Gainers & Losers Of The Day: ETRM, PIRS, GNVC, AEZS, XXII

(RTTNews) - The following are the biotech stocks that made their way onto the Day's Gainers & Losers' list of January 5, 2017.

1. EnteroMedics Inc. (ETRM)

Gained 89.95% to close Thursday's trading at $3.97.

News: Related to VBLOC neurometabolic therapy for the treatment of obesity.

The company's vBloc neurometabolic therapy has now been implanted at MedStar Health in Maryland and Roper St. Francis in South Carolina. This brings the total number of institutes to have implanted the therapy to 13.

The vBloc therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese. It has received FDA approval and CE Mark.

2. Prana Biotechnology Ltd. (PRAN)

Gained 31.61% to close Thursday's trading at $2.54.

News: No News

Latest developments:

The company's most advanced compound is PBT2 for Alzheimer's and Huntington's disease. Phase II trial results of PBT2 in Huntington disease and Alzheimer's disease were reported in February 2014 and March 2014, respectively. While the Huntington disease trial results were positive, the Alzheimer's trial results were not.

In February 2015, when the company met with the FDA and presented its plans to initiate a Phase III trial in Huntington Disease, the regulatory agency imposed a Partial Clinical Hold based on non-clinical (animal) findings, limiting the dose of PBT2 that can be given to patients with Huntington disease.

The last we heard was that the company has prioritised clinical development of PBT2 in Europe. When the company met with the Medical and Healthcare Regulatory Agency in London and the Medical Products Agency in Stockholm last month, both the agencies recommended further non-clinical work to be undertaken before proceeding with a phase III trial. In a Press release dated December 23, 2016 Prana noted that it has commenced a process of reviewing other potentially suitable opportunities to boost shareholder value in the medium to longer term.

3. GenVec Inc. (GNVC)

Gained 19.29% to close Thursday's trading at 4.02.

News: The company has entered into an exclusive option agreement with Washington University to license intellectual property and technology related to gene editing and pulmonary endothelial cell targeting. GenVec plans to initially focus on research utilizing the technology to develop treatments for hemophilia.

The option agreement is also said to complement and expand applications for the GenVec's AdenoVerse Gene-Delivery Platform.

The company's most advanced compound is CGF166 for hearing loss, under a phase 1/2 clinical trial. The drug candidate is being developed under a collaboration agreement with Novartis.

4. Pieris Pharmaceuticals Inc. (PIRS)

Gained 19.74% to close Thursday's trading at $1.76.

News: Piers has inked a deal with privately-owned French pharmaceutical company Servier.

Under the strategic immuno-oncology co-development alliance, Piers and Servier will jointly pursue several bispecific therapeutic programs including Pieris' proprietary dual checkpoint inhibitor PRS-332.

Besides an upfront payment of $31.3 million from Servier, Pieris is entitled to receive milestone payments worth approximately $338 million related to PRS-332, and up to roughly $201 million for each of the other programs.

5. Halozyme Therapeutics Inc. (HALO)

Gained 17.96% to close Thursday's trading at $12.61.

News: Phase II study of investigational agent PEGPH20 in advanced pancreas cancer met key goals.

A combined analysis of Stages 1 and 2 of the phase II trial showed a statistically significant increase in progression-free survival in patients treated with PEGPH20 plus ABRAXANE and Gemcitabine when compared to patients receiving ABRAXANE and Gemcitabine alone.

An analysis of Stage 2 of the study showed a 91 percent improvement in median PFS in the PEGPH20 arm over the control arm - i.e., 8.6 months in the PEGPH20 arm and 4.5 months in the control arm.

6. CTI BioPharma Corp. (CTIC)

Gained 12.34% to close Thursday's trading at $4.46.

News: The FDA has removed the clinical hold on Pacritinib, the company's lead drug candidate for primary myelofibrosis.

A full clinical hold was imposed on Pacritinib last February due to excess mortality and other adverse events in a pivotal trial of Pacritinib, dubbed PERSIST-1.

Now that the clinical hold has been lifted, the company expects to start a new trial, named PAC203, in the second quarter of 2017.

7. Otonomy Inc. (OTIC)

Gained 10.80% to close Thursday's trading at $17.95.

News: Phase III trial of OTIPRIO in patients with acute otitis externa met the primary endpoint.

In a pivotal phase III clinical trial in patients with acute otitis externa (AOE), also known as swimmer's ear, OTIPRIO met the primary endpoint by showing a statistically significant increase in clinical cure rate compared to sham (no treatment) at Day 8.

OTIPRIO is already approved for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery.

Otonomy expects to submit a supplemental New Drug Application with the FDA, seeking approval of OTIPRIO for acute otitis externa, in the first half of 2017.

8. Vital Therapies Inc. (VTL)

Gained 11.58% to close Thursday's trading at $5.30.

News: No news.

Anticipated event: Q4 and full-year 2016 financial results to be reported in March of 2017.

The company's lead product candidate is ELAD, an investigational extracorporeal liver assist device to supplement hepatic function in order to improve survival rates among subjects with liver failure.

A phase III trial of ELAD in Acute Alcoholic Hepatitis (AAH), dubbed VTL-308, is underway - with top-line results expected around mid-2018.

Losers

1. 22nd Century Group Inc (XXII)

Lost 14.15% to close Thursday's trading at $0.91

News: The FDA has requested more information related to independent clinical studies if the company wants to disclose that its BRAND A Very Low Nicotine tobacco cigarettes reduce smokers' exposure to nicotine.

According to 22nd Century, relative to "Big Tobacco" cigarette brands, including Marlboro, Camel, Newport and American Spirit, BRAND A contains 95% less nicotine.

The company has withdrawn its existing Modified Risk Tobacco Product Applications (MRTPAs) and Premarket Tobacco Product Applications (PMTAs) for "BRAND A" Very Low Nicotine tobacco cigarettes in order to file even more expansive and robust applications.

2. AEterna Zentaris Inc. (AEZS)

Lost 17.81% to close Thursday's trading at $3.00.

News: Confirmatory phase III clinical trial of Macrilen fails.

The phase III trial was designed to validate Macrilen as a growth hormone stimulation test for the evaluation of growth hormone deficiency in adults (AGHD) in comparison with insulin tolerance test, the historical gold-standard for the evaluation of AGHD. But the trial has failed to achieve its objective.

3. Ardelyx Inc. (ARDX)

Lost 10.38% to close Thursday's trading at $12.95.

News: No news

Near-term catalyst: The company's most-advanced drug candidate is Tenapanor, which is under phase III trial, for the treatment of hyperphosphatemia in end-stage renal disease (ESRD) patients on dialysis. Results from this study are expected this quarter (Q1, 2017).