Piper Jaffray says the FDA's Endocrinologic and Metabolic Drug Advisory Committee vote yesterday for Regeneron (REGN) and Sanofi's (SNY) Praluent was more contentious than expected. While the Committee recommended approval of the cholesterol lowering drug by a 13-3 margin, members had reservations over the lack of outcomes data and whether LDL-C could still be used as a surrogate in most patients, Piper tells investors in a research note. The firm sees the prospect of a "somewhat restricted" label, but still expects approval by the July 24 action date. It reiterates a Neutral rating on Regeneron with a $484 price target. The same FDA panel reviews Amgen's Repatha today. Shares of Regeneron are down $13.09 to $513.00 in pre-market trading.

After IGM Biosciences (IGMS) announced that the company's exclusive worldwide collaboration agreement with Sanofi (SNY) to create and develop IgM agonist antibodies will now focus exclusively on immunology and inflammation targets, Stifel analyst Stephen Willey said the firm believes the re-focusing of the collaboration away from oncology and exclusively to the three, yet-to-be-disclosed IAI targets "removes some longer-term economic optionality," but ultimately doesn't change the firm's thesis on the stock. The firm, which adds that Sanofi's decision aligns with its continued prioritization of IAI development opportunities and doesn't reflect anything aplitabart-related and notes that IGM now regains full control of these oncology programs and could potentially re-monetize these assets via future partnerships, would be buyers on related weakness. Stifel has a Buy rating and $25 price target on IGM Biosciences shares.

Amgen "provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE(R) in chronic obstructive pulmonary disease, or COPD, which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society 2024 International Conference on Monday, May 20, from 9:15-11:15 a.m. PDT. We are encouraged by the results of the COURSE Phase 2a proof-of-concept trial, which investigated tezepelumab in moderate to very severe COPD patients, across a broad range of eosinophil levels, irrespective of inflammatory drivers, emphysema, chronic bronchitis and smoking status. This study did not exclude any patients based on their baseline eosinophil count (BEC) and intentionally enrolled patients with a broad range of BECs. Overall, tezepelumab numerically reduced the annualized rate of moderate or severe COPD exacerbations versus placebo by 17% (90% CI: -6, 36; p=0.1042). Of note, more reductions were observed in a prespecified subgroup of patients with BEC greater than or equal to150 cells/muL (37% [95% CI: 7, 57]). The trend in reduction was greater in a small number of subjects with BEC greater than or equal to300 cells/microL."