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BTAI Up 105% In 5 Days, NVAX Gets A Shot In The Arm, BMY Snaps Up CELG

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Today's Daily Dose brings you news about this year's first, and one of the biggest pharmaceuticals deals; BioXcel Therapeutics' Alzheimer's study results; CAS Medical's preliminary unaudited Q4 sales results; Catabasis Pharma's update on DMD trial; Marker Therapeutics' pipeline progress; and Novavax' phase II clinical trial results of NanoFlu.

Read on…

Shares of BioXcel Therapeutics Inc. (BTAI) surged more than 39% on Thursday, following positive human proof-of-concept data from its phase I study of IV (intravenous) dexmedetomidine (Dex) for acute treatment of agitation in patients with Senile Dementia of the Alzheimer's Type (SDAT).

The positive data from this phase I trial provides evidence to support the continued clinical development of BXCL501 for the acute treatment of agitation under the accelerated Fast Track regulatory process, noted the Company.

BXCL501 is under a phase I placebo-controlled, single dose, dose-escalation study in healthy adult volunteers - with top-line data anticipated in the first half of 2019.

BTAI closed Thursday's trading at $5.02, up 39.83%.

CAS Medical Systems Inc. (CASM) has provided preliminary unaudited sales results for the fourth quarter and full year ended December 31, 2018.

The Company expects net sales from continuing operations for the fourth quarter of 2018 to be approximately $5.8 million, up 13% from $5.1 million for the fourth quarter of 2017.

Net sales from continuing operations for 2018 are expected to be approximately $21.9 million, up 17% from $18.8 million for 2017.

The financial results for the fourth quarter and full year of 2018 are expected to be reported in early March 2019.

CASM closed Thursday's trading at $1.79, up 7.19%.

Catabasis Pharmaceuticals Inc. (CATB) expects top-line results from its phase III trial of Edasalonexent (CAT-1004) in Duchenne muscular dystrophy, dubbed PolarisDMD, in the second quarter of 2020.

A total of nine PolarisDMD clinical trial sites are now open for enrollment across the United States and at least ten additional sites are expected to open shortly. Additionally, clinical trial applications to conduct the PolarisDMD trial in Canada and multiple countries in Europe have been approved, according to the Company.

In total, the PolarisDMD trial is expected to include approximately 40 clinical trial sites globally, with enrollment expected to be completed in 2019.

CATB closed Thursday's trading at $4.60, up 3.84%.

Celgene Corp. (CELG) soared more than 20% on Thursday, after agreeing to be acquired by Bristol-Myers Squibb Company (BMY) in a cash and stock transaction valued at approximately $74 billion.

Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene.

Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones.

The combination has been approved by the Boards of Directors of both companies.

Based on the closing price of Bristol-Myers Squibb stock of $52.43 on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders at closing is valued at $102.43 per Celgene share and one CVR.

When completed, Bristol-Myers Squibb shareholders are expected to own approximately 69 percent of the company, and Celgene shareholders are expected to own approximately 31 percent.

The transaction is expected to be completed in the third quarter of 2019.

CELG closed Thursday's trading at $80.43, up 20.69%.

Shares of Marker Therapeutics Inc. (MRKR) were up over 16% in extended trading on Thursday, following an update on its clinical trials of LAPP and MAPP multi-antigen targeted T cell (MultiTAA) therapies and TPIV200, its Folate Receptor Alpha (FRa) peptide cancer vaccine product candidate.

In phase I/II clinical trials of MultiTAA T cell therapies, LAPP and MAPP, sponsored by Baylor College of Medicine, 15 patients with active Lymphoma who have failed an average of four lines of prior therapy were treated. In a phase I/II clinical trial of MultiTAA therapy in multiple myeloma, 10 patients with active disease were treated
Enrollment has been completed in a phase II study of TPIV200 as a maintenance therapy for ovarian cancer patients in their first remission after surgery and platinum-based chemotherapy. An interim analysis of this study is planned for the end of the second quarter of 2019, with interim data expected to be reported by year end.

MRKR closed Thursday's trading at $5.87, down 5.48%. In after-hours, the stock was up 16.52% to $6.84.

MRI Interventions Inc.'s (MRIC.OB) ClearPoint PURSUIT Neuro Aspiration system has received FDA clearance.

The ClearPoint PURSUIT neuro aspiration device is indicated for the controlled aspiration of blood, clotted blood, cystic components of tumors, abscesses, colloid cysts, and cerebral spinal fluid using a manual syringe during the surgery of the ventricular system or cerebrum.

The device is expected to be commercially launched in the U.S. in the first half of 2019.

MRIC.OB closed Thursday's trading at $1.70, up 3.03%.

Neovasc Inc. (NVCN) has been notified by the NASDAQ of being not in compliance with maintaining a minimum market value of US $35 million for continued listing on the Nasdaq Capital Market pursuant to Listing Rule 5550(b)(2).

Based on the market value of the Company for the 30 consecutive business days from November 16, 2018, to January 2, 2019, the Company no longer meets the minimum market value requirement.

The Company has been provided 180 calendar days, or until July 2, 2019, to regain compliance with Nasdaq Listing Rule 5550(b)(2). To regain compliance, the Company's market value must exceed US$35 million for a minimum of 10 consecutive business days.

NVCN closed Thursday's trading at $0.62, down 1.43%. In after-hours, the stock was up 3.96% to $0.65.

Shares of Novavax Inc. (NVAX) were up 10% in extended trading on Thursday, following top-line results of its phase II clinical trial of NanoFlu.

The trial compared the safety and immune responses of various quadrivalent formulations of NanoFlu, with or without Novavax' Matrix-M adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older.

According to the Company, the phase II clinical trial confirmed phase I/II results, again demonstrating improved immune responses over Sanofi Pasteur's Fluzone High-Dose.

Novavax has planned to have an end-of-phase II meeting with the FDA in the first half of 2019, and a pivotal phase III clinical trial is expected to be initiated in 2019.

NVAX closed Thursday's trading at $2.04, up 3.55%. In after-hours, the stock was up 10.29% to $2.25.

SCYNEXIS Inc. (SCYX) has a couple of catalysts to watch out for this year.
Site initiation activities continue to progress for the phase II trial of oral Ibrexafungerp in combination with standard-of-care Voriconazole in patients with invasive pulmonary aspergillosis, dubbed SCYNERGIA.

A phase III study of SCY-078 in patients with refractory or intolerant fungal diseases, dubbed FURI, is underway, with top-line findings expected by February 2019.

Another ongoing phase III clinical program is VANISH, which comprises two trials (approximately 350 patients each) designed to evaluate the safety and efficacy of one-day oral Ibrexafungerp versus placebo for the treatment of VVC.

Pending successful completion of these two trials, SCYNEXIS plans to file an initial NDA for oral Ibrexafungerp for the treatment of vulvovaginal candidiasis in 2H 2020.

SCYX closed Thursday's trading at $0.54, up 0.51%. In after-hours, the stock was up 9.71% to $0.60.

UNITY Biotechnology Inc. (UBX) has selected UBX1967 as the lead development candidate in the ophthalmology pipeline and has executed the compound license agreement for the compound with Ascentage Pharma Group Corp Limited under a previously agreed compound library agreement.

UBX1967 is being evaluated in a range of age-related diseases of the eye, including neovascular age-related macular degeneration, proliferative diabetic retinopathy, and diabetic macular edema.

UNITY plans to file an IND application for UBX1967 in the second half of 2019.

UBX closed Thursday's trading at $16.30, down 2.16%.

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