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Biotech Stock Roundup: GILD's UC Drug Approval, REGN's COVID-19 Antibody Data & More

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The biotech sector continues to be in focus with pipeline and regulatory updates. The development of antibodies for coronavirus also continues to be the key focus as the pandemic refuses to lose steam. 

Recap of the Week’s Most Important Stories

Gilead Gets FDA Nod for Breast Cancer Drug: Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has given accelerated approval to breast cancer drug, Trodelvy (sacituzumab govitecan-hziy), for use in adult patients with locally advanced or metastatic urothelial cancer (UC). The approval has been granted to patients who have previously received platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. The accelerated approval was based on data from the international phase II, single-arm TROPHY study.

The FDA has granted full approval to Trodelvy for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, with at least one of them for metastatic disease. The regulatory body granted accelerated approval to Trodelvy in April 2020 based on the objective response rate and duration of response results in a phase I/II study.

The full approval expands this indication to include treatment of adult patients with unresectable locally-advanced or metastatic TNBC who have received two or more prior systemic therapies, with at least one of them for metastatic disease.

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 Reports Positive Data on COVID-19 Cocktail: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced positive data from a phase III study (2069B) in recently infected asymptomatic COVID-19 patients, evaluating the antibody cocktail REGEN-COV (casirivimab with imdevimab) 1,200 mg for subcutaneous (SC) administration. REGEN-COV reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint) and by 76% after the third day. Data also showed that REGEN-COV shortened symptom duration and markedly reduced viral levels.

The study met all primary and key secondary endpoints. Moreover, the total number of weeks for which patients experienced symptoms was nearly cut in half (45%) with REGEN-COV, and the viral burden was reduced by more than 90%.

Separately, Regeneron also announced that the phase III study (2069A) evaluating the ability of REGEN-COV to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals met its primary and key secondary endpoints. Results of the study showed that REGEN-COV 1,200 mg administered SC reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. REGEN-COV rapidly protected household contacts from exposure to SARS-CoV-2 at home, with 72% protection from symptomatic infections in the first week and 93% in subsequent weeks.

Regeneron also announced today that the newly updated National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines strongly recommend REGEN-COV to be used in non-hospitalized COVID-19 patients ("outpatients") at high risk of clinical progression.

Sage’s Mid-stage Study Meets Goal: Sage Therapeutics, Inc. (SAGE - Free Report) and partner Biogen Inc. (BIIB - Free Report) reported that the phase II study, KINETIC, on SAGE-324 for the treatment of people with essential tremor (ET) was successful. The study achieved its primary endpoint of a statistically significant reduction from baseline compared to placebo in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 upper limb tremor score at day 29. SAGE-324 demonstrated a 36% reduction in upper limb tremor amplitude from baseline at day 29 in the total studied population.

SAGE-324 demonstrated a 41% reduction in upper limb tremor amplitude compared to baseline in a more severe population. The companies are now evaluating the next steps for the development of SAGE-324.

Biogen Enters a License Agreement with Bio-Thera: Biogen entered a commercialization and license agreement with Bio-Thera Solutions, Ltd. to develop, manufacture and commercialize BAT1806, a phase III, clinical-stage anti-interleukin-6 (IL-6) receptor monoclonal antibody that is a proposed biosimilar of arthritis drug, Actemra (tocilizumab). The company will gain exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries, excluding China (including Hong Kong, Macau and Taiwan).

Earlier, the European Commission granted marketing authorization to an SC injection of Tysabri (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).

Bristol Myers’ Opdivo Combo Impressive in NSCLC studyBristol Myers Squibb (BMY - Free Report) announced encouraging results from the CheckMate -816 study on Opdivo (nivolumab) for the treatment of non-small cell lung cancer (NSCLC). Results from the study showed that neoadjuvant treatment with three cycles of Opdivo plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa NSCLC.

Earlier, the company announced positive top-line results from the CheckMate -648 study on Opdivo in combination with chemotherapy. The study results showed that the combination of Opdivo and chemotherapy demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival (OS) in patients whose tumors express PD-L1 and in the all-randomized patient population at the pre-specified interim analysis.


The Nasdaq Biotechnology Index lost 1.52% in the last five trading sessions. Among the biotech giants, Bristol Myers gained 2.58% during the period. Over the past six months, shares of Alexion have surged 24.23%. (See the last biotech stock roundup here: Biotech Stock Roundup: ACAD Down on CRL, EBS Gets Additional Order & Other Updates)

What's Next in Biotech?

Stay tuned for more pipeline and regulatory updates.

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