Moderna's COVID-19 Vaccine Approved For Children Aged 12 To 17 In EU

 * EMA: COVID-19 VACCINE SPIKEVAX APPROVED FOR CHILDREN AGED 12 TO 17 IN EU: 23/07/2021

* EMA SAYS THE USE OF THE SPIKEVAX VACCINE IN CHILDREN FROM 12 TO 17 YEARS OF AGE WILL BE THE SAME AS IN PEOPLE AGED 18 AND ABOVE

* EMA SAYS MOST COMMON SIDE EFFECTS IN CHILDREN AGED 12 TO 17 ARE SIMILAR TO THOSE IN PEOPLE AGED 18 AND ABOVE.

* EMA SAYS RECOMMENDED GRANTING EXTENSION OF INDICATION FOR COVID-19 VACCINE SPIKEVAX TO INCLUDE USE IN CHILDREN AGED 12 TO 17 YEARS

* EMA SAYS OVERALL SAFETY PROFILE OF SPIKEVAX DETERMINED IN ADULTS WAS CONFIRMED IN ADOLESCENT STUDY

* EMA SAYS SPIKEVAX PRODUCED A COMPARABLE ANTIBODY RESPONSE IN 12- TO 17-YEAR-OLDS TO THAT SEEN IN YOUNG ADULTS AGED 18 TO 25 YEARS

* EMA SAYS CHMP NOTED DUE TO LIMITED NUMBER OF CHILDREN AND ADOLESCENTS INCLUDED IN STUDY, TRIAL COULD NOT HAVE DETECTED NEW UNCOMMON SIDE EFFECTS

* EMA SAYS CHMP THEREFORE CONSIDERED THAT BENEFITS OF SPIKEVAX IN CHILDREN AGED 12 TO 17 OUTWEIGH RISKS

* EMA: NOTED TRIAL COULD NOT HAVE DETECTED ESTIMATED RISK OF KNOWN SIDE EFFECTS SUCH AS MYOCARDITIS & PERICARDITIS DUE TO LIMITED NUMBER OF CHILDREN IN STUDY

https://news.trust.org/item/20210723115609-lfd1m/

Adverum Stock Falls As It Stops Testing Ocular Gene Therapy Candidate

 

• Adverum Biotechnologies Inc ADVM has decided to drop the development of ADVM-022 intravitreal (IVT) injection gene therapy in diabetic macular edema (DME) after dose-limiting toxicity (DLT) was observed at the high dose (6 x 10^11 vg/eye) in patients with DME. 
• In April, Adverum's stock plunged after a Suspected Unexpected Serious Adverse Reaction of decreased ocular pressure was reported in one patient in the high-dose cohort of the INFINITY Phase 2 trial.
• After that disclosure, it immediately unmasked the trial and monitored all patients who received a single high dose of ADVM-022.
• Additional patients treated with a single high dose of ADVM-022 experienced decreased intraocular pressure refractory to steroids and required subsequent additional treatment.
• These events occurred 16-36 weeks after treatment with the high dose. No similar events have been observed in DME patients treated with the low dose or to date in any wet age-related macular degeneration (wet AMD) patients.
• Now, the company is planning to evaluate ADVM-022 at low doses (2 x 10^11 vg/eye and lower) and alternative prophylactic regimens in future Phase 2 trial in wet AMD.
• It plans to present long-term OPTIC data in wet AMD in 2H21, including 52-week data from Cohort 4 (high dose of 6 x 10^11 vg/eye with steroid eye drop prophylaxis, n=9), at a medical conference.
• Analyst Reaction: SVB Leerink lowered the price target from $5 to $2 but maintained a Market Perform rating.

https://www.benzinga.com/general/biotech/21/07/22120307/adverum-stock-falls-as-it-stops-testing-ocular-gene-therapy-candidate-in-diabetic-macular-edema-p

Cortexyme Announces Lead 3CLpro Inhibitor for Treatment of Covid-19

 Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal trial in Alzheimer’s disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the selection of a lead 3CLpro inhibitor (COR803) for treatment of coronavirus infections, including COVID-19 disease, caused by SARS-CoV-2 infection.

"There continues to be a large unmet need for coronavirus treatment. The target of COR803 is highly conserved across variants and among coronaviruses in general, therefore it is expected to address both current and future coronavirus strains, including the delta variant of SARS-CoV-2," said Casey Lynch, Cortexyme’s chief executive officer, co-founder, and chair. "We have selected COR803 based on compelling data to support its development as a potential therapy that could be prescribed at the first sign of infection or after known exposures without requiring patients to be hospitalized, as well as for those in critical care. The novel characteristics of COR803 reflect the breadth and capabilities of our proprietary research and development as Cortexyme continues to apply our innovative science to areas of high clinical need."

COR803 is a novel patent-pending small molecule 3CLpro inhibitor discovered and developed by Cortexyme based on its expertise in cysteine protease inhibition. 3CLpro, or Mpro, is a validated antiviral drug target shown to be essential in viral replication of SARS-CoV-2. COR803 has beneficial properties over other COVID-19 therapeutics and 3CLpro inhibitors in development including:

• Covalent irreversible binding of the viral 3CLpro enzyme;

• High potency: Antiviral EC90 of 30 nM in human lung cell viral replication assays;

• Highly selective for 3CLpro versus other cellular proteases including Cathepsin L; and

• Excellent systemic exposure utilizing intranasal or subcutaneous administration, allowing for clinical use in multiple settings such as outpatient and inpatient.

https://finance.yahoo.com/news/cortexyme-announces-lead-3clpro-inhibitor-120000662.html

Lonza: Strong H1 Momentum, 14.7% CER Sales Growth, 33.3% CORE EBITDA Margin

 . In H1 2021, Lonza continued its strong performance with 14.7%^1 sales growth and 33.3% CORE EBITDA margin, despite

    headwinds arising from COVID-19 
  . Continued focus on growth CAPEX investments, supported by strong business pipeline 
  . Expanded collaborations to support COVID-19 programs including Moderna 
  . Divestment of Specialty Ingredients business completed on 1 July 2021 
  . Path forward for a sustainable remediation project agreed for Gamsenried (CH) legacy landfill site will allow Lonza 
    to proceed with its ambitious sustainability agenda 
  . 2021 Outlook: CER sales growth guidance revised upwards to mid-teens. CORE EBITDA margin improvement in line with 
    Mid-Term Guidance trajectory 

Lonza confirms an upward revision to its 2021 Outlook, reflecting the expectation to achieve mid-teens CER sales 
growth. The company also anticipates a CORE EBITDA margin improvement in line with the Mid-Term Guidance trajectory, as 
guided at the beginning of the year. The 2021 Outlook assumes a similar level of COVID-related impacts, no significant 
adverse impact on demand and no further disruptions in supply chain or business operations. 
https://www.marketscreener.com/quote/stock/LONZA-GROUP-AG-2956013/news/EQS-Adhoc-Lonza-Reports-Strong-Momentum-in-H1-2021-with-14-7-CER-Sales-Growth-and-33-3-CORE-EBI-35927986/

AstraZeneca's Covid-19 Vaccine Effective Against Variants After 1 Dose: Canadian Study

 AstraZeneca PLC said Friday that real-world data coming from Canada suggest that its Covid-19 vaccine is effective against hospitalization or death from disease caused by virus variants after just one dose.

According to study results from the Canadian Immunization Research Network, Public Health Agency of Canada and the Canadian Institutes of Health Research, one dose of AstraZeneca's vaccine is 82% effective at preventing hospitalization or death caused by the coronavirus's Beta and Gamma variants. The same dose is also seen as effective at preventing hospitalizations and deaths from the virus's Delta variant, with 87% effectiveness against hospitalizations and 90% effectiveness in preventing death, the company said.

Study results were published as a pre-print, meaning they haven't yet been peer-reviewed.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-s-Covid-19-Vaccine-Effective-Against-Variants-After-One-Dose-Canadian-Study-Shows-35929376/

Analyst recommendations

 

Arvinas gets higher PT from Wedbush due to its collaboration with Pfizer.

• Biogen : Wedbush raises price target to $314 from $312, maintains neutral rating

https://www.marketscreener.com/news/latest/Analyst-recommendations-Apple-Aviva-Biogen-Comerica-Incorporated-Tesla---35930158/

Caribou Biosciences Announces Pricing of Upsized IPO

 Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome-editing biopharmaceutical company, announced today the pricing of its upsized initial public offering of 19,000,000 shares of common stock at a public offering price of $16.00 per share. All of the shares of common stock are being offered by Caribou. The gross proceeds of the offering, before deducting underwriting discounts and commissions, and other offering expenses payable by Caribou, are expected to be $304.0 million. In addition, Caribou has granted the underwriters a 30-day option to purchase up to an additional 2,850,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

The shares are expected to begin trading on the Nasdaq Global Select Market on July 23, 2021, under the ticker symbol “CRBU.” The offering is expected to close on or about July 27, 2021, subject to the satisfaction of customary closing conditions.

BofA Securities, Citigroup, and SVB Leerink are acting as joint book-running managers for this offering.

https://www.businesswire.com/news/home/20210722006072/en/Caribou-Biosciences-Announces-Pricing-of-Upsized-Initial-Public-Offering