Today’s Daily Dose brings you news about the first antibody therapy for the prevention of COVID-19, the FDA panel review of Reata Pharma’s Alport syndrome drug; disappointing data from Radius Health’s wearABLe study; and encouraging new data of Zymeworks’ Zanidatamab in breast cancer.
1. AstraZeneca’s Antibody Therapy Evusheld Makes A Mark
AstraZeneca PLC’s (AZN) Evusheld has received emergency use authorization in the U.S. for the prevention of COVID-19, with first doses expected to become available very soon.
Adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended, are eligible to take Evusheld. Recipients should not be currently infected with or have recently been exposed to someone who is infected with SARS-CoV-2.
Evusheld becomes the only antibody therapy authorized in U.S. to prevent COVID-19 symptoms before virus exposure, while also providing long lasting protection with a single dose.
AZN closed Wednesday’s trading at $55.13, up 0.68%.
2. FDA Panel Snubs Reata Pharma
Wednesday, an FDA panel voted that Reata Pharmaceuticals Inc.’s (RETA) Bardoxolone is not effective in slowing the progression of chronic kidney disease in patients with Alport syndrome and that its benefits do not outweigh its risks.
Alport syndrome is a rare, genetic form of chronic kidney disease caused by mutations in the genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney. Alport syndrome affects both children and adults. Approximately 30,000 to 60,000 Americans are affected with Alport Syndrome, and there is no approved treatment for this disease.
The FDA’s final decision on Bardoxolone is expected on February 25, 2022. The regulatory agency usually follows the recommendations of its panels although it is not mandatory to do so.
RETA closed Tuesday’s trading at $54.42.Trading was halted Wednesday.
3. Radius Shrinks On wearABLe Study Data
Shares of Radius Health Inc. (RDUS) plunged more than 44% on Wednesday, following disappointing results from its wearABLe study.
The wearABLe study is a phase III trial evaluating the non-inferiority of Abaloparatide transdermal system compared to Abaloparatide subcutaneous injection (TYMLOS) in postmenopausal women with osteoporosis.
Abaloparatide subcutaneous injection, sold under brand name TYMLOS, is also developed by Radius Health. In the third quarter of 2021, TYMLOS generated net revenue of $57 million for the company, up 13% over the comparable year-ago quarter.
RDUS closed Wednesday’s trading at a new 52-week low of $8.01, down 44.30%.
4. Relmada Prices Offering
Relmada Therapeutics Inc. (RLMD) has priced an upsized underwritten public offering of 8.82 million shares of its common stock at a public offering price of $17.00 per share. The gross proceeds to Relmada from the offering are expected to be approximately $150 million.
The offering is expected to close on December 13, 2021, subject to customary closing conditions. The underwriters have a 30-day option to purchase up to an additional 1.32 million shares of Relmada’s common stock at the public offering price, less underwriting discounts and commission.
RLMD closed Wednesday’s trading at $18.54, up 1.37%. In after-hours, the stock was down 8.31% to $17.
5. Zymeworks’ Zanidatamab Works Just Fine
Zymeworks Inc. (ZYME) presented encouraging new clinical data from a phase I study of its drug candidate Zanidatamab in heavily pretreated HER2-positive breast cancer.
The study involved 24 patients with heavily pretreated HER2-positive metastatic breast cancer who received Zanidatamab in combination with either Vinorelbine, Capecitabine or Paclitaxel. (Vinorelbine, Capecitabine or Paclitaxel are all approved chemotherapy drugs).
In 22 efficacy-evaluable patients in the trial, treatment with Zanidatamab and chemotherapy resulted in a confirmed objective response rate of 36.4% and disease control rate of 86.4% and the majority of patients experienced a decrease in their tumor size, according to the company.
Zanidatamab in combination with single agent chemotherapy is well tolerated, with the majority of treatment-related adverse events considered mild to moderate in severity, added the company.
Zanidatamab is currently being evaluated in two pivotal clinical trials, one for the first-line treatment of advanced or metastatic HER2-positive gastroesophageal adenocarcinoma , dubbed HERIZON-GEA-01, and one for previously treated HER2-amplified biliary tract cancer, dubbed HERIZON-BTC-01. The drug candidate is also being evaluated in several Phase 2 clinical trials for HER2 expressing gastroesophageal, colorectal, and breast cancers.
ZYME closed Wednesday’s trading at $18.95, up 3.84%.
Stocks At New Highs/Lows
McKesson Corp. (MCK) closed at a new 52-week high of $226.68, up 0.94%.
UnitedHealth Group Inc. (UNH) closed at a new 52-week high of $468.86, up 0.89%.
Zoetis Inc. (ZTS) closed at a new 52-week high of $229.62, up 1.74%.
Corcept Therapeutics Inc. (CORT) closed at a new 52-week low of $18.23, down 16.91%.
Ventyx Biosciences, Inc. (VTYX) closed at a new 52-week low of $15.80, down 6.89%.
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