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Biotech Stock Roundup: Gilead, Amgen, Vertex and Alexion Report Q3 Earnings & More

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The biotech sector was in focus in the past week with earnings updates from quite a few biotech giants. While the development of antibodies and vaccines for coronavirus remains in focus in this sector as the pandemic gains steam again, other pipeline updates also grabbed the spotlight.

Recap of the Week’s Most Important Stories

Earnings Updates by Gilead, Amgen, Vertex and Alexion:  Biotech giant Gilead’s (GILD - Free Report) third-quarter earnings and sales beat estimates in the third quarter owing to incremental sales from Veklury. However, the company lowered its forecast due to the impacts of the COVID-19 pandemic and the anticipated lower demand for the recently approved antiviral drug, Veklury.

Amgen’s (AMGN - Free Report) third-quarter results were strong, wherein it beat both earnings and sales estimates. However, higher sales of Prolia, Xgeva, Otezla and biosimilar products were offset by lower sales of some drugs due to COVID-19 and the erosion of mature brands from biosimilar/new competition. The company also narrowed its previously issued sales guidance for 2020 but upped the earnings outlook.

Vertex Pharmaceuticals (VRTX - Free Report) too beat estimates for both earnings and sales in the third quarter as strong cystic fibrosis (“CF”) product revenues led to higher earnings. Additionally, the company raised its annual revenue guidance, driven by Trikafta’s continued strong performance year to date and the potential impact of the Kaftrio launch on fourth-quarter revenues.

Alexion’s third-quarter results were strong as it beat on both top and bottom lines, driven by higher sales of Soliris, Ultomiris and Strensiq. Concurrently, the company increased total revenue and earnings guidance.

Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Regeneron’s Update on Antibody Cocktail Treatment: Regeneron (REGN - Free Report) received a recommendation from the independent data monitoring committee (IDMC) for studies on its antibody cocktail treatment, REGN-COV2, for COVID-19.  REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987). The committee recommended modification of studies for currently hospitalized patients.  Based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommends further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold until the collection and analysis of further data on patients already enrolled.  The IDMC also recommends continuing enrollment of hospitalized patients requiring either low-flow oxygen or nothing as the risk/benefit profile remains acceptable in these cohorts. Moreover, the IDMC recommends continuation of the outpatient trial without modification.

Earlier, the company announced that the FDA accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor, Libtayo (cemiplimab-rwlc), to treat patients with first-line locally-advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The target action date for the same is Feb 28, 2021.

Biogen’s AD Drug Application AcceptedBiogen (BIIB - Free Report) and partner Eisai, Co., Ltd. announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease (AD).  Per the company, a potential approval will make aducanumab the first therapy to reduce the clinical decline of Alzheimer’s disease and meaningfully change the course of AD. The candidate is also under review with the FDA with Priority Review status, the Prescription Drug User Fee Act (PDUFA) action date being Mar 7, 2021.

Aurinia Down on Pipeline Setback: Shares of late-stage clinical biopharmaceutical company, Aurinia Pharmaceuticals Inc. (AUPH - Free Report) , declined after it announced disappointing top-line data from the phase II/III AUDREY study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES). The study did not achieve statistical significance on its primary endpoint of a 10mm or greater improvement in Schirmer Tear Test (STT) at four weeks between active dose groups of VOS compared to vehicle. Consequently, Aurinia is suspending the development program for VOS based on these results.



Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

The Nasdaq Biotechnology index lost 2.31% in the last five trading sessions. Among the biotech giants, Bristol-Myers gained 4.26% during this period. Over the past six months, shares of Alexion have gained 12.69%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD's Veklury Approved, NVAX Provides Vaccine Update & More)

What's Next in Biotech?

Stay tuned for earnings and more pipeline updates.

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