It was a busy week for the biotech sector with quite a few regulatory and other pipeline updates. While coronavirus-related news continues to grab headlines, other regulatory events and pipeline news were also in the spotlight.
Recap of the Week’s Most Important Stories:
Regeneron Reports Promising Antibody Cocktail Data: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced the first data from a descriptive analysis of a seamless phase I/II/III study of its investigational antibody cocktail, REGN-COV2. The ongoing, randomized, double-blind study evaluates the effect of adding REGN-COV2 to usual standard-of-care compared to adding placebo to standard-of-care.
Data showed that the candidate reduced the viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits. The company stated that patients whose natural immune response was not adequate had the greatest treatment benefit, which suggests that REGN-COV2 holds potential as a therapeutic substitute for the naturally-occurring immune response.
Regeneron believes that data from this cohort, which evaluated the anti-viral activity of a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo, and identified patients who are most likely to benefit from the treatment, to be robust and encouraging. Currently, the study is ongoing and enrollment in the next cohort has been completed.
Regeneron has started discussing these results with regulatory authorities. The study is part of a larger program that also includes studies of REGN-COV2 for the treatment of hospitalized patients and the prevention of infection in people who have been exposed to COVID-19 patients.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead’s RA Drug Gets Approval in Europe: Gilead Sciences, Inc. (GILD - Free Report) and partner Galapagos NV announced that the European Commission (EC) has granted marketing authorization to rheumatoid arthritis (RA) drug, Jyseleca (filgotinib 200 mg and 100 mg tablets). The drug is a once-daily, oral, JAK1 inhibitor, which has been approved for the treatment of adults with moderate-to-severe active RA who have responded inadequately to or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The drug can be used as monotherapy or in combination with methotrexate (MTX).
The approval was based on positive data from the phase III FINCH and phase II DARWIN programs. Per the agreement, Galapagos will now receive a milestone payment of $75 million following the approval of Jyseleca by the European Commission. Earlier, Gilead and partner Eisai obtained the approval of Jyseleca for this indication in Japan.
CureVac Gains on Study Initiation: Shares of clinical-stage biopharmaceutical company, CureVac (CVAC - Free Report) , gained after it announced the dosing of the first participant in a phase IIa clinical study of its experimental COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study, CV-NCOV-002, is being conducted in Peru and Panama and will enroll a total of 690 healthy participants. In the above-mentioned program, participants are categorized into two groups — adults aged 61 years and above, and younger participants between 18 years and 60 years.
The participants will receive two vaccinations at an interval of 28 days. The study will evaluate different dose levels, starting at 6 µg, with the aim to confirm safety and evaluate the reactogenicity of the vaccine in older adults. Additionally, the humoral immune response after administration of CVnCoV will be assessed and the safety database will be expanded to prepare for the start of a phase IIb/III study in a geographical environment with a high incidence of COVID-19 infection. Data from the phase IIa study in older adults is expected later in the year.
Vertex’s CF Drug Gets Approval for Infants: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the FDA has approved its cystic fibrosis (CF) drug, Kalydeco (ivacaftor), for expanded use in infants aged between four and six months with at least one mutation in their CFTR gene that is responsive to Kalydeco. The FDA approval was based on data from a cohort in the 24-week phase III open-label safety cohort named ARRIVAL, which evaluated six eligible infants with CF, aged four to less than six months, having one of 10 mutations in the CFTR gene (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H).
Per the company, the safety profile demonstrated in this cohort was similar to the response observed in older children and adults. Kalydeco is already marketed for the treatment of CF in patients aged between six months and above in the United States and Europe.
Novavax Gains on Late-Stage Vaccine Study Initiation: Novavax, Inc. (NVAX - Free Report) announced that it has initiated the first phase III study in the United Kingdom evaluating the safety, efficacy and immunogenicity of its COVID-19 vaccine candidate, NVX-CoV2373. It is being conducted in partnership with the U.K. government’s Vaccines Taskforce and is expected to enroll around 10,000 individuals aged between 18 years and 84 years, regardless of any relevant comorbidity, over the next four to six weeks.
Data from this study are likely to support the regulatory submissions for licensure of the vaccine in the United Kingdom, the EU and other countries. NVX-CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology and includes its proprietary Matrix M adjuvant.
Myovant Slides on Prostate Cancer Study Data: Shares of Myovant Sciences (MYOV - Free Report) plunged after it announced disappointing results from a phase III study on relugolix in men with advanced prostate cancer. Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks in the HERO study.
In the subgroup of men with metastatic disease treated with relugolix, 74% were castration-resistance free through 48 weeks compared to 75% treated with leuprolide acetate. The candidate is being reviewed under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of Dec 20, 2020.
The Nasdaq Biotechnology index gained 2.59% in the last five trading sessions. Among the biotech giants, Amgen gained 4.77% during this period. Over the past six months, shares of Alexion have gained 31.14%. (See the last biotech stock roundup here: Biotech Stock Roundup: Bristol-Myers' Updates, VCNX's Disappointing Data & More)
What's Next in Biotech?
Stay tuned for more pipeline updates.
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