The Zacks Analyst Blog Highlights: Gilead, Amgen, Baxalta, PTC Therapeutics and Cara Therapeutics
Zacks Equity Research
Updated
For Immediate Release
Chicago, IL – March 03, 2016 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Gilead (GILD), Amgen (AMGN), Baxalta (BXLT), PTC Therapeutics (PTCT) and Cara Therapeutics (CARA).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup
The fourth quarter earnings season is winding down, with quite a few companies reporting last week. Immuno-oncology-focused companies like Kite (Read more: Kite Pharma Q4 Loss Wider but Focus Remains on KTE-C19 ) and Juno (Read more: Juno Posts In-Line Loss in Q4, Focus on Pipeline ) provided their numbers and updates on their pipeline, while obesity-focused companies like Orexigen and Arena (Read more: Arena's Q4 Loss Narrower but Revenues Fall Short ) continue to face challenges in the obesity market.
In addition to earnings reports, many companies came out with pipeline updates. Gilead (GILD) gained FDA approval for a new HIV treatment, while Amgen ( AMGN) is looking to get the label of its new cancer treatment expanded.
Recap of the Week’s Most Important Stories
1. Gilead, known for its strong presence in the HIV and hepatitis C virus (HCV) markets, gained FDA approval for its HIV treatment, Odefsey. Odefsey is the company’s second TAF-based regimen to gain FDA approval and is the smallest pill of any single tablet regimen for the treatment of HIV.
Odefsey consists of Gilead’s Emtriva (200 mg) and tenofovir alafenamide (25 mg) and Johnson & Johnson’s Edurant (25 mg). Gilead had submitted a Priority Review voucher, acquired from Knight Therapeutics, to the FDA along with the Odefsey NDA to cut down the review period to six months. Odefsey is under review in the EU where a CHMP opinion could be adopted in the second half of the year.
Gilead is quite focused on bringing new HIV treatments to market and to boost sales of its blockbuster HIV franchise. The company has another experimental HIV treatment, Descovy, under regulatory review – while the CHMP adopted a positive opinion for this treatment last week, the FDA action date is Apr 7.
2. Amgen is looking to expand the label of its immunotherapy, Blincyto, so that it can be used for the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rare and rapidly progressing cancer of the blood and bone marrow.
According to information provided by Amgen in its press release, ALL is the most common type of cancer in children. Although 95% of children with ALL achieve complete remission following first-line treatment, about 650 children in the U.S. either relapse or become refractory to treatment and have poor long-term outcomes, with overall survival of less than 10%. With limited treatments being available, there is significant unmet need in this area.
3. Immuno-oncology remains a much sought after therapeutic area – last week, Baxalta ( BXLT), which is set to be acquired by Shire, announced that it will collaborate with genome editing company, Precision BioSciences, for the development of a wide range of allogeneic chimeric antigen receptor (CAR) T cell therapies targeting areas of major unmet need in cancer.
The deal could see Baxalta shelling out up to $1.6 billion (on the achievement of milestones) as well as royalties on product sales. Cancer immunotherapy is a highly lucrative area as these therapies have the potential to change the treatment paradigm for cancer.
4. PTC Therapeutics’ (PTCT) shares continued to slide with the company being hit by a series of setbacks. While the major setback for the company was the FDA’s “Refusal to File” letter for the company’s regulatory application for its experimental Duchenne muscular dystrophy (DMD) treatment, Translarna, the company faced another setback related to the pricing and reimbursement of Translarna in Germany.
Translarna, which is approved in the European Economic Area (EEA), is commercially available in Germany since Dec 2014. However, with pricing and reimbursement discussions not ending on a satisfactory note, PTC is thinking of delisting Translarna from the German pharmacy ordering system.
On its fourth quarter call, the company said that there was a request for a 64% discount (57% discount on top of the 7% mandatory rebate). Meanwhile, fourth quarter results were also disappointing with the company posting a wider-than-expected loss.
5. Cara Therapeutics’ (CARA) shares were down on news that its adaptive pivotal trial of I.V. CR845 for postoperative pain has been placed on protocol clinical hold pending a pre-specified safety review. Elevating sodium levels have resulted in safety concerns.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
About Zacks Equity Research
Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.
Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.
Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today. Find out What is happening in the stock market today on zacks.com.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
