What’s moving these stocks in the pre-market hours today?
In the Green
1. Enlivex Therapeutics Ltd. (ENLV) is up over 72% at $17.70 in pre-market trading Monday on no news. The stock has been on a roll ever since the company reported positive top-line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition last Thursday. A phase IIb clinical trial of Allocetra for the treatment of organ failures associated with sepsis is expected to commence this quarter (Q4, 2020).
2. CHF Solutions Inc. (CHFS), a medical device company, is up over 30% at $0.47 in pre-market hours today on no news. The company markets the Aquadex SmartFlow system for ultrafiltration therapy. Aquadex therapy has been deployed in COVID-19 frontline hospitals as an adjunct therapy.
3. Bionano Genomics Inc. (BNGO) is up over 8% at $0.67 in pre-market hours today on no news. The company’s flagship product is the Saphyr system, which is used for basic and translational research of DNA. On September 29, the company announced that two hospitals in Slovenia and Australia have adopted Saphyr to improve the diagnosis and treatment of leukemias.
4. Evogene Ltd. (EVGN) is up over 7% at $3.99 in pre-market hours Monday on no news. This computational biology company focused on revolutionizing product development for life-science based industries received a $10 million equity investment from ARK Investment Management LLC and Alpha Capital Anstalt last month.
5. Solid Biosciences Inc. (SLDB) is up more than 5% at $4.40 in pre-market hours today on no news. On Oct.1, the company announced that its phase I/II study of SGT-001 for the treatment of Duchenne muscular dystrophy, dubbed IGNITE DMD, which was placed on hold by the FDA last November, has been allowed to resume. Dosing in the trial is expected to resume in the first quarter of 2021.
6. CTI BioPharma Corp. (CTIC) is up over 3% at $3.10 in pre-market hours today, adding to Friday’s gain of more than 20%. On September 29, the company announced its intention to proceed with the rolling New Drug Application submission for the potential accelerated approval of Pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia. The completion of NDA submission is anticipated next quarter. Pacritinib is also being tested in a phase III trial in hospitalized patients with severe COVID-19.
7. Sesen Bio Inc. (SESN) is up over 7% at $1.40 in pre-market hours on no news. The company is expected to complete the rolling Biologics License Application of Vicineum for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG) this quarter (Q4, 2020). The Marketing Authorization Application for Vicineum is expected to be filed with the European Medicines Agency in early 2021.
8. ADMA Biologics Inc. (ADMA) is up over 7% at $2.66 in pre-market hours on no news. On September 3, the company launched COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. For the second quarter ended June 30, 2020, the results of which were announced in early August, total revenues were $7.8 million compared to $6.6 million in the year-ago period.
9. Corbus Pharmaceuticals Holdings Inc. (CRBP) is up over 6% at $1.91 in pre-market trading Monday on no news. On September 8, the company announced disappointing topline results from its phase III study of Lenabasum in patients with diffuse cutaneous systemic sclerosis, dubbed RESOLVE-1. The news had sent the stock plunging 75% to $2.23 from the previous day’s close of $9.25.
In the Red
1. Xtant Medical Holdings Inc. (XTNT) is down over 5% at $4.78 in pre-market trading Monday, giving back some of what it gained Friday. On October 1, after the bell, the company announced the completion of its previously announced debt restructuring transaction. This debt restructuring transaction has significantly reduced the company’s total indebtedness to less than $16 million under its credit facility.
2. Co-Diagnostics Inc. (CODX) is down over 4% at $13.30 in pre-market trading today on no news, giving back some of what it gained on Friday. One of the company’s customers OralDNA Labs on Friday announced that the FDA had issued an amended Emergency Use Authorization for the OraRisk COVID-19 RT-PCR test allowing testing from a saline oral rinse collection. The news had sent the stock up more than 7% to $13.96 on Friday.
3. Selecta Biosciences Inc. (SELB) is down over 4% at $1.60 in pre-market hours today on no news. On September 30, after the bell, the company announced disappointing results from its phase II trial of SEL-212 in chronic refractory gout, dubbed COMPARE, sending the stock down 34% to $1.64.
4. Vaxart Inc. (VXRT) is down over 2% at $6.74 in pre-market hours on no news. Last month, the company was given FDA clearance to initiate a phase I trial of its oral COVID-19 vaccine. Two ongoing studies of the company’s vaccine candidate in hamsters are underway, with data expected mid-October.
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