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BTAI Hits A High, TNXP's RECOVERY Fails, MRK Plans A Spin-off

pharma sept27 06feb20 lt

Today's Daily Dose brings you news about Tonix Pharma's update on PTSD trial, Merck's Q4 financial results, BioXcel's progress made in its RELEASE trial, Biogen's patent win over Mylan, and Cardiovascular Systems' fiscal second-quarter financial results.

Read on…

BioXcel Therapeutics Inc. (BTAI) has received FDA clearance to initiate a phase Ib/II trial of BXCL501, the Company's proprietary sublingual thin-film formulation of dexmedetomidine, for the treatment of opioid withdrawal symptoms.

In the phase Ib/II trial of BXCL501, dubbed RELEASE, patients will be randomized into multiple-dose cohorts of BXCL501, or matching placebo, administered twice daily for five days.

The Company is preparing to initiate the RELEASE trial.

BTAI touched a new high of $21.97 in intraday trading on Wednesday, before closing at $19.98, up 15.16%.

Shares of Biogen Inc. (BIIB) soared as much as 32% on Wednesday, following a favorable decision rendered by the U.S. Patent and Trademark Office related to the Company's blockbuster multiple sclerosis drug Tecfidera, whose '514 patent has been challenged by Mylan (MYL).

In July 2018, Mylan filed a petition with the U.S. Patent Trial and Appeal Board seeking inter partes review of Biogen's patent over Tecfidera, which is slated to expire in 2028. The U.S. Patent Trial and Appeal Board instituted inter partes review of Tecfidera patent last July.

Now that the U.S. Patent and Trademark Office has sided with Biogen, at least for now there is no threat to Tecfidera.

Tecfidera brought in sales of $4.43 billion for Biogen last year compared to $4.27 billion in 2018.

Vumerity, a follow-up to Tecfidera, developed by Alkermes (ALKS) in collaboration with Biogen, received FDA nod last October. So, it is no wonder that Alkermes shares also gained because of the favorable ruling. ALKS stock was up over 10% to $19.40.

BIIB closed Wednesday's trading at $332.87, up 17.50%.

Beam Therapeutics Inc. (BEAM) has priced its initial public offering of 10.58 million shares of common stock at a price of $17.00 per share. The stock is expected to begin trading on the NASDAQ Global Select Market on February 6, 2020.

The underwriters have a 30-day option to purchase up to an additional 1.59 million shares of common stock.

Cardiovascular Systems Inc. (CSII) has reported a wider-than-expected loss for the fiscal second quarter, ended December 31, 2019, even as revenue grew 13.5%.

The recent second-quarter net loss was $3.4 million or $0.10 per share compared to net income of $0.5 million or $0.01 per share in the prior-year period. The fiscal 2020 second-quarter revenues were $68.3 million, an increase of 13.5% from the second quarter of fiscal 2019.

Wall Street analysts were expecting a loss of $0.01 per share on revenues of $67.97 million.

Looking ahead to fiscal 2020 ending June 30, 2020, the Company anticipates revenue of $280 million to $283 million, representing 13% to 14% growth over fiscal 2019.

CSII closed Wednesday's trading at $44.87, up 3.36%.

In a bid to deliver even greater value to patients and shareholders, Merck (MRK) has decided to spin off its Women's Health, trusted Legacy Brands and Biosimilar products into a new company.

The Company also announced financial results for the fourth quarter and full year of 2019.

The total sales in the fourth quarter of 2019 were $11.87 billion, up 8% over the year-ago quarter, but slightly less than the Wall Street analysts' consensus estimate of $11.98 billion.

On a non-GAAP basis, net income in the fourth quarter of 2019 was $2.98 billion or $1.16 per share compared to $2.75 million or $1.04 per share in the year-ago quarter. Analysts were expecting the Company to report earnings of $1.15 per share for the quarter.

Merck anticipates full-year 2020 revenue to be between $48.8 billion and $50.3 billion and non-GAAP EPS to be between $5.62 and $5.77. Revenue was $46.84 billion and non-GAAP EPS was $5.19 in full-year 2019.

MRK closed Wednesday's trading at $85.83, down 2.86%. In after-hours, the stock fell another 0.15% to $85.70.

Shares of Tonix Pharmaceuticals Holding Corp. (TNXP) slumped more than 60% in extended trading on Wednesday, following disappointing news related to phase III study of Tonmya in posttraumatic stress disorder, dubbed RECOVERY, which is 50% enrolled.

The Independent Data Monitoring Committee (IDMC) has recommended that the RECOVERY study be stopped for futility as Tonmya is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in the severity of posttraumatic stress disorder symptoms.

Seth Lederman, President, and Chief Executive Officer said, "We are disappointed for patients suffering from PTSD that the interim analysis did not detect a signal that would warrant continued enrollment in this Phase 3 study. These results underscore the difficulty in treating PTSD."

TNXP closed Wednesday's trading at $1.70, up 4.29%.

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