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Pharma Stock Roundup: Positive Data from Lilly & Teva, BMY's Deals & More

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This week, there were quite a few regulatory and pipeline updates with Lilly (LLY - Free Report) reporting positive results on its cancer drug Cyramza while the FDA expanded the label of Merck’s (MRK - Free Report) HIV drug Isentress.

Recap of the Week’s Most Important Stories

Lilly’s Cyramza Hits Primary Endpoint in Bladder Cancer Study: Lilly’s cancer drug Cyramza met the primary endpoint in a late-stage study in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. Although the study met the primary endpoint, Lilly said that regulatory agencies would most likely ask for overall survival (OS) data for regulatory filings. OS data is expected in mid-2018. Lilly has been working on expanding the label of Cyramza, which brought in sales of $614.1 million in 2016 (Read more: Eli Lilly's Cancer Drug Cyramza Positive in Phase III).

Expanded Label for Merck HIV Drug: Merck gained FDA approval for a new 1200 mg once-daily dose of its HIV drug, Isentress, for use in combination with other antiretroviral therapies for the treatment of HIV-1 in treatment-naïve patients or patients whose virus remains suppressed after treatment with an initial regimen of 400 mg of Isentress twice-daily. Isentress sales came in at $1.387 billion in 2016 (Read more: Merck's HIV Drug Isentress Gets FDA Approval for Higher Dose). Merck is a Zacks Rank #2 (Buy) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Teva Migraine Drug to Be Filed for FDA Approval in 2017: Teva’s (TEVA - Free Report) experimental migraine prevention drug, fremanezumab, delivered positive results in a late-stage study with the monthly and quarterly dosing regimens meeting all primary and secondary endpoints. Teva intends to seek FDA approval later this year. Meanwhile, data from another late-stage study for episodic migraine is expected shortly.   

Given the limited treatment options, fremanezumab represents significant commercial potential. According to information provided by Teva, more than a billion people suffer from migraine across the world including 38 million Americans (Read more: Teva's Migraine Candidate TEV-48125 Positive in Phase III).

However, Teva is not the only company working on a migraine drug. Amgen and partner Novartis recently filed for FDA approval of their CGRP receptor, erenumab, for the prevention of migraine. Meanwhile, Lilly is set to file for FDA approval of its experimental migraine drug, galcanezumab, in the second half of the year.

J&J Inks Deal with Protagonist: J&J’s (JNJ - Free Report) Janssen Biotech has signed up with Protagonist Therapeutics for the global co-development and commercialization of PTG-200, Protagonist's first-in-class, oral peptide IL-23 receptor antagonist for all indications including inflammatory bowel disease (IBD). The pre-clinical candidate is expected to enter the clinic in the second half of the year. Deal terms include an upfront payment of $50 million plus up to $940 million in development, regulatory, and sales milestones as well as double-digit tiered royalties on net product sales.

Bristol-Myers In Cancer Collaboration with Array: Bristol-Myers (BMY - Free Report) is teaming up with Array to investigate the safety, tolerability and efficacy of Array’s investigational MEK inhibitor, binimetinib in combination with Bristol-Myers’ Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen for the treatment of metastatic colorectal cancer in patients with microsatellite stable tumors (Read more: Bristol-Myers Partners Array to Investigate Cancer Candidate). Bristol-Myers has lagged the Zacks categorized Large Cap Pharmaceuticals industry year-to-date with shares declining 6.7% while the industry is up 10.2%.

FDA Accepts Pfizer Sutent sNDA: Pfizer (PFE - Free Report) , which is looking to expand the label of its cancer drug Sutent, said that the FDA has accepted a supplemental New Drug Application (sNDA) for the drug. The company is looking to expand Sutent’s label for use as an adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancer-containing kidney). The FDA is expected to give a response in Jan 2018. Sutent brought in sales of $1.1 billion in 2016.

Performance

Large Cap Pharmaceuticals Industry 5YR % Return

The NYSE ARCA Pharmaceutical Index was up 1.2% over the last four trading sessions. Glaxo (GSK - Free Report) was up 4% while Lilly gained 2.1%. Over the last six months, AstraZeneca was up 34.9% while Bristol-Myers was down 2.3% (See the last pharma stock roundup here: Label Expansion for Merck Drug, Aerie Up On Eye Data).
 

What's Next in the Pharma World?

Companies like Pfizer, Lilly, AstraZeneca, Bristol-Myers, Merck KGaA and Merck will all be at the annual meeting of the American Society of Clinical Oncology (ASCO) showcasing data on approved and pipeline candidates targeting cancer.

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