AstraZeneca COVID-19 Vax Caused Serious Spinal Issues In Test Patient: FT

AstraZeneca has provided more details on the COVID vaccine pause.

As StatNews reports, the participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.

Soriot went on to say that while the woman’s diagnosis has not been confirmed yet, she is improving and will likely be discharged from the hospital as early as Wednesday.

After ramping ovenight to erase the losses, AZN shares are sliding back on these new revelations.

https://www.zerohedge.com/markets/ft-confirms-astrazeneca-covid-19-vaccine-caused-serious-spinal-issues-test-patient

AstraZeneca may resume halted COVID-19 vaccine trial next week

AstraZeneca AZN, -0.93%AZN, +0.45% may resume its halted trial of its COVID-19 vaccine as early as next week, the Financial Times reported, citing people familiar with the matter. The company halted the trial after the discovery of a sick participant, who contracted transverse myelitis, the report said. The trial may see further pauses, the report said, citing a person close to the process.

https://www.marketwatch.com/story/astrazeneca-may-resume-halted-covid-19-vaccine-trial-next-week-report-2020-09-09

Trillium lands noteworthy equity stake from Pfizer

Shares of the clinical-stage immuno-oncology company Trillium Therapeutics (NASDAQ:TRIL) jumped by as much as 40% in pre-market trading Wednesday morning. The biotech’s shares are rocketing higher today for two material reasons:

1. Trillium rolled out a positive update for its dose-escalating studies for the CD47-targeting antibodies TTI-621 and TTI-622 after the closing bell Tuesday afternoon. The long and short of it is that both of the biotech’s lead drug candidates are off to a strong start in the clinic.
2. In a follow-on press release, the company also announced that Pfizer (NYSE:PFE) has agreed to take a $25 million equity stake in its common stock. As part of this ownership deal, Jeff Settleman, Pfizer’s senior vice president and chief scientific officer for oncology research and development, will reportedly join Trillium’s Scientific Advisory Board once it is formed.

Although Pfizer didn’t exactly break the bank with this initial equity stake, it is a significant development nonetheless. Trillium’s CD47 pipeline has enormous commercial potential as cutting-edge treatments for both solid tumors and blood cancers. Pfizer, for its part, has a well-documented history of buying novel cancer assets at a sky-high premium. So there’s is a good chance that this modest equity stake will morph into a deeper relationship over time.   

Is Trillium’s stock still a buy after this hefty jump? Although the biotech‘s lead clinical assets are only in early-stage development, it might be worthwhile to consider buying a few shares in the wake of Pfizer’s entrance into the picture.

Why is Pfizer’s sudden interest a big deal? Earlier this year, Gilead Sciences (NASDAQ:GILD) paid almost $5 billion to acquire the CD47 drugmaker Forty Seven. If Trillium’s pipeline continues to show promise in the clinic, its newfound partner might be willing to pay a similar price tag. That’s a rather intriguing possibility for potential shareholders. After all, Trillium’s market cap stood at less than $800 million at Tuesday’s close.  

https://www.fool.com/investing/2020/09/09/why-trillium-therapeutics-stock-is-on-fire-today/

Dr. Reddy’s launches store brand version of Voltaren Arthritis Pain in U.S.

Dr. Reddy’s Laboratories (NYSE:RDY) announces the launch of over-the-counter (OTC) Diclofenac Sodium Topical Gel 1%, the store brand version of Novartis’ Voltaren Arthritis Pain in the U.S. market.

Since the launch in May, Voltaren had total U.S. retail sales of ~$44M, according to IRI.

https://seekingalpha.com/news/3612355-dr-reddys-launches-store-brand-version-of-voltaren-arthritis-pain-in-u-s

AstraZeneca pares losses as trial pause ‘not necessarily’ a setback

Shares of AstraZeneca (NYSE:AZN) tumbled over 8% in after-hours trading on Tuesday after the drugmaker paused clinical trials of its experimental COVID-19 vaccine, with a participant in a U.K. study experiencing an unexplained illness.

However, the stock has since pared losses to 1% as British health minister Matt Hancock explained that the procedure is “not necessarily” a setback and it “depends on what they find when they do the investigation.”

“Temporary pauses in dosing of subjects is standard clinical trial practice and given the expedited path into Phase III (trials) for AZN/Oxford Uni Covid-19 vaccine AZD1222, we believe it is not surprising a serious adverse event triggered a study halt to investigate if drug-related,” analysts from Jefferies added in a research note, saying they “envisage a short-term stock correction which may prove misplaced.”

AstraZeneca confirmed that the pause “is a routine action” and it was trying to expedite the review to “minimize any potential impact on the trial timeline.”

https://seekingalpha.com/news/3612358-astrazeneca-pares-losses-trial-pause-not-necessarily-setback

Genentech commences clinical programs in MS with Fenebrutinib and Ocrevus

Roche (OTCQX:RHHBY) unit Genentech has initiated a Phase III clinical trial program for its investigational medicine fenebrutinib in multiple sclerosis (MS), along with a higher-dose program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial.

The Phase III clinical trial program includes two identical trials in RMS (named FENhance 1 and FENhance 2) and one in progressive MS (PPMS) (named FENtrepid).

All three trials are targeting clinical disability progression and have a primary endpoint of 12-week composite confirmed disability progression (cCDP-12), with the addition of a co-primary endpoint of annualized relapse rate in the RMS trials. The PPMS study is the first study in this patient population to have an active comparator – Ocrevus – rather than placebo.

Ocrevus higher-dose Phase IIIb clinical trial program: Genentech is initiating two new Phase IIIb trials, one in RMS (named MUSETTE) and one in PPMS (named GAVOTTE), which will evaluate a higher Ocrevus dose compared with the currently approved 600 mg dose, with both evaluated at the twice-yearly (six-monthly) dosing schedule.

Ocrevus CHIMES trial in minority patients: The company recently commenced the Phase IV CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) trial in African-American and Hispanic- and Latinx-Americans with RMS. These patient populations are more likely to experience more relapses and greater disability than Caucasians, yet are vastly underrepresented in most clinical trials.

All of the newly announced clinical trials are underway and anticipated to begin recruiting in the coming months.

https://seekingalpha.com/news/3612361-genentech-commences-clinical-programs-in-ms-fenebrutinib-and-ocrevus

Cigna expands health care plans across the country

Cigna (NYSE:CI) is enhancing its offerings to customers who access health coverage through the Affordable Care Act (ACA). The company’s plans will include a number of features that increase access to quality health care – all while holding down out-of-pocket costs.

These offerings will be available in 80 new counties in 2021, representing a 27% growth in customer reach.

In 2021, Cigna is offering individual and family plans on the individual exchanges for more than 300 counties spanning 10 states. Key features that customers will enjoy include:

Patient Assurance Program to cap insulin costs at $25M/month and access to a customer loyalty program.

Smarter digital interactions, including access to the myCigna mobile app and Cigna One Guide.

Cigna’s real-time benefit check program will increase financial predictability for customers.

https://seekingalpha.com/news/3612385-cigna-expands-health-care-plans-across-country