Replies to post #7384 on Halozyme Therapeutics Inc (HALO)

[maumar]

I think they are testing it for melanoma too. From MS:

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.