The Daily Biotech Pulse: Setback For NRx Pharma's COVID Study, Fast Track Tag For Pfizer's NASH Combo Therapy, Reata's Ataxia Drug In FDA Review

Zinger Key Points
  • The FDA has granted Fast Track designation to Pfizer's combination therapy for non-alcoholic steatohepatitis with liver fibrosis.
  • Pfizer is studying ervogastat/clesacostat in an ongoing Phase 2 trial expected to wrap in 2024.

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

Stocks In Focus

NRx Pharma Faces Setback In NIH-Sponsored COVID-19 Trial

Based on the review of approximately 460 patients, the Data Safety and Monitoring Board determined the evaluation of NRx Pharmaceuticals Inc's NRXP Zyesami (aviptadil) should cease due to futility.

The primary endpoint and the 90-day mortality secondary endpoint were not supportive, with 37% mortality in the aviptadil group vs. 36% in the placebo group in the ACTIV-3b study.

There were no safety concerns.

Shares are slipping 29% at 98 cents during the premarket session.

Lilly To Inject $2.1B In New Manufacturing Sites In Indiana

Eli Lilly And Co LLY will invest $2.1 billion in two new manufacturing sites to expand its manufacturing footprint in Indiana.

These new facilities will expand Lilly's manufacturing network for active ingredients and new therapeutic modalities, such as genetic medicines.

The proposed project is expected to create up to 500 new Lilly roles with an additional four indirect jobs for every Lilly position created. An estimated 1,500 construction jobs will be required while the facilities are being built.

Europe Approves Legend Biotech's CAR-T Therapy For Pretreated Multiple Myeloma

The European Commission has granted conditional marketing authorization to Legend Biotech Corp's LEGN Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies.

In 2017, Legend Biotech partnered with Janssen Biotech Inc to develop and commercialize cilta-cel.

Reata's Ataxia Drug Candidate Under FDA Priority Review

The FDA has accepted Reata Pharmaceuticals Inc's RETA 

application for omaveloxolone for Friedreich's ataxia.

Under priority review status, the PDUFA date is Nov. 30.

If approved, omaveloxolone would be the first approved therapy for Friedreich's Ataxia in the U.S.

Pfizer's Combination Therapy For NASH Fast-Tracked In US

The FDA has granted Fast Track designation to Pfizer Inc's PFE ervogastat and clesacostat combination therapy for non-alcoholic steatohepatitis (NASH) with liver fibrosis:

Pfizer is studying ervogastat/clesacostat in an ongoing Phase 2 trial expected to wrap in 2024.

Novocure, Merck Ink Trial Collaboration For Brain Cancer Trial 

Novocure Ltd NVCR has entered into a clinical trial collaboration agreement with Merck & Co Inc MRK to study the use of Tumor Treating Fields concomitant with Keytruda (pembrolizumab) for newly diagnosed glioblastoma. 

This is the second clinical collaboration between Novocure and Merck. 

Offerings

GeoVax Labs Inc GOVX announced a registered direct offering of 3.03 million shares at $1.65 per share

In a concurrent private placement, GeoVax will issue 9.09 million shares.

The aggregate gross proceeds are expected to be approximately $20 million. 

Shares are down 2.4% at $1.63 during premarket trading.

Posted In: BiotechNewsPenny StocksHealth CareFinancingOfferingsSmall CapFDAMoversTrading IdeasGeneral