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Biotech Stock Roundup: Earnings Updates From VRTX, AMGN, GILD; AIMT Gains FDA Nod

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It was a busy week for the biotech sector as many big biotechs came out with their fourth-quarter results. While Vertex Pharmaceuticals VRTX and Biogen BIIB reported impressive results, Gilead Sciences (GILD - Free Report) missed on earnings yet again. Meanwhile, Aimmune AIMT surged on the FDA approval of its allergy drug.

Recap of the Week’s Most Important Stories:

Earnings Updates From Bigwigs: Quite a few big biotech players came out with fourth-quarter results. Amgen and Alexion came out with strong numbers for the fourth quarter, beating both sales and earnings expectations. However, both companies issued a disappointing 2020 outlook.

Vertex Pharmaceuticals Inc. also beat on both metrics and provided an encouraging outlook for the next quarter. Strong cystic fibrosis product revenues led to higher earnings in the reported quarter. Biogen beat both earnings and sales estimates in the fourth quarter, driven by higher sales of key multiple sclerosis drugs, continued global growth of spinal muscular atrophy drug, Spinraza, and the expansion of its biosimilar business. Gilead reported mixed results, beating sales estimates on a strong HIV franchise. However, it missed on earnings and the outlook for 2020 was disappointing as well.

Vertex currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

United Therapeutics Announces Disappointing Data: United Therapeutics UTHR announced disappointing top-line results from the phase II/III DISTINCT study, evaluating Unituxin (dinutuximab) injection added to irinotecan compared to irinotecan or topotecan alone in patients with relapsed or refractory small cell lung cancer (SCLC). The study did not meet its primary efficacy objective of extending the overall survival with Unituxin and irinotecan versus irinotecan alone. The company is also seeking a label expansion for Unituxin in combination with irinotecan and temozolomide for the treatment of pediatric patients with relapsed or refractory neuroblastoma. United Therapeutics plans to meet with the FDA to discuss the proposed label expansion in the first half of 2020 and file a supplemental BLA shortly thereafter.

Aimmune's Peanut Allergy Drug Approved: Aimmune Therapeutics announced that the FDA approved its oral immunotherapy Palforzia  for the treatment of patients with peanut allergy. Palforzia is designed to reduce the incidence and severity of allergic reactions, including anaphylaxis, which may occur due to an accidental exposure to peanut. The drug is to be administered in conjunction with a peanut-avoidant diet and only in patients with a confirmed diagnosis of peanut allergy. Per the company, initial dose escalation may be administered to patients aged from four to 17 years and up-dosing and maintenance may be continued in patients aged four years and above.

Regeneron Expands Collaboration for New Coronavirus: Regeneron Pharmaceuticals, Inc. REGN announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develop new treatments combating the novel coronavirus, 2019-nCoV.  The company has several active collaborations with HHS's Biomedical Advanced Research and Development Authority. The HHS and Regeneron Other Transaction Agreement is mainly focused on the discovery, research, development and manufacturing of a portfolio of antibodies targeting up to 10 pathogens that pose significant risk to public health. This now includes the Influenza virus and 2019-nCoV.


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 gained 1.03% in the last five trading sessions. Among the biotech giants, Gilead gained 4.72% in the period. Over the past six months, shares of Vertex have gained 36.51%. (See the last biotech stock roundup here: Biotech Stock Roundup: EPZM Drug Gets FDA Nod, XLRN & HEPA Surge on Study Data). 

What's Next in Biotech?

Stay tuned for more earnings updates.

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