Neurocrine Bio inks deal with Takeda for psychiatry candidates

Neurocrine Biosciences (NASDAQ:NBIX) inks an agreement with Takeda Pharmaceutical Company Limited (NYSE:TAK) for exclusive rights to seven Takeda programs in psychiatry, including three clinical-stage assets for the potential treatment of schizophrenia (TAK-831), treatment-resistant depression (TAK-653) and anhedonia (inability to feel pleasure) (TAK-041).

Under the terms of the deal, NBIX will be responsible for development and commercialization. Takeda will receive $120M upfront, up to $495M in development milestones, up to $1.4B in commercial milestones and double-digit royalties on net sales. Takeda has the option to opt in or out of a 50/50 profit share on all clinical programs at certain points in development.

NBIX will host a conference call momentarily to discuss the agreement.

https://seekingalpha.com/news/3583358-neurocrine-bio-inks-deal-takeda-for-psychiatry-candidates

Sanofi enzyme replacement therapy shows mixed results in Pompe study

Sanofi (NASDAQ:SNY) announces positive results from a Phase 3 clinical trial, COMET, evaluating avalglucosidase alfa, an enzyme replacement therapy, in patients with late-onset Pompe disease, an inherited disorder characterized by the buildup of glycogen in the body’s cells due to the dysfunction of a certain enzyme.

The study met the primary endpoint demonstrating non-inferiority (no worse than) to alglucosidase alfa (Lumizyme) as measured by the change in respiratory function but it failed to demonstrate superiority, the other primary objective.

Since superiority was not shown, statistical testing of the secondary endpoints was not done.

The safety profiles were comparable.

Development is ongoing.

https://seekingalpha.com/news/3583373-sanofi-enzyme-replacement-therapy-shows-mixed-results-in-pompe-study

Biomerica files for emergency use of COVID-19 blood test

Biomerica (NASDAQ:BMRA) is up 23% premarket on the heels of submitting an Emergency Use Authorization (EUA) application to the FDA for an ELISA lab-based serology blood test for the detection of antibodies that identify if a person is infected with COVID-19.

This is the third COVID-19 antibody test introduced by the Company. The other two, which are finger-prick rapid tests.

BMRA also intends to obtain a CE mark to market and sell this ELISA laboratory test outside the US.

https://seekingalpha.com/news/3583377-biomerica-files-for-emergency-use-of-covidminus-19-blood-test

FDA OKs Lilly fast-acting insulin

The FDA approves Eli Lilly’s (NYSE:LLY) Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), a rapid-acting insulin to improve glycemic control in type 1 and type 2 diabetics.

The product will be included in the Lilly Insulin Value Program that allows patients to fill their monthly prescriptions for $35.

https://seekingalpha.com/news/3583304-fda-oks-lilly-fast-acting-insulin

Ideaya inks deal with GSK in synthetic lethality

IDEAYA Biosciences (NASDAQ:IDYA) is up 36% premarket on the heels of announcing a strategic partnership with GlaxoSmithKline plc (NYSE:GSK) in Synthetic Lethality, an emerging field in Oncology.

The partnership includes IDEAYA’s Synthetic Lethality programs MAT2A, Pol Theta, and Werner Helicase programs, which are projected to reach clinical trials within the next three years.

IDEAYA will lead the MAT2A program and will be responsible for all costs prior to the GSK option exercise.

The company will receive a 50% US profit share and ex-US royalties for the MAT2A and Werner Helicase programs, global royalties for the Pol Theta program and is responsible for 20% of global development costs for licensed products being developed with GSK.

IDEAYA will receive a $100M upfront cash payment, $20M equity purchase of common stock in a direct private placement, potential $50M cash option exercise fee for the MAT2A program and potential preclinical, clinical and sales milestones.

https://seekingalpha.com/news/3583306-ideaya-inks-deal-gsk-in-synthetic-lethality

Fed to begin buying corporate bonds

The Federal Reserve announced Monday that it would begin purchasing individual corporate bonds to support liquidity in the market and to make credit more accessible among large employers.
The move is an update to its Secondary Market Corporate Credit Facility – established with approval from, and $75 billion provided by, the CARES Act, which was implemented to help aid American families and businesses throughout the coronavirus pandemic.

The Fed will create a corporate bond portfolio, based on “a broad diversified market index of U.S. corporate bonds.” The bonds must satisfy the facility’s terms, including its minimum rating and a remaining maturity of five years or less.

The facility has already committed to purchasing exchange-traded funds (ETFs), which began last month. This week, it is expected to start corporate purchasing debt on the secondary market.
The Fed said it would stop buying corporate bonds and ETFs no later than Sept. 30 unless otherwise stipulated by its Board of Governors or the Treasury Department.
Monday’s announcement resonated with investors and sent stocks higher, with the Dow Jones Industrial Average and the S&P 500 both bouncing up into the green after trading down earlier in the session.
https://www.foxbusiness.com/economy/fed-to-begin-buying-corporate-bonds

UK funds human trials of potential COVID-19 vaccine from Imperial

Scientists at Imperial College London will start the first clinical trials of a potential COVID-19 vaccine this week with more than 45 million pounds ($56.50 million) in backing from the British government and philanthropic donors.

The trials are the first human tests of a new technology which the researchers say could transform vaccine development by enabling rapid responses to emerging diseases such as the COVID-19 infection caused by the new coronavirus.
Robin Shattock, a professor at Imperial’s department of infectious disease, said that rather than using a part of the virus, as many vaccines do, this potential vaccine uses synthetic strands of the virus’ genetic material – RNA – which are packaged inside tiny fat droplets.
When injected, it instructs muscle cells to produce virus proteins to protect against future infection. In animal tests, the vaccine was shown to be safe and showed “encouraging signs of an effective immune response”, Shattock’s team said in a statement.
About 300 healthy volunteers will receive two doses of the vaccine in the initial human trials to test whether it is safe in people and whether it produces an effective immune response against COVID-19. If it shows promise, larger trials with about 6,000 people would be set up later this year.
More than 100 potential COVID-19 vaccines are in development around the world, including several already in human trials from AstraZeneca, Pfizer, BioNtech, Johnson & Johnson, Merck, Moderna, Sanofi and CanSino Biologics.
Doug Brown, chief executive of the British Society for Immunology, welcomed the addition of Imperial’s vaccine and said that having a wide range of approaches increases the chance of success.
“This vaccine candidate…differs from other ongoing trials in that it uses novel RNA technology,” he said.

The Imperial team won £41 million pounds in funding from the UK government and received £5 million in philanthropic donations.
https://www.reuters.com/article/us-health-coronavirus-vaccine-imperial/uk-funds-human-trials-of-potential-covid-19-vaccine-from-imperial-idUSKBN23M2YE