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The Daily Biotech Pulse: FDA Authorizes Moderna, J&J Booster Shots; Regulatory Approvals For Bristol-Myers Squibb, Sanofi-Regeneron; Ventyx IPO

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The Daily Biotech Pulse: FDA Authorizes Moderna, J&J Booster Shots; Regulatory Approvals For Bristol-Myers Squibb, Sanofi-Regeneron; Ventyx IPO

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

CDC Committee Recommends Approval Of Merck, Pfizer's Pneumococcal Vaccine In Elderly, Immunocompromised Individuals

Merck & Co., Inc. (NYSE: MRK) said the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices unanimously voted in favor of updates to pneumococcal vaccination recommendations for adults 65 years and older, and for adults ages 19 to 64 with certain underlying medical conditions or other disease risk factors such as smoking or alcoholism.

In both groups, the ACIP voted to provisionally recommend vaccination either with a sequential regimen of Vaxneuvance followed by Pneumovax 23 or with a single dose of 20-valent pneumococcal conjugate vaccine.

The AICP also voted to recommend Pfizer, Inc. (NYSE: PFE)'s Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) for routine use to help protect adults against invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in the vaccine.

Merck shares were edging up 0.04% to $81.10 in premarket trading, while Pfizer shares were up 0.33% at $42.94

J&J, Moderna Booster Doses Authorized For Emergency Use Following Primary Shots; Mix-And-March Shots Authorized

The Food and Drug Administration issued authorization for booster doses of COVID-19 vaccine from Johnson & Johnson (NYSE: JNJ) as well as Moderna, Inc. (NASDAQ: MRNA).

The Johnson & Johnson booster shot will be the same formulation and dosage as the primary shot. It has been authorized for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine, and for eligible individuals who received a different authorized or approved COVID-19 vaccine.

Moderna's booster has been authorized at the 50-µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.

The booster dose is to be administered at least six months after completion of the primary series. The FDA also authorized a single booster dose of the Moderna COVID-19 vaccine for individuals who have completed a primary vaccination with other authorized or approved COVID-19 vaccines.

In premarket trading, Moderna shares were rallying 1.73% to $338.78 and J&J was adding 0.28% to $164.24.

Sanofi-Regeneron's Dupixent Gets Label Expansion As Add-On Treatment For Asthma In Children

Sanofi (NASDAQ: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) said the FDA has approved Dupixent as an add-on maintenance treatment of patients ages 6 to 11 with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Bausch Names Tom Vadaketh As CFO of Bausch Pharma

Bausch Health Companies Inc. (NYSE: BHC) announced that Tom Vadaketh will join the company as chief financial officer for its Bausch Pharma business effective Jan. 3, 2022. Sam Eldessouky, current CFO of the company, will become CFO of Bausch + Lomb contingent and effective upon the closing of the initial public offering of Bausch + Lomb, and at that time, Vadaketh will assume the role of CFO of Bausch Pharma.

Related Link: The Week Ahead In Biotech (Oct. 18-23): J&J, Biogen Kickstart Big Pharma Earnings, Regeneron-Sanofi, Roche Await FDA Decisions And IPOs

Bristol-Myers Squibb's Opdivo-Chemo Combo Approved For Treating Stomach Cancer In Europe

Bristol-Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved Opdivo, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score equal to or greater than 5.

Morphosys Announces Commencement Of Phase 2 Study Of Felzartamab In Autoimmune Disease Affecting Kidney

MorphoSys AG (NASDAQ: MOR) announced that the first patient has been dosed in the Phase 2 IGNAZ clinical trial evaluating felzartamab for patients with Immunoglobulin A Nephropathy. IgAN, also known as Berger's disease, is a chronic and debilitating autoimmune disease affecting the kidneys and the most common glomerular disease worldwide. Currently there are no approved treatments that can specifically prevent the production of galactose-deficient IgA1 nor its corresponding autoantibody.

OncoSec Chief Scientific Officer To Depart

OncoSec Medical Incorporated (NASDAQ: ONCS) announced that Chris Twitty, chief scientific officer, will be stepping down to pursue a new opportunity with a private oncology company. The company also said its leadership committee continues to meet with high quality candidates and expects to name a new CEO in the near-term.

Offerings

ADMA Biologics, Inc. (NASDAQ: ADMA) announced that it intends to offer shares of its common stock for sale in an underwritten public offering.

The stock was down 7.21% to $1.03 in premarket trading.

Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. All of the shares to be sold in the offering are to be sold by Crinetics.

In premarket trading, the stock was adding 4.80% to $20.75.

Click here to access Benzinga's FDA Calendar.

On The Radar

Clinical Readouts

28th Annual Congress of the European Society of Gene and Cell Therapy Presentations

Sio Gene Therapies Inc. (NASDAQ: SIOX): Phase 1/2 data for AXO-AAV-GM1 gene therapy for the treatment of infantile- and juvenile-onset GM1 Gangliosidosis and data from the Phase 1/2 dose evaluation study of AXO-Lenti-PD gene therapy for Parkinson's disease

Abeona Therapeutics Inc. (NASDAQ: ABEO): data from the Phase 1/2 study of ABO-102 investigational gene therapy for Sanfilippo syndrome Type A (Mucopolysaccharidosis IIIA) 

Editas Medicine, Inc. (NASDAQ: EDIT): initial Phase 1/2 clinical data from the BRILLIANCE clinical trial of EDIT-101, an in vivo CRISPR gene editing therapy, in CEP290-related retinal degeneration

Earnings

  • Quest Diagnostics Incorporated (NYSE: DGX) (before the market open)
  • Renalytix Plc (NASDAQ: RNLX) (before the market open)
  • NeuroMetrix, Inc. (NASDAQ: NURO) (before the market open)
  • Plus Therapeutics, Inc. (NASDAQ: PSTV) (after the close)

IPOs

California-based Ventyx Biosciences, Inc. (NASDAQ: VTYX) priced its upsized initial public offering of 9.473 million shares at $16 each, or the middle of the estimated price range of $15-$17. The shares of the clinical-stage biopharma focusing on therapies for patients with inflammatory diseases and autoimmune disorders, will begin trading on the Nasdaq under the ticker symbol "VTYX."

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

 

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