What’s moving these stocks in the pre-market hours today?
In the Green
1. Altimmune Inc. (ALT) is up over 15% at $9.04 in pre-market hours, gaining half of what it lost yesterday. The company anticipates commencing a Phase 1 safety and immunogenicity trial of AdCOVID, a single-dose intranasal vaccine candidate for COVID-19, this quarter, with a data read-out in Q1 2021.
2. Affimed N.V. (AFMD) is up over 9% at $4.10 in pre-market trading Tuesday, following a licensing and strategic collaboration agreement with global biopharmaceutical company Roivant Sciences to develop and commercialize novel Innate Cell Engagers or ICE molecules in oncology. Affimed will receive $60 million in upfront consideration and up to an additional $2 billion in future milestones.
3. BioNTech SE (BNTX) is up more than 7% in pre-market trading Tuesday, adding to yesterday’s gain of 13%. Yesterday, the company which is developing vaccine candidate BNT162b2 for COVID-19 along with Pfizer, revealed that BNT162b2 has been found to be more than 90% effective in preventing COVID-19 based on the first interim analysis of their global phase III study. The companies intend to seek Emergency Use Authorization for BNT162b2 from the FDA soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
4. Pfizer Inc. (PFE) is up over 4% at $40.80 in pre-market hours today, adding to yesterday’s gain of more than 7%. The COVID-19 vaccine candidate BNT162b2, which is being developed by Pfizer and BioNTech SE has demonstrated over 90% efficacy in a global phase III trial. The companies are planning to seek emergency nod from the FDA after achieving the safety milestone, which is currently expected to occur in the third week of November.
5. AstraZeneca PLC (AZN) is up over 3% at $55.94 in pre-market trading on no news. The company announced positive results from a phase III trial for the potential new medicine Tezepelumab in patients with severe, uncontrolled asthma yesterday. Late-stage clinical trials of the recombinant adenovirus vaccine candidate, AZD1222, are ongoing in a number of countries, including the UK, Brazil, South Africa and the US. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) started a rolling review of AZD1222 last month.
In the Red
1. Supernus Pharmaceuticals Inc. (SUPN) is down over 22% at $19.25 in pre-market hours today, following two disappointing regulatory news. The FDA refused to approve SPN-812, a novel non-stimulant, for the treatment of attention-deficit hyperactivity disorder, and declined to even accept for review the company’s New Drug Application for SPN-830 for the continuous treatment of motor fluctuations (“on-off” episodes) in Parkinson’s disease.
2. TherapeuticsMD Inc. (TXMD) is down more than 13% at $1.32 in pre-market hours Tuesday, following an underwritten public offering of its common stock.
3. Phio Pharmaceuticals Corp. (PHIO) is down more than 10% at $2.16 in pre-market hours today on no news. Yesterday, the stock was up 8%, following positive data from an in vivo study that showed the strong antitumoral efficacy of its preclinical compounds PH-762, PH-790 and PH-804.
4. Revance Therapeutics Inc. (RVNC) is down more than 5% at $26 in pre-market hours following news of a likely delay in the Nov.25 FDA decision on DaxibotulinumtoxinA for Injection, proposed for the treatment of moderate to severe glabellar (frown) lines. The inspection of the manufacturing site related to the product candidate, which has to be conducted prior to approval, has not yet been scheduled by the regulatory agency due to COVID-19 related travel curbs. The company also announced that a phase II clinical trial of DaxibotulinumtoxinA for Injection for the management of plantar fasciitis has not met the primary endpoint.
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