The FDA, which approved 22 treatments last year, has given its approval to 16 drugs so far in 2017 including 4 in April. Key approvals so far in 2017 include Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s BMRN Brineura (treatment of a specific form of Batten disease) among others. Some of these drugs have blockbuster potential.
With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance. Here is a look at a few important regulatory events scheduled for the month of May.
Merck & Co., Inc. MRK has two regulatory decisions lined up this month -- one for cancer treatment, Keytruda and the other for HIV drug, Isentress. Anti-PD-1 therapy, Keytruda, is under priority review for use in combination with chemotherapy for the first line treatment of a specific type of lung cancer with a response expected by May 10, 2017. Approval for this patient population would be a major boost for Merck given the commercial potential in this market. Keytruda is already approved for first-line use in non-small cell lung cancer (NSCLC) patients that have PD-L1 greater than or equal to 50%. Label expansion into the new indication would open up the non-squamous lung market and cover patients irrespective of PD-L1 expression. Keytruda generated sales of $1.402 billion in 2016.
Meanwhile, a once-daily formulation of Isentress is under review 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. A decision should be out by May 27, 2017. Isentress sales came in at $1.387 billion in 2016.
Year-to-date (YTD), Merck has underperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 5.9% compared to the industry gain of 6.7%.
Novo Nordisk NVO is also expected to get a response from the FDA this month regarding the approval status of its experimental hemophilia B treatment, nonacog beta pegol. The BLA for the drug had been filed in May 2016. Meanwhile, the drug got a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), in late Mar 2017. Novo Nordisk has outperformed the Zacks categorized Large Cap Pharmaceuticals industry YTD with shares gaining 7.9%.
Will French pharma giant, Sanofi SNY and partner Regeneron Pharmaceuticals, Inc. REGN be second time lucky with their experimental rheumatoid arthritis (RA) drug Kevzara (sarilumab)? The companies, which had got a complete response letter (CRL) for the IL-6R antibody in Oct 2016 due to manufacturing issues, is awaiting a decision from the FDA for the resubmitted application on May 22, 2017. Kevzara’s approval would be a major positive for the companies with the drug representing blockbuster potential.
While Sanofi has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 16.9% YTD, Regeneron has also performed better than the Zacks-categorized Medical-Biomedical/Genetics industry with shares gaining 5.9% compared to the industry gain of 4.9%.
Both Sanofi and Regeneron are Zacks Rank #3 (Hold) stocks. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Puma Biotechnology, Inc.’s PBYI experimental breast cancer treatment, neratinib, has an appointment with an FDA advisory panel on May 24, 2017. The Oncologic Drugs Advisory Committee (ODAC) will review neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab containing regimen. Although the FDA is not required to do so, it usually follows the recommendation of its advisory panels.
YTD, Puma has performed better than the Zacks-categorized Medical-Biomedical/Genetics industry with shares gaining 32.3%.
TherapeuticsMD, Inc. TXMD, an innovative women’s healthcare company, is expecting a final response from the FDA regarding its regulatory application for TX-004HR for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women. A decision should be out by May 7, 2017. Last month, the FDA had informed the company that there were some deficiencies that prevented discussion of labeling and post-marketing requirements/commitments. The company expects to get more information regarding the nature of the deficiencies when the FDA gives its final decision this month. TherapeuticsMD’s shares are down 11.4% YTD, underperforming the Zacks categorized Medical-Drugs industry which is up 4.9%.
Sell These Stocks. Now.
Just released, today's 220 Zacks Rank #5 Strong Sells demand urgent attention. If any are lurking in your portfolio or Watch List, they should be removed immediately. These sinister companies because many appear to be sound investments. However, from 1988 through 2016, stocks from our Strong Sell list have actually performed 6X worse than the S&P 500.
See today's Zacks "Strong Sells" absolutely free >>.
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
