TRPX On A High, PBYI Braces For Busy Times Ahead, NVCN On Watch

TRPX On A High, PBYI Braces For Busy Times Ahead, NVCN On Watch

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

1. Therapix Biosciences Ltd. (TRPX)

Therapix Biosciences is a Canada-based specialty clinical-stage pharmaceutical company developing unique cannabinoid technologies for treatment of central nervous system disorders.

Gained 37.31% to close Monday’s (Nov.5) trading at $9.20.

News: No news

Recent event:

On October 24, the Company signed a binding letter of intent to be acquired by Canada-based FSD Pharma Inc. (FSDDF.OB) for US$48 million, effective October 22, 2018.

The transaction combines two complementary businesses – the production and distribution of medical and recreational products by FSD Pharma, and the medical and pharmaceutical brands by Therapix Biosciences.

If all goes well as planned, the transaction is anticipated to be completed by Q1 2019.

2. Neovasc Inc. (NVCN)

Gained 16.92% to close Monday’s trading at $2.28.

News: No news

Pipeline:

Reducer, for the treatment of refractory angina is not currently commercially available in the United States. But it has been commercially available in Europe since 2015.

Tiara for the transcatheter treatment of mitral valve disease is currently under clinical investigation in the United States, Canada and Europe.

Recent event:

— On October 10, the FDA granted Breakthrough Device designation to Reducer. The Breakthrough Device designation is granted to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.

3. Restoration Robotics Inc (HAIR)

Restoration Robotics is a medical device company developing and commercializing ARTAS and ARTAS iX Robotic Hair Restoration Systems.

Gained 16.84% to close Monday’s trading at $2.29.

News: The Company announced financial results for the third quarter ended September 30, 2018.

Net loss for the third quarter of 2018 was $7.1 million or $0.20 per share on revenue of $4.8 million. Analysts polled by Thomson Reuters were expecting a loss of $0.17 per share and revenue of $5.55 million.

In the third quarter of 2018, the Company sold 11 ARTAS iX Robotic Hair Restoration Systems, including 10 in the U.S.

The net loss for the third quarter of 2017 was $6.6 million or $4.07 per share on revenue of $4.2 million.

4. Hancock Jaffe Laboratories Inc. (HJLI)

Hancock is a company specializing in medical devices that restore cardiac and vascular health.

Gained 14.50% to close Monday’s trading at $2.29.

News: No news

Pipeline:

The Company has three product candidates – the porcine tissue based VenoValve, which is intended to be surgically implanted in the deep venous system of the leg to treat Chronic Venue Insufficiency; the CoreoGraft, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery, and a porcine tissue based heart valve, which based upon its relatively small size and increased output, is an ideal candidate for pediatric aortic/mitral valve replacement.

Recent events:

— The Company went public on the Nasdaq Capital Market on May 31, 2018, at an offering price of $5.00 per unit.
— On October 9, the Company entered into a Sponsored Research Agreement with Texas Heart Institute for the development of its CoreoGraft.

5. Puma Biotechnology Inc. (PBYI)

Gained 13.90% to close Monday’s trading at $22.86.

News: No news

Recent event:

— On November 1, the Company announced financial results for the third quarter ended September 30, 2018.

On a non-GAAP basis, the adjusted net income for the third quarter of 2018 was $6.6 million or $0.16 per share on total revenue of $62.6 million. This compared with a non-GAAP adjusted net loss of $50.7 million or $1.36 per share, and total revenue of $6.1 million.

The total revenue of third quarter 2018 consisted of $52.6 million of net product revenue from sales of NERLYNX, Puma’s first and only commercial product to date, and $10.0 million of license revenue received from one of its sub-licensees.

Anticipated key milestones over the next 12 months:

— Report data from a phase III trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer, dubbed NALA, in the fourth quarter of 2018 or first half of 2019.
— Seek regulatory approval of NERLYNX for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries in the fourth quarter of 2018 and first half of 2019.
— Report additional data from phase II study of Neratinib in extended adjuvant treatment of HER2-positive early stage breast cancer, dubbed CONTROL, in the fourth quarter of 2018.
— Report additional data from the Phase II trial of Neratinib in patients with a wide variety of solid tumors with activating EGFR, HER2 or HER4 mutations, dubbed SUMMIT, in the fourth quarter of 2018 and first half of 2019.
— Meet with the FDA in the first quarter of 2019 to discuss the clinical development and regulatory strategy for Neratinib in HER2 mutated cancers based on the results of the ongoing SUMMIT Phase II trial.

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