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JNJ Single-shot COVID-19 Vaccine At FDA Altar, KPTI Expands Xpovio's Footprint, OTLK On Track

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Today's Daily Dose brings you news about Johnson & Johnson seeking FDA nod for its single-shot COVID-19 vaccine candidate, T2 Biosystems' molecular diagnostic test detecting Brazil variant of the SARS-CoV-2 virus, Sientra' better-than-expected Q4 preliminary revenue results, Karyopharm securing approval for XPOVIO in Israel and resignation of Merck's CEO.

Read on…

1. JNJ Seeks emergency FDA Nod For COVID-19 Vaccine

Johnson & Johnson (JNJ) has submitted an application to the FDA, seeking Emergency Use Authorization of its single-shot COVID-19 vaccine candidate.

In a phase III trial, dubbed ENSEMBLE, which included participants from different geographies and including those infected with an emerging viral variant, Janssen's COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.

The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination, according to the company.

Immediately following authorization, Johnson & Johnson expects to supply 100 million doses to the U.S. in the first half of 2021.

If authorized, Johnson & Johnson's vaccine would be the third COVID-19 vaccine for emergency use in the U.S. - the other two being Pfizer/BioNTech's BNT162b2 and Moderna's mRNA-1273 - both of which require two shots.

JNJ closed Thursday's trading at $161.99, up 0.93%.

2. Karyopharm Expands XPOVIO's Footprint

Karyopharm Therapeutics Inc. (KPTI) has secured approval for XPOVIO in Israel for the treatment of patients with either multiple myeloma or diffuse large B-cell lymphoma.

The company has an exclusive distribution agreement with Promedico Ltd. for the commercialization of XPOVIO in Israel and the Palestinian Authority. The drug received its initial approval in the U.S. in July 2019, and is under review by the European Medicines Agency.

Karyopharm is slated to report fourth quarter and full year 2020 financial results on Thursday, February 11, 2021.

The net product sales of XPOVIO are expected to be between $20.0 million and $20.5 million for the fourth quarter of 2020 and between $76.0 million and $76.5 million for the full year of 2020. The sales of XPOVIO were $17.7 million for the fourth quarter and $30.5 million for full year 2019.

KPTI closed Thursday's trading at $14.60, down 1.08%.

3. Merck CEO To Retire

Merck & Co, Inc.'s (MRK) chairman and CEO Kenneth Frazier will retire from his post as CEO, effective June 30, 2021.

However, Frazier will continue to serve on Merck's board of directors as executive chairman, for a transition period to be determined by the board.

Robert Davis, Merck's current executive vice president, global services and CFO, has been unanimously elected as the company's CEO, as well as a member of the board, effective July 1, 2021. Davis will become president of Merck, effective April 1, 2021, at which time the company's operating divisions—Human Health, Animal Health, Manufacturing, and Merck Research Laboratories—will begin reporting to him.

MRK closed Thursday's trading at $76.03, down 1.67%.

4. Outlook Therapeutics On Track

Outlook Therapeutics Inc. (OTLK) remains on track to report pivotal safety and efficacy data from its phase III trial of ONS-5010/LYTENAVA for the treatment of wet age-related macular degeneration, dubbed NORSE 2, in the third quarter of this year.

ONS-5010 /LYTENAVA is an investigational ophthalmic formulation of bevacizumab-vikg under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases.

Last August, the company reported topline results demonstrating anticipated safety and efficacy and positive proof-of-concept of ONS-5010/LYTENAVA for the treatment of wet age-related macular degeneration from a phase III clinical study, dubbed NORSE 1, the first of two registration clinical trials.

OTLK closed Thursday's trading at $1.79, up 21.7%.

5. Sientra's Sales Results Trump Estimates

Medical aesthetics company Sientra Inc.'s (SIEN) preliminary unaudited sales results for the fourth quarter and full year ended December 31, 2020, have topped analysts' estimates, thanks to its continued investment and market outperformance in the core breast products segment.

The total estimated net sales for the fourth quarter of 2020 are $22.6 million, a decrease of 2% compared to total net sales of $23.2 million for the same period in 2019. Wall Street analysts polled by Thomson Reuters expect the company to report net sales of $16.83 million.

The Breast Products segment net sales are estimated to be about $17.9 million in the fourth quarter 2020, an increase of 40% for the same period in 2019, while the miraDry segment net sales are expected to be roughly $4.8 million in the fourth quarter 2020, a 54% decrease from the year-ago quarter.

The net sales for the full year 2020 are estimated to be approximately $71 million, outperforming analysts' estimate of $65.43 million. The annual net sales were $83.7 million in 2019.

The company is scheduled to report Q4 and full year 2020 financial results in the second week of March.

SIEN closed Thursday's trading at $5.20, up 4.00%.

6. T2 Biosystems' Diagnostic Test Detects Brazil Variant

T2 Biosystems Inc.'s (TTOO) T2SARS-CoV-2 Panel, a molecular diagnostic test that detects SARS-CoV-2, the virus responsible for COVID-19 infections, has been found to be capable of detecting the Brazil variant of the SARS-CoV-2 virus, which was recently confirmed to be present in the United States.

The T2SARS-CoV-2 Panel, which provides results in less than two hours utilizing a nasopharyngeal swab sample, was issued Emergency Use Authorization by the FDA last August.

According to the company, the T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100 percent, is capable of performing seven tests simultaneously and up to sixty samples per day.

Preliminary unaudited total revenue is expected to be $7.8 million for the fourth quarter of 2020, and $18.1 million for the full year 2020. This compares to total revenue of $3.1 million in the fourth quarter of 2019 and $8.3 million for full year 2019.

The company is slated to report fourth quarter and full year 2020 financial results in the last week of this month.

TTOO closed Thursday's trading at $2.40, up 7.14%. In after-hours, the stock was up 46.25% at $3.51.

7. Stocks That Gained/Lost The Most In a Day

CNS Pharmaceuticals Inc. (CNSP) closed Thursday's trading at $3.50, up 68.27%.

Cyclo Therapeutics Inc. (CYTH) closed at $13.15, up 59.39%.

Midatech Pharma plc (MTP) closed at $3.80, up 47.29%.

Tyme Technologies Inc. (TYME) closed at $2.26, down 35.98%.

Cassava Sciences Inc. (SAVA) closed at $63.43, down 27.88%.

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