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- Hotlist Alert: FDA clears, oil flows & clinical trials IGNITE gains!
Hotlist Alert: FDA clears, oil flows & clinical trials IGNITE gains!
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Good day, 360!
Here are some of our top movers today. And please join us at 11AM EST for a special session on the BREAKOUT Multiplier (easy to sign up, FREE to attend!). Be the best prepared trader on the Street!
FOCUS LIST🔎
BCLI - Up over 75% in the pre-market after receiving FDA clearance to initiate Phase 3b trial of NurOwn® for ALS
SOC - Up over 14% in pre after announcing restart of oil production at the Santa Ynez Unit and anticipated oil sales from the Las Flores pipeline system in July 2025
GUTS - Up over 17% in pre after advancing Rejuva® gene therapy platform with submission of first clinical trial application module in Europe for RJVA-001 in Type 2 Diabetes
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HOTLIST🔥
BCLI - Up over 75% in the pre-market after receiving FDA clearance to initiate Phase 3b trial of NurOwn® for ALS
Brainstorm Cell Therapeutics Inc. (BCLI) is a biotechnology company that engages in the development and commercialization of autologous cellular therapies for the treatment of neurodegenerative diseases.
In the pre-market this morning, the company announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate its Phase 3b clinical trial of NurOwn® (autologous MSC-NTF cells) for the treatment of amyotrophic lateral sclerosis (ALS).
The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA), confirming the study's endpoints and statistical methodology are appropriate to support a future Biologics License Application (BLA) submission. This clearance allows the company to proceed with patient enrollment.
Shares of BCLI traded up over 75% in the pre-market in reaction to the news.
The $1.75 area acted as support in the pre-market and will be an important level to watch.
Above it, targets to the upside are $2, $2.20, $2.40, $2.60, $2.90 and then the pre-market high at $3. Beyond that, $3.70 and $4 come into play.
Below $1.75, targets to the downside are $1.50, $1.40 and then a gap fill at $1.32.
SOC - Up over 14% in pre after announcing restart of oil production at the Santa Ynez Unit and anticipated oil sales from the Las Flores pipeline system in July 2025
Sable Offshore Corp. (SOC) operates as an independent oil and gas company in the United States.
In the pre-market this morning, the company announced that as of May 15, 2025, it has restarted production at the Santa Ynez Unit and has begun flowing oil production to Las Flores Canyon.
Additionally, with the completion of the Gaviota State Park anomaly repairs on the Las Flores Pipeline System (the "Onshore Pipeline") on May 18, 2025, Sable has now completed its anomaly repair program on the Onshore Pipeline as specified by the Consent Decree, the governing document for the restart and operations of the Onshore Pipeline.
Sable expects to fill the ~540,000 barrels of crude oil storage capacity at LFC by the middle of June 2025 and subsequently recommence oil sales in July 2025.
Shares of SOC traded up over 14% in the pre-market in reaction to the news.
The first target for bulls is the pre-market high at $34.20. Beyond that, is all-time highs and blue sky. Round numbers such as $35, $40 and $50 come into play.
Below $34.20, targets to the downside are $33, $32.70, $32, $31, $30 and then a gap fill at $28.86.
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GUTS - Up over 17% in pre after advancing Rejuva® gene therapy platform with submission of first clinical trial application module in Europe for RJVA-001 in Type 2 Diabetes
Fractyl Health Inc. (GUTS) is a metabolic therapeutics company that develops therapies for the treatment of type 2 diabetes (T2D) and obesity.
In the pre-market this morning, the company announced that it has submitted the first module of its Clinical Trial Application (CTA) in Europe for RJVA-001, the Company’s gene therapy candidate from its Rejuva platform.
RJVA-001 is designed to express glucagon-like peptide-1 (GLP-1) locally in pancreatic beta cells using nutrient-responsive control, potentially enabling physiologic hormone secretion without the high circulating levels that contribute to side effects seen with systemic GLP-1 drug therapy.
Pending regulatory clearance, Fractyl anticipates initiating first-in-human dosing and reporting preliminary data in 2026.
Shares of GUTS traded up over 17% in the pre-market in reaction to the news.
The first target for bulls is the pre-market high at $2.10. Beyond that, $2.26 and $2.57 come into play.
Below $2.10, targets to the downside are $1.80, $1.75 and then a gap fill at $1.69 with $1.51 below that.
MARKET NEWS 📰
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