Assembly Bio commences mid-stage study of Hep B candidate

Assembly Biosciences (ASMB +2.7%) initiates an 80-subject proof-of-concept Phase 2 clinical trial evaluating ABI-H2158, combined with entecavir, in treatment-naïve patients with HBeAg-positive chronic hepatitis B infection without cirrhosis.

The primary endpoints are safety and the change from baseline in mean log10 HBV DNA at week 24 (efficacy measure).

The estimated primary completion date is January 2023.

Positive data from a Phase 1 trial were presented at The Liver Meeting in Boston in October 2019.

https://seekingalpha.com/news/3586113-assembly-bio-commences-mid-stage-study-of-hbv-candidate-abi-h2158

Financial stocks ride Volcker Rule change higher

Financial stocks charge into the green as regulators ease restrictions from the Volcker Rule.

JP Morgan (JPM, +2%), Wells Fargo (WFC, +2.5%), Citi (C, +1.7%), Goldman (GS, +2.6%), BofA (BA, +1.9%)

The FDIC approves adjustment to the Volcker Rule to allow banks to invest in venture capital and credit funds.

The regulators are also changing the requirement for banks to post margin for trades between affiliates, which could mean billions more at disposal for financial institutions.

https://seekingalpha.com/news/3586203-financial-stocks-ride-volcker-rule-change-higher

Aptevo rises sharply after royalty payment from Pfizer

Aptevo Therapeutics (APVO +40.7%) to receive a seven year quarterly royalty from Pfizer related to sales of RUXIENCE (rituximab biosimilar), which was approved by the FDA in July 2019 and launched by Pfizer in the US and Japan in early 2020.

“We are pleased to be receiving this first royalty payment from Pfizer and look forward to future quarterly payments. This funding will help to support the advancement of lead ADAPTIR bispecific candidate, APVO436, which is progressing in a Phase 1/1b study for acute myeloid leukemia” said Marvin White, President and CEO.

The product also received marketing authorization in the European Union in April 2020.

https://seekingalpha.com/news/3586173-aptevo-rises-sharply-after-royalty-payment-from-pfizer

Relay Therapeutics on deck for IPO

Relay Therapeutics (RLAY) has filed a preliminary prospectus for a $200M IPO.

The Cambridge, MA-based biopharmaceutical firm develops small molecule therapies based on its know-how in protein motion. Its Dynamo platform, which integrates experimental and computational approaches, enables it to more effectively identify previously undruggable protein targets.

Lead candidates are RLY-1971, an inhibitor of a protein called SHP2 (Src homology region 2 domain-containing phosphatase-2), and RLY-4008, an inhibitor of a protein called fibroblast growth factor receptor 2 (FGFR2).

A Phase 1 study evaluating the former in solid tumors launched last quarter. A Phase 1 trial assessing the latter in solid tumors should commence in H2.

2019 Financials: Operating Expenses: $84.0M (+68%); Net Loss: ($75.3M) (-54%); Cash Burn: ($66.1M) (-50%).

https://seekingalpha.com/news/3586198-relay-therapeutics-on-deck-for-ipo

Citron tweets on animal spirits driving Inovio Pharmaceuticals

In a tweet, noted short seller Citron Research reiterates its bearish view on Inovio Pharmaceuticals (INO +14.4%), a favorite among Robin Hood traders.

In April, it published a report questioning the veracity of its assertion that its “secret algorithm” enabled it to design a COVID-19 vaccine candidate in three hours, comparing the company to one-time early-stage star Theranos, since imploded after its false technology claims were exposed.

Citron sees the stock returning to $14 (~49% downside risk) in “short order.”

https://seekingalpha.com/news/3586208-citron-tweets-on-animal-spirits-driving-inovio-pharmaceuticals

Texas governor acts as data indicates ‘warning flag’

Texas Governor Greg Abbott has previously said that the positivity test rate rising above 10% (i.e., one in ten being tested, test positive for the virus) would constitute a “warning flag” for his state.

Yesterday, the seven-day moving average positivity rate rose to 10.42%, a level not seen since mid-April, when the state was still under lockdown.

Abbott is reacting this morning, banning elective surgeries in Dallas, Harris, Travis, and Bexar counties (homes to Dallas, Houston, Austin, and San Antonio). This will help ensure hospital bed availability to COVID-19 patients.

https://seekingalpha.com/news/3586190-texas-governor-acts-data-indicates-warning-flag

Sanofi mulling job cuts

Reuters reports that Sanofi (SNY +0.6%) is considering eliminating “hundreds” of jobs as it advances its reorganization plan aimed at cutting operating costs.

Two sources indicated that ~1,000 jobs in France are at risk (although massive layoffs there seem unlikely due to the costs of doing so and the political pressure to not do so).

Company officials have declined comment.

https://seekingalpha.com/news/3586191-sanofi-mulling-job-cuts-reuters