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Gainers & Losers Of The Day: CALA, EVOK, EYEG, OCRX, TENX...

JAN30 013017

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of January 30, 2017.

GAINERS

1. Calithera Biosciences Inc. (CALA)

Gained 46.74% to close Monday's (Jan.30) trading at $6.75.

News: Calithera has entered into a collaboration with Incyte Corp. (INCY) to develop CB-1158, a phase I drug candidate.

A phase I clinical trial assessing the safety and efficacy of Calithera's CB-1158 as a treatment for advanced solid tumors is underway.

As per the agreement terms, Incyte gains worldwide rights to Calithera's CB-1158 for hematology and oncology indications. In return, Calithera will receive a $45 million up-front payment and an $8 million equity investment from Incyte.

Incyte and Calithera will co-fund global development of CB-1158. Calithera is eligible to receive share of profits in the U.S., and over $430 million in potential development, regulatory and commercialization milestones on future sales of CB-1158 from Incyte.

2. PAVmed Inc. (PAVM)

Gained 17.65% to close Monday's trading at $6.00.

News: No news

Near-term catalyst: The last we heard from PAVmed was the 510(k) premarket notification submission for its first product, the PortIO Intraosseous Infusion System, on December 19, 2016.

The company expects receiving FDA clearance and beginning commercialization of the device this year.

3. Evoke Pharma Inc. (EVOK)

Gained 14.92% to close Monday's trading at $2.85.

News: No news

Anticipated event: A phase I pharmacokinetic (PK) study of Gimoti in healthy volunteers is expected to be initiated this year. Gimoti, a nasal formulation of metoclopramide, is under development for symptomatic relief of acute and recurrent diabetic gastroparesis in women. Metoclopramide in oral and IV formulations is approved by the FDA for gastroparesis.

The company reported results from its phase III trial of Gimoti last July. The primary endpoint of symptom improvement in acute and recurrent diabetic gastroparesis in adult women at Week 4 was not met. But statistical significance was demonstrated in patients with moderate to severe gastroparesis symptoms at baseline.

The proposed PK trial could serve as portion of an NDA for Gimoti, according to Evoke.

4. Ritter Pharmaceuticals Inc. (RTTR)

Gained 13.70% to close Monday's trading at $3.32.

News: No news

Near-term catalyst: Top-line results from phase 2b/3 clinical trial of RP-G28 for the treatment of lactose intolerance on schedule are expected to be announced this quarter (Q1, 2017).

5. Antares Pharma Inc. (ATRS)

Gained 13.40% to close Monday's trading at $2.20.

News: No news

Near-term catalyst: The company submitted a New Drug Application to the FDA for QuickShot Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector on December 21, 2016.
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.

6. Cymabay Therapeutics Inc. (CBAY)

Gained 10.18% to close Monday's trading at $1.84.

News: No news

Near-term catalysts:

- The results from phase II study of Seladelpar in primary biliary cholangitis are expected in 3Q 2017.
- The company's most advanced product candidate is Arhalofenate for treatment of gout, which has completed phase II studies. The drug candidate is licensed to Kowa Pharmaceuticals America, Inc. in the U.S. Licensing discussions for other territories are underway.

7. EyeGate Pharmaceuticals Inc. (EYEG)

Gained 9.82% to close Monday's trading at $1.79.

News: The company has reported positive topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel in corneal epithelial defects.

The trial assessed the safety and performance of EyeGate Ocular Bandage Gel on its own or combined with a Bandage Contact Lens (BCL) compared to the current standard of care, artificial tears and BCL. The primary endpoint of the study was complete wound closure by Day 3.

According to the trial results, 75% of the subjects treated with EyeGate Ocular Bandage Gel alone achieved complete wound closure by Day 3, compared to 53.8% of patients that received the standard of care.

LOSERS

1. Ocera Therapeutics Inc. (OCRX)

Lost 70.73% to close Monday's trading at $0.60.

News: The company's phase IIb study of Ornithine Phenylacetate (OCR-002) in hospitalized patients with Hepatic Encephalopathy has failed to demonstrate statistical significance.

In the study, dubbed STOP-HE, OCR-002, however, demonstrated a 17-hour reduction over placebo for the primary endpoint, which was time to improvement in Hepatic Encephalopathy symptoms.

2. Regulus Therapeutics Inc. (RGLS)

Lost 42.22% to close Monday's trading at $1.30.

News: The FDA has informed the company that it will not reconsider the clinical hold on RG-101, an investigational drug chronic hepatitis C virus infection, until additional safety and efficacy data from continued clinical and pre-clinical studies are submitted.

The data sought by the FDA are expected to be available only in the fourth quarter of 2017.

The FDA imposed the clinical hold on RG-101 last July after Regulus reported a second serious adverse event of jaundice in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going phase I US study - 117 days after receiving a single dose of RG-101.

3. Pulmatrix Inc. (PULM)

Lost 21.36% to close Monday's trading at $2.65.

News: The company has announced a $5 million registered direct offering.

The company has agreed to sell an aggregate of approximately 2 million shares of common stock, at a price of $2.50 per share, in the registered direct offering. The closing of this offering is expected to take place on or about February 2, 2017, subject to the satisfaction of customary closing conditions.

4. Diffusion Pharmaceuticals Inc. (DFFN)

Lost 17.74% to close Monday's trading at $3.20. The stock which rose an impressive 520% in 2 trading days - touching an intraday high of $15.50 on January 10, 2017 - has given back almost all of its gains.

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.

5. Sunshine Heart Inc. (SSH)

Lost 14.07% to close Monday's trading at $5.07.

News: No news

A 1-for-30 reverse split of common stock came into effect on January 13, 2017.
The number of authorized shares of the company's common stock will remain at 100,000,000, while the number of outstanding shares will be reduced from approximately 25.3 million to 0.8 million, noted the company in a Press release dated January 12, 2017.

Anticipated event: Q4 and full-year 2016 financial results are scheduled for March 1, 2017.

6. Tenax Therapeutics Inc. (TENX)

Lost 9.72% to close Monday's trading at $1.95.

News: No news

Near-term catalyst: The results from a phase III trial of Levosimendan for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome, dubbed LEVO-CTS, are pending. Last November, the company said it will report top-line data in January 2017.

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