YOU RICH BRO!!!!! Amylyx up 75% after FDA advisors back approval for ALS drug 07:20 AMLX Shares of Amylyx Pharmaceuticals are up $13.43, or 75%, to $31.33 in pre-market following yesterday's FDA panel meeting.
The queen is very ill. Boris wore her out yesterday and the new PM. Hopefully this isn't the end. But it may be....
UBS 'encouraged' by Snap's bullish targets for FY23 07:43 SNAP BofA 'encouraged by management's ambitions' after Snap CEO memo leak
Amylyx shares should rally $20 or more today, says Citi 07:13 AMLX Citi analyst Neena Bitritto-Garg raised the firm's price target on Amylyx Pharmaceuticals to $48 from $35 and keeps a Buy rating on the shares. Given the positive commentary from Billy Dunn, Office of Neuroscience Director and official signatory on the application at yesterday's FDA panel, positive commentary during the panel discussion, and the positive vote in support of approval, AMX0035 FDA approval by the September 29 action date is now "very highly likely," Bitritto-Garg tells investors in a research note. The analyst expects $20 or more share upside today. The stock in premarket trading is up 74%, or $13.23, to $31.31.
HOLD THE ANGRY EMAILS!!!!!! Ok GBA needs to apologize to all viewers. GBA did not handle this well at all. Until Van's shout out when the stk was held for news there was no prior coverage of the name by Van. No introduction to you all to AMLX except by me on on June 13 when apparently we pulled off a gummy. From June 13 post- AMLX story The Food and Drug Administration pushed its review date for Amylyx Pharmaceuticals' (AMLX) controversial ALS treatment on Friday, and the biotech stock skyrocketed. The news gave investors fresh hope after a panel of FDA experts decided there's not enough evidence to support the drug's benefit in amyotrophic lateral sclerosis. Also known as Lou Gehrig's disease, ALS is a progressive neurodegenerative condition that affects nerve cells in the brain and spinal cord. Previously, the FDA planned to make a decision on Amylyx's drug, dubbed AMX0035, in late June. But Amylyx recently submitted additional clinical data, and the agency needs three more months to review it. "Following the disappointing (advisory committee meeting) the investment community has expected AMX0035 to not get approved by the FDA, but it appears that the FDA is still struggling with its decision," SVB Securities analyst Marc Goodman said in a report to clients. On the stock market today, the biotech stock soared 26.4 to 12.35. At one point, shares rose nearly 43% during the regular session. Biotech Stock Trends Down Patient advocates have pushed for the FDA to approve Amylyx's drug. One expert speaking at the recent FDA advisory committee meeting argued it's comprised of two ingredients already on the open market. Still, just four out of 10 panelists voted in favor of the drug's benefit. In a study called Centaur, the medicine helped improve muscle function. But it's unclear whether it prolonged survival. Amylyx is running another study called Phoenix to confirm the drug's benefit, but it asked for early approval based on the Centaur study. Following the negative advisory committee vote on March 30, Amylyx shares plummeted nearly 14%. The biotech stock has continued to trend down since then. I never followed this up. I apologize.
Annovis Bio's CEO Maccecchini issues letter to stockholders 07:41 ANVS Annovis Bio released the following letter to stockholders from its Chief Executive Officer Dr. Maria Maccecchini. "Dear Fellow Stockholder, Over the years we have been talking about the potential of buntanetap to treat more than Alzheimer's disease. In cell models, animal models and human clinical studies, we have seen that buntanetap works in numerous acute and chronic neurodegenerative conditions... Buntenatap works by inhibiting specific neurotoxic proteins such as amyloid precursor protein, Tau, alpha-synuclein, TAR DNA binding protein 43, huntingtin and prion protein. These proteins have normal functions but in their neurotoxic aggregating form, they impair axonal transport, slow synaptic transmission, cause inflammation, and ultimately, kill nerve cells, resulting in the loss of affected function in various neurodegenerative conditions... Buntanetap is able to inhibit the translation of multiple neurotoxic proteins through this mechanism of action, and as a result has the potential to treat numerous acute and chronic neurodegenerative conditions that share this pathway. In mouse or rat models of Alzheimer's, Parkinson's, stroke, frontotemporal dementia, traumatic brain injury, glaucoma, and Down Syndrome, buntanetap has been shown to normalize the levels of these neurotoxic proteins and to restore function. Most importantly, this has been demonstrated in human clinical trials. In our recent Phase 2 clinical trial in Alzheimer's disease and Parkinson's disease, treatment with buntanetap resulted in reduction of aggregating proteins and statistically significant improvement in motor function in Parkinson's disease patients and cognition in Alzheimer's disease patients."