Freeline Therapeutics sets IPO terms

Freeline Therapeutics (FRLN) has launched the roadshow for its IPO of up to 7,352,941 American Depositary Shares (ADSs).

The price is currently expected to be between $16.00 and $18.00 per ADS, resulting in a total offering size of $117.6M to $132.4M.

Underwriters’ over-allotment is an additional 1,102,941 ADSs.

Previously: Freeline Therapeutics on deck for IPO (July 17)

Now read: Freeline Therapeutics Aims For $100 Million U.S. IPO »

https://seekingalpha.com/news/3598826-freeline-therapeutics-sets-ipo-terms

FDA OKs new Medtronic sacral nerve modulator

August 3, 2020

Medtronic (NYSE:MDT) announces the FDA nod for its InterStim Micro sacral nerve modulator (SNM) for the treatment of overactive bladder, fecal incontinence and non-obstructive urinary retention. The company says the device is the world’s smallest, half the size of other SNM products.

The FDA also approved the InterStim SureScan MRI leads that are used with the InterStim Micro and recharge-free InterStim II devices and allow full-body 1.5T and 3T MRI-conditional scans.

https://seekingalpha.com/news/3598836-fda-oks-new-medtronic-sacral-nerve-modulator

BioCryst Pharma’s BCX9930 Fast Track’d for red blood cell disease

The FDA has granted Fast Track designation for BioCryst Pharmaceuticals’ (NASDAQ:BCRX) oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

https://seekingalpha.com/news/3598838-biocryst-pharmas-bcx9930-fast-trackd-for-red-blood-cell-disease

Ligand Pharmaceuticals beats on revenue

Ligand Pharmaceuticals (NASDAQ:LGND): Q2 Non-GAAP EPS of $1.00; GAAP EPS of $1.32.

Revenue of $41.42M (+65.7% Y/Y) beats by $11.46M.

Press Release

https://seekingalpha.com/news/3598840-ligand-pharmaceuticals-beats-on-revenue

CymaBay’s seladelpar successful in late-stage study in bile duct disorder August 3, 2020

CymaBay Therapeutics (NASDAQ:CBAY) announces positive results from a Phase 3 clinical trial, ENHANCE, evaluating lead drug seladelpar in patients with primary biliary cholangitis (PBC), a chronic disease in which the liver’s bile ducts are slowly destroyed.

The study met the primary endpoint demonstrating a statistically significant responder rate compared to placebo. Specifically, 78.2% of the participants in the 10 mg arm and 57.1% of those in the 5 mg arm achieved the primary composite outcome versus 12.5% in the control arm.

The trial was terminated prior to completion of the 52-week treatment period so the primary endpoint was amended to a three-month time point prior to database lock.

In late November 2019, the FDA suspended all seladelpar studies after a potential safety signal was observed in a Phase 2b study. On July 23, it lifted all clinical holds after an investigation found no evidence of seladelpar-related liver injury.

Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases with the lead indication being PBC.

Management hosted a conference call this morning at 8:00 am ET to discuss the results.

https://seekingalpha.com/news/3598847-cymabays-seladelpar-successful-in-late-stage-study-in-bile-duct-disorder

UPS readies freezer farms to ship COVID-19 vaccines

United Parcel Service (NYSE:UPS) is building two giant freezer farms capable of super-cooling millions of vials of COVID-19 vaccines, preparing for the day when it will need to ship the products worldwide.

The under-construction facilities, located near UPS air hubs in the Netherlands and Louisville, KY, will house a total of 600 deep freezers, each able to hold 48K vials at temperatures as low as -112 degrees Fahrenheit.

The hard part will be the logistics involved in shipping the product under exacting conditions.

Competitors FedEx (NYSE:FDX) and DHL Global Forwarding have also been beefing up their temperature-controlled transport capabilities.

https://seekingalpha.com/news/3598922-ups-readies-freezer-farms-to-ship-covidminus-19-vaccines

Atossa on go to start early-stage study of COVID-19 nasal spray

An ethics committee in Australia has signed off on a Phase 1 clinical trial evaluating Atossa Therapeutics’ (ATOS +6.6%) AT-301, administered via nasal spray, for the potential treatment of patients who have been diagnosed with COVID-19 but are not experiencing symptoms requiring hospitalization.

The randomized double-blind study will assess the safety and tolerability of AT-301 in 32 healthy adult volunteers divided into two groups. Part A consists of two single-dose cohorts receiving either the active drug AT-301B or the placebo comparator AT-301A at two different doses. Part B is a multiple dose arm with cohorts receiving either AT-301B or AT-301A for 14 days at different doses.

AT-301 is designed for at-home use to proactively reduce COVID-19 symptoms and slow the infection rate to allow the patient’s immune system to fight the SARS-CoV-2 virus.

https://seekingalpha.com/news/3598996-atossa-on-go-to-start-early-stage-study-of-covidminus-19-nasal-spray