Thu, Mar. 5, 9:15 AM
Thu, Mar. 5, 8:06 AM
- Arrowhead Research (NASDAQ:ARWR) acquires Novartis' (NYSE:NVS) RNA interference (RNAi) R&D portfolio and associated assets, including certain patents and patent applications, an exclusive license to other patents and patent applications owned or controlled by Novartis, the assignment of a third party license and three preclinical product candidates.
- Specific assets include multiple patent families covering RNAi-trigger design rules and modifications that fall outside of competitors' patents which provides Arrowhead freedom to operate for any target or indication, the assignment of Novartis' license from Alnylam (NASDAQ:ALNY) that gives Arrowhead access to Alnylam IP, excluding delivery, covering 30 gene targets and three product candidates with varying amounts of preclinical data.
- Under the terms of the agreement, Arrowhead will pay $10M in cash (includes $7M paid previously) and $25M in ARWR stock within 30 days. Novartis is eligible to receive milestones and single-digit royalties on net sales.
- Arrowhead will host a conference call this morning at 8:30 am to discuss the deal.
Mon, Feb. 9, 4:03 PM
Mon, Feb. 2, 4:15 PM
Thu, Jan. 22, 9:15 AM
Mon, Jan. 12, 1:27 PM
- Arrowhead Research (ARWR -25.5%) plummets on more than double normal volume after the company disclosed that the FDA has placed a partial clinical hold on the multiple-dose study evaluating ARC-520 in patients with chronic hepatitis B infection. The company will be able to proceed with the 1 mg/kg dose but not the planned 2 mg/kg and 4 mg/kg parallel doses.
- The FDA also requested additional information including a final report from the single-dose Phase 2a study in patients who received 1-4 mg/kg ARC-520 and a final report from an ongoing multiple-dose non-clinical study. The agency committed to sending a letter to the firm detailing the issues within 30 days.
- The company intends to start additional Phase 2b trials in Asia and Europe in the coming weeks.
Mon, Jan. 12, 12:46 PM
Mon, Jan. 12, 9:14 AM
Fri, Jan. 2, 8:33 AM
Dec. 31, 2014, 9:15 AM
Dec. 30, 2014, 12:48 PM
Dec. 30, 2014, 12:26 PM
- Small cap Arrowhead Research (ARWR +17.5%) is up on 50% higher volume on rumors that Gilead Sciences (GILD -0.9%) may be eyeing the company for its RNA interference-based drugs.
- Arrowhead has yet to recover from the plunge in October after it reported Phase 2a results for its hepatitis B candidate, ARC-520, that fell short of investors' expectations.
- Gilead has three drugs in development for the treatment of chronic HBV infection: tenofovir alafanamide, a nucleotide reverse transcriptase inhibitor, GS-4774, a Tarmogen T cell immunity stimulator and GS-9620, a TLR-7 agonist in addition to the commercially available Viread (tenofovir disoproxil fumarate) and Hepsera (adefovir dipivoxil).
- Previously: Arrowhead explains the ARC-520 data (Oct. 9)
Nov. 26, 2014, 7:08 AM| Comment!
Nov. 25, 2014, 4:26 PM
Nov. 18, 2014, 4:14 PM
Oct. 9, 2014, 9:18 AM
- In an open letter to shareholders, Arrowhead Research (NASDAQ:ARWR) CEO Christopher Anzalone, Ph.D., says the market's reaction to the Phase 2a study of ARC-520 surprised the firm considering the consistent nature of the company's communications on the matter. He believes investors expected something different (obviously) or misunderstood the data.
- Their goal of a l log (90% knockdown) reduction in HBsAg after a single administration is arbitrary since the degree of knockdown necessary to de-repress the immune system and potentially enable a functional cure is unknown. They chose 1 log based on the scientific literature on the small number of patients on Interferon therapy who achieved a functional cure on the basis of a 1/2 log (70% knockdown) reduction in HBsAg after 12 weeks and a 1 log reduction after 24 weeks. Dr. Anzalone refers to the 1 log goal as "intellectually honest."
- The Phase 2a trial is a dose-finding study. Management disclosed that the first two dose levels (1 mg/kg, 2 mg/kg) would not meet their knockdown goals in the August 12 earnings call. They are prepared to go up to 4 mg/kg since there is little risk of toxicity based on their unblinded Phase 1 safety data. They have just completed dosing eight patients in the 3 mg/kg cohort and will escalate to 4 mg/kg as the data come in.
- In an animal study on a hepatitis B-infected chimpanzee, the HBsAg knockdown was 80 - 85% after it received the 3 mg/kg dose.
- The market appears receptive to Dr. Anzalone's explanation. Shares are up 9% premarket on healthy volume.
ARWR vs. ETF Alternatives
Other News & PR