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Wednesday, January 8, 2020

Walgreens Boots EPS misses by $0.04, misses on revenue

Walgreens Boots (NASDAQ:WBA): Q1 Non-GAAP EPS of $1.37 misses by $0.04; GAAP EPS of $0.95 misses by $0.20.
Revenue of $34.34B (+1.6% Y/Y) misses by $110M.

Synthetic Bio up on advancement of co-lead candidate

Thinly traded nano cap Synthetic Biologics (SYN +8.7%) is up a 17x surge in volume in reaction to its update on co-lead candidate SYN-004 (ribaxamase).
Based on FDA feedback, a single-center three-arm Phase 1b/2a clinical trial, expected to start this quarter, will assess SYN-004 in up to 36 adults patients undergoing allogeneic hematopoietic cell transplantation (HCT) who have received intravenous beta-lactam antibiotics in response to fever. The primary objectives are safety, tolerability and pharmacokinetics.
The study will be conducted at the Washington University School of Medicine in St. Louis.
SYN-004 is an oral enzyme tablet that is co-administered with the antibiotics. By degrading beta-lactams, it helps maintain the normal balance of the gut microbiome and prevents unwanted effects such as diarrhea and Clostridium difficile infection.

FDA OKs new surgical approach for Abbott heart pump

Abbott (ABT -0.2%announces that the FDA has signed off on an alternative, less-invasive, surgical technique for its HeartMate 3 Left Ventricular Assist Device (LVAD) that will allow more advanced heart failure patients to avoid open heart surgery, the traditional way to implant an LVAD.
The procedure, called lateral thoracotomy, enables the placement of the device via an incision between the patient’s ribs to access the heart.
The FDA approved HeartMate 3 in August 2017 for short-term hemodynamic support in advanced heart failure patients. In October 2018, the agency approved it as a destination therapy (permanent use) in patients who are not eligible for transplant.

Genetic Tech up 95% on U.S. launch of breast cancer test

Thinly traded nano cap Genetic Technologies Limited (GENE +94.7%) rockets up on a whopping 333x surge in volume in reaction to the impending U.S. commercial launch of its GeneType for Breast Cancer test designed to assess breast cancer risk in patients at least 35 years old.
It plans to commence a limited release across 20 centers in eight states this quarter followed by full launch in Q2.

Collegium sees Xtampza sales as high as $160M this year

Collegium Pharmaceutical (NASDAQ:COLL) provides its 2020 outlook.
Xtampza ER (oxycodone) sales: $150M – 160M.
Nucynta (tapentadol) franchise sales: $170M – 180M.
Operating expenses: $130M – 140M.

Tuesday, January 7, 2020

VTv Therapeutics after market as Perelman boosts stake

VTv Therapeutics (NASDAQ:VTVT) is up 7% after hours following a boost to the majority stake held by Ron Perelman’s MacAndrews & Forbes.
Today the company exercised a right to cause MacAndrews & Forbes to buy 1.25M shares at $1.60 each – part of an agreement between the two reached Dec. 23.
MacAndrews & Forbes funded $2M to the company in return.

Cumberland Pharma rolls out new ibuprofen product

Cumberland Pharmaceuticals (NASDAQ:CPIX) has announced the launch of a new ready-to-use Caldolor product, following previous FDA approval for a new delivery method.
The ibuprofen product now comes in a ready-to-use bag that can be administered without dilution, the company says. the bag contains 800 mg of ibuprofen in a 200 mL patented low-sodium formulation for injection.
“We have been encouraged by the significant number of physicians who have incorporated Caldolor into their pain management regimens as a way to combat the negative effects of opioid use,” says CEO A.J. Kazimi.
Shares are up 3% after hours.