is no longer under clinical hold. The company expects to initiate a trial of Pacritinib, named PAC203, in the second quarter of 2017.

CTI BioPharma is also looking out for partnership for the development and commercialization of Pacritinib in certain territories outside the U.S.

The confirmatory trial of the company's commercial product PIXUVRI continues to progress - with top-line results expected later this year. If positive, this trial could provide the opportunity for full approval and label expansion by EMA, and discussions with the FDA about accelerated PIXUVRI approval in the US for the treatment of patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

7. NewLink Genetics Corp. (NLNK)

Gained 18.30% to close Monday's trading at $13.12.

News: No news

Anticipated event:

The company's proprietary drug candidate is Indoximod, which is in multiple Phase 2 studies as a potential treatment for advanced melanoma, pancreatic cancer, breast cancer and malignant brain tumors. The compound is being positioned to enter late stage development in the second-half of this year.

Another key drug candidate of NewLink is GDC-0919, which is being developed in partnership with Genentech/Roche. It is under Phase I/Ib studies in solid tumors.

8. Pernix Therapeutics Holdings Inc (PTX)

Gained 14.55% to close Monday's trading at $3.36.

News: No news

Anticipated event: Q4 and full-year 2016 financial results on March 8, 2017.

9. Nabriva Therapeutics AG (NBRV)

Gained 14.11% to close Monday's trading at $7.60.

News: No news

Near-term catalyst: Review of the company's phase III trial of Lefamulin in patients with moderate to severe community-acquired bacterial pneumonia by an independent committee expected next month.

10. Marinus Pharmaceuticals Inc. (MRNS)

Gained 13% to close Monday's trading at $1.13.

News: No news

Near-term catalysts:

Report top-line data from a phase II trial of Ganaxolone as a treatment for orphan, genetic epilepsies in mid-2017.

Initiate phase II studies of Ganaxolone in women with postpartum depression and in patients with refractory status epilepticus in the first half of 2017.

Losers

1. AMAG Pharmaceuticals, Inc. (AMAG)

Lost 35.57% to close Monday's trading at $23.00.

News: Preliminary Q4 and full-year 2016 financial results announced.

AMAG expects fourth quarter 2016 total non-GAAP revenue to be between $150 million and $155 million while consensus forecast among analysts polled by Thomson Reuters is $154.12 million.

The 2016 non-GAAP revenue is expected to be between $546 million and $551 million while the consensus forecast is $551.3 million.

The company is scheduled to report the financial results on February 15, 2017.

2. Alcobra Ltd (ADHD)

Lost 13.89% to close Monday's trading at $2.17.

News: The clinical hold on a Phase III trial of MDX in adult patients with ADHD has not been fully lifted but has been modified from "Full" to "Partial" hold.

A full clinical hold was imposed on the company's Phase III clinical study of MDX in adult patients with ADHD (Attention-deficit/hyperactivity disorder), known as the "MEASURE" study, last September by the FDA due to adverse neurological findings in a pre-clinical study.

The official minutes from the company's meeting with the FDA held in early December 2016 released today reveals that "The FDA has agreed to modify the Full Clinical Hold to a Partial Hold to allow the conduct of a Phase I safety study. The FDA will review results from this safety study and consider the complete lifting of the Full Clinical Hold currently in place on the MDX programs".

3. AtriCure Inc. (ATRC)

Lost 12.36% to close Monday's trading at $16.59.

News: Preliminary results for Q4 and full-year 2016 results announced.

The company expects revenue to be approximately $41.2 million for fourth quarter 2016 and $155.1 million for full year 2016, both of which fall short of analysts' consensus estimate of $41.49 million and $156.7 million, respectively.

The company is scheduled to report the financial results on February 21, 2017.

4. Atossa Genetics Inc (ATOS)

Lost 11.04% to close Monday's trading at $1.45.

News: The site of phase II study of Fulvestrant in patients with ductal carcinoma in situ or breast cancer who are scheduled for lumpectomy or mastectomy is being transferred.

The study was initiated at Columbia University Medical Center Breast Cancer Programs (New York) and is now being transferred to Montefiore Medical Center in New York. The enrollment in the study has been slower than expected, particularly as the study site is being moved, according to the company. The enrollment is now expected to be completed by August 2017.

5. Agios Pharmaceuticals Inc. (AGIO)

Lost 9.94% to close Monday's trading at $42.78.

News: The company outlined key 2017 milestones

Near-term catalysts:

Agios plans to submit NDA for wholly owned AG-120 in relapsed or refractory (R/R) acute myeloid leukemia (AML) by the end of this year.

Initiate a phase III trial combining AG-120 and VIDAZA in frontline AML in the first half of 2017.

6. Eagle Pharmaceuticals Inc. (EGRX)

Lost 9.41% to close Monday's trading at $68.10.

News: Mizuho Securities analyst has downgraded the rating of EGRX to Underperform from Neutral, and has reduced the price target to $64 from $78.

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