Immutep announces GMP manufacturing process developed for IMP761 » 08:0412/0612/06/22
Immutep announced that a…
Immutep announced that a GMP compliant manufacturing process has been established for IMP761, its proprietary preclinical candidate for autoimmune diseases. The 200L scale attained by Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organisation, will ensure supply of IMP761 for IND-enabling studies and ensuing clinical trials. As the first immunosuppressive agonist antibody to LAG-3 acting upstream on activated T cells to target the root cause of self-antigen-specific T cell induced disease, IMP761 is a potential game-changer in how autoimmune diseases are treated. Pre-clinical testing of IMP761 in oligoarticular juvenile idiopathic arthritis, published in Pediatric Research in May 2021, showed that agonistic activation of LAG-3 in this Th1-driven autoimmune disease setting resulted in a decreased secretion of nearly all measured cytokines, and that of IL-10, IL-12, IL-1beta, IL-4, and IL-6 reached the level of significance. Immutep CEO Marc Voigt said: "We are pleased to have a GMP manufacturing process for IMP761 in hand with our manufacturing partner Northway Biotech as we move towards initiating IND-enabling studies in the first half of 2023 and subsequent clinical development. As a first-in-class LAG-3 immunosuppressive antibody, IMP761 has been designed to address the root cause of autoimmune diseases by specifically silencing self-reactive exhausted effector T cells that express LAG-3 and accumulate at disease sites."
Checkpoint Therapeutics to effect 1-for-10 reverse stock split » 16:3212/0512/05/22
Checkpoint Therapeutics announced that it will effect a 1-for-10 reverse stock split of its issued and outstanding common stock. Checkpoint expects its common stock to begin trading on a split-adjusted basis on the Nasdaq Capital Market as of the commencement of trading on December 6. The reverse stock split was approved on November 3 by Checkpoint's board of directors and stockholders representing approximately 58% of the voting power of Checkpoint's outstanding capital stock. The reverse stock split is intended to improve the marketability and liquidity of Checkpoint's common stock and to remain in compliance with Nasdaq's continued listing requirements.
Defense bill with marijuana reform attached is delayed, Marijuana Moment says » 15:4712/0512/05/22
ACB, CGC, IGC, CANN, ZYNE, CRON, TLRY, CVSI, CNTTF, GTBIF, TCNNF, GDNSF
House lawmakers have…
House lawmakers have pushed back committee consideration of the National Defense Authorization Act, which advocates hoped to see advance with marijuana reform provisions included, amid disputes over multiple issues, Kyle Jaeger of Marijuana Moment reported. At the same time, offices of several Republican senators met with the Department of Justice to talk about their concerns with pending cannabis banking reforms. The NDAA is being closely watched to see if it will be used as a vehicle for marijuana banking and other reform legislation, but Chairman Jim McGovern said the package is not ready yet. Publicly traded companies in the space include Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), Goodness Growth (GDNSF), Green Thumb Industries (GTBIF), India Globalization Capital (IGC), Tilray (TLRY), Trulieve Cannabis (TCNNF) and Zynerba (ZYNE). Reference Link
Jaguar Health's Napo sponsors episode of The Gayly Dose podcast » 08:4112/0512/05/22
Jaguar Health and its…
Jaguar Health and its wholly owned subsidiary Napo Pharmaceuticals announced that Napo sponsored the latest episode of The Gayly Dose podcast. The episode, titled "An Unspoken Truth About HIV," focuses on HIV-related diarrhea and aired on World AIDS Day, December 1, 2022. Jeremiah Robinson, a Physician Assistant who is certified as an HIV Specialist by the American Academy of HIV Medicine and serves as a member of Napo's Mytesi Speaker Bureau, appeared on this episode of The Gayly Dose to discuss the impact that chronic diarrhea can have on all aspects of the lives of people living with HIV, how important it is for HIV patients to speak to their healthcare provider about their bowel movements, and how Mytesi, Napo's antidiarrheal medicine that is FDA approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy, works.
Zynerba announces long-term data from Phase 2 INSPIRE trial with Zygel » 07:3912/0512/05/22
Zynerba Pharmaceuticals presented positive long-term 38-week data from the Phase 2 INSPIRE trial with Zygel in children and adolescents with 22q11.2 deletion syndrome. The data were presented in a poster at the 61st Annual Meeting of the American College of Neuropsychopharmacology, being held December 4-7, 2022 in Phoenix, Arizona. The poster, titled, "An Open-Label Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome," shows that through 38-weeks of treatment, statistically significant improvements were seen in children and adolescents treated with Zygel in the Pediatric Anxiety Rating Scale, all five scales of the Anxiety, Depression and Mood Scale, and all five subscales of the Aberrant Behavior Checklist - Community. These results are consistent with the previously reported 14-week treatment data suggesting a positive risk-benefit profile for Zygel in improving anxiety-related and behavioral symptoms in children and adolescents with 22q when added to a stable standard of care. The INSPIRE trial enrolled 20 patients in the U.S. and Australia. Seventeen of the 20 patients completed week 14. Patients with a greater than or equal to 35% improvement in the ABC-C irritability subscale were allowed to continue treatment for an additional 24 weeks. Thirteen patients continued treatment, with 12 patients completing week 38. At the end of both Period 1 and Period 2, statistically significant improvements from baseline were seen in the PARS-R, all five subscales of the ADAMS, and all five subscales of the ABC-C. Zygel was generally well tolerated, and the safety profile was consistent with data from previous Zygel clinical trials.
Nasdaq grants Windtree Therapeutics 180-day extendion to regain compliance » 07:3412/0512/05/22
Windtree Therapeutics announced that the NASDAQ Stock Market has granted Windtree an additional 180 days to regain compliance with Nasdaq's $1.00 minimum bid price rule requirement under Nasdaq Listing Rule 5550(a)(2), following the expiration of the initial 180 days period to regain compliance on November 30, 2022. As a result of the extension, the Company now has until May 29, 2023 to regain compliance with the $1.00 minimum bid price rule requirement. If at any time before May 29, 2023, the bid price of the Company's common shares closes at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification to the Company that it has achieved compliance with the bid price requirement. If the Company chooses to implement a reverse stock split to regain compliance, it must complete the reverse split no later than 10 business days prior to the expiration of the additional 180 calendar day period in order to timely regain compliance. If the Company does not regain compliance with the bid price requirement by May 29, 2023, Nasdaq will provide written notification to the Company that its shares will be subject to delisting. At such time, the Company may appeal the delisting determination to a Nasdaq Hearings Panel. There can be no assurance that, if the Company does appeal a subsequent delisting determination, such appeal would be successful. The Company would remain listed pending the Panel's decision. The current notification from Nasdaq has no immediate effect on the listing or trading of the Company's shares, which will continue to trade on the Nasdaq Capital Market under the symbol "WINT".
Axsome Therapeutics files automatic mixed securities shelf 17:3012/0212/02/22
White House announces signing of medical marijuana research expansion act » 13:4912/0212/02/22
ACB, CGC, IGC, CANN, ZYNE, CRON, TLRY, CVSI, CNTTF, GTBIF, TCNNF, GDNSF
On Friday, December 2,…
On Friday, December 2, the President signed into law H.R. 8454, the "Medical Marijuana and Cannabidiol Research Expansion Act," which establishes a new registration process for conducting research on marijuana and for manufacturing marijuana products for research purposes and drug development, the White House announced. Publicly traded companies in the cannabis space include Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), Goodness Growth (GDNSF), Green Thumb Industries (GTBIF), India Globalization Capital (IGC), Tilray (TLRY), Trulieve Cannabis (TCNNF) and Zynerba (ZYNE). Reference Link
UroGen Pharma announces data from OPTIMA II study of UGN-102 » 12:0412/0212/02/22
UroGen Pharma announced…
UroGen Pharma announced new data from the OPTIMA II study designed to obtain long-term follow-up data on UGN-102 that shows median duration of response of 24.4 months for UroGen's investigational drug UGN-102 currently in Phase 3 development for low-grade, intermediate-risk non-muscle invasive bladder cancer. The study was presented at SUO on December 2. Patients who completed the OPTIMA II study were eligible to participate in this rollover study. Outcomes include DOR in patients who remained in complete response at the end of OPTIMA II, events of disease recurrence and progression, post-study treatments and death. At the time of data cut off, data were available for 15 of the 25 patients. The median DOR among the 15 patients was 24.4 months. Seven patients remained in CR, six patients had recurrence of LG disease, one patient had progression to high-grade disease and one patient withdrew consent but remained in CR at the last evaluation prior to discontinuation. All patients were alive at the last contact, and five patients were known to have had post-study treatment with transurethral resection of the bladder tumors or fulguration. DOR was calculated as the time from documented CR in OPTIMA II to disease recurrence or death or last adequate disease assessment. The data cut off for this report is February 25, 2022.
NextCure price target lowered to $1 from $5 at BofA » 12:0312/0212/02/22
BofA analyst Alec…
BofA analyst Alec Stranahan lowered the firm's price target on NextCure to $1 from $5 and keeps an Underperform rating on the shares. The firm's bearish thesis is inflated by the discontinuation of NC318, lack of actionable data from SITC, and the difficult setup for NC410 given the lack of clinical validation of FIND-10, Stranahan tells investors in a research note.