Regulatory and pipeline updates are back in focus this week in the biotech sector. While Gilead Sciences (GILD - Free Report) gets an approval for its HBV drug in China, shares of Arena (ARNA - Free Report) surged on the back of a licensing deal for its late-stage candidate.
Recap of the Week’s Top Stories:
Gilead Clinches Approval for Vemlidy in China: Gilead announced that the China National Medical Products Administration (NMPA) has approved Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily treatment for chronic hepatitis B in adults and adolescents (aged 12 years or above with body weight of minimum 35 kg). The approval was supported by data from a couple of international phase III studies (Studies 108 and 110) among 1,632 treatment-naive and treatment-experienced adult patients with HBeAg-negative and HBeAg-positive HBV disease. Importantly, Vemlidy, a targeted prodrug of tenofovir, has demonstrated antiviral efficacy similar to Viread 300 mg but at one-tenth of the dose. Vemlidy demonstrated improved renal and bone laboratory safety parameters compared with Viread. Vemlidy is already approved in the United States and Europe. Label expansion of the drug in additional countries will boost sales.
Gilead currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amgen’s Blincyto Gets Positive CHMP Opinion: Amgen (AMGN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the label expansion of leukemia drug, Blincyto. The committee recommended the use of Blincyto monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in the first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
The positive CHMP opinion was based on encouraging data from the phase II study, BLAST. Findings from the study showed that Blincyto resulted in a complete MRD response or no detectable MRD in 78% of patients within one treatment cycle. The European Commission will now review CHMP’s opinion. The committee had earlier in July provided a negative opinion for this label expansion following which, Amgen requested a re-examination. Blincyto was approved for the MRD-positive B-cell precursor ALL indication in the United States during March this year.
Vertex Gains Positive CHMP Opinion for Orkambi: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the expanded use of cystic fibrosis (CF) drug Orkambi. The committee recommended the drug’s approval for the treatment of CF patients aged 2-5 years old, possessing two copies of the F508del mutation. The submission was made on the basis of hopeful data from a phase III study on 60 patients. Notably, Orkambi is already approved in the United States and Europe for treating CF in patients aged six or older, and carrying two copies of the F508del mutation. It got a nod in the United States for the two to five-year age group in August.
Arena Stock Rallies on Deal With United Therapeutics : Shares of Arena soared after the company announced that it signed an agreement with United Therapeutics (UTHR - Free Report) for out-licensing the global rights to ralinepag, its late-stage candidate for the treatment of pulmonary arterial hypertension (PAH). Per the terms, Arena will grant United Therapeutics the exclusive, worldwide rights to develop, manufacture and commercialize ralinepag. In return, Arena is eligible to receive up to $1.2 billion including an upfront payment of $800 million, a potential milestone up to $400 million and tiered low double-digit royalties on the net sales of ralinepag from United Therapeutics. The company will also receive low double-digit tiered royalties on annual net sales of ralinepag.
The NASDAQ Biotechnology index lost 1.86% in the last five trading sessions. Among the major biotech stocks, Vertex lost 6.2% in the last five trading sessions. Over the past six months, shares of Biogen have rallied 15% while Celgene has dropped 10.6%. (See the last biotech stock roundup here: Biotech Stock Roundup: Gilead, Regeneron Present Data, Cocrystal Pharma Surges)
What's Next in Biotech?
Stay tuned for more regulatory and pipeline updates.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>