"AI Woodstock": Will Nvidia live up to expectations?

 You probably need to hop into a time machine and go back a few years to recall a time when any company garnered as much interest as Nvidia. The stock of this artificial intelligence company has surged almost 80% on Wall Street since the beginning of the year, propelling its market value to $2.2 trillion and earning it the title of the world's third-largest company. Only Microsoft and Apple sit ahead of it on the esteemed list.

To showcase the latest developments in the AI world, Nvidia has decided to return for the first time since 2019 to a physical conference near its headquarters in San Jose, California. The company has invited senior leaders from the field worldwide to the event. What initially started as a local company gathering has quickly transformed into a global congregation of the top AI leaders. It seems that's the nature of things when you're a company that has added a trillion dollars to its market cap in less than three months.

The SAP Center is all set for the start of Nvidia GTC.

(Photo: Shay Salinas)

Despite officially being a technological event, the buzz surrounding the company has managed to spark high expectations on Wall Street. Bank of America, for instance, has dubbed it "AI Woodstock" and raised the stock's target price from $925 to $1,100 ahead of the conference. According to the bank, despite a 270% surge in the stock price over the last 12 months, there's still room for further gains as the stock is currently trading at a lower earnings multiple than when ChatGPT launched in November 2022. But Bank of America isn't the only entity bullish on the stock. Bloomberg's data reveals that Nvidia stock currently boasts 60 "buy" recommendations, 7 "hold" recommendations, and 0 "sell" recommendations.

The conference, scheduled to last four days from March 18 to 21, will kick off on Monday with an opening address by the company's CEO, Jensen Huang. The esteemed CEO, who has become a figure in high demand akin to some heads of state, typically commences the event with presentations of new products and an outline of his vision for the future of technology. However, this time, the pressure on him will be heightened following the company's remarkable returns, making it the best-performing company in the S&P 500 index since the beginning of 2024.

https://www.calcalistech.com/ctechnews/article/h1ecmd4c6

Abeona Therapeutics Shares Drop After FDA Inspection of Cleveland Facility

 Abeona Therapeutics shares were down 13% to $7.50 after the company said the U.S. Food and Drug Administration has completed a pre-license inspection of its Cleveland, Ohio, manufacturing facility.

The stock hit its 52-week high of $9.01 on March 6, and is up 208% in the past 12 months.

The company said the inspection was in relation to its Biologics License Application for pz-cel, or prademagene zamikeracel, for recessive dystrophic epidermolysis bullosa.

During the inspection, the FDA reviewed the facilities, systems, and processes at the Cleveland site. The FDA also observed the manufacturing process for pz-cel, as well as performance of in-process and release assays.

The two-week inspection ended March 1. Upon completion of the inspection, a Form 483 was issued with observations related to process controls.

On Friday, the company submitted a response to the FDA, outlining already implemented and ongoing steps toward resolution that follow FDA guidance provided during the audit. The FDA's review of Abeona's pz-cel BLA is ongoing, with a target Prescription Drug User Fee Act date of May 25. The FDA doesn't currently plan to conduct an Advisory Committee.

https://www.morningstar.com/news/dow-jones/202403185332/abeona-therapeutics-shares-drop-13-after-fda-inspection-of-cleveland-facility

Lantern Pharma begins Phase 1 a/b in non-Hodgkin’s lymphoma trial

 Lantern Pharma has dosed two subjects in a Phase Ia/Ib clinical trial of its investigational drug LP-284 for relapsed or refractory non-Hodgkin’s lymphoma (NHL).

A new small molecule, LP-284 has a synthetically lethal mechanism of action that kills cancer cells harbouring mutations in DNA damage repair pathways.

The multicentre, open-label trial aims to determine the safety and tolerability of varying doses of the molecule.

LP-284 will be assessed for its potential to treat mantle cell lymphoma (MCL), double hit lymphoma (DHL), high-grade B-cell lymphomas (HGBL), and selected solid tumours and sarcomas.

The trial will also investigate the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with relapsed or refractory (r/r) lymphomas and solid tumours.

Characterising the pharmacokinetics (PK) of LP-284 and evaluating its clinical activity are the trial’s secondary objectives.

https://www.clinicaltrialsarena.com/news/lantern-non-hodgkins-lymphoma-trial/

Intellia Starts Phase 3 on Single-Dose CRISPR Treatment for Transthyretin Amyloidosis with Cardiomyopathy

 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced the first patient dosed in the global pivotal, Phase 3 MAGNITUDE trial of NTLA-2001. NTLA-2001 is an investigational in vivo CRISPR-based therapy designed as a single-dose treatment to inactivate the TTR gene and thereby prevent the production of TTR protein for the treatment of transthyretin (ATTR) amyloidosis. The MAGNITUDE trial is evaluating the efficacy and safety of NTLA-2001 in patients with ATTR amyloidosis with cardiomyopathy.

https://www.biospace.com/article/releases/intellia-therapeutics-announces-first-patient-dosed-in-the-phase-3-magnitude-study-of-ntla-2001-as-a-single-dose-crispr-based-treatment-for-transthyretin-amyloidosis-with-cardiomyopathy/

Citius: BLA Resubmission of LYMPHIR for Cutaneous T-Cell Lymphoma Accepted

 FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2024

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024.

https://www.biospace.com/article/releases/citius-pharmaceuticals-announces-fda-acceptance-of-the-bla-resubmission-of-lymphir-denileukin-diftitox-for-the-treatment-of-adults-with-relapsed-or-refractory-cutaneous-t-cell-lymphoma/

NRX to Distribute Shares of HOPE Therapeutics and Royalty Rights on Ketamine Sales to Existing NRx Shareholders

 

• NRx Pharmaceuticals Board of Directors has authorized its Chairman, CEO, and management to take all necessary steps to affect the Dividend and Royalty Rights to NRXP Shareholders and applicable warrant holders
• Dividend is intended to distribute 49% of HOPE Therapeutics stock and a Royalty Right for 1% of Ketamine sales made by HOPE
• Effective date to be declared as soon as all required legal, accounting, and regulatory steps have been completed
• Proxy voting instructions included below

"This Dividend is another important step to building value for all of the Company's stakeholders.  We are pleased to be taking these concrete steps to unlocking the power and value of our Ketamine franchise for the investors who have supported the company and patients who need this potentially lifesaving product," said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals and co-CEO of Hope Therapeutics.  "As we build HOPE into a thriving, publicly-traded Specialty Pharmaceutical company we look forward to continuing to reward our investors."

Instructions and further details will be communicated through the Company's website and usual channels as they become available.

HOPE Therapeutics was recently formed to advance HTX-100 (IV Ketamine) to a New Drug Application filing and subsequent commercialization in the near term, and also facilitate sales of ketamine through high quality 503 a and 503b licensed pharmacies beginning in 2Q24.  HOPE will additionally focus on digital therapeutics and other technologies to extend the pharmacologic effect of ketamine. Together, these efforts are intended to create a revenue generating Specialty Pharmaceutical company in 2024.

Proxy Voting
By now shareholders should have received a proxy statement and voting card for NRx's special meeting to be held on March 21, 2024.  All votes need to be completed by March 20, 2024.  

If you have a control number, you can vote here: https://www.cstproxyvote.com/

If you have not yet received any voting instructions, the Company can help. If you have any issues with voting, please reach out to Stephen Freyman of Alliance Advisors for immediate assistance.  Stephen's contact info is sfreyman@allianceadvisors.com T: 1 (973) 518 3365.

https://www.biospace.com/article/releases/nrx-pharmaceuticals-nasdaq-nrxp-announces-plan-to-distribute-shares-of-hope-therapeutics-and-royalty-rights-on-ketamine-sales-to-existing-nrx-shareholders/

Oculis Results and Update

 

• A successful year including NASDAQ listing and positive results from two Phase 3 programs in OCS-01: Phase 3 Stage 1 DIAMOND trial for Diabetic Macular Edema (DME), and Phase 3 OPTIMIZE-1 trial for inflammation and pain following cataract surgery
• On-track to report topline data from OCS-02 (Licaminlimab) Phase 2b RELIEF trial in Dry Eye Disease (DED) in Q2 2024, OCS-01 Phase 3 OPTIMIZE-2 trial, and OCS-05 proof-of-concept ACUITY trial in Q4 2024
• Cash, cash equivalents and short-term investments of $108.9 million funding operations and planned clinical trials, as well as advancements in DIAMOND-1 and DIAMOND-2 Phase 3 trials
• R&D Day held on February 28, 2024, showcasing OCS-01 DME and OCS-02 DED and their transformative treatment potentials

https://www.biospace.com/article/releases/oculis-reports-q4-and-full-year-2023-financial-results-and-update-on-company-progress/