Pre-market Movers In Healthcare Sector: ADXN, CLSN, CLBS, JAGX, ECOR, ADMP…

stockmarkets dec27 21jan21 lt

What's moving these stocks in pre-market hours today?

In the Green

1. Addex Therapeutics Ltd (ADXN) is up 140% at $25.34 in pre-market trading Thursday, on news that its partner Janssen Pharmaceuticals Inc., a Johnson & Johnson (JNJ) company, has received FDA clearance to begin a Phase 2a proof of concept study with JNJ-40411813 (ADX71149), in patients with epilepsy. The first patient is expected to be treated during Q2 2021.

2. Celsion Corp. (CLSN) is up over 45% at $1.85 in pre-market trading Thursday, adding to yesterday's gain of nearly 40%, on no news. A phase III study of ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer, dubbed OPTIMA, was stopped for futility last July on the recommendation of an independent Data Monitoring Committee. The company continues to follow patients for overall survival. A phase II/II study with GEN-1 in advanced ovarian cancer, dubbed OVATION 2, is underway.

3. Caladrius Biosciences Inc. (CLBS) is up 22% at $3.52 in pre-market hours today, adding to yesterday's gain of 77%. A phase IIb trial of trial of CLBS16 as a therapy for coronary microvascular dysfunction is underway, with topline data anticipated in 3Q, 2022. Enrollment in a registration eligible trial of HONEDRA in Japan in Critical Limb Ischemia and Buerger's Disease is expected to be completed next quarter.

4. Jaguar Health Inc. (JAGX) is up 20% at $3.54 in pre-market hours. The company announced the closing of a $6.0 million issuance and sale of designation-backed Note related to possible tropical disease Priority Review Voucher. The company intends to use the funds for the clinical development of Lechlemer, a drug candidate being developed for the symptomatic relief of diarrhea from cholera.

5. electroCore Inc. (ECOR) is up over 19% at $2.97 in pre-market hours today, adding to yesterday's gain of 30%. On January 19, the company announced the decision by CMS to recommend a unique HCPCS code for non-invasive vagus nerve stimulation. The coding decision, which will go into effect on April 1, 2021, is a major step forward in obtaining additional coverage within the medical benefit pathway, according to Dan Goldberger, CEO of electroCore.

6. ENDRA Life Sciences Inc. (NDRA) is up over 17% at $2.39 in pre-market hours today, adding to yesterday's gain of 17%, on no news. The company's flagship product is TAEUS, which is currently cleared for sale in countries that recognize the CE mark. This device is initially focused on the measurement of fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions. A 510(k) application for TAEUS has been submitted to the FDA.

7. Lipocine Inc. (LPCN) is up over 17% at $2.44 in pre-market hours today, adding to yesterday's gain of 17%. The company's lead oral testosterone product Tlando was given tentative approval by the FDA last month (Dec.2020). The final approval for Tlando will be given when the exclusivity period previously granted to rival product Jatenzo, developed by Clarus Therapeutics, expires on March 28, 2022. Early this month, the company announced positive topline results from its Phase 2 clinical study of LPCN 1144 in biopsy-confirmed non-cirrhotic non-alcoholic steatohepatitis male subjects, dubbed LiFT. The 36-week biopsy data from the LiFT study are expected in mid-2021.

8. Iterum Therapeutics plc (ITRM) is up over 16% at $2.03 in pre-market hours, adding to yesterday's gain of 33%, on no news. The company's lead product candidate is Sulopenem, an oral and IV penem antibiotic, licensed from Pfizer. On November 30, 2020, the company had submitted its New Drug Application to the FDA for Oral Sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen.

9. ReWalk Robotics Ltd. (RWLK) is up more than 11% at $2.23 in pre-market hours on no news. The company manufactures, and markets wearable robotic exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke.

10. Cardiff Oncology Inc. (CRDF) is up over 11% at $12.40 in pre-market hours today, on no news. The lead drug candidate is Onvansertib which in combination with FOLFIRI/bevacizumab is under a Phase 1b/2 clinical trial in second line KRAS-mutated metastatic colorectal cancer, and in combination with Zytiga and prednisone in a phase II trial in metastatic Castration Resistant Prostate Cancer.

11. BIOLASE Inc. (BIOL), a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine, is up 9% at $1.05 in pre-market hours today, on no news. On Jan.12, the company signed a deal with Dental Care Alliance (DCA), one of the largest dental support organizations (DSO) in the United States with more than 330 affiliated practices in 20 states, to expand laser adoption and hands-on training programs in targeted geographies.

In the Red

1. Obalon Therapeutics Inc. (OBLN) is down over 20% at $6.60 in pre-market hours trading Thursday, giving back some of what it gained yesterday. The stock soared more than 400% yesterday on news of the company entering into a merger agreement with ReShape Lifesciences Inc. (RSLS.OB).

2. Adamis Pharmaceuticals Corporation (ADMP) is down 11% at $1.27 in pre-market trading, giving back some of what it gained yesterday. The stock was up more than 70% yesterday on news of the company submitting an Investigational New Drug application to the FDA for the investigational use of Tempol for the treatment of COVID-19.

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