Biotech Stock Roundup: Earnings Updates From VRTX, AMGN, GILD; AIMT Gains FDA Nod
Zacks Investment Research | Feb 04, 2020 11:15PM ET
It was a busy week for the biotech sector as many big biotechs came out with their fourth-quarter results. While Vertex Pharmaceuticals (NASDAQ:VRTX) and Biogen (NASDAQ:BIIB) reported impressive results, Gilead Sciences (NASDAQ:GILD) missed on earnings yet again. Meanwhile, Aimmune (NASDAQ: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. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
United Therapeutics Announces Disappointing Data: United Therapeutics (NASDAQ: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. (NASDAQ: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.
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