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Coronavirus vaccine maker Moderna Inc (NASDAQ: MRNA) is closing in on the final stages of its vaccine program and could have the efficacy data by Thanksgiving, paving the way for a potential Emergency Use Authorization approval by the FDA, Bloomberg reported, citing an interview with the company's CEO Stephane Bancel.What Happened: Moderna's coronavirus vaccine, codenamed mRNA-1273, is in Phase 2 testing and could yield efficacy data as early as Thanksgiving if everything goes right, Bancel told Bloomberg. The CEO also discussed about the possibility of the FDA according EUA at high risk."They might decide to give us emergency use approval for people at very high risk, while the agency more carefully reviews the data before granting approval for a broader population, " Bancel said.Moderna is measuring whether the vaccine prevents COVID-19 or potentially prevents infection, she said. Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.Working On Pricing: Moderna's CEO also suggested in the interview the company is working on how best to price a coronavirus vaccine to make it both affordable and viable for the company. "What we need to make sure is that the vaccine is affordable. But vaccines won't be free," Bancel said. Moderna is scheduled to start a Phase 3 trial evaluating about 30,000 volunteers, in Jul while the NIAID-sponsored Phase 1 trial and the company-managed Phase 2 trial are ongoing.Preliminary results from the Phase 1 study released in mid-May demonstrated positive immunogenicity and safety.MRNA Price Action: The stock was down 5.27% at $63.06 at the time of publication. Related Links:Moderna Analyst Says Coronavirus Vaccine Candidate Has 65% Chance Of Success Coronavirus Vaccine Frontrunner Moderna Appoints Former Amgen Executive As CFO See more from Benzinga * Moderna Closing In On Deal To Supply Coronavirus Vaccine To Israel: Report * Sinovac Makes Headway In Coronavirus Vaccine Race With Positive Preliminary Phase 1/2 Results * Moderna On Track To Start Phase 3 Coronavirus Vaccine Trial In July(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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Inovio Pharmaceuticals Inc (NASDAQ: INO) shareholders are suing the company in U.S. District Court alleging the vaccine maker misled investors by saying it came up with a coronavirus vaccine candidate in about three hours.When Inovio shared a developmental timeline for its DNA vaccine, codenamed INO-4700, in early March, the company said it designed the vaccine in three hours after the receiving the genetic sequence.That statement amounts to a deliberate misrepresentation to the public to inflate Inovio's stock price, the shareholders said in the lawsuit, which was filed Monday in the Eastern District of Pennsylvania. Inovio Shareholders Allege Stock Pumping: Ever since CEO J. Joseph Kim flaunted the "three-hour achievement" in a televised mid-February interview, the company has continued to release updates on the vaccine program in a bid to keep the stock on an upward trajectory, acccording to the lawsuit. The investors reiterated in the lawsuit that Inovio had not designed a viable coronavirus vaccine in three hours, but rather arrived at a vaccine construct.When short sellers targeted Inovio over the three-hour statement, the company said on Twitter that it had designed only a vaccine construct.The lawsuit shows a lack of understanding of the science behind DNA medicines, an Inovio spokesperson told Benzinga on Tuesday. The company designed a vaccine construct for INO-4800 within three hours after the viral sequence became publicly available; produced the vaccine at a small scale and entered preclinical trials in January; entered human trials in April; and plans to report results later in June, the spokesperson said. "Based on extensive prior work creating DNA vaccines using our proprietary DNA medicines platform, we are confident that we have a viable approach to address the COVID-19 outbreak." Inovio's COVID-19 Journey: Inovio's shares rallied through February and hit a high of $19.36 March 19, only to retreat to $5.13 in the wake of short seller reports.The company is already facing another proposed class action lawsuit filed March 12. Inovio has also accused a manufacturing partner in a lawsuit of refusing to divulge information required to scale up manufacturing, according to Fierce Pharma. According to the latest update provided by Inovio on its INO-4700 vaccine candidate in early June, the company said it plans to start a two-stage Phase 1/2 trial in South Korea.INO Price Action: At last check, Inovio shares were slipping 1.92% to $13.88. Related Links:Inovio Analysts Tackle Coronavirus Vaccine Timeline, Funding, Pipeline After Q1 Report Moderna Analyst Says Coronavirus Vaccine Candidate Has 65% Chance Of Success See more from Benzinga * Revisiting The Coronavirus Vaccine Race: Updates On The 10 Candidates In Clinics * Inovio Analyst Watches Coronavirus Play 'From The Sidelines' * The Daily Biotech Pulse: ASCO Presentations Begin, Altimmune Pops On Insider Buying, Immutep Gets R&D Grant(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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