Cantor Fitzgerald analyst Eliana Merle lowered her price target for Aerpio Pharmaceuticals to $3 from $8 after the company announced the Time-2B Phase 2b study missed its primary endpoint in diabetic retinopathy. The shares are currently trading close to cash, which overly discounts the potential for partner milestones and the ongoing glaucoma program, Merle tells investors in a research note. She sees a favorable risk/reward into potential updates on Aerpio’s other programs and keeps an Overweight rating on the name.
https://thefly.com/landingPageNews.php?id=2881003
Tuesday, March 19, 2019
Endo announces publication of Phase 2 data evaluating CCH
Endo International announced the publication of Phase 2 data evaluating collagenase clostridium histolyticum, or CCH, for the treatment of cellulite in Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery. CCH is the first and only investigational injectable treatment designed specifically to reduce the appearance of cellulite by disrupting the collagen structure of fibrous septae, which cause dimpling of the skin. Consistent with the recently released Phase 3 studies, the Phase 2 data recently published in the journal online, demonstrate that CCH delivered a clinically meaningful and statistically significant improvement as compared to placebo for all primary and secondary endpoints.
https://thefly.com/landingPageNews.php?id=2881009
https://thefly.com/landingPageNews.php?id=2881009
Magenta Therapeutics plans to begin Phase 1 study of MGTA-145 agent in 2019
The company plans to achieve the following key milestones in 2019: Present preclinical data on C100 anti-CD45 targeted conditioning program in autoimmune diseases and declare development candidate; Present preclinical data on C200 anti-CD117 targeted conditioning in gene therapy, and advance development candidate; Begin Phase 1 study of MGTA-145 first-line mobilization agent in healthy volunteers in the first half of 2019, and present clinical data in the second half of 2019; Present additional clinical data from the Phase 2 study of MGTA-456 in IMDs.
https://thefly.com/landingPageNews.php?id=2881025
https://thefly.com/landingPageNews.php?id=2881025
Magenta Therapeutics declared development candidate in C200 program
At the end of 2018, Magenta declared a development candidate in its C200 targeted conditioning program, which is designed to deplete stem cells in the bone marrow. The Company presented data at the TCT meeting in February 2019 on the development candidate, an anti-CD117 amanitin ADC, showing that it potently and selectively depleted hematopoietic stem cells in non-human primates while preserving the immune system. The ADC was well tolerated at the efficacious doses. Magenta has begun investigational new drug-enabling studies with this ADC and plans to develop it as a conditioning agent for stem cell gene therapy, in patients with genetic disorders such as sickle cell disease, where current conditioning regimens are toxic.
https://thefly.com/landingPageNews.php?id=2881033
https://thefly.com/landingPageNews.php?id=2881033
Aerie Pharmaceuticals price target cut to $65 from $73 at Canaccord
Canaccord analyst Dewey Steadman maintained a Buy rating on Aerie Pharmaceuticals and cut his price target to $65 from $73 after weekly Rhopressa data showed modest sequentially growth for the week ending March 8 after a strong prior week. In a research note to investors, Steadman says 10 weeks into the quarter, he is bringing down revenue estimates below consensus as he thinks volumes don’t justify a $17M+ revenue estimate for the quarter.
https://thefly.com/landingPageNews.php?id=2881035
https://thefly.com/landingPageNews.php?id=2881035
Emergent BioSolutions Initiates Phase 3 for Post-Exposure Anthrax Med
Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 3 trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) following a two-dose schedule administered intramuscularly in healthy adults. AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracisexposure.
“Emergent is pleased with the advancement of the AV7909 development program,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions. “Dosing the first subject in this large clinical study is a milestone achievement and we look forward to continuing to execute on our development and procurement contract for AV7909.”
AV7909 is designed to elicit a faster immune response than the currently available anthrax vaccine. It is comprised of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant, the immunostimulatory oligodeoxynucleotide compound CPG 7909. The addition of CPG 7909 to AVA has been shown, in previous Phase 1 and Phase 2 studies, to safely accelerate and enhance the immune response.
In evaluating the lot consistency of AV7909, the study will be using three consecutively manufactured lots of the vaccine candidate. This Phase 3 randomized, double-blind, parallel-group study plans to enroll 3,850 adults across 35 sites within the U.S. with an overall study duration of approximately 20 months. More information on the study is available on https://clinicaltrials.gov/ct2/show/NCT03877926.
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