Nanox Acquisition Zebra Medical Vision Secures 8th 510K FDA Clearance

  NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that Zebra Medical Vision secures 8th 510K FDA clearance for its Coronary Artery Calcium (CAC) solution as part of its population health offering.

On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD. This agreement, once consummated, will put Zebra-Med on track to expand its mission of helping to diagnose populations at scale with its AI-based solutions, enabling IDNs and commercial payers to detect and treat patients at risk for chronic conditions while accurately adjusting their covered population risk.

https://finance.yahoo.com/news/nanox-announce-zebra-medical-vision-123000195.html

Pfizer begins study of oral drug for prevention of COVID-19

 Pfizer Inc said on Monday it has started a mid-to-late-stage study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.

The company and its rivals, including U.S.-based Merck & Co Inc and Swiss pharmaceutical Roche Holding AG, have been racing to develop the first antiviral pill for COVID-19.

Pfizer said it would study the drug, PF-07321332, in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID-19 infection.

The trial would test PF-07321332 with a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection.

Merck and partner Ridgeback Biotherapeutics said earlier this month they had begun enrolling patients in a late-stage trial of their experimental drug molnupiravir for prevention of COVID-19 infection.

Pfizer had also said earlier this month it started a mid-to-late-stage trial of PF-07321332 for the treatment of COVID-19 in non-hospitalized, symptomatic adult patients.

https://finance.yahoo.com/news/1-pfizer-begins-study-oral-111913384.html

Merck KEYTRUDA Met Primary Endpoint in Advanced Hepatocellular Carcinoma

 

In Phase 3 KEYNOTE-394 Study, KEYTRUDA Showed Statistically Significant Improvement in OS Versus Placebo

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-394 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in Asian patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib met its primary endpoint of overall survival (OS). The study found that treatment with KEYTRUDA plus best supportive care resulted in a statistically significant improvement in OS compared with placebo plus best supportive care. KEYNOTE-394 also met its key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR), with statistically significant improvements for KEYTRUDA compared with placebo. No new safety signals were observed. These results will be presented at an upcoming medical meeting.

https://finance.yahoo.com/news/merck-announces-keytruda-pembrolizumab-met-104500651.html

Sarepta to Initiate Part B of Duchenne Study After FDA Input

 Company Anticipates Part B of MOMENTUM to Serve as Pivotal Study for SRP-5051 and to Seek Accelerated Approval if Successful

- Ambulatory and Non-Ambulatory Patients Between the Ages of 7 to 21 Will Be Eligible to Enroll in Part B of MOMENTUM

 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that following positive interactions with the U.S. Food and Drug Administration (FDA), the Company plans to initiate Part B of the MOMENTUM study (Study 5051-201), in the fourth quarter. MOMENTUM is a global trial investigating the use of SRP-5051, the Company’s next-generation peptide-conjugated phosphorodiamidate morpholino oligomer (PPMO) to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.

The study will enroll between 20-40 patients between ages 7 to 21 amenable to exon 51 skipping who are naïve to SRP-5051. Additionally, those previously dosed in Study 5051-201, Part A or Study 5051-102 who meet the entrance criteria will be eligible to participate. Both ambulatory and non-ambulatory patients are eligible for participation. The Company will submit the protocol in the next week.

https://finance.yahoo.com/news/sarepta-therapeutics-initiate-part-b-123000448.html

NRx Pharma: Improved Survival at One Year in Highly Comorbid COVID-19 Patients

  ZYESAMI™ (aviptadil) Has Previously Demonstrated a Statistically Significant Increase in Survival of Highly Comorbid COVID-19 Patients in Two 60-day Trials

- In a Study of Highly Comorbid Patients, ZYESAMI Provided a Threefold, Statistically Significant Increase in Likelihood of Survival at One Year

NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage, biopharmaceutical company, today announced top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAM.

"These latest data are encouraging and will help those of us on the frontlines treat the sickest COVID patients, potentially providing new treatment options and strategies," said Dr. J. Georges Youssef.

Between June and September 2020, a trial was conducted at a leading tertiary care hospital involving patients with Critical COVID-19 whose level of comorbidity excluded them from the randomized phase 2b/3 clinical trial of ZYESAMI. A statistically significant difference in both survival and recovery from respiratory failure was reported at 28 days. Those findings are soon to be published in a peer-reviewed journal.

Participants in this trial have now been followed for one year from initial enrollment. Top-line results show a statistically significant (P<.0001) 3-fold advantage in likelihood of being alive at one year post treatment (60% vs. 20%) among those treated with ZYESAMI, in addition to standard of care, compared to those who received the standard of care alone. Assignment to ZYESAMI in the trial was based on the specific medical team which admitted the patient to the intensive care unit (ICU). Once in the ICU, all patients were cared for by the same medical team, and according to the same treatment protocols.

https://finance.yahoo.com/news/nrx-pharmaceuticals-announces-improved-survival-110400729.html

Acceleron in advanced talks for $11B sale

 U.S. drugmaker Acceleron Pharma Inc is in advanced talks to be acquired by a large pharmaceutical company for more than $11 billion, Bloomberg News reported on Friday, citing people familiar with the matter.

The acquisition would be made at about $180 per share in cash, the report said.

Details about the potential buyer were not known, but the report added that several global drugmakers, including Bristol-Myers Squibb Co, which owns 11.5% of Acceleron's stock, are seen as potential suitors.

Acceleron, based in Cambridge, Massachusetts is a clinical-stage biopharmaceutical company with a total market value of $10.2 billion. The company focuses on the discovery, development and commercialization of therapeutics to treat serious and rare diseases.

https://www.foxbusiness.com/markets/acceleron-in-advanced-talks-for-11b-sale

Biohaven Updates On Phase 3 Trial, Multiple System Atrophy (MSA) Program

 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced results from a focused analysis of a clinical trial of verdiperstat in multiple system atrophy (MSA).  Verdiperstat did not statistically differentiate from placebo on the prespecified primary efficacy measure, nor on the key secondary efficacy measures. Initial analysis of safety data was consistent with the overall profile of verdiperstat from prior clinical trial experience. Additional analyses are still pending, and full study results will be presented at an upcoming scientific meeting.

Irfan Qureshi, M.D., Vice President of Neurology at Biohaven commented, "While we are disappointed that verdiperstat did not demonstrate efficacy for the treatment of MSA, Biohaven remains committed to fighting on behalf of people living with neurodegenerative diseases. There are currently no approved disease modifying therapies for MSA and we must continue to advance the science to improve treatment outcomes for patients suffering from this disease. We are extremely grateful to the international MSA community – especially the patients and their families, investigators and their teams, and patient advocacy groups – who made the trial possible."

Verdiperstat is an investigational first-in-class, potent, selective, brain-penetrant, and irreversible myeloperoxidase (MPO) enzyme inhibitor that Biohaven is developing for the treatment of neurodegenerative diseases. Verdiperstat may help preserve neurons through inhibition of MPO-induced pathological oxidative stress and further inflammation that contribute to cellular injury in neurodegenerative disease.

Although the mechanism of action for verdiperstat, myeloperoxidase inhibition, was shown not to be effective for MSA, the rationale of targeting brain inflammation remains strong in other disease states.  An ongoing clinical trial evaluating the efficacy of verdiperstat in amyotrophic lateral sclerosis (ALS) is being conducted in collaboration with the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and is expected to complete enrollment in the fourth quarter of 2021.

https://www.prnewswire.com/news-releases/biohaven-provides-update-on-phase-3-trial-and-multiple-system-atrophy-msa-program-301385193.html