$ALNY Blows Up in the After-Hours, Leaving FBR Analyst in Shambles

Biotech has been the sole denizen for extreme profit over the past decade, especially since the vultures in silicon valley privately fund all of the really good investment opportunities and only release them from their greedy fucking mittens when valuations exceed that of anything considered to be normal. But every once in a while, the biotech mine field claims a victim. In the after hours session, Chris James, biotech analyst at FBR, is very busy wiping off a bucket of eggs that was just tossed into his stupid face — following months of ALNY pumping — depending on both weak and bad information.

Shares of ALNY are off by a staggering 40% in the after hours after suspending research into an experimental RNAi drug called Revusiran.

Via Briefing.com

The co announced that upon the recommendation of the ENDEAVOUR Phase 3 study Data Monitoring Committee to suspend dosing, the Company has decided to discontinue development of revusiran, an investigational RNA interference therapeutic that was being developed for the treatment of hereditary ATTR amyloidosis with cardiomyopathy. This decision was made yesterday evening and has been communicated to investigators, study sites, and regulatory authorities.

Following recent reports in the Phase 2 OLE study of new onset or worsening peripheral neuropathy, the ENDEAVOUR DMC assembled yesterday at the Company’s request to review these reports and ENDEAVOUR data on an unblinded basis. The DMC did not find conclusive evidence for a drug-related neuropathy signal in the ENDEAVOUR trial, but informed the Company that the benefit-risk profile for revusiran no longer supported continued dosing. The Company subsequently reviewed unblinded ENDEAVOUR data which revealed an imbalance of mortality in the revusiran arm as compared to placebo.

The decision to discontinue development of revusiran does not affect patisiran, which is currently in Phase 3 development for the treatment of hATTR amyloidosis with polyneuropathy (hATTR-PN), or any other Alnylam investigational RNAi therapeutic program in development.

Based on a current assessment of the safety data across the Company’s other programs, which include the ALN-PCSsc program partnered with The Medicines Company, there is no evidence of a drug-related neuropathy signal in over 800 treated subjects and patients with exposure of up to 34 months. This includes patisiran, which utilizes a lipid nanoparticle delivery formulation, and the seven other clinical programs in Alnylam’s pipeline, which all use Enhanced Stabilization Chemistry (ESC) GalNAc delivery technology. ESC-GalNAc conjugates enable dose and exposure levels that are 12-30 times lower than revusiran, which uses Standard Template Chemistry (STC) GalNAc delivery technology. The Company reaffirms its “Alnylam 2020” guidance and remains committed to the advancement of these investigational RNAi therapeutics for treatment of diseases with high unmet medical need.

Here is what C. James penned on July the 5th, 2016 — reiterating his insane price target of $180 for ALNY.

Alnylam Pharma: Data at ISA highlight sustained benefit in hATTR-PN; Phase III ENDEAVOR time line accelerated — FBR noting they had an opportunity to speak with mgmt; four key takeaways: (1) Initial 24-month patisiran data support potential halting of disease progression with a mean mNIS+7 score decrease of 6.7 points, from baseline at 24 months, versus an expected mean increase of 26–30 points; (2) baseline characteristics from the Phase III APOLLO study with patisiran reflect the global patient population; (3) despite unclear results from the Phase II OLE study with revusiran, firm believes the Phase III ENDEAVOR study, which is enrolling faster than anticipated, will be well positioned to determine clinical benefit from revusiran; (4) both patisiran and revusiran were generally well tolerated, with one, possibly drug-related, serious adverse event of lactic acidosis reported in the Phase II OLE study with revusiran.Overall, they believe these data reaffirm patisiran’s potential to be ALNY’s first approved RNAi therapeutic, and they look forward to the Phase III APOLLO readout, expected in mid 2017.