It was a pretty ho-hum week for the biotech sector before the earnings rush. The key highlights of the week include regulatory and pipeline updates.
Recap of the Week’s Top Stories:
Amgen Gets EC Approval For Label Expansion of Oncology Drug Blincyto: Amgen (AMGN - Free Report) obtained European Commission (EC) approval for label expansion of its oncology drug, Blincytbo. The drug is now approved as monotherapy for the treatment of adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. The approval was based on positive data from the phase II BLAST study in frontline and relapsed/refractory ALL. The drug is already approved in the United States for this indication.
Earlier, Amgen and its partner UCB announced that an FDA advisory committee has given a positive recommendation to approve their pipeline candidate, Evenity (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk of fracture.
Of the 19 members of FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC), 18 voted in favor of approval after reviewing safety and efficacy data from some pivotal phase III studies. The FDA is not mandated to follow the recommendation of an advisory committee but generally it does.
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vertex Gets EC Approval for Orkambi: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the European Commission has approved the label extension for Orkambi (lumacaftor/ivacaftor). The drug is now approved for the treatment of children with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of the F508del mutation. The latest approval was based on data from a phase III open-label safety study in 60 patients that showed treatment with Orkambi was generally well tolerated for 24 weeks, with a safety profile in these pediatric patients generally consistent with patients aged 6 years and older. The drug is already approved in the EU for the treatment of CF in patients aged 6 and older who have two copies of the F508del mutation.
Immunomedics Gets CRL for Lead Drug: Clinical-stage biopharmaceutical Immunomedics, Inc., (IMMU - Free Report) suffered a setback when the company received a Complete Response Letter (CRL) from the FDA with regard to the Biologics License Application (BLA) for its lead candidate sacituzumab govitecan. The BLA is seeking accelerated approval of sacituzumab govitecan for treating patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. The issues related to the CRL primarily focused on Chemistry, Manufacturing and Control matters and hence, the company is not required to generate any new clinical or preclinical data. The company plans to work with the FDA to solve this issue. Last July, the FDA notified the company that the BLA has been accepted and the agency granted Priority Review with a target action date of Jan 18, 2019.
Alnylam Partners With Medison Partner: Alnylam (ALNY - Free Report) entered into an exclusive agreement with Israel’s leading pharmaceuticals partner, Medison Pharma to commercialize its newly approved RNAi therapeutic Onpattro and other investigational therapeutics under development in the Alnylam RNAi portfolio in Israel. Onpattro was approved in the EU in August 2018 for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. The other candidates include givosiran, a late-stage investigational RNAi therapeutic for the treatment of acute hepatic porphyria (AHP) and lumasiran, a late-stage investigational RNAi therapeutic for the treatment of Primary Hyperoxaluria Type 1 (PH1).
Incyte Treats First Patient in GVHD Trial Incyte (INCY - Free Report) announced that the first patient has been treated in the phase III trial, GRAVITAS-309, on itacitinib for the first-line treatment of patients with chronic graft-versus-host disease (GVHD). The trial will evaluate the efficacy and safety of itacitinib, Incyte’s novel and selective JAK1 inhibitor, in combination with corticosteroids compared to corticosteroids alone as a first-line treatment for moderate or severe chronic GVHD. A phase III study (GRAVITAS-301) of itacitinib for the treatment of patients with acute GVHD is already underway, with results expected in 2019.
The NASDAQ Biotechnology index gained 1.42% in the last five trading sessions. Among the major biotech stocks, Alexion gained 6.4%. Over the past six months, shares of Regeneron have rallied 10.52%, while Alexion has dropped 15.08%. (See the last biotech stock roundup here: Biotech Stock Roundup: LOXO, SAGE, CELG Gains, J.P. Morgan Healthcare Conference in Focus)
What's Next in Biotech?
Stay tuned for more regulatory and pipeline updates.
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