Over a week ago | ||||
The most talked about and…
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As previously reported,… As previously reported, BofA analyst Tazeen Ahmad downgraded Annexon to Neutral from Buy with a price target of $3, down from $8, after the ARCHER trial of ANX007 in patients with geographic atrophy, or GA, did not reach statistical significance on its endpoint. While the firm views the data overall as "mixed," it still thinks there is a potential path forward for ANX007 and it believes the large GA market could support multiple drugs. However, it has lowered its U.S. and EU peak penetration assumptions and otherwise adjusted its model after the trial results. | ||||
BofA analyst Tazeen Ahmad… BofA analyst Tazeen Ahmad downgraded Annexon to Neutral from Buy with a price target of $3, down from $8. | ||||
BTIG lowered the… BTIG lowered the firm's price target on Annexon to $7 from $15 but keeps a Buy rating on the shares after the company announced that its ARCHER trial endpoint did not reach statistical significance in geographic atrophy. The positive aspects of the readout were confined to a responder analysis of patients that saw a greater than or equal to15-letter drop in BCVA, or best corrected visual acuity, over the course of the trial, and these results also appeared to be dose-dependent, the analyst tells investors in a research note. BTIG adds however that the firm is staying positive on the basis of the Guillain-Barre Syndrome readout, where the competition is less and the disease is more aggressive. | ||||
JPMorgan analyst Anupam… JPMorgan analyst Anupam Rama downgraded Annexon to Neutral from Overweight with a price target of $9, down from $19. The Phase 2 ARCHER data of ANX007 in geographic atrophy was mixed, with no statistically significant benefit on lesion size reduction but it showed surprising benefits on visual function gains, the analyst tells investors in a research note. Going forward, the firm sees some potential regulatory and clinical risk. As such, it removed ANX007 in geographic atrophy from the model. Annexon has now had two mixed mid-stage data sets, which will not help overall sentiment on the shares, JPMorgan writes. | ||||
Annexon announced topline… Annexon announced topline results from its ARCHER Phase 2 trial of ANX007 in patients with geographic atrophy, or GA. Results from the 12-month treatment period of ARCHER showed that patients treated monthly and every-other-month with ANX007 were protected against vision loss as measured by changes from baseline in the widely accepted functional endpoint of best corrected visual acuity, or BCVA. Patients in the monthly treatment group showed a 72% reduction in risk of 15-letter loss and patients in the every-other-month treatment group showed a 48% reduction in risk of 15-letter loss. Patients in the pooled treatment group showed a 59% reduction in risk of greater than15-letter loss. These data represent the first demonstration of a complement-based therapy to protect against vision loss in a prospective 12-month clinical trial and support the differentiated mechanism of action of ANX007, which is designed to target and preserve photoreceptor cells, synapses and function. The primary endpoint of mean rate of change in GA lesion area compared to sham at 12 months did not reach statistical significance. A 6.2% reduction in lesion growth was observed in monthly treatment group (p=0.526), a 1.3% reduction was observed in the every-other-month treatment group and a 3.7% reduction was observed in the pooled patient population. ANX007 was generally well tolerated as both a monthly and every-other-month treatment. | ||||
Reports Q1 cash and cash… Reports Q1 cash and cash equivalents and short-term investments were $228.2M million as of March 31. Based on the current operating plan, Annexon continues to expect its cash, cash equivalents and marketable securities as of March 31 to be sufficient to fund the company's operating expenses and capital expenditure requirements related to currently ongoing clinical trials into 2025.. "The first quarter was another period of strong execution of our flagship and next-wave clinical-stage programs for the treatment of complement-mediated diseases of the body, brain and eye, thereby enabling multiple clinical catalysts over the next several quarters," said Douglas Love, president and CEO of Annexon. "Our platform approach of blocking classical complement-driven inflammation where it initiates on diseased tissue has demonstrated robust patient benefit in multiple autoimmune and neurodegenerative diseases. We are excited by the potential of demonstrating patient benefit in our first ophthalmologic indication with the Phase 2 ANX007 ARCHER trial in geographic atrophy, whereby stopping the initiation of the inflammatory classical complement cascade may reduce retinal inflammation and improve macular health. We are eagerly anticipating results from our pivotally designed and executed ARCHER trial in mid-2023." |
Over a month ago | ||||
SMid Cap Biotech Analyst… SMid Cap Biotech Analyst Rama holds a conference call with CEO Love on March 20 at 11 am hosted by JPMorgan. Webcast Link | ||||
SMid Cap Biotech Analyst… SMid Cap Biotech Analyst Rama holds a conference call with CEO Love on March 20 at 11 am hosted by JPMorgan. | ||||
SMid Cap Biotech Analyst… SMid Cap Biotech Analyst Rama holds a conference call with CEO Love on March 20 at 11 am hosted by JPMorgan. |