After surveying with 25 glaucoma specialists who have used Rhopressa in their clinical practice, Cantor Fitzgerald analyst Elemer Piros reiterates an Overweight rating on Aerie Pharmaceuticals with an $86 price target. In the survey, 84% of physicians indicated that the safety and efficacy of Rhopressa in their practices have either met or surpassed expectations, Piros tells investors in a research note. Further, physicians provided positive feedback from their experiences with prescribing Rhopressa, says the analyst. In addition, Piros says he was unable to identify any correlation with patient compliance or physician expectations with levels of hyperemia.
Monday, February 4, 2019
Biohaven achieves targeted therapeutic exposures of BHV-3500
Biohaven Pharmaceutical announced that administration of intranasal BHV-3500 in a Phase 1 clinical trial has achieved targeted therapeutic exposures and that the compound will advance into a Phase 2 trial to evaluate efficacy for the acute treatment of migraine. BHV-3500 is a novel, third generation calcitonin gene-related peptide receptor antagonist being developed by Biohaven.
AC Immune price target lowered to $8 from $18 at H.C. Wainwright
H.C. Wainwright analyst Andrew Fein lowered his price target for AC Immune to $8 to reflect the discontinuation of crenezumab in the valuation. However, despite this setback, the analyst still believes that the fundamental approach of AC Immune is “de-risking in itself” with multiple targets in multiple modalities. The company possesses one of the deepest pipelines in the neurodegenerative space, Fein tells investors in a research note. He reiterates a Buy rating on the shares.
https://thefly.com/landingPageNews.php?id=2858231
https://thefly.com/landingPageNews.php?id=2858231
Actinium Pharmaceuticals begins second dosing cohort of leukemia candidate
Actinium Pharmaceuticals announced that the Medical College of Wisconsin has started dosing patients in the second cohort of its novel trial of Actimab-A in combination with CLAG-M in patients with relapsed or refractory AML or Acute Myeloid Leukemia. This trial is evaluating the impact that the addition of targeted internalized radiation via Actimab-A to the salvage chemotherapy regimen CLAG-M will have on safety and tolerability, response rates, rates of BMT or bone marrow transplant, PFS or progression-free survival, and OS or overall survival. No dose limiting toxicities were reported in the first patient cohort. Assuming no DLTs are observed in the second cohort, three patients will be treated and the study will progress to the third and final cohort will study Actimab-A at a dose of 0.75 uCi/kg.
https://thefly.com/landingPageNews.php?id=2858277
https://thefly.com/landingPageNews.php?id=2858277
Genesis in real estate partnership with Next for 15 nursing homes
Genesis HealthCare announced that it has entered into a real estate partnership with Next Healthcare Capital involving 15 skilled nursing facilities previously leased from Welltower. Seven additional facilities historically leased from Welltower were sold to a third party. Genesis will no longer operate the seven facilities after the sale. Welltower sold the real estate of 15 facilities to the new partnership, of which Genesis acquired a 46% ownership interest. Genesis also acquired a fixed price purchase option to acquire the real estate beginning in 2026 at a 10% premium above the original acquisition cost. Genesis will continue to operate these facilities pursuant to a new lease with the partnership. The remaining interest is held by Next, a privately owned healthcare real estate investment firm. The 15 facilities had been included in the company’s master lease with Welltower and were subject to 2% annual rent escalators. Under the new lease, there are no rent escalators for the first five years. The seven facilities that Genesis will no longer operate had aggregate annual revenue of approximately $73M. As a result of the transaction, Genesis estimates its annual EBITDAR will decline $2.5M and annual cash lease obligations will be reduced approximately $3.2M. In year one, the transaction is accretive to EBITDA by $700,000.
https://thefly.com/landingPageNews.php?id=2858305
https://thefly.com/landingPageNews.php?id=2858305
BioXcel Therapeutics expands indication for med to treat withdrawal symptoms
BioXcel Therapeutics announced proof-of-concept data from its Phase 1b study of intravenously-administered dexmedetomidine in patients suffering from opioid withdrawal symptoms. The positive data from this Phase 1b trial provides evidence to expand the potential market for BXCL501, a proprietary sublingual film of Dex, beyond its current focus for acute treatment of agitation in neuropsychiatric indications. The study further confirms that BXCL501’s selective alpha-2a adrenergic receptor mechanism has potential application in opioid withdrawal symptoms, in addition to the acute treatment of agitation in schizophrenia, bipolar disorder and dementia. Opioid addiction is difficult to overcome largely because of the severe symptoms associated with withdrawal, an area in need of more effective non-opioid treatment options. BTI conducted the clinical study in a total of 15 patients with opioid dependence. Ten subjects were enrolled in the treatment arm while five subjects were enrolled in the placebo arm. Symptoms of opioid withdrawal were evaluated using the Clinical Opioid Withdrawal Scale, or COWS, an 11-item scale that measures a constellation of withdrawal symptoms experienced after abstaining from opioid use. All ten subjects receiving IV Dex responded to treatment, while there were no responders in the placebo arm. Results from this study demonstrated that IV Dex effectively mitigated the physiological symptoms of opioid withdrawal. These encouraging results support further expansion of BXCL501 for the treatment of withdrawal symptoms associated with opioid abuse. Additionally, previously published studies support the potential of Dex as an adjunctive treatment for symptoms of alcohol withdrawal.
https://thefly.com/landingPageNews.php?id=2858319
https://thefly.com/landingPageNews.php?id=2858319
Neurotrope in R&D pact with National Cancer Institute on leukemia med
Neurotrope Inc. NTRP, +1.65% a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer’s disease (AD), today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the research and clinical development of Bryostatin-1. Under the CRADA, Neurotrope will collaborate with the NCI’s Center for Cancer Research, Pediatric Oncology Branch (POB) to develop a Phase I clinical trial testing the safety and toxicity of Bryostatin-1 in children and young adults with CD22 + leukemia and B-cell lymphoma. In the growing era of highly effective immunotherapies targeting cell-surface antigens (e.g., CAR-T cell therapy), and the recognition that antigen modulation plays a critical role in evasion of response to immunotherapy, the ability for Bryostatin-1 to upregulate CD22 may serve a synergistic role in enhancing the response to a host of CD22 targeted therapies.
Nirali N. Shah, M.D. of the NCI’s POB will be Principal Investigator for the study, and Daniel Alkon, M.D., President and Chief Scientific Officer of Neurotrope, will serve as Co- Principal Investigator.
“We believe that this collaboration with the NCI’s Center for Cancer Research provides further validation of the potential for Bryostatin-1 to affect disease pathways across a broad spectrum of indications,” said Dr. Alkon. “In oncology, Bryostatin’s potential capability to increase CD22 expression may enhance the development of newer and more effective therapies for children and young adults suffering with CD22-positive leukemia and B-cell lymphoma. The enthusiasm for this collaboration stems from the POB’s long vested interest and experience targeting CD22, and we look forward to leveraging the expertise of Dr. Shah and her team to enhance our ongoing efforts to identify the most promising potential applications for Bryostatin-1.”
Bryostatin-1 is a macrocytic lactone shown to increase CD22 expression in chronic lymphocytic leukemia. Under the CRADA, Bryostatin-1 is expected to be tested in the clinic to evaluate its ability to modulate CD22 in patients with relapsed/refractory CD22+ disease, while evaluating safety, toxicity and overall response.
“The initiation of our oncology collaboration with the NCI, coupled with the recent positive safety evaluation of our confirmatory Phase 2 AD trial, both demonstrate Bryostatin’s broad potential,” stated Dr. Charles Ryan, Chief Executive Officer of Neurotrope. “We enter 2019 with strong momentum clinically as well as operationally, with the successful completion of a financing in December 2018. We expect that 2019 will be a transformational year for Neurotrope as we move toward data in our AD program in the second half of the year, and seek out additional collaborations to fully explore the platform potential of Bryostatin-1.”
Neurotrope also announced today the completion of the first safety evaluation of the Company’s ongoing, placebo-controlled confirmatory Phase 2 trial evaluating Bryostatin-1 (20 µg) in 100 moderate to severe Alzheimer’s disease patients not on memantine. The study’s data safety and monitoring board found no safety concerns and recommended continuation of the trial as designed. Enrollment in the study, which was initiated in July 2018, is proceeding as planned, with data expected during the second half of 2019.
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