SJLife Sciences

We’re pleased to announce an important milestone for the #narcolepsy community, specifically for pediatric patients and their caregivers.    Learn more about another positive step in our efforts to transform the lives of people with narcolepsy.  https://lnkd.in/gFm6kxvx

🚨🚨🚨 AbbVie 👏 People with advanced Parkinson's Disease finally have a new treatment option thanks for AbbVie's recent FDA green light for their asset VYALEV™. People with PD are in real need of new treatment due to the progressive nature of the disease meaning oral medications aren't as effective with motor symptom controls resulting in potential surgical treatment being required. This is "the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations" and will allow patients to receive continuous delivery of levodopa throughout the day. The approval comes off the back of a Phase 3, 12 week study which evaluated the efficacy of VYALEV and the findings demonstrated superior improvement in motor fluctuations. 🎉

Bright Minds Biosciences.... are they following in the footsteps of Longboard?

🚨🧠 Neuroscience Clinical News – 7 day recap: 11/10 (1/2) As expected, an incredibly busy week. So much news means I will separate clinical and financial news into two posts – see comments for financial. 🥼 Clinical: Halia Therapeutics, Inc. announced their first healthy volunteer has been dosed in a Phase I trial of HT-4253, a novel oral LRRK2 inhibitor targeting neuroinflammation for Alzheimer’s. Oragenics, Inc have successfully completed a study of their concussion drug, ONP-002. Oragenics plan to move forward with Phase II testing in patients. Arrivo BioVentures LLC have begun a Phase 1 study of SP-624. This is the first potential treatment specifically for women with Major Depressive Disorder (MDD). The asset is also being studied in a large Phase 2b study with the primary endpoint being efficiency. PTC Therapeutics, Inc. provided positive updates on their drug vatiquinone for the target of Friedreich ataxia (FA). Endpoints in two separate long-term extension studies show evidence of slowing disease progression. PTC aim to submit an NDA by the end of the year. Vanqua Bio have posted positive interim results from a Phase 1 clinical trial of VQ-101, aimed at treating GBA-Parkinsons and other related disorders. Success in Phase 1a sees Vanqua initiate Phase 1b to evaluate those with and without GBA mutations. Viatris announced positive top-line results from a Phase 3 study of EFFEXOR® in Japanese Adults suffering from Generalised Anxiety Disorder (GAD). The study met all primary and secondary efficacy endpoints and the company plan to present full results in the future. Capsida Biotherapeutics presented new IND-enabling data on their IV delivered gene therapy for Parkinsons associated with GBA mutations (PD-GBA). CAP-003 offers the potential to normalise GCase activity in patients through a safe single IV infusion which enables the potential for long-term disease modification and slowing of disease progression. CAP-003 is earmarked to enter the clinic in H1 2025. Avextra have announced the approval of NEUROBIS by the Italian Medicines Agency – a Phase II clinical trial using a proprietary cannabis-based medicine for the treatment of neurodegenerative diseases. GRIN Therapeutics, Inc. have initiated a study dubbed Astroscape for the treatment of tuberous sclerosis complex (TSC) and focal cortical dysplasia (FCD) type II with radiprodil following encouraging data from a global Phase 1b open-label Honeycomb study. 📝 Applications: Neuvivo have submitted an NDA for NP001, which is aiming to treat ALS by restoring balance over uncontrolled inflammation within the body’s own innate immune system. InspireMD have had their IDE application approved to initiate CGUARDIANS II which is a study of CGuard Prime targeted for both CAS and TCAR procedures. Denovo Biopharma have been granted Fast Track designation for DB104 – a treatment being developed for patients suffering with treatment-resistant depression. 

🚨🧠 Neuroscience Finance & Licensing News – 7 day recap: 11/10 (2/2) As expected, an incredibly busy week. So much news means I will separate financial and clinical news into two posts – see comments for clinical. 💰 Financing ShiraTronics, Inc. have raised $66M in oversubscribed Series B financing. This will allow them to advance their neurostimulation therapies for chronic migraine patients including their recently launched FDA trial, RELIEV-CM2 which is designed to evaluate the safety and effectiveness for those who have failed current medical therapies and have treatment resistant chronic migraine. Selonterra, Inc. have been awarded a second grant worth $2.5M from The Michael J. Fox Foundation for Parkinson's Research. Selonterra have a primary focus within neurodegeneration including Alzheimer’s and Parkinsons and the grant will allow them to progress their small molecules towards clinical candidates and strengthen the link of novel targets to clinical dysfunctions in Parkinsons. PsychoGenics have been awarded a contract worth a potential $80M aiding them to test and identify novel investigational therapeutics for the treatment of acute and chronic pain to mitigate the risks associated with opioid use. The contract is funded by the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH Helping to End Addiction Long-term Initiatives (NIN HEAL). Nyxoah have sold 3 million shares raising $27M gross proceeds pursuant to their $50M at the market offering. Nyxoah are a medtech company developing alternatives for Obstructive Sleep Apnea through neuromodulation. The investment will allow them to build on their DREAM study data. Scholar Rock reported Apitegromab met it’s primary endpoint in a Phase 3 study - SAPPHIRE - targeting patients with Spinal Muscular Atrophy; statistically significant and clinical meaningful improvement in motor function was seen at week 52 compared to those given a placebo. Scholar's stock surged off the back of this news and have also announced the pricing of an upsized underwritten public offering with expected gross proceeds of roughly $300M. Cerevance have achieved the second milestone in their research collab with Merck Group. The collaboration is targeting Alzheimer's and other neurological disorders using NETSseq to identify targets. 🤝 Licensing Pharmanovia have announced the expansion of their neurology portfolio with a new licensing agreement with CSL for XADAGO® a medicine to help patients control Parkinson’s symptoms. Astellas Pharma and AviadoBio have announced an exclusive option and license agreement for AVB-101. AVB-101 is completing its first cohort and in phase ½ development for patients with frontotemporal dementia with progranulin mutations (FTD-GRN). AviadoBio will received a $20M equity investment and up to $30M in upfront payments and are eligible to receive up to $2.18B in license fees and milestone payments plus royalties if Astellas exercises their option.