What’s moving these stocks in the pre-market hours today?
1. Onconova Therapeutics Inc. (ONTX) is up over 29% at $0.42 in pre-market trading Monday, adding to Friday’s gain of 28%, on no specific news. Late last month, the company announced that INSPIRE, its pivotal Phase 3 study of IV Rigosertib in higher-risk myelodysplastic syndromes (HR-MDS) patients, did not meet its primary endpoint of improved survival. Applications submitted for Rigosertib to participate in federally funded human studies in COVID-19 disease are expected to be reviewed by the federal funding agencies.
2. Acasti Pharma Inc. (ACST) is up more than 7% at $0.23 in pre-market trading Monday, adding to Friday’s gain of more than 11%. Late last month, the company announced that its phase III TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia did not meet the primary endpoint.
3. Ocugen Inc. (OCGN) is up over 6% at $0.38 in pre-market hours Monday. The company is scheduled to make a presentation at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit today at 1:40 p.m.
4. Vaxart Inc. (VXRT) is up over 5% at $8.65 in pre-market hours today. A phase I clinical trial of the company’s oral COVID-19 vaccine candidate is expected to start recruitment this month. A hamster challenge study to provide efficacy data and insights into the optimal dose regimen of the oral COVID-19 vaccine candidate is underway, with data anticipated mid-October.
5. COMPASS Pathways Plc (CMPS) is up over 6% at $31 in pre-market hours today, adding to Friday’s gain of more than 70%. The company went public on the Nasdaq Global Select Market on September 18, 2020, offering its American Depositary Shares at a price of $17 each.
6. Sonnet BioTherapeutics Holdings Inc. (SONN) is up more than 2% at $2.82 in pre-market hours, adding to Friday’s gain of nearly 11%. Early this month, the company successfully completed a preclinical Severe Combined Immunodeficient (SCID) mouse study of its fully human Interleukin 12 (IL-12) candidate, SON-1010, which supports the compound for oncology applications. An IND for SON-1010 is expected to be submitted in 2021. Its lead compound is SON-080, for chemotherapy-induced peripheral neuropathy, ready to enter phase II development.
In the Red
1. Immutep Limited (IMMP) is down over 12% at $1.66 in pre-market hours Monday, giving back some of what it gained on Friday. The company announced new interim data from its ongoing Phase II TACTI-002 study of drug candidate Eftilagimod alpha with Merck’s Keytruda in non-small cell lung carcinoma and head and neck carcinoma patients. The news had sent the stock up over 18% on Friday.
2. DBV Technologies S.A. (DBVT) is down more than 7% at $1.80 in pre-market hours today. The company’s investigational Viaskin Peanut, a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years, failed to secure FDA approval last month.
3. Lipocine Inc. (LPCN) is down over 3% at $1.55 in pre-market trading Monday, giving back some of what it gained on Friday. The company’s Tlando, an investigational testosterone replacement therapy, is still awaiting the FDA decision which was originally due on August 28.
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