What’s moving these stocks in the pre-market hours today?
In the Green
1. Tiziana Life Sciences PLC (TLSA) is up over 13% at $3.90 in pre-market hours Wednesday, following news of the company’s plan to demerge its StemPrintER and SPARE genomics-based personalized medicine business into a separate and independent listed company, Accustem Sciences Limited. It is intended that Accustem will seek admission to trading on the London Stock Exchange plc by way of an IPO in late Q4 2020 and potentially a dual listing on NASDAQ in 2021.
2. Applied DNA Sciences Inc. (APDN) is up more than 12% at $9.17 in pre-market hours today, following news that the company along with Evvivax S.R.L., a spin-out of Takis Biotech, are expected to launch a clinical trial of its COVID-19 Linear DNA vaccine candidate for veterinary use. The clinical trial will test LineaDNA vaccine candidate in about 30 healthy domestic feline companion animals and follow them for six months.
3. AVEO Pharmaceuticals, Inc. (AVEO) is up over 12% at $6.50 in pre-market trading, following news of the publication of final overall survival results from the company’s phase III TIVO-3 study in the journal European Urology. TIVO-3 is the pivotal phase III trial comparing Tivozanib to approved drug Nexavar as a treatment for relapsed or refractory renal cell carcinoma. Tivozanib is under FDA review, with a decision expected on March 31, 2021.
4. Tonix Pharmaceuticals Holding Corp. (TNXP) is up over 6% at $0.85 in pre-market trading Wednesday on news that the company has enrolled the first patient in the observational COV-LOGIC study. This study is designed to collect the blood and nasopharyngeal (NP) swabs from individuals who have, and have not, been previously infected with SARS-CoV-2, or who have been intimately exposed to persons confirmed to have been infected with SARS-CoV-2. The company’s COVID-19 vaccine candidate is TNX-1800, which is under animal testing, with data expected in the fourth quarter of this year. Results from the COV-LOGIC study are anticipated in the first half of 2021.
5. ObsEva SA (OBSV) is up over 6% at $2.94 in pre-market hours. The company is scheduled to present an update on its pipeline at the H.C Wainwright 22nd Annual Global Investment Virtual Conference today.
6. Achieve Life Sciences Inc. (ACHV) is up nearly 5% at $10.35 in pre-market trading on no specific news. The lead product candidate is Cytisinicline, a plant-based alkaloid, which is believed to aid in smoking cessation. The company announced successful topline results from the New Zealand RAUORA phase III non-inferiority clinical trial comparing Cytisinicline to Pfizer’s drug for smoking cessation Chantix in Maori (indigenous New Zealanders) and whanau (family) of Maori in June. The cytisinicline data is slated to be featured in two presentations on Friday, September 18th, at the SRNT-E virtual conference.
7. Verastem Inc. (VSTM) is up nearly 4% at $1.46 in pre-market trading Wednesday. The company is scheduled to discuss new data from low-grade serous ovarian cancer cohort of its phase I/II study of VS-6766, dubbed FRAME, today.
8. Editas Medicine, Inc. (EDIT), a genome editing company, is up nearly 4% at $33.01 in pre-market trading Wednesday.
In the Red
1. Plus Therapeutics Inc. (PSTV) is down 10% at $2.72 in pre-market trading today, giving back some of what it gained yesterday. The company’s lead investigational drug, Rhenium NanoLiposomes, for the treatment of patients with recurrent glioblastoma, was granted Fast Track designation by the FDA yesterday, which had sent the shares up over 24%. Rhenium NanoLiposomes is under a phase I/II study in recurrent Glioma, dubbed ReSPECT.
2. Satsuma Pharmaceuticals Inc. (STSA) is down nearly 6% at $4.57 in pre-market trading Wednesday. On September 10, the company reported disappointing results from its phase III efficacy trial of STS101 powder in the acute treatment for migraine did not show statistically significant differences in the co-primary endpoints when compared to placebo. The stock has lost more than 60% since then.
3. Eton Pharmaceuticals Inc. (ETON) is down over 5% at $7.45 in pre-market trading, adding to yesterday’s loss of 5%. The FDA decision on EM-100, due on September 15, is awaited. EM-100 is an over-the-counter preservative-free formulation of ketotifen ophthalmic solution, proposed for the treatment of ocular itching associated with allergic conjunctivitis. It was out-licensed to Bausch Health Companies Inc. (BHC) in 2019.
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