Wedbush analyst David Nierengarten added Argenx to the firm’s Best Ideas List and raised his target price for shares to $125 from $121 based on increasing confidence in efgartigimod’s broad market opportunity in antibody-mediated autoimmune diseases. In a research note to investors, Nierengarten says he believes recent share weakness in response to additional disclosed ITP data in the company’s most recent prospectus associated with a share offering is “overblown” and creates an even more attractive entry point for investors. The analyst has an Outperform rating on shares.
Thursday, September 20, 2018
Cronos Group, Aleafia Health announce start of medical cannabis study
Aleafia Health and Cronos Group announced the commencement of a joint medical cannabis study to improve the management and treatment of insomnia and daytime sleepiness. The study is funded in part by Peace Naturals Project, a licensed producer of medical cannabis that is wholly owned by Cronos Group. The study will be led by physicians practicing within the Canabo Medical Clinic network, which is wholly owned by Aleafia. According to a July 2017 report from the Canadian Centre on Substance Use and Addiction, entitled Drug Summary: Prescription Sedatives, 11.4% of adults aged 25 and older had used a prescription sedative in the past year. The study will aim to assist in the treatment of insomnia and the development of non-addictive, natural sleep aids.
Craig-Hallum says Tandem Diabetes ‘remarkable run is not over,’ starts at Buy
Craig-Hallum analyst Alexander Nowak initiated Tandem Diabetes with a Buy rating as he believes the stock’s “remarkable run is not over” given his belief that the company’s 13% share of the $1.6B insulin pump market is going higher. Also, Tandem is developing Control IQ, which Nowak considers “a vital component” to “unlocking an incremental $14B opportunity,” he tells investors. Nowak set a $52 price target on Tandem Diabetes shares, which closed yesterday down 5.7% at $39.95.Target $52.
https://thefly.com/landingPageNews.php?id=2793007
Celgene will not exercise option to license OncoMed ovarian cancer candidate
OncoMed (OMED) announced that Celgene (CELG) has notified OncoMed that due to strategic product portfolio considerations Celgene has decided not to exercise its option to license OncoMed’s bispecific antibody navicixizumab. Celgene continues to retain its options to license OncoMed’s etigilimab and rosmantuzumab under the collaboration. OncoMed and Celgene are working to formalize the termination of the collaboration agreement with respect to navicixizumab, and OncoMed expects to retain worldwide rights to navicixizumab. OncoMed is currently conducting a Phase 1b clinical trial of navicixizumab in combination with paclitaxel in patients with platinum-resistant late-stage ovarian cancer.
https://thefly.com/landingPageNews.php?id=2793057
Pfizer granted FDA Breakthrough Therapy tag for pneumonia vax
Pfizer announced that its 20-Valent Pneumococcal Conjugate Vaccine candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older. Pfizer expects to start Phase 3 trials in a few months. The FDA decision is informed by the results of the 20vPnC Phase 2 randomized, double-blind trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date. Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint. Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, which may include more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. The FDA previously granted Fast Track designation for 20vPnC in October 2017 for use in adults aged 18 years and older. The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
https://thefly.com/landingPageNews.php?id=2793059
Galectin has prelim data from Phase 1b trial of Keytruda combo
Galectin Therapeutics announced additional preliminary clinical data from cohort 3 of an investigator-initiated Phase 1b clinical trial of GR-MD-02 used in combination with Keytruda in patients with metastatic melanoma for which Keytruda is indicated or those patients whose melanoma progressed during or recently after Keytruda monotherapy. The Providence Cancer Institute translational medicine team is conducting this phase 1b clinical trial, initiated under direction of principal investigator Brendan D. Curti. The objectives of this study were to determine a safe dose of GR-MD-02 used in combination with Keytruda and to measure the response rate to combined therapy. When aggregated with the cohorts previously reported, the data shows a 50% objective response rate in advanced melanoma with GR-MD-02 in combination with Keytruda, and a significant decrease in the frequency of suppressive myeloid-derived suppressor cells, or MDSC, following treatment in the responding patients was observed. The published data on Keytruda alone have shown an objective response rate of 33% in this patient population. Fourteen advanced melanoma patients across three dose cohorts now have objective response rate, or ORR and disease control rate, or DCR, data. Six patients in cohort 3 have now been added to the three patients in cohort 2 and the five patients in cohort 1. Cohorts 1 and 3 each had two patients with an objective response. All three patients in cohort 2 had an objective response.
https://thefly.com/landingPageNews.php?id=2793063
Portola Pharmaceuticals names Scott Garland CEO
Portola Pharmaceuticals announced the appointment of Scott Garland as president and CEO effective October 8. Garland brings to his new role more than two decades of broad executive leadership experience, including a track record driving multiple billion dollar product launches. He will also serve on the company’s board. Garland joins Portola from Relypsa where he was president and previously CCO. During his tenure, Garland was responsible for the integration and growth of the U.S. operations after Relypsa was acquired.
https://thefly.com/landingPageNews.php?id=2793115
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