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Wednesday, March 01, 2023 10:10:05 AM
Halozyme (OW, $65 PT) – We anticipate two catalysts for HALO in 1H23.
Approval decision for SC efgartigimod in gMG. The PDUFA date for the
subcutaneous (SC) formulation of efgartigimod in generalized myasthenia
gravis (gMG) is 6/20/23. Recall that this PDUFA date was recently extended
from 3/20/23 to 6/20/23. See our prior note on HALO here , and Matthew
Harrison’s note on the event for ARGX here. Expectations: We would
expect an on-time approval. Stock Impact: We believe there is significant
investor focus on SC efgartigimod and its relevance to HALO as the
product is considered a key contributor to Halozyme’s Wave 3 portfolio. As
a result, if the PDUFA were to be extended further beyond 6/20/23 we
would expect HALO down 5%-10% as investor concerns grow regarding the
risk to 2023 guidance. In the event of a surprise CRL, we would expect
HALO shares to face 10%+ acute pressure. If SC efgartigimod is approved
on or ahead of schedule we would expect HALO shares up 3%-5%.
Readout of ADHERE study of SC efgartigimod in CIDP. Data from the PhII
ADHERE study evaluating the SC formulation of efgartigimod in Chronic
Inflammatory Demyelinating Polyneuropathy (CIDP) is expected in 2Q23
from Argenx (covered by Matthew Harrison). Expectations: We believe
ADHERE is likely to read out successfully. Stock Impact: We would expect
study success / study failure to drive a +/- 5%-10% impact to HALO.
Recent HALO News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/24/2024 09:48:14 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/24/2024 08:05:48 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/23/2024 08:37:10 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/23/2024 08:11:58 PM
- Halozyme to Report Second Quarter 2024 Financial and Operating Results • PR Newswire (US) • 07/23/2024 12:30:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/22/2024 08:13:03 PM
- Halozyme Announces Roche's OCREVUS® SC with ENHANZE® Receives European Commission Approval for Relapsing and Primary Progressive Multiple Sclerosis • PR Newswire (US) • 06/25/2024 05:15:00 AM
- Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo Co-Formulated with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy • PR Newswire (US) • 06/21/2024 09:15:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/18/2024 08:22:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:17:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/13/2024 08:15:42 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/11/2024 08:40:33 PM
- Halozyme Raises Full Year 2024 Financial Guidance and Updates 5-Year Financial Outlook • PR Newswire (US) • 06/06/2024 12:30:00 PM
- Halozyme Announces Issuance of New European Patent for ENHANZE® Drug Delivery Platform • PR Newswire (US) • 06/05/2024 08:05:00 PM
- Halozyme to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference • PR Newswire (US) • 06/04/2024 08:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 09:24:16 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/22/2024 08:08:43 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/21/2024 08:00:43 PM
- Halozyme Announces Bristol Myers Squibb Received Updated Action Date from the U.S. Food and Drug Administration for Subcutaneous Nivolumab Co-Formulated with ENHANZE® • PR Newswire (US) • 05/21/2024 11:15:00 AM
- Halozyme to Participate in Upcoming Investor Conferences • PR Newswire (US) • 05/08/2024 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/07/2024 08:09:58 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/07/2024 08:05:55 PM
- HALOZYME REPORTS FIRST QUARTER 2024 FINANCIAL AND OPERATING RESULTS • PR Newswire (US) • 05/07/2024 08:01:00 PM
- Mahesh Krishnan Elected to Halozyme's Board of Directors • PR Newswire (US) • 04/25/2024 08:45:00 PM
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