FDA OKs compassionate use of Mesoblast stem cells in kids’ Covid-19 complications

Mesoblast (NASDAQ:MESO) initiates an expanded access protocol (EAP) in the U.S. for compassionate use of its allogeneic mesenchymal stem cell product candidate, remestemcel-L, in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C).

Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP.

https://seekingalpha.com/news/3588616-fda-oks-compassionate-use-of-mesoblast-stem-cells-in-children-covidminus-19-complications

Regeneron advancing COVID-19 cocktail

Regeneron Pharmaceuticals (NASDAQ:REGN) initiates a large-scale Phase 3 clinical trial evaluating its double antibody cocktail, REGN-COV2, for the prevention of COVID-19 in uninfected people who have experienced close exposure to a patient with active COVID-19 infection.

The company is jointly conducting the 2,000-subject study with the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

It has also advanced into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials assessing the cocktail in hospitalized and non-hospitalized COVID-19 patients.

REGN-COV2, produced by the company’s proprietary VelocImmune mice, consists of two neutralizing antibodies that bind non-competitively to the critical receptor binding domain of the coronavirus’ spike protein, diminishing the ability of mutant viruses to avoid treatment and protecting against spike variants that have arisen in the human population.

https://seekingalpha.com/news/3588625-regeneron-advancing-covidminus-19-cocktail

FDA OKs Abbott’s next-gen defibrillators

Abbott (NYSE:ABT) announces the FDA nod for its Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices.

The company says new features include a patient-preferred design without compromising battery life and MRI compatibility and a smartphone app for improved remote monitoring.

The Gallant system was CE Mark’d in February.

https://seekingalpha.com/news/3588661-fda-oks-abbotts-next-gen-defibrillators

Bellus Health lead drug flunks chronic cough study

July 6, 2020

BELLUS Health (NASDAQ:BLU) craters 79% premarket on robust volume in reaction to unsuccessful results from a Phase 2 clinical trial, RELIEF, evaluating escalating doses of lead candidate BLU-5937 in patients with refractory chronic cough.

The study failed to achieve the primary endpoint of a statistically significant reduction from baseline in awake coughs per hour at eight time points at the four doses tested.

In a subgroup of participants experiencing high cough counts (at least 32.4 coughs per hour on average), all four doses tested did produce statistically significant reductions in cough frequency (-28% to -32%).

On the safety front, BLU-5937 was well-tolerated with no serious treatment-related adverse events reported. The most common adverse events were taste alteration and partial taste loss.

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

Small molecule BLU-5937 is a orally available antagonist of the P2X3 receptor, a validated target for chronic cough. The company previously claimed that preclinical tests showed that BLU-5937 significantly reduced cough with no taste loss, an unwanted side effect associated with Merck’s (NYSE:MRK) P2X3 antagonist gefapixant.

https://seekingalpha.com/news/3588638-bellus-health-lead-drug-flunks-chronic-cough-study

FDA lifts partial hold on mid-stage study of ADC’s camidanlumab tesirine

The FDA has removed its partial clinical hold on a pivotal Phase 2 clinical trial evaluating ADC Therapeutics’ (NYSE:ADCT) antibody-drug conjugate camidanlumab tesirine in patients with relapsed/refractory Hodgkin lymphoma.

The company says it “worked diligently” to provide responses to the agency’s request for information but does disclose the specific nature of the request.

A partial clinical hold suspends recruitment but allows current participants to continue treatment.

Camidanlimab tesirine is comprised of a CD25-targeting monoclonal antibody in-licensed from Genmab A/S (NASDAQ:GMAB) linked to tesirine, the pyrrolobenzodiazepine (PBD) dimer payload.

https://seekingalpha.com/news/3588649-fda-lifts-partial-hold-on-mid-stage-study-of-adc-therapeutics-camidanlumab-tesirine

Myriad partners with OptraHealth for AI-based cancer information tool

Myriad Genetics (NASDAQ:MYGN) partners with OptraHEALTH to implement a cognitive ChatBOT named Gene to provide genetic and financial assistance information to prospective patients.

Gene interfaces with Myriad’s market-leading online hereditary cancer quiz, which is now taken by approximately one million people per year.

Shares are up 3.4% premarket to $11.97

Source: Press Release

https://seekingalpha.com/news/3588664-myriad-partners-optrahealth-for-ai-based-information-tool-for-hereditary-cancer-patients

Precision Bio regains rights to in vivo Hep B program

Precision BioSciences (NASDAQ:DTIL) will regain full rights and all data it generated for the in vivo chronic hepatitis B virus (HBV) program developed under its 2018 collaboration agreement with Gilead Sciences (NASDAQ:GILD).

Under the terms of agreement, Precision Bio was responsible for the development, formulation, and preclinical study of investigational nucleases whereas Gilead was responsible for the development and commercialization.

Upon the collaboration’s conclusion, effective September 4, 2020, Precision Bio will regain full clinical development and commercialization rights to the program.

The Company does not anticipate any changes to its cash runway. As of March 31, DTIL had cash and equivalents of $154.2M.

https://seekingalpha.com/news/3588675-precision-bio-regains-rights-to-in-vivo-hbv-program