| Over a week ago | ||||
Bernstein initiated… Bernstein initiated coverage of Arrowhead with a Market Perform rating and $27 price target. The analyst believes ARO-APOC3 and ARO-ANG3, the company's lead cardiometabolic assets, will deliver substantial value to patients, but is "not so sure about shareholders." The firm believes the addressable market for severe hypertriglyceridemia is only 500,000 patients in the U.S., in contrast to management's estimate of 3M-4M. | ||||
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Arrowhead announced the… Arrowhead announced the FDA has granted Fast Track designation to ARO-APOC3 for reducing triglycerides in adult patients with familial chylomicronemia syndrome, or FCS. ARO-APOC3 was previously granted Orphan Drug designation by the FDA and the European Union. ARO-APOC3 is Arrowhead's investigational RNAi therapeutic targeting apolipoprotein C-III, or APOC3, being developed as a treatment for patients with severe hypertriglyceridemia, or SHTG, mixed dyslipidemia, or MD, and FCS. FCS is a rare genetic disorder that causes severely elevated triglyceride levels, which can result in acute and potentially fatal pancreatitis. There are currently no FDA approved therapies to treat FCS. | ||||
Arrowhead announced… Arrowhead announced interim results from Part 1 of AROC3-1001, an ongoing Phase 1/2 clinical study of ARO-C3, the company's investigational RNA interference, or RNAi, therapeutic designed to reduce production of complement component 3, or C3, as a potential therapy for various complement mediated diseases. The company plans to present additional results at an upcoming complement-focused medical meeting. Dosing in Part 2 of the Phase 1/2 study is expected to begin in the first half of 2023. In Part 1 of AROC3-1001, ARO-C3 interim results included: A dose-dependent reduction in serum C3, with 88% mean reduction at highest dose tested; A dose-dependent reduction in AH50, a marker of alternative complement pathway hemolytic activity, with 91% mean reduction at highest dose tested; Duration of pharmacologic effect supportive of quarterly or less frequent subcutaneous dose administration. Overall, no clinically significant laboratory findings or patterns of adverse changes in any clinical laboratory parameters. No dose limiting toxicity, serious or severe adverse events, or study discontinuation due to adverse events. Most common adverse events include headache, COVID-19, generally mild injection site reactions, and seasonal allergy. | ||||
| Over a month ago | ||||
Arrowhead Pharmaceuticals… Arrowhead Pharmaceuticals (ARWR) announced that it has gained rights to ARO-PNPLA3, formerly called JNJ-75220795, which was part of a 2018 research collaboration and option agreement between Arrowhead and Janssen Pharmaceuticals , one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ). ARO-PNPLA3 is an investigational RNA interference, RNAi, therapeutic developed using Arrowhead's proprietary TRiMTM platform and designed to reduce liver expression of patatin-like phospholipase domain containing 3, PNPLA3, as a potential treatment for patients with non-alcoholic steatohepatitis. ARO-PNPLA3 is currently in a Phase 1 clinical study. PNPLA3 has strong genetic and preclinical validation as a driver of fat accumulation and damage in the livers of patients who carry the common I148M mutation. "We are impressed by the initial Phase 1 clinical data for JNJ-75220795, now called ARO-PNPLA3. We understand that Janssen is undergoing a strategic R&D portfolio review and subsequently advised us of their decision to return full rights to this promising NASH candidate back to Arrowhead," said Christopher Anzalone, Ph.D., Arrowhead's president and CEO. "ARO-PNPLA3 is a potentially complementary addition to our growing pipeline of RNAi candidates in the cardiometabolic space. We look forward to the availability of additional data on ARO-PNPLA3 as we design a Phase 2 study and assess options for communicating full Phase 1 results." | ||||
B. Riley analyst Mayank… B. Riley analyst Mayank Mamtani lowered the firm's price target on Pharmaceuticals to $55 from $59 and keeps a Buy rating on the shares. The analyst says the company's pipeline disclosures were not as worse as feared. | ||||
RBC Capital analyst Luca… RBC Capital analyst Luca Issi lowered the firm's price target on Arrowhead (ARWR) to $77 from $83 and keeps an Outperform rating on the shares. The analyst cites the company having confirmed that Janssen (JNJ) is deprioritizing HBV as part of a broader strategic decision within infectious diseases. The firm remains positive on the stock however with the view that its A1AT will "ultimately be a drug", its cardiovascular assets are "relatively de-risked", and that its upcoming respiratory data may unlock value beyond liver. | ||||
Baird analyst Joel Beatty… Baird analyst Joel Beatty lowered the firm's price target on Arrowhead to $58 from $60 and keeps an Outperform rating on the shares. The analyst said he maintained his rating but admitted the earnings call did leave us feeling less near-term conviction as management confirmed its HBV partnership is likely to end soon. | ||||
Piper Sandler analyst… Piper Sandler analyst Edward Tenthoff lowered the firm's price target on Arrowhead (ARWR) to $52 from $55 but keeps an Overweight rating on the shares after its Q1 earnings this evening. The analyst is removing the value of Janssen's (JNJ) JNJ-3989/ARO-HBV royalties from the firm's model, which reduces its projected enterprise value to $5.57B from $5.83B. | ||||
Reports Q1 revenue… Reports Q1 revenue $62.55M vs $27.44M last year. | ||||
