TRXC Up 100% This Month, XTNT Gets FDA Nod, FMI Building Solid Foundation

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

1. TransEnterix Inc. (TRXC)

Gained 12.83% to close Monday's (May 21) trading at $3.43.

News: No news

Recent events:

On May 8, 2018, the Company reported solid financial results for the first quarter ended March 31, 2018.

Adjusted net loss narrowed to $11.3 million or $0.06 per share on revenue of $4.8 million in the recent first quarter. This compared with an adjusted net loss of $12.6 million or $0.11 per share and revenue of $1.9 million in the three months ended March 31, 2017.

In the quarter ended March 31, 2018, the Company sold two Senhance Systems.

The Senhance System is currently cleared for use in the U.S. for laparoscopic colorectal and laparoscopic gynecologic surgery, accounting for approximately 1.5 million procedures in the U.S. annually.

In January of 2018, the Company sought FDA's permission to expand the indications for use of the Senhance System to include laparoscopic inguinal hernia and gallbladder surgery. If the FDA clears the Company's request, the additional indications are expected to bring the Senhance System's total addressable procedures in the U.S. to approximately 3 million.

2. NuCana plc (NCNA)

Gained 11.94% to close Monday's trading at $26.44.

News: The Company announced the appointment of Cyrille Leperlier to its Board as an independent non-executive Director.

Clinical Trials & Near-term Catalysts:

The Company's product candidates are Acelarin and NUC-3373.

Acelarin is currently being evaluated in the indications of ovarian cancer, biliary cancer and pancreatic cancer.

-- On November 15, 2017, the Company announced the enrollment of the first patients in both the United States and the United Kingdom in its phase II study evaluating single-agent Acelarin in patients with platinum-resistant ovarian cancer. -- A phase III trial comparing Acelarin with gemcitabine for people with pancreatic cancer, dubbed ACELARATE, a phase I study of Acelarin with cisplatin for bile duct cancer, and a phase Ib study of Acelarin and Carboplatin for patients with recurrent ovarian cancer are also underway. -- NUC-3373 is currently in a Phase 1 study for the potential treatment of a wide range of advanced solid tumor cancers.

3. Genesis Healthcare Inc. (GEN)

Gained 9.34% to close Monday's trading at $1.99.

News: No news

Recent event:

On May 18, 2018, the Company announced operating results for the first quarter ended March 31, 2018.

On a GAAP basis, the net loss attributable to the Company in the first quarter of 2018 widened to $68.5 million or $0.70 per share on revenue of $1.30 billion. This compared with a net loss attributable to the Company of $50.8 million or $0.55 per share and revenue of $1.39 billion in the first quarter of 2017.

4. Opiant Pharmaceuticals Inc. (OPNT)

Gained 7.98% to close Monday's trading at $17.45.

News: No news

Recent event:

On May 8, 2018, the Company reported financial results for the first quarter ended March 31, 2018.

Net loss in the recent first quarter widened to $9.3 million or $3.68 per share from $2.8 million or $1.39 per share for the comparable period of 2017.

Opiant's first quarter 2018 revenue rose to $1.7 million from $11,000 during the corresponding period of 2017. The increase was due primarily to the recognition of net revenue of $1.6 million arising from the royalty payments from the sale, by Adapt Pharma Operations Ltd., of NARCAN Nasal Spray.

The Company ended March 31, 2018 with cash of roughly $11.3 million.

5. Soleno Therapeutics Inc. (SLNO)

Gained 7.73% to close Monday's trading at $1.95.

News: No news

Clinical Trials & Near-term Catalysts:

A multi-center phase III clinical trial of Diazoxide Choline Controlled-Release ("DCCR") for the treatment of Prader-Willi Syndrome was initiated in May of this year. This trial is anticipated to take approximately 9-12 months to complete.

6. Xtant Medical Holdings Inc. (XTNT)

Gained 7.73% to close Monday's trading at $6.41.

News: The Company has received FDA clearance for InTice-C Porous Titanium Cervical Interbody System.

InTice-C represents the latest addition to the Company's spinal implant portfolio, and is its first spinal implant to be engineered using a best-in-class porous titanium material.

Recent event:

On May 8, the Company reported financial and operating results for the first quarter of 2018.

Net loss for the recent first quarter was $5.3 million or $0.70 per share compared to a loss of $5.8 million or $3.87 per share for the same period in the prior year. Revenue for the first quarter of 2018 declined to $17.9 million, down from $22.1 million compared to the same period of the prior year.

7. XTL Biopharmaceuticals Ltd. (XTLB)

Gained 7.65% to close Monday's trading at $2.11.

News: No news

8. Deciphera Pharmaceuticals Inc. (DCPH)

Gained 7.63% to close Monday's trading at $27.21.

News: The Company announced that it has elected Steven Hoerter, Chief Commercial Officer at Agios Pharmaceuticals, Inc., to its Board of Directors, thereby increasing the number of Deciphera directors to nine from eight.

Clinical Trials & Near-term Catalysts:

A pivotal phase III study of DCC-2618 in 4th-Line and 4th-line plus gastrointestinal stromal tumor is underway.

A pivotal phase III study of DCC-2618 in 2nd-Line gastrointestinal stromal tumor is on track to commence later this year.

A company-sponsored Phase 1b study with Rebastinib in patients with metastatic breast cancer is expected to be initiated later in 2018.

9. Foundation Medicine Inc. (FMI)

Gained 7.27% to close Monday's trading at $87.00.

News: The Company's FoundationOne CDx has been awarded new Advanced Diagnostic Laboratory Test (ADLT) status by the Centers for Medicare and Medicaid Services.

The CMS will provide reimbursement for covered FoundationOne CDx tests at the rate of $3,500. FoundationOne CDx is the first FDA-approved comprehensive genomic profiling assay for all solid tumors that incorporates multiple companion diagnostics.

Recent event:

On May 2, 2018, the Company reported financial and operational results for the first quarter ended March 31, 2018.

The total revenue was $52.8 million in the first quarter of 2018 compared to $26.3 million in the first quarter of 2017. Looking ahead, the company expects 2018 revenue to be in the range of $200 million to $220 million. The annual revenue in 2017 was $152.9 million.