Recap of the Week's Most Important Stories
Geron Up on Interim Data: Geron's shares were up 19.5% on the completion of the second internal data review of the studies being conducted on the company's telomerase inhibitor imetelstat. The studies, IMerge and IMbark, are being conducted in patients with lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF), respectively. However, development partner Janssen will take a decision regarding the commencement of the phase III stage of the IMerge study later this year and a decision regarding the continued development of imetelstat for the relapsed or refractory MF indication next year (Read more: Geron Stock Rises after Positive Interim Update on Imetelstat ). Geron is a Zacks Rank #2 (Buy) stock. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
OncoMed Slumps on Study Failure: Clinical-stage company, OncoMed, suffered back-to-back setbacks with a pipeline candidate failing in a mid-stage study and a partner pulling out of a collaboration. The company said that demcizumab failed to achieve the primary endpoint in a phase II study conducted in treatment-naïve metastatic pancreatic cancer patients. OncoMed has decided to discontinue the study and is conducting additional analyses with its partner, Celgene CELG .
The second setback for OncoMed came with the news about Bayer Pharma's decision to not exercise its option to license OncoMed's Wnt pathway inhibitors vantictumab and ipafricept for strategic reasons. With these developments, OncoMed's shares hit a 52-week low (Read more: OncoMed Cancer Candidate Fails Trial, Bayer Opts Out of Deal ).
Breakthrough Status for Regeneron Drug: Regeneron REGN got Breakthrough Therapy status for evinacumab in the U.S. for the treatment of hypercholesterolemia in patients with homozygous familial hypercholesterolemia (HoFH). Breakthrough Therapy status helps the development and review of drugs that target serious or life-threatening conditions. An inherited disorder, HoFH is the most severe form of hypercholesterolemia and can lead to premature cardiovascular disease due to very high levels of LDL cholesterol. Regeneron, which reported positive interim mid-stage data on evinacumab, is currently planning a phase III study (Read more: Regeneron's Evinacumab Gets Breakthrough Therapy by FDA ).
Actelion's Uptravi Safety Concerns Cleared by EMA: The European Medicines Agency (EMA), which was conducting a safety review of Actelion's pulmonary arterial hypertension (PAH) drug Uptravi, said that it has completed the review. The review was initiated following 5 patient deaths in France. The EMA said that existing as well as new patients can continue using the drug in accordance with the current prescribing information. No changes were made to the label following the safety review. Uptravi is one of the key drugs in Actelion's PAH portfolio. Actelion is on track to be acquired by Johnson & Johnson in the second quarter.
Pediatric Label Expansion for Gilead HCV Drugs: Gilead's GILD hepatitis C virus (HCV) drugs, Harvoni and Sovaldi gained FDA approval for use in pediatric patients 12 years and older. With this approval, children in this age group will have access to two direct-acting interferon-free antiviral regimens that offer high cure rates for HCV genotypes 1 through 6. The approval expands the patient population for these drugs with Gilead estimating that there are about 23,000-46,000 pediatric HCV patients in the U.S. with most infected at birth. The label expansion is good news for Gilead which has been struggling to drive sales of its HCV franchise. The franchise, which was once a key revenue generator for Gilead, is expected to record a steep decline in sales this year with changing market dynamics and increasing competition weighing on the segment (Read more: Gilead HCV Drugs Gets FDA Nod for Label Expansion ).
So far in 2017, Gilead has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining 7.8% compared to the industry gain of 2.7%
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined 1.1% over the last five trading sessions. Among major biotech stocks, Regeneron declined 4.1% while Vertex VRTX gained 1.7%. Over the last six months, Vertex was up 39.9% while Gilead was down 10.6% (See the last biotech stock roundup here: Acorda Down on Court Ruling, Patent Challenge for CELG Drug ).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates. Incyte INCY could also get a response from the FDA for Olumiant (baricitinib), a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA).
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