The Daily Biotech Pulse: Pfizer Goes Shopping, AstraZeneca Inks Bispecific Antibody Deal, Aptinyx Faces Clinical Study Setback, Erytech Jumps On Data And More

Zinger Key Points
  • Regeneron Pharmaceuticals and Sanofi announced that the European Commission has expanded the marketing authorization for Dupixent in the European Union.
  • Pfizer announced a definitive agreement to acquire ReViral, a privately held, clinical-stage biopharma developing antiviral therapeutics that target respiratory syncytial virus, for up to $525 million, including upfront and development milestones.

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

Stocks In Focus

AstraZeneca In-Licenses Preclinical Bispecific Antibody Candidate From Harbour BioMed For Up To $350M

Harbour BioMed, a biopharma based out of the Netherlands and China, announced a global out-licensing agreement with AstraZeneca plc AZN for the bispecific antibody HBM7022. The investigational asset is being evaluated in preclinical trials.

Under the agreement, in exchange for the global R&D, registration, manufacturing and commercialization rights, AstraZeneca will pay an upfront payment of $25 million, with potential additional milestone payments up to $325 million and tiered royalties on net sales.

Pfizer To Acquire RSV Therapeutic Company ReViral For Up To $525M

Pfizer, Inc. PFE announced a definitive agreement to acquire ReViral, a privately held, clinical-stage biopharma developing antiviral therapeutics that target respiratory syncytial virus, for up to $525 million, including upfront and development milestones.

ReViral has a portfolio of therapeutic candidates, including sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell. If successful, annual revenue potential from these programs could reach or exceed $1.5 billion, Pfizer said.

Regeneron-Sanofi Get Label Expansion For Dupixent In Europe To Treat Pediatric Asthma Patients With Type 2 Inflammation

Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY announced that the European Commission has expanded the marketing authorization for Dupixent in the European Union.

Dupixent is now also approved in children ages 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation, who are inadequately controlled with medium to high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Spero Announces Publication Of Positive Phase 3 Data For Urinary Tract Infection Treatment Candidate In NEJM

Spero Therapeutics, Inc. SPRO announced publication in the New England Journal of Medicine, positive results from the Phase 3 study of its investigational oral carbapenem antibiotic tebipenem pivoxil hydrobromide in complicated urinary tract infection.

The company has a regulatory filing pending with the U.S. Food and Drug Administration for the drug candidate for the indication, with a PDUFA goal date of June 27.

The stock was adding 9.57% to $7.67 in premarket trading.

Vaxxinity Gets $9.25M CEPI Funding For Late-Stage Study Of COVID Booster Shot

Vaxxinity, Inc. VAXX and CEPI announced that they will co-fund the ongoing global pivotal Phase 3 clinical trial of Vaxxinity's next generation UB-612 COVID-19 vaccine candidate as a heterologous — or "mix-and-match" — booster dose. CEPI will provide up to $9.25 million in funding.

The Phase 3 trial, which began in the US earlier this year, is evaluating the ability of UB-612 to boost COVID-19 immunity against the original strain and multiple variants of concern including omicron — in people aged 16 years or older, who have been previously immunized with an authorized COVID-19 vaccine.

Vaxxinity shares were down 3.45% to $4.20 in premarket trading.

Related Link: The Week Ahead In Biotech (April 3-April 9): BioXcel FDA Decision, Neurology Conference Presentations Take The Spotlight

Aptinyx Shelves Study Of NYX-2925 After Failed Midstage Study In Painful Diabetic Peripheral Neuropathy

Aptinyx, Inc. APTX said the Phase 2b clinical study of NYX-2925 in patients with painful diabetic peripheral neuropathy did not achieve statistically significant separation from placebo on the study's primary endpoint.

"Unfortunately, the data from this study do not currently point to a path forward in development for painful DPN," said Andy Kidd, CEO of Aptinyx.

The company said NYX-2925 can offer a novel therapeutic approach for fibromyalgia. It expects to report data from the Phase 2b study in the indication in the early to mid third quarter. 

Adverum To Amend IND Filing For Gene Therapy Candidate In Retinal Disorder Trial

Gene therapy company Adverum Biotechnologies, Inc. ADVM said it has received feedback via a Type C meeting written response from the U.S FDA related to its planned Phase 2 trial of ADVM-022 in wet age-related macular degeneration.

Adverum had requested the FDA's feedback to ensure alignment with the regulatory agency ahead of filing the investigational new drug amendment for the Phase 2 trial.

The company said it expects to complete the IND amendment process by mid-2022 and remain on track to initiate Phase 2 study in the third quarter.

ERYTECH Announces Publication Of Phase 2 Data For Blood, Bone Marrow Cancer Drug

ERYTECH Pharma S.A. ERYP announced publication in the British Journal of Haematology, positive results from the Phase 2 study of eryaspase in acute lymphoblastic leukemia patients. Eryaspase demonstrated sustained asparaginase enzyme activity and it was generally well tolerated when added to chemotherapy.

The stock was jumping 40.13% to $2.20 in premarket trading.

Click here to access Benzinga's FDA Calendar.

Enochian Ropes In Pfizer Veteran to Lead Clinical Operations

Enochian Biosciences, Inc. ENOB, which is developing gene-modified cellular and immunotherapies for infectious diseases and cancer, said it has tapped Pfizer veteran Greg Duczynski as senior vice president for clinical operations. At Pfizer, he was last leading an international trial of gene therapy.

Offerings

Selecta Biosciences, Inc. SELB said it has agreed to sell 27.439 million shares of its common stock and accompanying warrants to purchase up to 20.57 shares of common stock at a combined offering price of $1.41 per share and accompanying warrant.

The gross proceeds to Selecta from the offering are expected to be approximately $38.7 million.

The stock was slipping 4.62% to $1.24 in premarket trading.

On The Radar

Earnings

AngioDynamics, Inc. ANGO (before the market open)

Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures

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