BIIB & GILD earnings update, VRTX down on regulatory news

BIIB & GILD earnings update, VRTX down on regulatory news

The biotech sector was in the spotlight last week with earnings updates from most of the big players. Other important pipeline and regulatory updates were also at the center of attention.

Summary of the most important stories of the week:

Earnings updates from Bristol Myers, Gilead and others: Quite a few biotech industry bigwigs have reported first quarter results over the past week.

Bristol-Myers’ BMY’s performance was decent as earnings and sales beat estimates. However, the company lowered its annual guide as multiple myeloma drug Revlimid is addressing generics, which will negatively impact sales.

Biogen However, BIIB’s performance was disappointing. Biogen reported first quarter 2022 earnings per share of $ 3.62, which missed Zacks’ consensus estimate of $ 4.41. The earnings reflect the impact of the cancellation of its Alzheimer’s drug, the Aduhelm inventory. Sales were $ 2.52 billion, down 6% from the quarter a year ago, penalized by the continued decline in sales of its key drugs. Sales exceeded Zacks’ consensus estimate of $ 2.50 billion.

Gilead Sciences, Inc. GILD reported strong first quarter results driven by sales of its COVID-19 antiviral treatment, Veklury (remdesivir). The company posted earnings of $ 2.12 per share for the quarter, which beat the Zacks Consensus Estimate of $ 1.77 and jumped from $ 2.04 in the quarter a year ago. Total revenues of $ 6.6 billion topped the Zacks Consensus Estimate of $ 6.2 billion and were up 3% from last year’s quarter due to increased demand for Biktarvy and Veklury HIV therapy.

Amgen AMGN reported first-quarter 2022 earnings of $ 4.25 per share, which beat Zacks’ consensus estimate of $ 4.22. Amgen’s earnings increased 15% year-over-year, driven by higher revenues and fewer shares. Total revenue of $ 6.24 billion exceeded Zacks’ consensus estimate of $ 6.06 billion and increased 6% year-over-year, driven by growth in product sales and increased other revenue.

Vertex Down on the regulatory update: Actions of Vertex Pharmaceuticals VRTX dropped after the company provided updates on its Phase I / II study on the VX-880. The candidate is an experimental, fully differentiated, allogeneic stem cell-derived islet cell therapy that produces insulin, produced using proprietary technology. VX-880 is being evaluated for type 1 diabetes (T1D) patients with reduced hypoglycemic awareness and severe hypoglycemia. Two patients in Part A received VX-880 at half the target dose.

The first patient treated in Part A of the study achieved insulin independence on day 270, with an HbA1c of 5.2%. The second patient who was given the Part A dosing showed strong increases in fasting and stimulated C-peptide and a reduction in exogenous insulin requirement up to day 150. The Independent Data Monitoring Committee reviewed the totality of the data. safety and efficacy of the first two patients treated in Part A of the study and the recommended advancement to Part B, in which patients receive the full target dose of VX-880.

However, the actions decreased as the FDA suspended the study due to the determination that there is not enough information to support the dose increase with the product.

Vertex has a Zacks Rank # 2 (Buy). you can see The full list of today’s Zacks # 1 Rank (Strong Buy) stock here.

Bristol Myers Heart Medication Approval: Bristol Myers Squibb announced that the FDA has approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart class II-III hypertrophic obstructive cardiomyopathy Association (NYHA) (Obstructive HCM) to improve functional capacity and symptoms. The approval was based on the phase III EXPLORER-HCM study which demonstrated benefit in patients treated with Camzyos compared to placebo. However, the prescribing information for Camzyos includes a boxed warning about the risk of heart failure.

The FDA had previously extended the candidate review. The drug has been added to the company’s portfolio since the acquisition of MyoKardia in 2020.

Performance

Medical industry – biomedical and genetics 5 years of yield

Medical industry – biomedical and genetics 5 years of yield

Medical industry – biomedical and genetics 5 years of yield

The Nasdaq Biotechnology Index has lost 1.02% in the past five trading sessions. Among the biotech giants, Biogen fell 0.62% over the period. In the past six months, Moderna shares have lost 57.64%. (See the latest roundup of biotech stocks here: Roundup of biotech stocks: GILDs COVID-19 Drug Update, AXSM Down on Regulatory Update)

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What are the prospects for biotechnology?

Stay tuned for more pipeline and regulatory updates, along with earnings updates.

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Biogen Inc. (BIIB): Free Stock Analysis Report

Bristol Myers Squibb Company (BMY): Free Stock Analysis Report

Amgen Inc. (AMGN): Free Stock Analysis Report

Gilead Sciences, Inc. (GILD): Free stock analysis report

Vertex Pharmaceuticals Incorporated (VRTX): Free stock analysis report

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