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Halozyme Announces Bristol Myers Squibb Received Updated Action Date from the U.S. Food and Drug Administration for Subcutaneous Nivolumab Co-Formulated with ENHANZE®

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Halozyme Therapeutics announced that Bristol Myers Squibb received an updated Prescription Drug User Fee Act (PDUFA) goal date from the U.S. FDA for their Biologics License Application. This application pertains to the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme's ENHANZE (rHuPH20). The new target date is December 29, 2024. This formulation aims to cover all previously approved adult, solid tumor Opdivo indications, either as monotherapy or in combination treatment. The application is based on the CheckMate-67T Phase 3 trial, which showed noninferior pharmacokinetics, efficacy, and consistent safety compared to the intravenous version. If approved, it will be the first subcutaneous PD-1 inhibitor.

Positive
  • Updated PDUFA goal date set for December 29, 2024, accelerating regulatory clarity.
  • Application based on successful Phase 3 trial (CheckMate-67T) demonstrating noninferior pharmacokinetics and consistent safety.
  • Potential for the first and only subcutaneously administered PD-1 inhibitor, which could offer a competitive edge.
  • Broader application scope, covering all previously approved adult, solid tumor Opdivo indications.
Negative
  • Delay in FDA decision could impact short-term investor sentiment and stock performance.
  • Potential risks if the FDA does not approve the subcutaneous formulation, affecting market expectations.

Subcutaneous formulations are designed to enhance patient convenience and potentially improve compliance by reducing administration time compared to intravenous options. This move by Bristol Myers Squibb and Halozyme to develop a subcutaneous form of nivolumab (Opdivo) using Halozyme's ENHANZE® technology is noteworthy because it aims to offer a new administration route for an existing, well-established therapy. The CheckMate-67T trial's results supporting noninferior pharmacokinetics, efficacy and consistent safety compared to the intravenous formulation are significant. These results imply that the subcutaneous form could achieve similar therapeutic outcomes with potentially fewer logistical challenges, making it an attractive option for both patients and healthcare providers.

Should the FDA approve this formulation, it would represent the first subcutaneously administered PD-1 inhibitor, a novel milestone in oncology treatment. This could have major implications for treatment regimens, especially in outpatient settings.

From a financial perspective, an FDA approval of the subcutaneous form of nivolumab could significantly impact Halozyme's and Bristol Myers Squibb's revenue streams. Subcutaneously administered drugs often carry a premium pricing structure due to the increased convenience and ease of use they offer. This could potentially lead to an increase in sales for Opdivo, expanding its market share among patients and healthcare providers seeking more convenient treatment options.

Moreover, Halozyme could benefit from royalty payments and milestone revenues from Bristol Myers Squibb if the product is successfully commercialized. Investors should note the potential for revenue growth tied to the successful launch and market adoption of this new formulation. However, one should also consider the possibility of delays or additional regulatory hurdles that could impact the timeline and financial forecasts linked to this initiative.

In the competitive landscape of oncology drugs, the introduction of a subcutaneous option for a leading PD-1 inhibitor like nivolumab could be a game-changer. Currently, other PD-1 inhibitors are available only in intravenous forms, which can be time-consuming and less convenient for patients. The shift to a subcutaneous formulation could allow Bristol Myers Squibb to differentiate Opdivo from competitors, potentially capturing a larger share of the market.

Additionally, this could influence the broader oncology market dynamics by setting a precedent for other pharmaceutical companies to explore similar formulations for their therapies. This could spur innovation and lead to increased competition, ultimately benefiting patients through more options and potentially improved outcomes.

Updated Prescription Drug User Fee Act goal date of December 29, 2024

SAN DIEGO, May 21, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Bristol Myers Squibb was reassigned a Prescription Drug User Fee Act goal date from the U.S. Food and Drug Administration for their Biologics License Application for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29, 2024. 

The application is based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab with ENHANZE® to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation. If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor. 

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.

Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.

For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the Prescription Drug User Fee Act goal date for the Biologics License Application for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with ENHANZE®, possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients and broadening the treatment options for the indication referred to in this press release. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partners, potential additional data readouts, indications and eligible patients for the ENHANZE® co-formulated treatment referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning any potential changes to the Prescription Drug User Fee Act goal date referred to in this press release, whether new ENHANZE® collaborative products, including  Opdivo® (nivolumab) co-formulated with ENHANZE®, are ultimately developed, approved or commercialized or whether the indications for the ENHANZE® co-formulated treatment referred to in this press release will be approved, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Contacts:

Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com

Samantha Gaspar 
Teneo
212-886-9356
samantha.gaspar@teneo.com

Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.) (PRNewsfoto/Halozyme Therapeutics, Inc.)

 

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What is the new PDUFA goal date for the subcutaneous formulation of Opdivo with ENHANZE?

The updated Prescription Drug User Fee Act goal date is December 29, 2024.

What is the significance of the CheckMate-67T Phase 3 trial for HALO?

The trial demonstrated noninferior pharmacokinetics, efficacy, and consistent safety compared to the intravenous formulation.

What are the potential benefits if the FDA approves the subcutaneous formulation of Opdivo?

If approved, it will be the first and only subcutaneously administered PD-1 inhibitor, offering a competitive advantage.

What might be the impact on HALO stock if the FDA does not approve the new formulation?

A non-approval could negatively impact market expectations and investor sentiment, potentially affecting HALO's stock performance.

Halozyme Therapeutics, Inc.

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