With the end of Q2 earnings, the focus is on pipeline and regulatory updates in the biotech sector. COVID-19 vaccine news is also back in the spotlight.
Recap of the Week’s Most Important Stories:
Updates From Gilead: Shares of Gilead Sciences, Inc. GILD gained after the company announced positive data on breast cancer drug, Trodelvy (sacituzumab govitecan-hziy). Results from the second interim analysis of the key secondary endpoint of overall survival (OS) in phase III TROPiCS-02 study evaluating Trodelvy in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy showed statistically significant and clinically meaningful data. The safety profile for Trodelvy was consistent with prior studies. Gilead has submitted a supplemental biologics license application (sBLA) to the FDA.
Concurrently, the company announced an agreement with Everest Medicines to acquire the remaining worldwide rights to breast cancer drug Trodelvy. Everest Medicines and Immunomedics entered into an agreement in April 2019 granting the former an exclusive license to develop and commercialize Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia, excluding Japan. Thereafter, in October 2020, Gilead acquired Immunomedics. Per the new agreement, Gilead will assume responsibility for clinical development and commercialization in Greater China and South Korea, among other Asian markets. Gilead will make a $280 million upfront payment to Everest. Everest is eligible to receive up to $175 million in potential additional payments upon achievement of certain regulatory and commercial milestones. Gilead will also be able to recruit Everest employees working directly on the Trodelvy program. The transaction is expected to close later this year.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regulatory Update From NVAX: Novavax NVAX has submitted an application to the FDA for Emergency Use Authorization (EUA) for its COVID-19 vaccine, adjuvanted as a booster in adults aged 18 and older. The EUA seeks label expansion for the use of Novavax’s vaccine as a homologous and heterologous booster dose in adults (aged 18 years and older). This application for EUA is supported by data from the phase III PREVENT study conducted in the United States and Mexico and the U.K.-sponsored COV-BOOST phase II trial. Novavax can now target a wider adult population in the United States market who have already been vaccinated but are yet to receive a booster dose of the vaccine if the booster dose is authorized. Last month, the vaccine was granted EUA in the United States as a primary two-dose regimen for use in adults.
Moderna’s Booster Vaccine Approved in the UK: Shares of Moderna MRNA gained after the Medicines and Healthcare products Regulatory Agency (“MHRA”) in the U.K. authorized the company’s Omicron containing bivalent booster in the country. MHRA granted conditional authorization for the use of the Omicron-containing bivalent COVID-19 booster vaccine, mRNA-1273.214 as a booster dose for COVID-19 in individuals 18 years of age and older. Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains mRNA-1273 (Spikevax) and is a vaccine candidate targeting the Omicron variant of concern (BA.1).
The authorization is based on positive data from a phase II/III study wherein mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50µg booster dose of the original vaccine in baseline seronegative participants. A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age.
Aptinyx Down on Study Results: Shares of clinical-stage biopharmaceutical company, Aptinyx APTX were down after it announced disappointing results from a phase IIb study evaluating the effects of NYX-2925 in patients with fibromyalgia. The study was a randomized, double-blind, placebo-controlled study (n=300) designed to evaluate the efficacy and safety of the candidate in patients with fibromyalgia. Following a screening period, eligible patients were randomized to receive oral doses of NYX-2925 50 mg, NYX-2925 100 mg, or placebo once daily over the treatment period. The primary endpoint in the study was the change from baseline in average daily pain as reported on the zero-to-ten NRS during week 12 of the study. However, the candidate did not achieve statistically significant separation from placebo on the study’s primary endpoint.
The Nasdaq Biotechnology Index has gained 2.10% in the past five trading sessions. Among the biotech giants, Regeneron has gained 4.27% during the period. Over the past six months, shares of Vertex have surged 28.52%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGNs Q2 Earnings, CCXI Acquisition & More Updates)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for other updates.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Moderna, Inc. (MRNA) : Free Stock Analysis Report
Novavax, Inc. (NVAX) : Free Stock Analysis Report
Aptinyx Inc. (APTX) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research