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TENX Heartened After Meeting With FDA, RXII To Report Data In May, GALT On Watch


The following are some of today's top gainers in the pharma/biotech sector.

1. Tenax Therapeutics Inc. (TENX)

Gained 47.56% to close Wednesday's (Apr.4) trading at $7.85.

News: The Company announced that it had a productive pre-Investigational New Drug (pre-IND) meeting with the FDA for a phase II study of Levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF).

The FDA has supported the study design and endpoints for demonstrating proof-of-concept in PH-HFpEF patients. The Company expects to start the study in late June or July.

2. RXi Pharmaceuticals Corp. (RXII)

Gained 24.91% to close Wednesday's trading at $3.31.

News: The Company announced that it will be presenting new data from its Dermatology Franchise at the International Investigative Dermatology (IID) Conference, being held May 16-19, 2018.

Clinical Trials:

-- The lead compound is RXI-109, which successfully completed a phase II trial for dermal scarring last December.
-- RXI-109 is also being tested in a phase 1/2 study in an ophthalmology indication namely in patients with advanced, wet age-related macular degeneration and associated retinal scarring, dubbed Study 1501.
-- Also in the pipeline are Samcyprone, which is being evaluated in a phase IIa clinical trial in subjects with at least one cutaneous, plantar or periungual wart, and RXI-231, a cosmetic ingredient in a proprietary gel formulation designed to aid in the reduction of pigmentation to improve skin appearance.

Near-term Catalysts:

-- The Company is expected to present an update on its phase II study with RXI-109 for the reduction of hypertrophic scars on May 17, 2018
-- Updates on its phase II study with Samcyprone for the treatment of cutaneous warts, and the consumer testing program with its cosmetic product RXI-231 to improve the appearance of skin pigmentation are expected to be presented on May 18, 2018.

3. Catalyst Pharmaceuticals Inc. (CPRX)

Gained 16.37% to close Wednesday's trading at $2.63.

News: No news

Recent event:

-- On March 29, 2018, the Company resubmitted its New Drug Application for Firdapse for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). Once an NDA is submitted, the FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing, after which time the Agency will notify the company submitting the NDA of its decision.

In February 2016, the FDA had refused to even accept for review the Firdapse NDA, saying that it was not sufficiently complete.

4. Vericel Corporation (VCEL)

Gained 15.54% to close Wednesday's trading at $11.15.

News: No news

Recent event:

-- On March 5, 2018, the Company reported stellar Q4 financial results.

Net income for the fourth quarter of 2017 was $0.3 million or $0.01 per share on total net revenue of $23.4 million. This compared with a net loss of $6.2 million or $0.34 per share, and total net revenue of $16.5 million in the fourth quarter of 2016.

Excluding license revenue, net revenue in the fourth quarter of 2017 was $22.2 million, up 34% over the comparable year-ago quarter.

The Company markets MACI, a restorative cartilage repair product in the sports medicine market, and Epicel, the only permanent skin replacement in the severe burn care field.

Looking ahead, the Company expects total net product revenues for the full year 2018, excluding additional license revenue, to be in the range of $73 million to $78 million compared to total net product revenue, excluding license revenue, of $62.8 million in 2017.

5. Galectin Therapeutics Inc. (GALT)

Gained 15.33% to close Wednesday's trading at $4.74.

News: The Company will present a late-breaker oral presentation on Saturday April 14, 2018 in the Main Plenary at The International Liver Congress 2018.

The session will focus on the Company's recent Phase 2b NASH-CX trial results and the innovative work it is doing for patients with non-alcoholic steatohepatitis (NASH) cirrhosis and portal hypertension. The results were reported last December.

Near-term Catalysts:

-- The Company will be meeting with the FDA in early May 2018 to present the results of its phase IIb trial results of its proprietary compound GR-MD-02 in patients with NASH with cirrhosis, dubbed NASH-CX Trial. The purpose of the meeting is to seek agreement on a plan for a Phase 3 clinical trial.
-- The Company has filed a request with the FDA to grant GR-MD-02 Breakthrough Therapy Designation as therapy for patients with NASH cirrhosis without esophageal varices.
-- Discussions with a number of pharmaceutical companies about potential partnerships are underway.

6. Prothena Corporation plc (PRTA)

Gained 12.58% to close Wednesday's trading at $44.21.

News: No news

Clinical Trials & Near-term Catalysts:

-- Top-line results from a phase IIb study of NEOD001 in previously treated subjects with light chain (AL) Amyloidosis, dubbed PRONTO, are expected in the second quarter of 2018.
-- A phase III study of NEOD001 for the potential treatment of AL amyloidosis, dubbed VITAL, is ongoing.
-- A phase I multiple ascending dose study of PRX004 for the treatment of ATTR amyloidosis is expected to begin around mid-2018.
-- A phase II study of PRX002/RG7935 for the treatment of Parkinson's disease, initiated in the second quarter of 2017, is underway.

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