logo
Plus   Neg
Share
Email

INSY On A High, KIDS Making Giant Strides, No Stopping APVO, EDIT Uncut

Jan02-UP-010318-lt.jpg

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

1. INSYS Therapeutics Inc. (INSY)

Gained 19.85% to close Tuesday's (Jan.2) trading at $11.53.

News: No news

Recent event:

-- On December 26, 2017, the Company's cannabidiol (CBD) oral solution secured FDA's Fast Track designation for the treatment of Prader-Willi syndrome.

Prader-Willi syndrome is a rare and complex genetic disorder characterized by insatiable appetite in children that often leads to obesity and type 2 diabetes.
Cannabidiol (CBD) oral solution for Prader-Willi syndrome is under pre-clinical testing, and the Company plans to start the clinical development program in this indication in late first quarter of 2018.

Clinical Trials & Near-term Catalysts:

-- The Company's New Drug Application for Buprenorphine Sublingual Spray for the management of moderate-to-severe acute pain is under FDA review - with a decision expected on July 28, 2018.
-- A phase I proof-of-concept study of two formulations of epinephrine nasal spray for the treatment of anaphylaxis, or severe allergic reaction, commenced early December. Initial results from this study are expected to be available in February 2018. Enrollment in the study is estimated to be complete in the first quarter of 2018.
-- On December 19, 2017, the Company announced the initiation of a phase II trial of Cannabidiol (CBD) oral solution for the treatment of refractory childhood absence epilepsy in pediatric patients. This study is expected to be completed in late 2018.

2. MannKind Corporation (MNKD)

Gained 14.66% to close Tuesday's trading at $2.66.

News: No news

Recent events:

-- On November 7, 2017, the Company reported third quarter financial results.

The net loss for the third quarter of 2017 was $32.9 million or $0.31 per share compared to net income of $126.5 million or $1.32 per share in the year-ago quarter. Included in the year-ago quarterly net income was collaboration revenue of $161.8 million related to the termination of the Sanofi agreement.

For the third quarter of 2017, Afrezza net revenue was $2.0 million, up 28% over the second quarter of 2017 and 246% over the third quarter of 2016.

On October 2, 2017, the FDA approved an update to the Afrezza label, regarding its rapid onset of activity and duration of effect.

3. Inovio Pharmaceuticals Inc. (INO)

Gained 13.32% to close Tuesday's trading at $4.68.

News: The Company has entered an amended agreement providing ApolloBio Corp. with the exclusive right to develop and commercialize VGX-3100 within Greater China (China, Hong Kong, Macao, Taiwan).

VGX-3100 is Inovio's DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV). In a phase 2b trial, VGX-3100 demonstrated clinical efficacy and was generally well tolerated, without the side effects and obstetric risks associated with surgical excision.

As part of the amended agreement, the two companies have agreed to terminate ApolloBio's right to purchase Inovio stock. The agreement entitles Inovio to receive $23 million in upfront payment; an additional $20 million in future regulatory milestone payments and double-digit tiered royalties on sales.

4. OrthoPediatrics Corp. (KIDS)

Gained 13.24% to close Tuesday's trading at $21.73.

News: No news

OrthoPediatrics is a medical device company committed to designing, developing and marketing anatomically appropriate implants and devices for children with orthopedic conditions.

Recent events:

-- On October 12, 2017, the Company went public on the NASDAQ Global Market, offering its shares at a price of $13.00 each.
-- On November 8, 2017, the Company reported third quarter financial results.

Net loss for the third quarter of 2017 was $1.5 million or $1.70 per share compared to a net loss of $0.8 million or $1.38 per share in the year-ago quarter. Total revenue for the recent third quarter was $12.4 million, a 22.1% increase compared to $10.1 million for the same period last year.

Revenue is generated from the sale of its implants and instruments like PediLoc, PediPlates, Cannulated Screws, PediFlex nail, PediNail, PediLoc Tibia, ACL Reconstruction System, Locking Cannulated Blade, Locking Proximal Femur, RESPONSE Spine, Bandloc and Pediguard, to name a few.

5. Forward Pharma A/S (FWP)

Gained 12.84% to close Tuesday's trading at $4.13.

News: No news

6. Aptevo Therapeutics Inc. (APVO)

Gained 12.03% to close Tuesday's trading at $4.75.

News: No news

You can find more about APVO in our premium stock report. Our premium subscribers were alerted to the stock on November 6, 2017, when it was trading around $2.83.

7. Corbus Pharmaceuticals Holdings Inc. (CRBP)

Gained 11.97% to close Tuesday's trading at $7.95.

News: No news

Clinical Trials:

The Company's lead product candidate is Anabasum, which is currently being evaluated in a Phase 3 "RESOLVE-1" study in systemic sclerosis. It is also under phase II studies in cystic fibrosis, dermatomyositis and lupus.

8. Editas Medicine Inc. (EDIT)

Gained 11.68% to close Tuesday's trading at $34.32.

News: No news

You can find more about EDIT in our premium stock report. Our premium subscribers were alerted to the stock on May 5, 2017, when it was trading around $20.27.

Near-term catalyst:

-- An Investigational New Drug (IND) application for EDIT-101 is expected to be submitted to the FDA in mid-2018.

EDIT-101 is the Company's lead program to treat Leber Congenital Amaurosis type 10, a retinal degenerative disorder that causes childhood blindness.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT