The biotech industry was in focus with earnings results from
Biogen ( BIIB Quick Quote BIIB - Free Report) . Other pipeline and regulatory updates were in focus as well. : Recap of the Week’s Most Important Stories : Biotech giant Biogen Biogen’s Second Quarter Results beat on both earnings and sales in the second quarter. However, the numbers declined on a year-over-year basis due to lower sales of Tecfidera, which were partially offset by higher sales of Tysabri. Sales of recently approved Alzheimer’s disease (AD) drug, Aduhelm, came in at $2 million. Concurrently, the company upped its annual sales guidance.
Biogen and partner
Ionis ( IONS Quick Quote IONS - Free Report) reported positive top-line data on its investigational AD treatment. Data from a phase Ib placebo-controlled, multiple ascending dose clinical study showed that BIIB080/IONIS-MAPTRx met its primary objective of safety and tolerability in patients with mild AD. Data showed robust time and dose-dependent lowering of tau protein in cerebrospinal fluid (CSF) over the three-month treatment period and sustained reductions during the six-month post-treatment period. These data were presented in a poster session at the 2021 Alzheimer’s Association International Conference (AAIC) held virtually.
Biogen currently carries a Zacks Rank #3 (Hold). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here : Amgen to Acquire Teneobio Amgen ( AMGN Quick Quote AMGN - Free Report) announced that it will acquire a privately held, clinical-stage biotechnology company, Teneobio, for an upfront cash payment of $900 million. Tenebio is also entitled to milestone payments worth up to an additional $1.6 billion in cash. The acquisition is expected to close in the second half of 2021. The acquisition includes Teneobio's proprietary bispecific and multispecific antibody technologies. The acquisition will add TNB-585, a phase I bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), to Amgen’s pipeline. The candidate complements Amgen's existing prostate cancer portfolio, which includes acapatamab (formerly AMG 160) and AMG 509, both in phase I. : Setback for Incyte Incyte ( INCY Quick Quote INCY - Free Report) suffered a setback when the FDA issued a Complete Response Letter (CRL) for the biologics license application (BLA) for its intravenous PD-1 inhibitor, retifanlimab, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The agency stated that the BLA cannot be approved in its present form. The FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlimab for the treatment of patients with advanced or metastatic SCAC, in tandem with the Oncologic Drugs Advisory Committee’s recommendation on Jun 24, 2021. Incyte will discuss the next steps with the FDA. : Shares of Seres Plunges on Study Data Seres Therapeutics, Inc. ( MCRB Quick Quote MCRB - Free Report) plummeted significantly after it announced dismal top-line results from its mid-stage study on pipeline candidate, SER-287. The phase IIb ECO-RESET study is evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. There weren’t any meaningful clinical differences and no statistical significance was observed in absolute clinical remission rates among the three treatment arms (10.3% for the full induction dose, n=68 and 10.6% for the step-down induction dose, n=66 versus 11.6% for placebo, n=69).
Consequently, the company has decided to close the open-label and maintenance portions of the study, given the lack of a clinical efficacy signal identified in the ECO-RESET study.
: Regulatory Update From Moderna Moderna, Inc. ( MRNA Quick Quote MRNA - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for its COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older. Hence, the European Commission will consider authorizing the use of the Moderna COVID-19 vaccine in adolescents aged 12 years and older. Earlier, Moderna announced data from the ongoing phase II/III study, which enrolled 3,732 participants aged 12 years to less than 18 years in the United States. The study met its primary endpoint. Performance
The Nasdaq Biotechnology Index lost 1.68% in the last five trading sessions. Among the biotech giants, Biogen gained 3.56% during the period. Over the past six months, shares of Biogen have surged 25.48%. (See the last biotech stock roundup here:
) Biotech Stock Roundup: REGN's Cocktail Approval, Updates From BMY, BMRN & VRTX Image Source: Zacks Investment Research What's Next in Biotech?
Stay tuned for more earnings, pipeline and regulatory updates.