The Daily Biotech Pulse: Windtree Jumps On Istaroxime Data, Arcturus' COVID-19 Vaccine Trial Data, FDA Rejects Teva's Schizophrenia Med, Otonomy Aces Hearing Loss Study

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

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Arcturus Self-amplifying COVID-19 mRNA Vaccine Candidate Meets Primary Goal In Phase 3 Study

Arcturus Therapeutics Holdings Inc ARCT shared topline data from an ongoing Phase 1/2/3 trial evaluating the ARCT-154 COVID-19 vaccine candidate.

ARCT-154 is Arcturus' self-amplifying mRNA COVID-19 vaccine candidate.

Two 5-mcg doses of ARCT-154 demonstrated 55% vaccine efficacy for protection against COVID-19. The company has advanced ARCT-154 (5 mcg) toward a pivotal booster study that will involve approximately 2,400 participants.

Shares are trading 8.95% lower at $23.00 during the premarket session.

Windtree Reveals Encouraging Data From Istaroxime Study In Early Cardiogenic Shock

Windtree Therapeutics Inc WINT announced positive primary results with istaroxime in rapidly raising systolic blood pressure.

The study met its primary endpoint in SBP profile over six hours, with the istaroxime treated group performing significantly better than the control group.

Further details of the study results are planned to be presented at the European Society of Cardiology Heart Failure meeting to be held next month.

Shares are surging 46% at $1.50 during the premarket session.

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FDA Rejects Teva - MedinCell's Schizophrenia Candidate

Teva Pharmaceutical Industries Ltd's TEVA US subsidiary and MedinCell SA MDCLF have received FDA Complete Response Letter (CRL) regarding TV-46000/mdc-IRM for schizophrenia.

The drug candidate is risperidone extended-release injectable suspension for subcutaneous use.

Teva is reviewing its next steps based on the letter and will work closely with the FDA to address their recommendations.

Shares are down 4.52% at $9.72 during the premarket session.

Navidea's Tc99m Tilmanocept Imaging Can Differentiate Fibroid Pathotype Of Rheumatoid Arthritis

Navidea Biopharmaceuticals Inc NAVB announced preliminary results from the ongoing NAV3-32 Phase 2B study of Tc99m Tilmanocept.

Preliminary results on the first eleven patients indicate that quantitative Tc99m tilmanocept uptake in the hands and wrists of patients is proportional to the amount of macrophage involvement in individual rheumatoid arthritis patients' joint inflammation. 

Additionally, Tc99m tilmanocept uptake in RA-inflamed joints could discretely differentiate patients with the fibroid pathotype.

AlloVir's Lead Cell Therapy Secures RMAT Tag In Stem Cell Transplant 

The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to AlloVir Inc's ALVR lead T cell therapy, posoleucel, to prevent clinically significant infections and disease from six devastating viruses in stem cell transplant patients.

This is the third RMAT designation that the FDA has granted to posoleucel.

Shares are trading 25.1% higher at $6.77 during the premarket session.

Otonomy Posts Mid-Stage Hearing Loss Study Data

Otonomy Inc OTIC has announced topline results from the Phase 2a clinical trial of OTO-413 in subjects with hearing loss. 

The trial demonstrated that a single intratympanic injection of 0.3 mg OTO-413 provided clinically meaningful treatment benefit versus placebo across multiple speech-in-noise hearing tests. 

Shares are up 8.29% at $2.35 during premarket trading.

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