The Daily Biotech Pulse: European Backing For Novavax's COVID-19 Shot In Adolescents, Sanofi-GSK's Updated Vaccine Effective Against Omicron, FDA's Clinical Hold On Sarepta's Duchenne Trial

Zinger Key Points
  • Against omicron, Sanofi-GSK's vaccine shows 72% efficacy in all adults and 93.2% in seropositives.
  • Sarepta says Part B of MOMENTUM study is ongoing, and on track to complete enrollment by end of 2022.

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Europe Backs Novavax's COVID-19 Shot For Adolescents

The European Union has recommended expanded conditional approval of Novavax Inc's NVAX Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for adolescents ages 12-17. 

Separately, the Taiwan Food and Drug Administration has granted emergency use authorization for the Nuvaxovid COVID-19 vaccine in individuals ages 18 and over.

Novavax and Taiwan have executed a supply agreement, and the doses for Taiwan would represent the first shipment of Nuvaxovid to a country participating under the COVAX Facility.

Sanofi-GSK's Beta-Containing COVID-19 Vaccine Shows Omicron Efficacy 

Sanofi SA SNY and GSK plc GSK have announced positive data from their vaccine trial of adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. 

"Sanofi-GSK's vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation," Sanofi said in a statement.

In a trial involving 13,000 adults, the vaccine demonstrated an efficacy rate of 64.7% against symptomatic COVID and 72% against infections specifically caused by the omicron variant.

BioNTech's Testicular Cancer CAR-T Receives Priority Medicines Tag In Europe

The European Medicines Agency has granted Priority Medicines designation to BioNTech SE's BNTX BNT211 for the third- or later-line treatment of testicular germ cell tumors.

The product candidate is currently being investigated in an ongoing Phase 1/2 study to evaluate the safety and preliminary efficacy in heavily pretreated patients with relapsed or refractory advanced solid tumors.

FDA Slaps Clinical Hold On Sarepta's Duchenne Trial

The FDA has instituted a clinical hold on Sarepta Therapeutics Inc's SRPT SRP-5051 (vesleteplirsen) trial in Duchenne muscular dystrophy patients who are amenable to exon 51 skipping. 

The hold in Part B of Study 5051-201, also known as MOMENTUM, follows a serious adverse event of hypomagnesemia (low serum magnesium level in the blood). 

FDA is requesting information on all cases of hypomagnesemia, including a small number of non-serious grade 2 cases.

Celyad Announces Management Transition

Celyad Oncology SA's CYAD CEO & CFO Filippo Petti has resigned to pursue other opportunities.

Michel Lussier, a co-founder of the company, has been named the interim CEO.

FDA Sets AdComm Meeting For Cytokinetics's Omecamtiv Mecarbil Application

The FDA has scheduled the Cardiovascular and Renal Drugs Advisory Committee meeting for Cytokinetics Incorporated CYTK's marketing application for omecamtiv mecarbil.

The meeting is scheduled for Dec. 13, 2022. The FDA has assigned a PDUFA target date of February 28, 2023. 

Omecamtiv mecarbil is a cardiac myosin activator for heart failure with reduced ejection fraction.

Insider Trading

Tracon Pharmaceuticals Inc TCON: Opaleye Management reported purchasing 841,989 shares at an average price of $1.31/share in form 4 filing.

Voyager Therapeutics Inc VYGR: EcoR1 Capital LLC reported purchasing 477,400 shares at an average of $5.58/share in form 4 filing.

On The Radar

PDUFA Dates

Bristol Myers Squibb & Co BMY: Supplemental marketing application for Breyanzi for relapsed or refractory LBCL after the failure of first-line therapy is currently under FDA Priority Review.

Posted In: BiotechEarningsLarge CapNewsPenny StocksHealth CareFDAManagementInsider TradesMoversTrading IdeasGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.