SPPI Shines On NSCLC Data, TNDM Sales Up 42%, TORC Breathes Easy, VRAY Abuzz

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

1. Spectrum Pharmaceuticals Inc. (SPPI)

Gained 41.90% to close Tuesday's (Apr.10) trading at $20.76.

News: The Company provided an update on its phase II study of Poziotinib in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer, being conducted at MD Anderson Cancer Center.

As per the update, in the first 11 patients, the confirmed objective response rate was 64%, way above the Company's expectations of 20% to 30%.

The original cohort of the MD Anderson's study is designed to enroll 30 EGFR patients, and it is fully enrolled, and the expanded cohort of 20 patients is nearing the completion of enrollment.

The comprehensive data from this study is expected to be presented at a major medical meeting later this year.

2. Tandem Diabetes Care Inc. (TNDM)

Gained 22.55% to close Tuesday's trading at $7.01.

News: The Company announced preliminary results for the quarter ended March 31, 2018.

Tandem Diabetes is a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States.

Pump shipments increased by 56 percent to approximately 4,400 pumps in the first quarter of 2018 from 2,816 pumps in the same period of 2017. Sales increased to approximately $27.0 million in the first quarter of 2018 from $19.0 million in the same period of 2017.

The Company intends to report its first quarter 2018 financial and operating results on Thursday, April 26, 2018 after the markets close.

3. CEL-SCI Corp. (CVM)

Gained 19.71% to close Tuesday's trading at $1.64.

News: No news

Clinical Trial & Near-term Catalyst:

-- The phase III head and neck cancer study for lead investigational immunotherapy Multikine is fully enrolled.

The Company is following the study subjects for outcomes and will be able to analyze all of the data for safety and efficacy when 298 deaths have occurred in the two main comparator arms of the study and the corresponding data have been recorded in the study database.

The primary efficacy endpoint of the study is a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone.

4. REGENXBIO Inc. (RGNX)

Gained 18.92% to close Tuesday's trading at $37.40.

News: No news

Recent event:

-- On April 9, 2018, Novartis announced that it is acquiring AveXis Inc. (AVXS) for $218 per share.

REGENXBIO has an exclusive agreement with AveXis for the development and commercialization of products to treat Spinal Muscular Atrophy. Under the terms of the agreement, REGENX granted AveXis an exclusive, worldwide license, with rights to sublicense, to REGENX's NAV rAAV9 vector for treatment of SMA disease in humans. In return for these rights, REGENX receives an up-front payment, certain milestone fees and royalties on net sales of products incorporating NAV rAAV9.

Clinical Trials & Near-term Catalysts:

-- Completed dosing of third cohort in RGX-314 Phase I clinical trial for wet AMD. -- Continuing dosing of second cohort in RGX-501 Phase I/II clinical trial for Homozygous Familial Hypercholesterolemia (HoFH). -- Present topline data from RGX-314 and RGX-501 clinical trials in late 2018. -- Initiate dosing in clinical trials for RGX-111 for MPS I and RGX-121 for MPS II in mid-2018.

5. resTORbio Inc. (TORC)

Gained 16.81% to close Tuesday's trading at $9.38.

News: No news

Recent event:

-- The Company went public on the Nasdaq Global Select Market on January 26, 2018, offering its shares at a price of $15.00 each.

Clinical Trial & Near-term Catalysts:

-- A phase IIb trial of RTB101, an orally-administered, selective TORC1 inhibitor alone, or in combination with everolimus, in reducing the incidence of respiratory tract infections (RTIs) in elderly subjects is underway.

Data from this trial are expected in the second half of 2018.

6. Cronos Group Inc. (CRON)

Gained 14.36% to close Tuesday's trading at $6.37.

Cronos Group is a Canadian licensed producer and distributor of medical cannabis.

News: No news

Recent events:

-- On March 19, 2018, MM Enterprises USA, LLC, a leading U.S. cannabis company with facilities in California, Nevada, and New York, entered into an agreement with Cronos Group to form a first-of-its-kind cross border joint venture.

The joint venture, called MedMen Canada Inc. will develop branded cannabis products and open stores across Canada by year's end.

-- On March 21, 2018, the Company entered into an agreement with a syndicate of underwriters co-led by GMP Securities L.P. and BMO Capital Markets to sell 10.42 million common shares on a "bought deal" basis, at a price of $9.60 each.

The offering closed on April 6, 2018, and gross proceeds from it were approximately $100.0 million.

7. ViewRay Inc. (VRAY)

Gained 11.25% to close Tuesday's trading at $7.12.

News: No news

The Company manufactures and markets MRIdian radiation therapy system. MRIdian is the only FDA-cleared and CE-marked MR-image guided radiation therapy system.

Recent event:

-- On April 4, 2018, the University Clinic Heidelberg in Germany announced that it has completed installation and commissioning of the hospital's new MRIdian Linac, the next-generation linear accelerator-based MR image-guided radiation therapy system. -- On March 27, 2018, the Company announced that it surpassed its 50th MRIdian MR image-guided radiation therapy system order during the first quarter of 2018 - a landmark achievement in the company's history of bringing next-generation technology to the fight against cancer.

The Company's total revenue in 2017 was $34.0 million, primarily from six revenue units, up from $22.2 million, primarily from four revenue units, in 2016.

For the full year 2018, ViewRay anticipates total revenue to be in the range of $80 million to $90 million.