Biotech Digest – CLRB Reports Positive Results, TNDM Receives New Patent, DERM Inks New Deal

Top Pick of the Day: ANTH

Anthera Pharmaceuticals (ANTH) stock shot up as the company announced that the FDA has designated its blisibimod an Orphan Drug for the treatment of immunoglobulin A nephropathy. The condition is also known as Berger's disease and is a disorder in which IgA builds up in the kidneys. Orphan drug designation confers various benefits such as a seven-year period of market exclusivity for the indication, if approved.
The stock reacted positively to the news and gained over 15 percent in the pre market session. The company stock is currently down 74 percent on Year to Date basis while its 12 months loss stands at 94 percent.

Focus Ticker: CLRB

Cellectar Biosciences (CLRB) stock shot up as the company announced achieving overall survival of 22.5 months to date after a single dose infusion of 12.5mCi/m2 in patients with multiple myeloma. The trial will remain ongoing and overall survival data may change. The company also reported that the fourth cohort of its Phase 1 clinical trial of CLR 131 in multiple myeloma is fully enrolled. CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated as a single-dose treatment in a Phase 1 clinical trial in patients with relapsed or refractory (R/R) multiple myeloma (MM). It is also being tested in a Phase 2 clinical trial for R/R MM and select R/R lymphomas with either a one- or two-dose treatment.
The company stock jumped over 11 percent in its previous trading session, trimming its 12 months losses to 32 percent.

Sector News

Sanofi (SNY) reported filing a patent infringement suit against Merck in relation to tow patents covering insulin glargine Lantus. Merck recently filed an NDA for an insulin glargine vial drug product. The application contains a paragraph IV certification challenging all of the Sanofi patents covering Lantus and Lantus SoloStar.

Zimmer Biomet Holdings (ZBH) reported receiving a subpoena from the Office of the Inspector General of the Department of Health and Human Services in June. The subpoena requested for records pertaining the company’s professional consulting arrangements, including medical education, product development and clinical research for the period January 1, 2010 to the present.

Approvals

Tandem Diabetes Care (TNDM) reported the grant of U.S. Patent No. 9,715,327 to the USPTO. The patent covers safety features for the prevention of unintended changes in touchscreen-enabled ambulatory infusion pumps, including insulin pumps. The patent will provide protection until 2033.

Johnson & Johnson (JNJ) received the Orphan Drug designation from the FDA for its cadazolid product, designed for treating Clostridium difficile (C. diff) infection in pediatric patients. Cadazolid is a quinoxolidinone antibiotic and is being developed by Actelion.

Deals and Collaborations

Dermira (DERM) reported its new agreement with Roche pertaining exclusive global rights to develop and commercialize lebrikizumab, an interleukin 13 (IL-13)-targeting monoclonal antibody. Under the terms of the deal, Dermira will be responsible to $80 million upfront and $55 million in 2018. It will also pay $40 million triggered by the start of its first Phase 3 study, up to $210M in regulatory and first-sale milestones and up to $1.025B in sales-related milestones, exclusive of interstitial lung disease.

Earnings

Protalix BioTherapeutics (PLX) announced its revenue for the six months ended June 30, 2017 at $9.2 million, up from $2.4 million during the same period of 2016. The increase is mainly due to increased sales of drug product to Brazil and drug substance to Pfizer Inc. Its net loss for the period stood at $20.6 million, or $0.16 per share, basic and diluted, excluding a one-time, non-cash net charges of $38.1 million.

Analyst Ratings

Brokerage Action Company Rating Price Target Impact on Share Price Actions
Stifel Nicolaus Upgrades AcelRx Pharmaceuticals (ACRX)
Hold -> Buy Low

Cantor Fitzgerald Reiterates Aetna (AET)
Overweight $150.00 -> $175.00 Low

Wells Fargo & Company Reiterates Allergan PLC. (AGN)
Outperform $270.00 -> $280.00 Low

HC Wainwright Reiterates Akebia Therapeutics (AKBA)
Buy $24.00 Low

HC Wainwright Reiterates Amarin Corporation PLC (AMRN)
Buy $10.00 Low

Morgan Stanley Reiterates AveXis (AVXS)
Overweight $118.00 Low

Stifel Nicolaus Reiterates Becton, Dickinson and Company (BDX)
Buy Low

Subscribe to KKD Healthcare Analytics for an entire Biotech digest. 

How did you like this article? Let us know so we can better customize your reading experience.

Comments

Leave a comment to automatically be entered into our contest to win a free Echo Show.