Online health insurance marketplace GoHealth Inc said on Wednesday it plans to raise up to $790 million in its initial public offering at a valuation of about $6.26 billion.
Wednesday, July 8, 2020
EU secures potential COVID-19 drugs from Roche, Germany’s Merck
The European Commission has struck deals with drugmakers Roche and Merck KGaA to secure supplies of experimental treatments for COVID-19, a Commission source told Reuters on Wednesday.
The deals cover Roche’s arthritis medicine RoActemra and Merck’s multiple sclerosis drug Rebif – both seen as potential treatments for COVID-19 – and will secure supplies to any of the 27 EU member states willing to buy them, the source said.
The source, who declined to be identified because of the sensitivity of the topic, did not disclose the terms of the deals. Roche, Merck and a Commission spokeswoman were not immediately available for comment.
The deals follow requests from EU states in May to acquire the two drugs and come as governments around the world jostle for access to potential therapies and vaccines against COVID-19, even before their efficacy is proven.
Roche is doing a late-stage, 330-patient trial of Actemra, known as RoActemra in some markets, in COVID-19 patents after the anti-inflammatory drug used against rheumatoid arthritis was deployed in China in patients suffering from a severe immune system reaction.
The medicine has also been tested on COVID-19 patients in combination with Gilead’s antiviral remdesivir, the only drug so far authorized by the EU for use against COVID-19.
In early June, an Italian trial of Actemra in patients with early-stage COVID-19 showed it failed to help them.
Rebif was developed by Swiss biotech firm Serono before Merck bought the company.
Both drugs target proteins in the body associated with inflammation, and there is some hope they may help severely ill COVID-19 patients suffering from a so-called cytokine storm, an immune system reaction that in can lead to organ failure.
The companies said in letters to the Commission that they could meet demand from EU countries, the source said, declining to name the EU states that had expressed interest in the drugs.
EU countries will now have to agree with the companies on the supplies needed, the source added.
Brussels is also in talks with Gilead to obtain doses of remdesivir for member states and boost its production capacity. It also wants to reserve supplies of vaccines being developed by Johnson & Johnson and Sanofi.
In June, France, Germany, Italy and the Netherlands said they had secured 400 million doses of a potential COVID-19 vaccine developed by Britain’s AstraZeneca.
Concerns over remdesivir’s availability were ignited after Gilead pledged almost all its output to the United States.
AstraZeneca’s Lynparza OK’d in Europe for BRCA+ pancreatic cancer
The European Commission has approved AstraZeneca’s (NYSE:AZN) PARP inhibitor Lynparza (olaparib) for the treatment of patients with germline BRCA-mutated metastatic pancreatic cancer.
About 5-7% of metastatic pancreatic cancer patients have such a germline mutation.
Lynparza is approved in the U.S. and several other countries as first-line maintenance treatment for these patients.
https://seekingalpha.com/news/3589368-astrazenecas-lynparza-okd-in-europe-for-brca-pancreatic-cancer
Kiadis inks license deal with Sanofi valued as high as €875M
Kiadis Pharma N.V. (OTC:KIADF) has granted an exclusive global license to its K-NK004 cell program to Sanofi (NASDAQ:SNY), including exclusive rights to its K-NK platform for two other preclinical programs (excluding K-NK002 and K-NK003).
Under the terms of the deal, Kiadis will receive €17.5M upfront, up to €857.5M in milestones and low-double digit royalties on net sales.
The agreement covers Kiadis’ proprietary CD38 knockout K-NK therapeutic for use in combination with Sanofi’s Sarclisa (isatuximab-irfc), a CD38-directed cytolytic antibody approved in the U.S. four months ago and in Europe last month for treatment-resistant multiple myeloma (MM).
Kiadis says the combination of its CD38 knockout K-NK cells with Sarclisa has the potential to be the first-in-class treatment for MM.
Concert Pharma CTP-543 a Breakthrough Therapy for alopecia areata
The FDA has granted Breakthrough Therapy Designation for Concert Pharmaceuticals’ (NASDAQ:CNCE) oral Janus kinase inhibitor, CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
Concert Pharma intends to initiate a Phase 3 CTP-543 clinical program in Q4.
Regenxbio advances MPS II gene therapy in clinical study
REGENXBIO (NASDAQ:RGNX) announces that it has completed dosing of three subjects in cohort 2 in a Phase 1/2 clinical trial evaluating gene therapy RGX-121 in patients with mucopolysaccharidosis type II (MPS II), a rare inherited disorder in which the body lacks a key enzyme to break down long chains of sugar molecules called glycosaminoglycans. The buildup of the sugars in cells leads to a range of sequelae including short stature, joint deformities, cognitive decline and heart problems.
The gene therapy was well-tolerated with no treatment-related serious adverse events. Additional data should be available in H2.
On a similar note, a single patient with MPS I who received gene therapy RGX-111 is also doing well, experiencing no serious treatment-related adverse events. Additional site activations are underway.
Medtronic bids for Intersect ENT
According to informed sources, Medtronic (NYSE:MDT) has made an offer for sinus implant developer Intersect ENT (NASDAQ:XENT).
The Menlo Park, CA-based device maker has struggled during the COVID-19 pandemic. Q1 sales were down 26% leading to a ~30% cut in headcount.
XENT up 35% premarket on modest volume.
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