New FDA status sends this Alzheimer’s biotech soaring

And freleoaders are welcome                                                                                                                                                                                                                                                                                                                                                                                                                 July 10, 2024 | [Read Online]( Good day, 360! Here are our top investing ideas today. These setups look primed! And join us ALL day in the [hottest trading room around]( 🔥. It’s ok to freeload, take it from Talavera: FOCUS LIST🔎 AP - Up over 50% in the pre-market after announcing commercial contract wins and strong growth in sales order backlog LGVN - Up over 80% in pre after U.S. FDA grants Lomecel-B™ Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer’s Disease AMLX- Up over 6% in pre after announcing acquisition of Phase 3-ready GLP-1 Receptor Antagonist (Avexitide) with FDA Breakthrough Therapy Designation $2,000 Small Account Journey NEW $2k balance started this week… here’s what you missed: Trade #1 NVDA +52% realized Trade #2 NFLX +40% realized Trade #3 COMING SOON Don’t miss any more! Join the challenge! Join Jason! The next 50 16 subscribers who commit save 75% [Apply Coupon Code: SAVE75]( Rated 4.8/5. Read Jason’s 1100+ reviews here! HOTLIST🔥 AP - Up over 50% in the pre-market after announcing commercial contract wins and strong growth in sales order backlog Ampco-Pittsburgh Corporation (AP) together with its subsidiaries, engages in manufacture and sale of specialty metal products and customized equipment to commercial and industrial users worldwide. In the after-hours yesterday the [company announced]( that its wholly-owned subsidiary, Union Electric Steel Corporation had been selected to supply the initial provisioning (mill fill) of rolls for two new rolling mill projects under construction. The roll contracts for these new mills are: A new cold mill for Ternium Mexico S.A. de C.V. – Pesqueria, a major North American steel producer, with roll deliveries expected to begin in the first half of 2025 valued at approximately $6.7 million; and A new plant being built in Scandinavia by a major European OEM mill builder requiring rolls to be delivered in the first half of 2025 valued at approximately $5.0 million. In addition, the Corporation has updated its sales order backlog and expects to report that its Air and Liquid Processing segment achieved a record level of new orders in the quarter ended June 30, 2024. Order activity surged more than 50% versus the quarter ended March 31, 2024, to achieve the highest quarterly order intake in the segment’s history. The stock traded up over 50% in the pre-market on the news. The $1.37 area acted as resistance in the pre-market and will be an important level to watch. Above it, targets to the upside are $1.50, $1.60, $1.70 and then the pre-market high at $1.90. Beyond that, $2, $2.20 and $2.40 come into play. Below $1.37, targets to the downside are $1.25, $1.15, $1, $0.90 and then a gap fill at $0.7649. LGVN - Up over 80% in pre after U.S. FDA grants Lomecel-B™ Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer’s Disease Longeveron Inc. (LGVN) is a clinical stage biotechnology company that develops cellular therapies for aging-related and life-threatening conditions in the United States and Japan. In the pre-market this morning, the [company announced]( that the U.S. FDA granted Lomecel-B™ Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer’s Disease. Lomecel-B™ is a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimer’s Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-B™ is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer’s Disease. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline regenerative medicine products, including cell therapies. LGVN traded up over 13% in the pre-market in reaction to the news. The first target for bulls is the pre-market high at $5.85. Beyond that, $6, $8 and $10 come into play. Below $5.85, targets to the downside are $5.47, $5, $4.40, $3.60, $3.40, $3.20, $3, $2.80, $2.60 and then $2. Missed our Independence Week Specials?  Contact Davis & mention 360… and see what he can do.  1-800-585-4488 / davis@ragingbull.com AMLX- Up over 6% in pre after announcing acquisition of Phase 3-ready GLP-1 Receptor Antagonist (Avexitide) with FDA Breakthrough Therapy Designation Amylyx Pharmaceuticals Inc. (AMLX) is a commercial-stage biotechnology company that engages in the discovery and development of treatment for amyotrophic lateral sclerosis (ALS) and neurodegenerative diseases. In the after-hours yesterday, the [company announced]( the acquisition of Phase 3-ready GLP-1 Receptor Antagonist (Avexitide) with FDA Breakthrough Therapy Designation. - Avexitide is a novel, first-in-class GLP-1 receptor antagonist with the potential to treat hyperinsulinemic hypoglycemia - FDA Breakthrough Therapy Designation granted for avexitide for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism - Acquisition builds on Amylyx’ endocrine and neuroscience expertise and aligns with pipeline focus of delivering important potential treatment options to communities with high unmet needs - Phase 3 program for avexitide in PBH expected to begin in Q1 2025, with data readout anticipated in 2026; FDA has agreed to the primary endpoint expected to be utilized in Phase 3 - Data from two Phase 2 studies of avexitide in people with PBH demonstrated highly statistically significant reductions in severe hypoglycemic events, an endpoint supported by the FDA - Avexitide was generally well tolerated, with a favorable safety profile replicated across five clinical trials in people with PBH On July 9, 2024, Amylyx completed the acquisition of substantially all of the rights, title and interests in, to and under those assets and interests used by the seller in the development, manufacture and commercialization of avexitide from Eiger for $35.1 million plus the aggregate amount of determined cure costs and assumed liabilities. As part of the transaction, Amylyx assumed certain contractual obligations from Eiger, including a 3% royalty on future sales of avexitide in PBH, if approved, to certain academic institutions. The stock traded up over 6% in the pre-market in reaction to the acquisition. The $1.80 area acted as resistance in the pre-market and will be an important level to watch. Above it, targets to the upside are $1.89 and then the pre-market high at $2.01. Beyond that, $2.10, $2.50 and $2.85 come into play. Below $1.80, targets to the downside are $1.75, $1.70 and then a gap fill at $1.65. MARKET NEWS 📰 P.S. Make sure you text “RAGE” to (888) 404-5747 to get all of our latest HOT STOCK ideas! Questions or concerns about our products? 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