Noticias y eventos de Jupiter Neurosciences Inc (JUNS)JUNSJupiter Neurosciences Inc

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PharmAla Enters $100M License Agreement with Jupiter

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a license agreement, enrollment completion and a patent filing.PHARMALA, JUPITER ENTER LICENSE AGREEMENT:PharmAla Biotech Holdingsannounced Tuesday that it haswith Jupiter Neurosciencesunder which PharmAla has granted Jupiter an exclusive, perpetual, royalty-bearing license to develop, manufacture and commercialize ALA-002, PharmAla's lead drug candidate, in the United States. PharmAla retains all rights to ALA-002 outside the U.S. and will continue to advance the molecule internationally. Under the agreement, the total consideration payable to PharmAla is up to approximately $100M, consisting of a $3,333,333 upfront payment and up to $96,666,666 in contingent development, regulatory and commercialization milestone payments, plus royalties on all future U.S. net sales following the conclusion of milestone payments. The milestone payments and royalties are contingent on the achievement of specified development, regulatory and sales events, which may not be achieved."This Agreement is a landmark transaction for PharmAla and its shareholders. It delivers near-term capital, meaningful milestone and royalty participation, and a dedicated U.S. development partner in Jupiter, all while PharmAla retains full ownership of ALA-002 outside the United States," said Nick Kadysh, CEO, PharmAla. "We developed ALA-002 to deliver an improved MDMA-based therapeutic candidate for patients who need better treatment options across a range of neuropsychiatric disorders. Jupiter's focus on central nervous system disorders and its commitment to advancing innovative brain therapies in the United States make this a strong strategic fit, and allow us to concentrate our own resources on advancing ALA-002 and our broader MDXX pipeline in the rest of the world."HELUS COMPLETES APPROACH STUDY ENROLLMENT:Helus Pharmaannounced Tuesday that it hasof HLP003 in patients living with Major Depressive Disorder. APPROACH enrolled adults with moderate to severe MDD, who experience inadequate response despite a stable antidepressant regimen. Completion of enrollment represents an important milestone for Helus Pharma and advances the company toward the expected release of topline data in Q4. The APPROACH study, and broader PARADIGM Program, incorporate key considerations outlined in the FDA's recently finalized guidance. Enrollment is continuing in EMBRACE, the second pivotal study in the Phase 3 PARADIGM Program. Eligible participants from APPROACH and EMBRACE may also roll over into EXTEND, Helus Pharma's long-term extension study, which is designed to further evaluate safety, durability of clinical effect and the potential role of redosing."Completion of enrollment in APPROACH ahead of schedule demonstrates the focus and execution of our clinical team, investigators and study partners. We thank them and the trial participants for achieving this important milestone. We believe the pace of enrollment of participants reflects not only the efficiency of our clinical team, but also the strength of our screening and site selection processes. Despite rigorous eligibility requirements, we successfully enrolled participants with baseline disease severity aligned with that of our Phase 2 study, reinforcing the quality and integrity of the Phase 3 study population," said Eric So, Interim CEO. "With participant enrollment now complete, our focus turns to completing the study and preparing for topline data in Q4 2026. We believe the durability, remission rates, and overall profile demonstrated in our Phase 2 study support the potential of HLP003 to meaningfully improve outcomes for patients living with MDD, and we look forward to advancing the program through the next stage of development and toward a potential FDA New Drug Application in 2028."Guggenheim lowered the firm's price target on Helus Pharma to $45 from $48 and kept a Buy rating on the shares. The Eli Lillytransaction for AtaiBeckleyvalidates the short-acting psychedelic thesis for pharma and "confirms that this class is now firmly on their strategic radars," said the analyst, who argued that Helus and GH Research"should be on investor radars."CLEARMIND REPORTS HONG KONG PATENT FILING:Clearmind Medicineannounced Monday the filing of afor psychedelic compounds targeting the treatment of Post-Traumatic Stress Disorder and other mental health disorders. The Hong Kong patent application forms part of Clearmind's exclusive worldwide licensing agreement with Yissum Research Development Company of the Hebrew University of Jerusalem. Under the terms of the licensing agreement, Clearmind holds exclusive global rights to develop, manufacture, and commercialize novel compounds developed at Yissum. Clearmind is responsible for advancing the development program in accordance with regulatory requirements.Additionally on Friday, the company noted the significant regulatory and inter-agency developments supporting the development of innovative treatments for serious neuropsychiatric and addiction disorders. This developments include final FDA guidance on psychedelic clinical investigations, a planned public hearing on the therapeutic use of psychedelics, and new Memoranda of Understanding and collaborative initiatives involving the U.S. Department of Health and Human Services, Department of Veterans Affairs, FDA, National Institute on Drug Abuse, ARPA-H, and Health Resources and Services Administration.Adi Zuloff-Shani, CEO, stated, "At a time when patients in the veterans community and the general population have too few treatment options for intractable neuropsychiatric and addiction disorders, we are grateful that Secretary Kennedy is looking to transform treatment opportunities through the expansion of new therapeutic approaches."NRX SAYS DARPA SELECTS PROPOSAL FOR NEGOTIATION:In April, NRx Pharmaceuticalsannounced the incorporation of NRx Defense Systems, a Florida-based research and development subsidiary charged with the development of neuroplastic treatments that combine D-cycloserine with Transcranial Magnetic Stimulation under robotic-enabled neuro-navigation. The company anticipated NRXD participating in future government and non-governmental research and development, based on Phase I and II research conducted by the company's Chief Medical Innovation Officer. On July 21, NRXDDefense Sciences Office, notifying the company that its proposal to conduct a clinical trial, entitled Synaptic Plasticity Augmented Rapid Circuit Stimulation had been selected by DARPA for negotiation of a potential award. The protocol for the SPARC-TMS trial was approved as a phase 2/3 trial by the FDA. The trial aims to demonstrate the potential efficacy of robotic-enabled TMS combined with NRX-101 in achieving remission from depression. The study is planned to be conducted at Harvard Mclean hospital, at clinics operated by HOPE Therapeutics, and at designated military treatment facilities including the Walter Reed National Military Medical Center.ATAIBECKLEY DOWNGRADES:TD Cowen downgraded AtaiBeckleyafter Eli Lilly agreed to acquire the company for $6.75 per share upfront cash plus up to $2.50 per share in contingent payments.Berenberg downgraded AtaiBeckley to Hold from Buy with a $7.45 price target.Additionally, H.C. Wainwright downgraded AtaiBeckley to Neutral from Buy with a price target of $7.50, down from $25. The transaction delivers AtaiBeckley shareholders near-term certainty and transfers substantial execution risk, the analyst said.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Bright Minds, Compass Pathways, Definium Therapeutics, Enveric Biosciences, Filament Health, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Psyence Group, Revive Therapeutics, Sibannacand Silo Pharma.