The FDA, which approved 22 novel drugs last year, has given its approval to 35 drugs so far in 2017 including a key approval in October – Gilead Sciences’s GILD Yescarta, a cell-based gene therapy for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. This makes Yescarta the second gene therapy to gain FDA approval, the first being Novartis AG’s NVS Kymriah. Kymriah was approved in late August 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (“ALL”).
Other key approvals this year include Lilly’s Verzenio (advanced or metastatic breast cancer), Gilead’s Vosevi (hepatitis C virus), Puma’s Nerlynx (to reduce the risk of breast cancer returning), J&J’s Tremfya (moderate-to-severe plaque psoriasis), Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Quite a few 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 and could act as major catalysts. Here is a look at a few important regulatory events scheduled for the month of November.
Keryx’s Auryxia under Review for Label Expansion: Keryx Biopharmaceuticals, Inc. KERX, which is focused on developing medicines for renal disease, is seeking FDA approval for the label expansion of Auryxia. The company is looking to get Auryxia approved for the treatment of patients with iron deficiency anemia and non-dialysis dependent chronic kidney disease (“CKD”). A decision should be out on November 6. Approval for this indication would expand the patient population for Auryxia which brought in sales of $24.6 million in the first half of 2017.
Keryx’s shares are up 2.9% year to date, compared to the industry’s 2.7% rally.
Label Expansion for Bristol-Myers’s Sprycel? Bristol-Myers Squibb Company BMY is looking to expand the label of its blockbuster drug, Sprycel, so that it can be used for the treatment of children with Ph+ chronic phase (“CP”) chronic myeloid leukemia (“CML”). The company is also seeking approval for a powder for oral suspension (“PFOS”) formulation of Sprycel. A response from the FDA for the regulatory application, which is under priority review, is expected on November 9. Label expansion should boost Sprycel sales further – the drug brought in sales of $1.5 billion in the first nine months of 2017.
Bristol-Myers’s shares are up 6.4% year to date, compared to the industry’s 15.1% rally.
Bristol-Myers is a Zacks Rank #3 (Hold) stock – you can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Will it be Third Time Lucky for Dynavax’s Heplisav-B? Dynavax Technologies Corporation DVAX is awaiting a response from the FDA for its hepatitis B vaccine, Heplisav-B, this month. Earlier this year, the vaccine had got a favorable recommendation (12-1) from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). With the positive vote, expectations were high that the company would finally gain approval for the vaccine which had previously received two complete response letters (one in November 2016 and the other in February 2013). However, the FDA action date of August 10 was pushed out by three months with the agency asking for more detailed information about the company's proposed post-marketing study for the vaccine.
With the additional information being considered a major amendment to the Biologics License Application (“BLA”), the FDA is expected to give its response regarding the approval status of the vaccine by November 10. Approval would allow Dynavax to go ahead with its plans to launch the vaccine early next year.
Dynavax’s shares are up 431.7% year to date, compared to the industry’s 2.7% rally.
Heron’s Cinvanti under Review for CINV: Commercial-stage biotech company, Heron Therapeutics, Inc. HRTX is awaiting a decision from the FDA for Cinvanti, which is under review for the prevention of chemotherapy-induced nausea and vomiting (“CINV”). Approval would strengthen Heron’s CINV franchise by adding a second, complementary therapeutic agent. The FDA is expected to give its decision on November 12.
Heron’s shares are up 18.7% year to date while the industry recorded a decline of 0.9%.
Will Ultragenyx Gain FDA Approval for its First Product? Clinical-stage biopharmaceutical company, Ultragenyx Pharmaceutical Inc. RARE has an FDA action date coming up this month for vestronidase alpha or rhGUS which is under review for mucopolysaccharidosis 7 (MPS 7) also known as Sly syndrome. About 200 patients across the world are afflicted by this disease, which is one of the rarest forms of MPS. Currently, there are no approved treatments for MPS 7. Approval for rhGUS on November 16 would transform Ultragenyx into a commercial-stage company.
Ultragenyx’s shares are down 31.8% year to date, compared to the industry’s 2.7% rally.
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