What’s moving these stocks in the pre-market hours today?
In the Green
1. Auris Medical Holding Ltd. (EARS) is up over 100% at $1.72 in pre-market trading Tuesday on no news. The company’s lead product candidate is AM-125 Intranasal Betahistine for acute vertigo, under a phase II trial. Positive data from Part A of the phase II study was reported last month and the trial is proceeding with Part B. Enrollment is expected to be completed by end of Q1 2021. Next up in the pipeline is AM-201 for prevention of antipsychotic-induced weight gain for which an IND seeking FDA clearance to initiate a phase II trial is expected to be submitted in Q1, 2021.
2. Altimmune Inc. (ALT) is up over 19% at $15.10 in pre-market hours today, following pre-publication of a comprehensive preclinical evaluation of its single-dose, intranasal COVID-19 vaccine candidate, AdCOVID. A single intranasal dose of AdCOVID given to two strains of mice uniquely stimulated three key immune components: serum neutralizing antibody, T cell responses, and mucosal immunity in the respiratory tract. The company anticipates filing an IND with the FDA and commencing a phase I safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020.
3. Enlivex Therapeutics Ltd. (ENLV) is up over 7% at $12.13 in pre-market trading Tuesday on no news. On October 1, the company reported positive top-line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition. A phase IIb clinical trial of Allocetra for the treatment of organ failures associated with sepsis is expected to commence this quarter (Q4, 2020).
4. Inventiva S.A. (IVA) is up over 6% at $14.50 in pre-market hours today on news that the FDA has granted Breakthrough Therapy designation to its drug candidate Lanifibranor for the treatment of NASH. Lanifibranor has been successfully trialed in a phase IIb study in NASH, dubbed NATIVE. A phase III clinical trial evaluating Lanifibranor in NASH is planned for the first half of 2021.
5. ADiTx Therapeutics Inc. (ADTX) is up over 4% at $2.00 in pre-market hours on no news. Last month, the company signed a collaboration agreement with Salveo Diagnostics Inc. to commercialize the AditxtScore Platform starting this quarter. AditxtScore for COVID-19 is designed for use in detecting antibodies against SARS-CoV-2 antigens. The application seeking Emergency Use Authorization for AditxtScore was submitted to the FDA on Aug.24.
6. iBio Inc. (IBIO) is up over 4% at $2.17 in pre-market trading today on no news. The company’s leading candidate for the prevention of SARS-CoV-2 infection is BIO-201, which in preclinical studies has shown to generate an immune response to SARS-CoV-2 sequences and neutralize protein interaction.
In the Red
1. Emergent BioSolutions Inc. (EBS) is down more than 6% at $104.01 in pre-market trading Tuesday on no news. The company is slated to report Q3 financial results in the first week of November. For Q2 2020, the total revenues were $394.7 million. On average, Wall Street analysts are expecting revenue of $436.33 million for Q3, 2020.
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