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Tuesday, August 4, 2020

Merck in-licenses NASH candidate from Hanmi Pharmaceutical

Merck (NYSE:MRK) inks an agreement with South Korea’s Hanmi Pharmaceutical securing exclusive global rights to the latter’s efinopegdutide (formerly HM12525A), a once-weekly glucagon-like peptide-1/glucagon receptor dual agonist, for the potential treatment of nonalcoholic steatohepatitis (NASH).
Under the terms of the deal, Merck will pay Hanmi $10M upfront, up to $860M in milestones and double-digit royalties on net sales. Hanmi retains an option to commercialize the product in Korea.

Redx Pharma Shares Skyrocket on AstraZeneca Agreement

Shares in Redx Pharma PL rose sharply on Tuesday after the company said that it signed an out licensing agreement with AstraZeneca PLC for the development and commercialization of RXC006, a porcupine inhibitor for fibrotic diseases.
Shares at 0710 were up 45 pence, or 180%, at 70 pence.
The London-listed, drug discovery-and-development company said it will receive up to $17 million in early payments, and that it is eligible to receive up to a further $360 million in development and commercial milestones, plus tiered royalties of mid-single digit percentages, based on any future net sales.
The company said that under the deal AstraZeneca will take RXC006 forward into clinical development, targeting fibrotic diseases including idiopathic pulmonary fibrosis.
Porcupine inhibition is a novel anti-fibrotic approach, the company said.

BAYER AG: Goldman Sachs gives a Buy rating

August 4, 2020

In a research note published by Keyur Parekh, Goldman Sachs advises its customers to buy the stock. The target price remains set at EUR 74.

Novartis’s Kymriah meets endpoint in follicular lymphoma trial

Novartis CAR-T cell therapy Kymriah met its primary endpoint at an interim analysis of a phase-II trial in patients with relapsed or refractory follicular lymphoma, the Swiss drugmaker said on Tuesday.
Findings of the ELARA trial will support regulatory submissions, with filing in the United States anticipated in 2021 and in the European Union afterwards, it said.

Bayer AG EPS beats by €0.08, misses on revenue

Bayer AG (OTCPK:BAYZF): Q2 Non-GAAP EPS of €1.59 beats by €0.08; GAAP EPS of -€9.79.
Revenue of €10.05B (-6.2% Y/Y) misses by €350M.
Adjusted EBITDA of €2.88B vs. estimates of €2.74B.

Regeneron says COVID cocktail prevents, treats virus in animals August 4, 2020

Regeneron Pharmaceuticals (NASDAQ:REGN) says its COVID-19 antibody drug combination under development both prevented and treated the disease in rhesus macaques and hamsters, sparking hope that it might work for people.
The company says its REGN-COV2 cocktail of two monoclonal antibodies was able to “almost completely block establishment of virus infection” in the animal study and minimized infection in a second study in which animals were infected with a much higher level of the virus.
The lead researchers also say the animals did not show any signs of increased viral load or worsening of pathology after treatment, an important safety signal that suggests it will not worsen symptoms in humans.
Regeneron already has launched late-stage clinical trials in humans to assess the antibody treatment’s ability to prevent and treat COVID-19.


Monday, August 3, 2020

Fed policymakers call for fiscal support to save U.S. economy

The U.S. economy, battered by a resurgence in the spread of COVID-19, needs increased government spending to tide over households and businesses and broader use of masks to better control the virus, U.S. central bankers said on Monday.
The calls for increased government intervention came as U.S. lawmakers and the White House resumed talks on a new government relief package, including a possible extension of unemployment benefits that expired on Friday.
“The ball is in Congress’ court,” Chicago Fed President Charles Evans told reporters on a call. “Fiscal policy is fundamental to a better baseline outlook, to a stronger recovery and getting the unemployment rate down, people back to work safely, and ultimately reopening the schools safely.”
Without more government aid, Evans said, “aggregate demand trouble is brewing.” Translated for non-economists: people could stop spending and the bottom could really fall out of the economy.
Or, as Richmond Fed President Thomas Barkin put it, “quickly pulling away the support that consumers and businesses are receiving would be a pretty traumatic move for what’s happening in the economy.”
The full court Fed press for more government spending came as Republicans appeared reluctant to spend much more than the $3 trillion Congress had already committed to bolstering the economy in the face of the virus. But things have gotten worse since then, Barkin said.
“Four months ago, when we did the first stimulus, we thought the economy faced a pothole and the stimulus put a plate over it so we could navigate,” he told the Northern Virginia Chamber of Commerce. “Now escalation of the virus may be making that pothole into a sinkhole and creating a need for a longer plate.”
Echoing those sentiments in slightly different terms were Dallas Federal Reserve Bank President Robert Kaplan and St. Louis Fed President James Bullard. Kaplan pushed back on the notion that the extra $600 weekly benefits to the unemployed had made it harder for businesses to hire, while Bullard said earlier efforts to keep businesses and households whole through the crisis have paid off so far.
“We’ve looked at a number of studies, we’ve done our own work: we don’t see it as much in the data but I can tell you I’m hearing it from business people,” Kaplan told Bloomberg TV earlier Monday when asked about whether the enhanced jobless aid was deterring people from returning to work.
“While it may have made it hard for certain individual businesses to hire, it has helped create jobs, because it has helped bolster consumer spending, so the net effect still has probably been positive for the economy for employment.”
Kaplan also said he did not agree with his colleague, Minneapolis Fed President Neel Kashkari, who at the weekend said he thought the U.S. economy should shut back down again for four to six weeks to suppress spread of COVID-19.
Instead, Kaplan said, universal mask-wearing could substantially mute transmission of the virus without a widespread lockdown. “I think we are going to have to learn to live with this virus. We are going to have to learn to re-engage in our daily activities but still control the virus,” he said. “Widespread mask-wearing is essential to that.”
Bullard, too, emphasized mask-wearing as a significant risk-management tool, especially as he does not expect health officials to be able to reduce disease transmissions to zero because it is so contagious. He also warned against placing too much emphasis on the development of a successful vaccine.
“If you put too much emphasis on the idea that a vaccine is going to come and save us, and someone’s going to crack a very difficult scientific problem … then you get people not doing anything and sitting around waiting for the vaccine,” Bullard said in a presentation during an online event hosted by the bank’s Memphis, Tennessee, branch. “So if you do that, you do risk a depression because you could get a lot of business failures while you’re waiting, potentially a very long time for a vaccine to come and save the day.”
The regional bank presidents’ comments came just days after the Fed’s latest two-day policy meeting, at which officials repeated their pledge to do all in their power to help the economy weather the recession that began in February as the outbreak began ricocheting around the globe. The U.S. central bank has slashed interest rates to near zero – where they are expected to remain for years – and has rolled out roughly a dozen emergency programs to backstop financial markets and support businesses.
Bullard also said he expects that economic growth has resumed in the current third quarter, but that after a better-than-expected start to the rebound in May and June, the rebound slowed in July with the resurgence in infections in many areas of the country.
“We shouldn’t expect a completely smooth transition as you go forward because this is a crisis and there’s going to be ups and downs,” Bullard said.
Those swings were on display Monday, as U.S. manufacturing activity rose even as factory job losses persisted. California – the most populous U.S. state – reported a decline in hospitalizations and cases, but the state’s farmbelt has a severe outbreak, concentrated among Latinos.

Evans, in an uncharacteristically passionate outburst during his call with reporters, said that the virus’ unequal toll was an “indictment” of unequal access to U.S. healthcare.
“The state of equal healthcare in this country is abysmal,” he said.