It was a busy week for the biotech sector with regulatory and other pipeline updates. While coronavirus-related news continues to grab headlines, other regulatory events were also in the spotlight.
Recap of the Week’s Most Important Stories:
Gilead Submits BLA for NHLs, Partners With HiFiBiO Therapeutics: Gilead Sciences, Inc.’s (GILD - Free Report) unit, Kite, submitted a supplemental Biologics License Application (sBLA) to the FDA for chimeric antigen receptor (CAR) T cell therapy, Yescarta (axicabtagene ciloleucel), for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy. Yescarta was previously granted Breakthrough Therapy Designation (BTD) by the FDA for these indications. The sBLA submitted was supported by data from the primary analysis of the phase II ZUMA-5 study. Yescarta is already approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Kite also entered into a two-year research collaboration and license agreement with HiFiBiO Therapeutics. Per the collaboration, HiFiBiO will use its proprietary technology platforms to identify novel acute myeloid leukemia (AML) and anti-AML specific antibodies for Kite’s use in cell therapies.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Albireo Gains From Positive Data on Odevixibat: Shares of Albireo Pharma, Inc. (ALBO - Free Report) surged after it announced positive top-line results on pipeline candidate, odevixibat, from late-stage study PEDFIC 1. Odevixibat is a highly potent, non-systemic ileal bile acid transport inhibitor (IBATi), which is being evaluated for the treatment of progressive familial intrahepatic cholestasis (PFIC) patients. A global phase III study, PEDFIC 1, is evaluating the efficacy and safety of odevixibat. The study met its two primary endpoints, demonstrating that odevixibat reduced serum bile acid responses (sBAs) and improved pruritus assessments with a single-digit diarrhea rate. Albireo intends to complete regulatory filings in the EU and the United States by early 2021, in anticipation of a potential regulatory approval, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021, if approved.
Heron Gains on Successful Meeting With the FDA: Shares of Heron Therapeutics, Inc. (HRTX - Free Report) gained after it announced a successful Type A meeting with the FDA for pipeline candidate, HTX-011. The alignment was reached on the company’s plans to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of this year. HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug, meloxicam. We note that a complete response letter (CRL) was issued by the FDA regarding the NDA on Jun 26, 2020, relating to non-clinical information.
Akebia Plunges on Study Results: Akebia Therapeutics, Inc (AKBA - Free Report) announced disappointing top-line results on pipeline candidate, vadadustat, from the second study of its two phase III cardiovascular outcomes programs — collectively called PRO2TECT. Vadadustat is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor. The studies evaluated the efficacy and safety of vadadustat compared with darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients who are not receiving dialysis.
Data showed that vadadustat achieved the primary and key secondary efficacy endpoint in each of the two studies, demonstrating non-inferiority (NI) to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). However, vadadustat failed to meet the primary safety endpoint of non-inferiority to darbepoetin alfa for the first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction and non-fatal stroke in both PRO2TECT studies.
Amarin Plunges on Vascepa Patent Litigation: Amarin Corporation plc (AMRN - Free Report) plummeted after it provided an update following the decision by the U.S. Court of Appeals for the Federal Circuit in the company’s ongoing patent litigation for Vascepa. The court upheld the March ruling by the U.S. District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to the Vascepa capsule franchise. Vascepa is the sole marketed drug of the company, generating majority of its revenues. An earlier-than-expected generic launch will adversely impact the sales of the drug, reducing the company’s revenues and profits.
The Nasdaq Biotechnology index lost 4.64% in the last four trading sessions. Among the biotech giants, Vertex lost 6.13% during this period. Over the past six months, shares of Incyte have gained 26.22%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMY to Buy Forbius, BMRN Gets CRL & Other Updates)
What's Next in Biotech?
Stay tuned for more pipeline updates.
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