Rocket Pharma initiates RP-L301 study for red blood cell disorder

Rocket Pharmaceuticals (NASDAQ:RCKT) announces that the first patient has received investigational therapy in the Phase 1 clinical trial of RP-L301, the lentiviral vector (LVV)-based gene therapy for the treatment of Pyruvate Kinase Deficiency (PKD), a rare monogenic red blood cell disorder.

The trial is expected to enroll six adult and pediatric transfusion-dependent PKD patients in U.S. and Europe and will be comprised of three cohorts to assess RP-L301 in young pediatric (age 8-11), older pediatric (age 12-17) and adult populations.

Preliminary Phase 1 data are anticipated in Q4.

https://seekingalpha.com/news/3590500-rocket-pharma-initiates-rp-l301-study-for-red-blood-cell-disorder

Teva launches ProAir Digihaler in U.S.

July 13, 2020

Teva Pharmaceutical Industries (NYSE:TEVA) unit Teva Respiratory, LLC announces the U.S. commercial launch of ProAir Digihaler (albuterol sulfate 117 mcg) Inhalation Powder for the treatment or prevention of bronchospasm in patients at least four years old who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

The device features built-in Bluetooth Wireless Technology sensors, which connect to a companion mobile app and provide inhaler event information.

The wholesale acquisition cost (WAC) is $146.67, exclusive of rebates and discounts.

https://seekingalpha.com/news/3590525-teva-launches-proair-digihaler-in-u-s

Herbalife sees big jump in Q2 volume points, highest on record

On a preliminary basis, Herbalife (NYSE:HLF) expects ~1.7B volume points, up 12.4% from a year ago and the largest volume point quarter in its history.

The biggest jumps occurred in North America (+38.5%), EMEA (Europe, Middle East, Africa) (20.9%) and China (+17.7%).

On another note, it has launched a self-tender offer for up to $750M of its common shares at per-share prices of $44.75 – 50.00. The offer will expire at 5:00 pm ET on August 11 unless extended.

https://seekingalpha.com/news/3590532-herbalife-sees-big-jump-in-q2-volume-points-highest-on-record

Pandion Therapeutics sets terms for upsized IPO

Pandion Therapeutics (PAND) has filed a preliminary prospectus for its IPO of 5.5M common shares at $16 – 18, expected to yield $93.5M (midpoint), up from its initial filing for a $75M offering.

https://seekingalpha.com/news/3590578-pandion-therapeutics-sets-terms-for-upsized-ipo

Spark’s hemophilia A gene therapy shows sustained benefit in Phase 1/2 study

Roche (OTCQX:RHHBY +0.6%) unit Spark Therapeutics reports updated data from three dose cohorts in a Phase 1/2 clinical trial evaluating gene therapy candidate SPK-8011 in hemophilia A patients. The results were presented virtually at the International Society of Thrombosis and Hemostasis Congress.

14 participants have been dosed, two at the lowest level, three at the middle level and nine at the highest level. The safety profile to date has been “acceptable.” On the efficacy front, there was a 91% reduction in annualized bleed rate and 96% reduction in factor VIII (FVIII) infusions. FVIII expression has been stable and durable between 2.0 and 3.3 years of follow-up.

As reported in August 2018, two patients in the highest dose cohort lost FVIII expression likely due to capsid-based immune responses.

Dosing in a Phase 3 trial should start in 2021.

Related ticker: BioMarin Pharmaceutical (BMRN +1.2%)

https://seekingalpha.com/news/3590606-sparks-hemophilia-gene-therapy-shows-sustained-benefit-in-phase-1-2-study

Hong Kong Disneyland re-closing as virus cases rise

Hong Kong Disneyland (DIS +0.4%) is re-closing the park amid a resurgence of COVID-19 cases.

It had reopened nearly a month ago with capacity limits and new safety measures, but since then the government has closed a number of entertainment and fitness businesses.

Hong Kong said today it would cap all public gatherings at four people, shut down dine-in services at restaurants from 6 p.m. to 5 a.m., and close gyms and game arcades for seven days.

https://seekingalpha.com/news/3590588-hong-kong-disneyland-re-closing-virus-cases-rise

Gritstone Oncology down 32% on cancer vaccine data

Thinly traded micro cap Gritstone Oncology (NASDAQ:GRTS) slumps 32% premarket on increased volume on the heels of its presentation of interim results from two Phase 1 clinical trials, GRANITE and SLATE, evaluating personalized and off-the-shelf neoantigen therapeutic vaccine candidates, respectively, in patients with solid tumors.

Investors appear to have expected more significant treatment effects.

Phase 2 studies are next up.

https://seekingalpha.com/news/3590559-gritstone-oncology-down-32-on-cancer-vaccine-data