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VIE Joins COVID-19 Fight, CBMG To Be Taken Private, FDA Postpones Decision On EM-100, ONTX On Watch

biotech aug13 lt

Today's Daily Dose brings you news about Cellular Biomedicine to be taken private, delay in the FDA decision on Bausch Health's EM-100 proposed for the treatment of ocular itching associated with allergic conjunctivitis, progress in EyeGate's MoxiGel, a combination product for the treatment of bacterial conjunctivitis, anticipated milestones of Onconova Therapeutics, and Viela Bio joining the fight against COVID-19.

Read on…

1. Cellular Biomedicine to be Taken Private

Cellular Biomedicine Group, Inc. (CBMG) is all set to be taken private by a consortium led by Bizuo Liu, CEO of the company.

CBMG's stockholders will receive US$19.75 in cash for each outstanding share of common stock held immediately prior to the effective time of the merger, the company noted.

CBMG closed Wednesday's trading at $19.27, up 35.04%.

2. FDA Postpones Decision on EM-100 to Sep.15

The FDA decision on EM-100, an over-the-counter preservative-free formulation of ketotifen ophthalmic solution, proposed for the treatment of ocular itching associated with allergic conjunctivitis, has been postponed to September 15 from August 10, 2020.

Developed by Eton Pharmaceuticals Inc. (ETON), EM-100 was out-licensed to Bausch Health Companies Inc. (BHC) in 2019. The FDA had refused approval for EM-100 last July.

Eton Pharma said that the delay is due to a proprietary name change submission and that it is confident of the product being approved.

BHC closed Wednesday's trading at $17.39, down 1.53%. ETON closed the day's trading at $6.38, down 6.93%.

3. EyeGate Gets Positive FDA Feedback for MoxiGel

Shares of EyeGate Pharmaceuticals Inc. (EYEG) jumped over 30% on positive feedback following its pre-IND meeting with the FDA related to the development of MoxiGel, a combination product for the treatment of bacterial conjunctivitis.

The new product will combine EyeGate's lead product Ocular Bandage Gel eye drop with an antibiotic that is currently approved for the treatment of bacterial conjunctivitis.

The company plans to complete its ongoing pre-clinical work and file an IND for MoxiGel in the first half of 2021.

EYEG closed Wednesday's trading at $5.38, up 30.27%. In after-hours, the stock gained another 1.30% and was at $5.45.

4. Kitov Pharma Implements Reverse Split

Kitov Pharma Ltd. (KTOV) has decided to implement a one-for-ten reverse split of its American Depositary Shares that will be effective at the beginning of trading on August 21, 2020.

The primary purpose of the reverse split is to enable the company to regain compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Capital Market, noted Kitov in an SEC filing.

KTOV closed Wednesday's trading at $0.74, down 3.45%. In after-hours, the stock plunged 26.66% to $0.55.

5. Onconova to Report INSPIRE Data This Quarter

Onconova Therapeutics Inc. (ONTX) has an important catalyst coming its way this quarter.

As previously announced the company's phase III trial of intravenous Rigosertib in patients with myelodysplastic syndromes, dubbed INSPIRE, has reached the required number of survival events to conduct data evaluation. The topline data from the INSPIRE trial are expected to be reported by the end of this quarter.

ONTX closed Wednesday's trading at $1.06, down 3.64%.

6. Pennant Group Boosts Earnings Outlook

Shares of The Pennant Group, Inc. (PNTG) touched a new 52-week high on Wednesday, following strong financial results for the second quarter and rosy earnings outlook for the year.

On an adjusted basis, earnings per share for the second quarter were $0.24, an increase of 118.2% over the spin-adjusted prior-year quarter while total revenue was $92.7 million, up 12.1% over the prior-year quarter.

Looking ahead, the company has raised its 2020 annual adjusted earnings per share guidance to a range of $0.71 to $0.78, the midpoint of which represents a 34.2% increase over the midpoint of the previous guidance. The annual revenue outlook has been reaffirmed in the range of $376 million to $386 million.

Analysts polled by Thomson Reuters expect the company to earn $0.48 per share on revenue of $377.02 million in 2020.

PNTG closed Wednesday's trading at $36.77, up 40.67%.

7. TCR2 Therapeutics Braces for Busy Months Ahead

TCR2 Therapeutics Inc. (TCRR), a clinical-stage immunotherapy company with a pipeline of novel T cell therapies for patients suffering from cancer, has a couple of anticipated milestones to keep an eye on in the coming months.

An interim update from the phase I portion of the company's phase I/II clinical trial of TC-210 for patients with mesothelin-expressing solid tumors is expected in the second half of this year. Positive interim data from the first five patients in the phase I portion of the TC-210 trial were reported last month.

The company expects an interim update from the phase I portion of its phase I/II clinical trial of TC-110 for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in the second half of this year.

A manufacturing facility of the company in Stevenage, UK, also awaits certification this year.

The company anticipates an IND filing for a third TRuC-T cell program in 2021.

TCRR closed Wednesday's trading at $16.74, down 0.42%.

8. Viela Bio joins the fight against COVID-19

Shares of Viela Bio Inc. (VIE) jumped more than 5 percent on Wednesday, as the company continues with its commercial launch activities related to recently FDA-approved UPLIZNA and gets ready to resume its clinical trials which had been paused due to the pandemic.

The company secured FDA approval for UPLIZNA for the treatment of adult patients with neuromyelitis optica spectrum disorder on June 11, 2020. UPLIZNA is expected to enter phase III trials in myasthenia gravis and IgG4-related disease next quarter. A phase II trial of UPLIZNA for kidney transplant desensitization remains voluntarily paused due to the COVID-19 pandemic.

New patient enrollment in a phase II trial with VIB4920 in patients with kidney transplant rejection has resumed while a phase IIb trial with VIB4920 in patients with Sjögren's syndrome is expected to resume enrolment next quarter. Due to the COVID-19 pandemic, new patient enrollment in both trials had been voluntarily paused.

Viela is also planning to initiate a phase I study with VIB7734 in patients with COVID-19-related acute lung injury this quarter. Results from this study are anticipated in Q1 2021.

As of June 30, 2020, the company had $448.4 million in cash, cash equivalents, and investments and no outstanding debt.

VIE closed Wednesday's trading at $38.41, up 5.58%.

9. VBL Therapeutics Asked To Continue OVAL Study

VBL Therapeutics (VBLT) has been asked by the independent Data Safety Monitoring Committee to continue its ongoing phase III study of Ofranergene obadenovec (VB-111) in patients with platinum-resistant ovarian cancer, dubbed OVAL, as planned.

The recommendation follows the second, pre-planned interim analysis in which the committee reviewed unblinded Overall Survival (OS) data of the first 100 randomized patients with a followup of at least 3 months. OS is the primary endpoint of the OVAL study. The committee also looked at the response rate and safety information.

The next Data Safety Monitoring Committee review of the OVAL study is expected in the first quarter of 2021.

VBLT closed Wednesday's trading at $1.34, up 2.29%.

10. Stocks That Moved On No News

Biofrontera AG (BFRA) closed Wednesday's trading at $30.50, up 50.10%.

STRATA Skin Sciences Inc. (SSKN) closed Wednesday's trading at $1.62, up 32.79%.

Annexon Inc. (ANNX) closed Wednesday's trading at $28.63, up 19.59%.

ThermoGenesis Holdings Inc. (THMO) closed Wednesday's trading at $4.53, down 19.82%.

Xtant Medical Holdings Inc. (XTNT) closed Wednesday's trading at $1.31, down 18.13%.

For comments and feedback contact: editorial@rttnews.com

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