PFE/BNTX Covid Jab Neutralizes UK Strain, Pura Vida Ups Stake In OCX, Woodcock Is Interim FDA Chief

Today’s Daily Dose brings you news about BNT162b2 vaccine’s capability to neutralize the new UK coronavirus variant, the resignation of Stephen Hahn, the 24th Commissioner of the FDA, the executive changes at Lineage Cell Therapeutics and registered offering of OncoCyte.

Read on…

1. Lineage Cell’s CFO Resigns

Lineage Cell Therapeutics Inc.’s (LCTX) Chief Financial Officer, Brandi Roberts, has resigned in order to accept a leadership position at another company.

The CEO of Lineage Cell, Brian Culley, will serve as Interim Chief Financial Officer. Meanwhile, the company has initiated a search for a new CFO.

The company has a couple of anticipated milestones for this quarter.

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.

LCTX closed Wednesday’s trading at $3.00, up 20.97%. In after-hours, the stock was down 4.67% at $2.86.

2. Pura Vida Boosts stake in Oncocyte

Oncocyte Corp.’s (OCX) two largest institutional investors have agreed to purchase approximately $25 million of the company’s common shares in a registered offering priced at $3.424 per share.

The lead investor in the offering, Pura Vida Investments LLC, has agreed to purchase $20 million of Oncocyte’s common shares, thereby increasing its stake in the company from less than 10% to approximately 16%. The other participant in the offering is Broadwood Partners, L.P., a long-term investor and Oncocyte’s largest shareholder.

The offering is expected to close during the week of January 26, 2021. The shares outstanding at the close of this offering will be 78.66 million while cash and cash equivalents will total over $37 million.

OCX closed Wednesday’s trading at $4.12, up 17.05%. In after-hours, the stock was up another 11.89% at $4.61.

3. Pfizer/BioNTech COVID-19 Vaccine Neutralizes UK Virus Strain

Pfizer Inc. (PFE) and BioNTech SE’s (BNTX) COVID-19 vaccine, BNT162b2, is capable of neutralizing the SARS-CoV-2 U.K. strain, also known as B.1.1.7 lineage or VOC 202012/01 too, reveals results of an in vitro study.

BNT162b2 is approved for emergency use to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 16 years of age and older.

The B.1.1.7 lineage is a rapidly spreading variant of SARS-CoV-2 initially detected in the U.K. that carries a larger than usual number of genetic changes with 10 mutations located in the spike protein. A previous study has shown that the BNT162b2 vaccine is efficient in neutralizing N501Y mutant SARS-CoV-2, the South African variant.

As per Johns Hopkins’ latest tally, the total number of coronavirus cases worldwide stands at 96.82 million, with fatalities of 2.07 million.

According to the World Health Organization, the new UK virus variant has been reported in at least 60 countries.

PFE closed Wednesday’s trading at $36.50, down 0.63%.

4. Janet Woodcock Named Interim FDA Chief

Stephen Hahn, who was sworn in as the 24th Commissioner of the FDA on December 17, 2019, has resigned, as the nation transitioned to the Biden administration. Janet Woodcock has been named Acting Commissioner.

Woodcock holds a Bachelor of Science in chemistry from Bucknell University (Lewisburg, PA), and a Doctor of Medicine from the Feinberg School of Medicine at Northwestern University Medical School. She joined the FDA in 1984 as Director of the Division of Biological Investigational New Drugs, as well as serving as the Center for Biologics Evaluation and Research’s Acting Deputy Director for a period of time.

From late 2020, she has been lending her expertise to “Operation Warp Speed” for developing therapeutics during the COVID-19 pandemic while also working as the Principal Medical Advisor to the Commissioner on key priorities on behalf of the Office of the Commissioner.

5. Stocks That Gained/Lost The Most

Obalon Therapeutics Inc. (OBLN) closed Wednesday’s trading at $8.28, up 414.29%.

Adamis Pharmaceuticals Corporation (ADMP) closed at $1.43, up 77.64%.

Caladrius Biosciences Inc. (CLBS) closed at $2.89, up 77.30%.

BioLineRx Ltd. (BLRX) closed at $2.45, down 22.71%.

AcelRx Pharmaceuticals Inc. (ACRX) closed at $1.95, down 17.02%.

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