October 15, 2009 11:55 PM
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UPDATED: Immunomedics Ignored, HGS Adored as Annual Rheumatology Confab Kicks Off
(MoneyWatch) The American College of Rheumatology's annual confab kicks off this weekend, and one item not on the menu is detailed Phase IIb data for Immunomedics and partner UCB's lupus drug epratuzumab.
Back in August, Immunomedics issued a hype-y press release claiming "positive" and "clinically meaningful" data that could provide a "new hope" for lupus patients--but they failed to provide any details or even say whether or not the trial had met its endpoints. Analysts said there was a benefit only in one of five dose groups and that it wasn't significant, but the stock popped 60 percent anyway, conveniently supporting a financing. (Update: A new press release from Immunomedics states that all doses tested were "numerically superior" to placebo; p-values weren't provided but the company reminded folks that the trial was not powered for statistical significance.)
Investors expected detailed data to be unveiled at ACR, but epratuzumab is not on the ACR's list of late-breaker abstracts. Avik Roy, analyst with Monness Crespi Hardt & Co., said the ACR's decision "implies that they did not find the epratuzumab data compelling."
Headlining the late-breaker abstracts, however, is another lupus drug: Human Genome Sciences' Benlysta (belimumab). Top-line data announced in July represented the first real Phase III success in lupus and sent HGS' stock up 277 percent.
The details of that Phase III trial will be presented Tuesday afternoon, and the abstract shows that both dose groups met the primary endpoint and at least one of the two dose groups hit statistical significance on each secondary endpoint, with no safety issues. Analysts will no doubt be sifting through the details provided during the presentation, and at an analyst event later that evening, for any predictors of success or failure in HGS' second Phase III Benlysta trial, data from which are due in December.
Back in August, Immunomedics issued a hype-y press release claiming "positive" and "clinically meaningful" data that could provide a "new hope" for lupus patients--but they failed to provide any details or even say whether or not the trial had met its endpoints. Analysts said there was a benefit only in one of five dose groups and that it wasn't significant, but the stock popped 60 percent anyway, conveniently supporting a financing. (Update: A new press release from Immunomedics states that all doses tested were "numerically superior" to placebo; p-values weren't provided but the company reminded folks that the trial was not powered for statistical significance.)
Investors expected detailed data to be unveiled at ACR, but epratuzumab is not on the ACR's list of late-breaker abstracts. Avik Roy, analyst with Monness Crespi Hardt & Co., said the ACR's decision "implies that they did not find the epratuzumab data compelling."
Headlining the late-breaker abstracts, however, is another lupus drug: Human Genome Sciences' Benlysta (belimumab). Top-line data announced in July represented the first real Phase III success in lupus and sent HGS' stock up 277 percent.
The details of that Phase III trial will be presented Tuesday afternoon, and the abstract shows that both dose groups met the primary endpoint and at least one of the two dose groups hit statistical significance on each secondary endpoint, with no safety issues. Analysts will no doubt be sifting through the details provided during the presentation, and at an analyst event later that evening, for any predictors of success or failure in HGS' second Phase III Benlysta trial, data from which are due in December.
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