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Pre-market Movers In Healthcare Sector: LCTX, DARE, SRNE, NOVN, HSTO…

January 27, 2021

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

In the Green

1. Lineage Cell Therapeutics Inc. (LCTX) is up over 70% at $4.20 in pre-market trading Wednesday, on no news. A phase 1/2a clinical study of OpRegen for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy, with encouraging preliminary signs of tolerability and efficacy, is ongoing. New and accumulated OpRegen data from the ongoing study are expected to be presented this quarter. Patient enrollment in a phase I clinical study with VAC2 for the treatment of non-small cell lung cancer is also expected to be completed by the end of the first quarter of 2021.

2. Daré Bioscience Inc. (DARE) is up over 50% at $3.63 in pre-market trading Wednesday, adding to yesterday’s gain of nearly 64%, on no news. The company has a couple of anticipated milestones to watch out for this year. The NDA for DARE-BV1 for Bacterial Vaginosis is expected to be submitted this year. The topline data from a phase I trial of DARE-HRT1 is also expected this year. DARE-HRT1 is being developed as a potential new option for hormone therapy (HT) for the treatment of vasomotor symptoms, commonly called hot-flashes, and the genitourinary syndrome of menopause to prevent bone loss and fracture associated with menopause.

3. ENDRA Life Sciences Inc. (NDRA) is up nearly 42% at $2.46 in pre-market hours today, adding to yesterday’s gain of 65%, 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 has been submitted to the FDA.

4. Senseonics Holdings Inc. (SENS) is up 25% at $3.44 in pre-market hours today, adding to yesterday’s gain of 80%. Yesterday, the company announced that EmblemHealth is now providing coverage for the Eversense CGM System, effective immediately. Senseonics’ Eversense Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days.

5. AIkido Pharma Inc. (AIKI) is up over 20% at $1.32 in pre-market hours. A SEC filing dated Jan. 19, reveals that the company did not obtain approval from stockholders to effect a one-for-ten reverse stock split.

6. Sorrento Therapeutics Inc. (SRNE) is up over 13% at $10.73 in pre-market trading today after disclosed data demonstrated that in in vitro assays, its second-generation therapeutic antibody STI-2020 preserves binding against UK B.1.1.7 SARS-CoV-2 mutated spike protein.

7. Novan Inc. (NOVN) is up 14.50% at $1.50 in pre-market hours today, following news that its pivotal phase III study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum, dubbed B-SIMPLE4, has reached 90% of the approximately 850 subjects targeted for enrollment in the study. Completion of patient enrollment is targeted for the first quarter of 2021, with topline efficacy results targeted for the second quarter of 2021.

8. TransEnterix Inc. (TRXC) is up 13% at $3.95 in pre-market hours today, adding to yesterday’s gain of 68%. The company’s flagship product is Senhance System, an FDA-cleared abdominal robotic surgery platform. Yesterday, the company received CE Mark approval for the Intelligent Surgical Unit that enables machine vision capabilities on the Senhance Surgical System.

9. Gritstone Oncology Inc. (GRTS) is up nearly 9% at $24.25 in pre-market hours today, adding to yesterday’s gain of 248%. Yesterday, the company announced its decision to advance its second generation COVID-19 vaccine program, dubbed CORAL, to phase I stage. The phase 1 clinical trial will be conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium, with preliminary data expected in mid-2021.

In the Red

1. BioLineRx Ltd. (BLRX) is down nearly 18% at $2.60 in pre-market hours Wednesday, on news of a $30 million bought deal offering. The closing of the offering is expected to occur on or about January 22, 2021.

2. Histogen Inc. (HSTO) is down 13% at $1.02 in pre-market trading Wednesday, on news of the FDA imposing a clinical hold on the company’s planned phase I/II clinical trial of HST-003 for knee cartilage regeneration. The clinical hold, which has been verbally notified, is due to pending CMC (Chemistry, Manufacturing, and Control) information that is required by the FDA to complete the review of the company’s Investigational New Drug application.

3. AcelRx Pharmaceuticals Inc. (ACRX) is down 9% at $2.13 in pre-market hours, following the filing of a shelf registration.

4. CytomX Therapeutics, Inc. (CTMX) is down 8% at $7.80 in pre-market hours, following commencement of an underwritten public offering of $75.0 million of its common stock. The underwriters are expected to be granted a 30-day option to purchase up to an additional $11.25 million of its common stock at the public offering price, less underwriting discounts and commission.

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