PARIS (dpa-AFX) - What's moving these stocks in the pre-market hours today?
In the Green
1. Shares of Endologix Inc. (ELGX) are up over 46% at $0.37 in pre-market trading on Tuesday. Yesterday, the stock was down more than 67%, after the Company announced the initiation of a voluntary Chapter 11 case and simultaneous filing of a consensual plan of reorganization supported by Deerfield Partners.
2. Novavax Inc. (NVAX) is up over 39% at $110.60 in pre-market trading, following a $1.6 billion funding from Operation Warp Speed, a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021. The Company's COVID-19 vaccine candidate NVX-CoV2373 is under a phase I/II trial, with preliminary immunogenicity and safety results from the phase I portion of the trial expected in July 2020. If the results are promising, the phase II portion of the trial will be initiated quickly. A pivotal phase III trial of NVX-CoV2373 with up to 30,000 subjects is expected to commence beginning in the fall of 2020.
The funding received under the Operation Warp Speed program will be used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX-CoV2373, as early as late 2020.
3. Vaxart Inc. (VXRT) is up more than 13% in pre-market trading on no news. The Company is developing an oral vaccine for COVID-19 and is planning to seek FDA clearance for conducting a phase I study of its oral COVID-19 vaccine soon. If all goes well, the clinical study is expected to be initiated this summer. Vaxart is also one of the few companies selected by Operation Warp Speed.
4. Otonomy Inc. (OTIC) is up 13% at $3.60 in pre-market trading, following positive top-line results from a phase I/II clinical trial of OTO-313 in patients with persistent tinnitus of at least moderate severity.
5. Endo International plc (ENDP) is up more than 17% at $4.25, following FDA approval of Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO is the first FDA-approved injectable treatment for cellulite.
6. Shares of Aeterna Zentaris Inc. (AEZS) are up over 27% at $0.53 in pre-market trading on Tuesday on no news.
In the Red
1. Shares of Evolus Inc. (EOLS) are down over 37% at $5.32 in pre-market trading, following the decision of the Administrative Law Judge (ALJ) overseeing the United States International Trade Commission case filed by Allergan and Medytox in January 2019 against Daewoong and Evolus to review the case. The full Commission's final determination is targeted for November 6, 2020. The case relates to Evolus's Jeuveau, a follow-on biologic to Allergan's Botox.
2. Cellectis S.A. (CLLS) is down more than 14% at $16.28 in pre-market trading, following a clinical hold on the Company's phase I open-label First-In-Human dose-escalation clinical study of UCARTCS1A product candidate for the treatment of patients with relapsed or refractory multiple myeloma, dubbed MELANI-01, due to safety concerns.
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