DiaMedica Therapeutics announced that the FDA has accepted DiaMedica’s Investigational New Drug application (“IND”) for the initiation of a Phase Ib clinical trial of DM199 in patients with moderate or severe Chronic Kidney Disease, or CKD, caused by Type I or Type II diabetes. The multi-site clinical study will enroll 32 subjects to evaluate DM199 safety, tolerability and drug levels in this specific population. The study will enroll subjects over a 12 day period and will also include other end points that include renal biomarkers. The results from this Phase Ib study will assist DiaMedica in the design of upcoming Phase II studies in patients suffering from rare diseases and CKD. The DM199 drug levels from this Phase Ib study will also help determine the optimal dose levels for testing in the Phase II studies.
Thursday, January 3, 2019
Agenus gets $1M from Gates Foundation to enable QS-21 innovations
Agenus (AGEN) announced that the Bill & Melinda Gates Foundation awarded it a grant of ~$1M to develop an alternative, plant cell culture-based manufacturing process to ensure the continuous future supply of Agenus’ proprietary QS-21 Stimulonadjuvant, a key component of multiple vaccines targeting infectious and endemic diseases. Agenus’ QS-21 Stimulon is a proprietary adjuvant, currently incorporated as part of Glaxo Smith Kline’s (GSK) highly efficacious Shingrix vaccine. Additionally, Agenus’ QS-21 Stimulonis used in GSK’s Mosquirix vaccine and numerous other clinical-stage vaccines, including Agenus’ own cancer vaccines. Given the criticality of QS-21 in making vaccines efficacious, Agenus plans to develop a cell-culture based, environment friendly manufacturing technique as an alternative future supply. QS-21 is currently extracted from Chilean soap bark trees, exclusively sourced from a localized area in Chile. “We are delighted to be working in partnership with the Bill & Melinda Gates Foundation in our efforts to revolutionize the way we produce QS-21,” said Dr. Garo Armen, Chairman and CEO of Agenus. “The Gates Foundation has recognized the value of consistent supply of high-quality QS-21 to power vaccines. We appreciate their commitment to bringing innovation to drive access to important therapies.”
Celgene downgraded to Market Perform from Outperform at Leerink
Leerink analyst Geoffrey Porges downgraded Celgene (CELG) to Market Perform from Outperform after the company agreed to be acquired by Bristol-Myers (BMY), stating that “the best deal is sometimes the only deal.” He lowered his price target on Celgene shares to $102 from $112.
Celgene downgraded to Hold from Buy at Canaccord
Canaccord analyst John Newman downgraded Celgene (CELG) to Hold from Buy and lowered his price target on the shares to $102 from $140, citing the company’s agreement to be acquired by Bristol-Myers (BMY).
https://thefly.com/landingPageNews.php?id=2843419
BeiGene should be up, not down, on Celgene takeover news, says Maxim
After Bristol-Myers Squibb (BMY) announced an agreement to acquire Celgene (CELG), Maxim analyst Jason McCarthy noted that BeiGene (BGNE) shares have been under pressure, which he attributes to questions around Celgene’s partnership with the company for tislelizumab. Assuming the transaction closes, he sees two potential scenarios: either Bristol-Myers ends the partnership and BeiGene regains global rights to tislelizumab or Bristol maintains the partnership as it could potentially want a second PD1 in its checkpoint portfolio to target indications not addressed by Opdivo. He sees the first scenario, that Bristol ends the deal, as most likely, but in that case McCarthy argues that BeiGene would be positioned “to get an even better deal” than it got with Celgene as tislelizumab is now in ten ongoing pivotal trials, nine of which BeiGene is already running, and is closer to an approval or approvals. The analyst, who sees the negativity in the stock on today’s news as a buying opportunity and believes BeiGene shares should be up, not down, keeps a Buy rating and $170 price target on the stock.
https://thefly.com/landingPageNews.php?id=2843425
Amunix announces licensing agreement with Merck for ProTIA platform
Amunix Pharmaceuticals announced that it has entered into a licensing agreement with Merck for rights to develop therapeutics against an undisclosed target using Amunix’s proprietary protease-triggered immune activator, or ProTIA, technology platform. Under terms of the agreement, Amunix will receive an upfront payment from Merck and is eligible to receive payments associated with the achievement of certain developmental milestones as well as royalties on sales of any products derived from the collaboration. Further financial details were not disclosed.
https://thefly.com/landingPageNews.php?id=2843439
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