It was a ho-hum week for the biotech sector with Incyte (INCY - Free Report) coming out with strong results for the fourth quarter, and pipeline and regulatory updates from a few small biotech players.
Recap of the Week’s Most Important Stories:
Strong Q4 Results From Incyte: Incyte Corporation reported better-than-expected results for the fourth quarter of 2019, wherein both earnings and sales beat expectations. Demand for Jakafi in all three approved indications (polycythemiavera, myelofibrosis and the recent label expansion in acute graft-versus-host disease) continues to grow. The guidance for 2020 was encouraging as well.
Bellerophon Soars on Positive Data: Shares of clinical-stage biotherapeutics company, Bellerophon Therapeutics, Inc. , soared after it announced positive top-line data from a recently completed acute, intra-patient, dose-escalation, hemodynamics study (PHPF-002) of INOpulse for the treatment of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF). The top-line results from PHPF-002 demonstrated that acute treatment with INOpulse provided statistically and clinically significant improvements in hemodynamic parameters.
Horizon Gets FDA Approval for New Procysbi Dosage: Horizon Therapeutics plc (HZNP - Free Report) announced today that the FDA has approved Pprocysbi (cysteamine bitartrate) delayed-release oral granules in packets for adults and children one year of age or above living with nephropathic cystinosis. The new dosage form provides another option for people living with cystinosis, in addition to the currently available Procysbi capsules.
Horizon carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
FDA Accepts Epizyme’s Application of Tazverik: The FDA has accepted for filing Epizyme’s (EPZM - Free Report) New Drug Application (NDA) for the accelerated approval of Tazverik (tazemetostat) for patients with relapsed or refractory follicular lymphoma (FL), who have received at least two prior lines of systemic therapy. The FDA granted Priority Review and has set a target action date of Jun 18, 2020. Epizyme’s sNDA submission is based primarily on updated phase II efficacy and safety data for Tazverik in this patient population.
We note that Tazverik is already indicated for the treatment of adults and pediatric patients aged 16 years or above with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Seattle Genetics’ Application for Tucatinib Accepted: The FDA has accepted for priority review Seattle Genetics’ (SGEN - Free Report) New Drug Application (NDA) for experimental drug, tucatinib. The company is seeking FDA approval of tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The FDA has set a target action date of Aug 20, 2020. Tucatinib is an oral, small-molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2.
The Nasdaq Biotechnology index lost 0.08% in the last four trading sessions. Among the biotech giants, Incyte gained 4.15% in the period. Over the past six months, shares of Biogen have gained 43.01%. (See the last biotech stock roundup here: Biotech Stock Roundup: Earnings Updates From VRTX, AMGN, GILD; AIMT Gains FDA Nod).
What's Next in Biotech?
Stay tuned for more pipeline updates.
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