Jaguar8 wrote a post · 2 hours ago

🔶December 2024 Upcoming Catalysts. Save it. In alphabetical order

$ABVC BioPharma (ABVC.US)$ - Progress continues in our ADHD program with Phase IIb trials at multiple prominent sites. We aim to have an interim report by Q4 2024. ABV-1601 for MDD in cancer patients has completed Phase I study preparation, including the Site Initiation Visit (SIV). The study is set to initiate by the end of 2024.

$Ascent Solar Technologies (ASTI.US)$- Following delivery and the successful completion of the on-orbit technology for use in the target environment (low Earth orbit (LEO)), it is Ascent's intent to design and manufacture Plug and FlyTM arrays in concert with the customer for delivery of these units as early as Q4 2024-Q1 2025. The arrays delivered will provide primary power to the next generation satellites, significantly reducing part count, weight, and system complexity

$Bluejay Diagnostics (BJDX.US)$ - We initiated the SYMON-II pivotal clinical study in the third quarter of 2024. We plan to start patient enrollment during the fourth quarter of 2024.

$Bionomics (BNOX.US)$ - Bionomics shareholders have today approved, by the requisite majority, the proposed Scheme of Arrangement in relation to the Company's proposed re-domiciliation from Australia to the United States, under which Neuphoria Therapeutics Inc., a Delaware corporation. Subject to these remaining conditions being satisfied or waived, implementation of the Scheme is expected to occur on or about December 24, 2024 and shares of Neuphoria are expected to begin trading on Nasdaq under the symbol "NEUP"

$Bio-Path Holdings (BPTH.US)$ - Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. “We look forward to completing Investigational New Drug (IND)-enabling testing in the fourth quarter of 2024.

$Brera Holdings (BREA.US)$ - Signed a binding term sheet to make a strategic investment in SS Juve Stabia SpA ("Juve Stabia" or "the Club"), a historic Italian Serie B football club celebrating 117 years of tradition. SEC filings will contain details of its strategic investment in Juve Stabia, and further updates will be provided on an ongoing basis, starting with the initial closing agreed to take place by December 31, 2024.

$BioXcel Therapeutics (BTAI.US)$ - The new outpatient study has received funding approval from the Pharmacotherapies for Alcohol and Substance Use Disorders Alliance (funded through a Cooperative Agreement between the U.S. Department of Defense Congressionally Directed Medical Research Program and RTI International). Patient screening and enrollment is expected to start in the fourth quarter of 2024.

$Compugen (CGEN.US)$ - On track to initiate Phase 1 trial evaluating COM503 (anti-IL18BP) in solid tumors in Q4 2024.

$Cognition Therapeutics (CGTX.US)$ - Last patient has completed their final clinic visit in the Phase 2 SHIMMER study of CT1812 in patients with mild-to-moderate dementia with Lewy bodies (DLB). The Company anticipates that topline results will be available in December 2024

$Cocrystal Pharma (COCP.US)$ - We expect to report topline results from the CDI-988 Phase 1 study in late 2024 or early 2025.

$Cue Biopharma (CUE.US)$ - While we are currently strategically prioritizing our autoimmune programs, we plan to continue to follow the patients treated in the CUE-102 Phase 1 monotherapy setting and anticipate providing further updates on the maturing data in the fourth quarter of 2024. We believe this result supports the potential for CUE-501 to have an improved safety and tolerability profile in patients relative to pan T cell engagers, while also maintaining the benefits of an off-the-shelf biologic relative to the manufacturing challenges and costs associated with cell therapy approaches. We anticipate providing a CUE-501 program update in the fourth quarter of 2024.

$Cutera (CUTR.US)$ - On July 31, 2024, the Company announced a strategic partnership with L’Oréal Japan Co. to exclusively promote, market, sell and distribute select SkinCeuticals products to medical and physician-led clinics in Japan. Under the terms of the agreement, the partnership will initially span three years, with options for renewal. Cutera plans to introduce the SkinCeuticals product line to customers in Japan during the fourth quarter of 2024 and expects the financial impact of the distribution agreement to be immaterial in 2024.

$Entero Therapeutics (ENTO.US)$ - On November 8, 2024, Entero Therapeutics, Inc., a Delaware corporation (the "Company") entered into a binding term sheet (the "Binding Term Sheet") with Journey Therapeutics, Inc. ("Journey"), a life sciences company. Pursuant to the Binding Term Sheet, the Company will acquire 100% of the outstanding equity interests of Journey in return for 99% of the Company's fully-diluted equity (the "Acquisition"). Under the Binding Term Sheet, Journey and the Company are subject to an exclusivity period that is a minimum of 30 days, and such exclusivity shall continue after the 30-day period until a party delivers a notice of termination of exclusivity (the "Exclusivity Period"). During the Exclusivity Period, both parties are restricted from soliciting, negotiating or entering into any agreements with third parties for the sale of their respective businesses or material assets.

$DigiAsia (FAAS.US)$ - has secured allocation of an initial tranche of 5,120 NVIDIA H200 GPUs (NASDAQ:NVDA). The access to NVIDIA's GPUs will propel DIGIASIA's development of cutting-edge AI solutions for enterprise customers in fintech, telecom, and government sectors. The first iteration of these NVIDIA-powered solutions is expected to be deployed by the fourth quarter of 2024.

$Galectin Therapeutics (GALT.US)$ - NAVIGATE trial readout on track for December 2024.

$Gain Therapeutics (GANX.US)$ - Initiation of Phase 1b trial evaluating GT-02287 in Parkinson's disease patients expected in Q4 2024. Pre-IND meeting with the U.S. Food and Drug Administration (FDA) anticipated by the end of 2024.

$Galmed Pharmaceuticals (GLMD.US)$ - We plan on releasing new data from in-vitro and ex-vivo studies in these programs during the fourth quarter of 2024.

$Inhibikase Therapeutics (IKT.US)$ - The last patient and last visit in the Phase 2 201 Trial evaluating risvodetinib (also known as IkT-148009) in untreated Parkinson’s disease occurred in October, 2024; topline data is expected in the fourth quarter of 2024

$Inozyme Pharma (INZY.US)$ - Interim data from ENERGY 1, a Phase 1b trial of INZ-701 in infants with ENPP1 Deficiency, on track for fourth quarter of 2024.

$Invivyd (IVVD.US)$ - Next generation molecule VYD2311 first-in-human clinical trial dosing began in August 2024 with anticipated preliminary data readout late Q4 2024.

$Kaival Brands Innovations (KAVL.US)$ - Delta Corp Holdings Limited, a Fast Growing Asset-Light Logistics Company Enters into a Definitive Merger and Share Exchange Agreement with Kaival Brands Innovations Group, Inc. Following closing of the transactions, which the parties expect will occur in the fourth quarter of 2024, the combined company would be traded on Nasdaq

$AEye (LIDR.US)$ - We made significant progress with our partners over the quarter. ATI, our partner in China, is demonstrating Apollo to potential customers. We are also engaged in multiple global OEM quoting activities with our Tier 1 partner, LITEON, and plan to begin development of an Apollo manufacturing line in the fourth quarter of 2024.

$Lipella Pharmaceuticals (LIPO.US)$ - Our commitment to developing a safe and effective therapy for Oral Lichen Planus patients remains steadfast as we activate additional sites and begin enrolling the next dose cohort. The pace of our progress has been promising, and we are on track to deliver top-line data by year-end.

$Spectral AI (MDAI.US)$ - Spectral AI has successfully enrolled and completed image collection for the BARDA burn study, a critical step in training the AI algorithm for the DeepView AI®-Burn device. The Company anticipates data results in late December.

$NovaBay Pharmaceuticals (NBY.US)$ - The first provides for the sale of our Avenova eyecare business to PRN and the second proposal provides for the proposed liquidation and dissolution of the Company. We are reconvening the Special Meeting on Wednesday, December 18, 2024 to allow additional time for stockholders to vote on Proposal One and Proposal Two.

$New Era Helium (NEHC.US)$ - Sharon AI and New Era Helium have formalized their commitment by signing a binding Letter of Intent (LOI) from a previously announced non-binding LOI. The companies anticipate formalizing the joint venture agreement on or before December 23, 2024.

$NRX Pharmaceuticals (NRXP.US)$ - On track to file New Drug Applications (NDAs) for NRX-100 (IV Ketamine) in treating suicidal ideation in depression, including bipolar depression and NRX-101 (Oral D-Cycloserine/Lurasidone) for Accelerated Approval in bipolar depression with suicidality or akathisia by year end 2024

$NextTrip (NTRP.US)$ - Signed a non-binding Letter of Intent (LOI) to acquire Five Star Alliance, an online luxury travel agency founded in 2004 and renowned for its curated collection of five-star luxury hotels and resorts worldwide. The transaction is expected to be accretive. The acquisition is anticipated to close in Q4 2024, pending definitive agreements and customary closing conditions

$Nexalin Technology (NXL.US)$ - The new Gen-3 device is also scheduled for additional pilot trials and/or pivotal trials for anxiety and insomnia in the United States and China beginning in the fourth quarter of 2024.

$Oragenics (OGEN.US)$ - We anticipate a Phase 2 clinical trial will be performed administering ONP-002 intranasally in concussed patients 2x a day for up to fourteen days. The Phase 2a feasibility study is expected to be performed in Australia with a target initiation date in the fourth quarter of 2024 to be followed closely by a Phase 2b proof of concept study in the US.INZY - Interim data from ENERGY 1, a Phase 1b trial of INZ-701 in infants with ENPP1 Deficiency, on track for fourth quarter of 2024.

$OS Therapies (OSTX.US)$ - Topline Data from Phase 2b clinical trial of OST-HER2 in Osteosarcoma expected to be released in December 2024.

$Paltalk (PALT.US)$ - Special meeting of stockholders will be held on December 30, 2024 in connection with the acquisition by the Company of Newtek Technology Solutions, Inc. (“NTS”), and pursuant to that certain Agreement and Plan of Merger, dated as of August 11, 2024, by and among the Company, PALT Merger Sub 1, Inc., PALT Merger Sub 2, LLC, NewtekOne, Inc. and NTS.

$PepGen (PEPG.US)$ - FREEDOM2 is a Phase 2 randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) clinical trial evaluating PGN-EDODMT in approximately 24 adult patients with DM1 in Canada, the United Kingdom, and, subject to regulatory clearance, the United States. The Company expects to initiate dosing in FREEDOM2 by year-end. The Company is also working to optimize the design of the multinational CONNECT2 Phase 2 double-blind, placebo-controlled, MAD, 25-week trial. The CONNECT2 clinical trial is open in the United Kingdom. The Company continues to engage with regulators in the European Union and expects to open the clinical trial in the United States by year-end, subject to regulatory clearance.

$ProMIS Neurosciences (PMN.US)$- ProMIS is on-track to initiate its PMN310 Phase 1b clinical trial by year-end 2024.

$Prestige Wealth (PWM.US)$ - On November 12, 2024, it entered into a definitive acquisition agreement pursuant to which PWM will purchase all shares of Tokyo Bay Management Inc. ("Tokyo Bay"), a company incorporated under the laws of the British Virgin Islands. The acquisition of Tokyo Bay is expected to close in the fourth quarter of 2024 and will enhance the Company’s strategy and development in Asia wealth management industry.

$PolyPid (PYPD.US)$ - Outcome of the unblinded interim analysis in Company’s ongoing SHIELD II Phase 3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections is expected in December 2024.

$Regulus Therapeutics (RGLS.US)$ - The Company remains on track for an End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) by year-end 2024.

$Reviva Pharmaceuticals (RVPH.US)$ - Topline data from OLE trial expected in December 2024.

$Signing Day Sports (SGN.US)$ - Schedule of events in its expected role as National Recruiting Partner for the 2025 U.S. Army Bowl Regional Combine Series. The 2024 U.S. Army Bowl National Combine and U.S. Army Bowl Game will take place later this month, from December 18–22, at the home of the Dallas Cowboys, The Star, in Frisco, Texas

$Sidus Space (SIDU.US)$ - LizzieSatTM-2 has been turned over to SpaceX and is ready for launch on the Bandwagon-2 rideshare mission, which is targeted for no earlier than December of 2024.

$Theratechnologies (THTX.US)$ Theratechnologies recently entered an exclusive licensing agreement with lonis Pharmaceuticals for olezarsen.
The PDUFA action date for olezarsen's FDA review is set for December 19, 2024. If approved, this would target familial chylomicronemia syndrome (FCS) and potentially expand Theratechnologies' market presence.

$Tonix Pharmaceuticals (TNXP.US)$ - Submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in October for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), Tonix's drug candidate for the management of fibromyalgia. Tonix expects to hear a decision on NDA acceptance by the FDA in mid-December.

$Vivani Medical (VANI.US)$ - In July 2024, the Company announced that it expects to initiate the first clinical study in the NPM-115 program in the fourth quarter of 2024 in Australia, pending regulatory clearance in that country.

$WiSA Technologies (WISA.US)$ - Entered into a definitive asset purchase agreement to purchase the Datavault® intellectual property and information technology assets of privately held Data Vault Holdings Inc.® Subject to customary conditions and approval by the stockholders of WiSA Technologies, the closing is expected before December 31, 2024.

$Xilio Therapeutics (XLO.US)$ - Xilio expects to report initial Phase 2 data for the combination in approximately 20 patients with metastatic MSS CRC in the fourth quarter of 2024.

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Jaguar8

Spread kindness and love. Life is short. Don’t let greed eat you.

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