How Moderna’s Slowing COVID-19 Vaccine Enrollment Could Delay Interim Readout, , on October 5, 2020 at 9:20 pm

By ILP
On 10/05/2020
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Moderna Inc (NASDAQ: MRNA)’s CEO said last week that it will not seek emergency use authorization for its coronavirus vaccine candidate mRNA-1273 before the Nov. 3 U.S. presidential election.Trial Enrollment Hits 94% Of Target: Moderna’s vaccine candidate is in a large-scale Phase 3 trial dubbed COVE with a target enrollment of 30,000 participants.About 28,043, or 93.5%, of the targeted participants have been enrolled into the study, Moderna said in a late Friday tweet.Of those people, 19,369 have been administered a second dose.> As of Friday, October 2, 2020, 28,043 participants have been enrolled in the Phase 3 COVE study and approximately 33% of participants enrolled cumulatively are from diverse communities. 19,369 participants have received their second vaccination. https://t.co/ToJWTx59PI pic.twitter.com/dR3r19CKav> > — Moderna (@moderna_tx) October 2, 2020The study protocol calls for administering two doses of mRNA-1273 — the first on day one and the second on day 29.About 33% of the participants were from diverse communities, Moderna said. The company announced the dosing of the first patient in the trial on July 27.See also: The Week Ahead In Biotech: Avenue’s FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO Slowing Enrollment Behind The Delay? Moderna’s muted expectations concerning an expedited rollout under an emergency use authorization is partly attributable to the slowdown in enrollment in recent weeks, according to one sell-side analyst. “Moderna’s slower enrollment rate (partially due to an effort to include more diverse demographics) will likely push their earliest possible timeline for positive first interim efficacy readout until after the U.S. election,” Raymond James analyst Steven Seedhouse said in a note.The analyst said he expects Pfizer Inc. (NYSE: PFE)/BioNTech SE – ADR (NASDAQ: BNTX) to be first with an interim efficacy readout before the election and probably before the Oct. 22 general vaccine Adcom meeting. Hard numbers substantiate the conjecture concerning the reason for the potential delay in Moderna’s vaccine program. Source: Moderna Nov. 25 is likely the date when enough safety data will become available to be included in an emergency use authorization application, Moderna CEO Stephane Bancel told the Financial Times last week.MRNA Price Action: Moderna shares gained 4.56% in Monday’s session, closing at $71.95.Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates Latest Ratings for MRNA DateFirmActionFromTo Sep 2020SVB LeerinkDowngradesMarket PerformUnderperform Aug 2020SVB LeerinkMaintainsMarket Perform Aug 2020SVB LeerinkMaintainsMarket Perform View More Analyst Ratings for MRNA View the Latest Analyst Ratings See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * October FDA, CDC Meetings On Coronavirus Vaccines Set Stage For Emergency Use Authorization * The Daily Biotech Pulse: Eton Snags Second FDA Nod For Month, Vaccine Updates from Moderna, CureVac(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.,

How Moderna's Slowing COVID-19 Vaccine Enrollment Could Delay Interim ReadoutModerna Inc (NASDAQ: MRNA)’s CEO said last week that it will not seek emergency use authorization for its coronavirus vaccine candidate mRNA-1273 before the Nov. 3 U.S. presidential election.Trial Enrollment Hits 94% Of Target: Moderna’s vaccine candidate is in a large-scale Phase 3 trial dubbed COVE with a target enrollment of 30,000 participants.About 28,043, or 93.5%, of the targeted participants have been enrolled into the study, Moderna said in a late Friday tweet.Of those people, 19,369 have been administered a second dose.> As of Friday, October 2, 2020, 28,043 participants have been enrolled in the Phase 3 COVE study and approximately 33% of participants enrolled cumulatively are from diverse communities. 19,369 participants have received their second vaccination. https://t.co/ToJWTx59PI pic.twitter.com/dR3r19CKav> > — Moderna (@moderna_tx) October 2, 2020The study protocol calls for administering two doses of mRNA-1273 — the first on day one and the second on day 29.About 33% of the participants were from diverse communities, Moderna said. The company announced the dosing of the first patient in the trial on July 27.See also: The Week Ahead In Biotech: Avenue’s FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO Slowing Enrollment Behind The Delay? Moderna’s muted expectations concerning an expedited rollout under an emergency use authorization is partly attributable to the slowdown in enrollment in recent weeks, according to one sell-side analyst. “Moderna’s slower enrollment rate (partially due to an effort to include more diverse demographics) will likely push their earliest possible timeline for positive first interim efficacy readout until after the U.S. election,” Raymond James analyst Steven Seedhouse said in a note.The analyst said he expects Pfizer Inc. (NYSE: PFE)/BioNTech SE – ADR (NASDAQ: BNTX) to be first with an interim efficacy readout before the election and probably before the Oct. 22 general vaccine Adcom meeting. Hard numbers substantiate the conjecture concerning the reason for the potential delay in Moderna’s vaccine program. Source: Moderna Nov. 25 is likely the date when enough safety data will become available to be included in an emergency use authorization application, Moderna CEO Stephane Bancel told the Financial Times last week.MRNA Price Action: Moderna shares gained 4.56% in Monday’s session, closing at $71.95.Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates Latest Ratings for MRNA DateFirmActionFromTo Sep 2020SVB LeerinkDowngradesMarket PerformUnderperform Aug 2020SVB LeerinkMaintainsMarket Perform Aug 2020SVB LeerinkMaintainsMarket Perform View More Analyst Ratings for MRNA View the Latest Analyst Ratings See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * October FDA, CDC Meetings On Coronavirus Vaccines Set Stage For Emergency Use Authorization * The Daily Biotech Pulse: Eton Snags Second FDA Nod For Month, Vaccine Updates from Moderna, CureVac(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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