SunTrust analyst David MacDonald lowered his price target on Walgreens Boots Alliance to $58 and kept his Hold rating after its “weak” Q2 results and a “meaningful” cut to its guidance. The analyst says the outlook changes were driven by “reimbursement headwinds, sluggish retail volumes, and a challenging UK operating environment”. In spite of the management’s “several mitigation efforts”, MacDonald contends that industry challenges will not “meaningfully abate in the near/intermediate term”, adding that it will take time for Walgreens Boots management to “drive increased efficiency and re-accelerate growth.”
Wednesday, April 3, 2019
Lipocine seeks injunction against marketing of Clarus’ Jatenzo
Lipocine announced that it has filed suit against Clarus Therapeutics in the United States District Court of Delaware alleging that Clarus’s Jatenzo product infringes six of Lipocine’s U.S. patents: 9,034,858; 9,205,057; 9,480,690; 9,757,390; 6,569,463; and 6,923,988. “We have invested significant resources in developing innovations that have led to our importantly held strong intellectual property rights. We will defend those rights when infringed upon,” said Lipocine CEO Mahesh Patel.
Inogen price increase an unexpected positive, says Piper Jaffray
Piper Jaffray analyst JP McKim notes that the Inogen G5 officially was released to customers via the DTC channel and will be made available BTB domestic and BTB international in the coming months through a controlled roll out. The analyst says that the company can now market the G5 as market leading on all important categories like weight, flow rate, battery life and sound and will therefore go for a premium price. The company is increasing its minimum advertised price to $2,995 for the G5, up from $2,300 for G4/G3, he points out, adding that he believes this price increase was not expected by investors and sees it as a positive as people adjust their models. McKim reiterates an Overweight rating and $185 price target on the shares.
Iovance clinical updates strengthen investment thesis, says H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis says today’s clinical updates from Iovance Biotherapeutics strengthen his investment thesis. The company’s efforts to amend clinical programs and generate more powerful tumor-infiltrating lymphocytes therapies are each crucial for gaining market share in multiple clinical indications beyond melanoma, Pantginis tells investors in a research note titled “Important Chess Moves to Head Regulatory Agencies off at the Pass.” He believes the advances Iovance is making on multiple fronts, including the clinical and commercial, should be viewed as important inflection points for the shares. The analyst keeps a Buy rating on Iovance Biotherapeutics with a $26 price target.
Zynerba extends rally as FDA explores cannabis derived product regulation
The FDA will hold a public hearing on potential regulatory pathways for cannabis products on May 31
Zynerba (ZYNE) is on the rise for a second straight session on Wednesday after the Food and Drug Administration issued a statement yesterday on new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products. Commenting on the FDA news, Ladenburg analyst Michael Higgins said he believes the agency will be taking further steps in 2019 to remove any non-prescription products being sold that include tetrahydrocannabinol and cannabidiol, which he views as favoring the market adoption of Zynerba’s Zygel.
POTENTIAL REGULATORY PATHWAYS: The FDA issued a statement yesterday from outgoing Commissioner Scott Gottlieb on new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, in which he stated in part: “In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis and its components, including cannabidiol, or CBD…We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products.” The FDA is announcing a number of new steps and actions to advance its consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under its existing authorities, Gottlieb said. These new steps include: A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety; The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health; Updates to its webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products; and the issuance of multiple warning letters to companies marketing CBD products with “egregious and unfounded claims that are aimed at vulnerable populations.”
ANALYST SEES NEWS FAVORING ZYNERBA: In a research note to investors yesterday, Ladenburg’s Higgins said he believes the FDA will be taking further steps in 2019 to remove any non-prescription products being sold that include THC and CBD, while allowing the production and marketing of hemp as it follows the Agriculture Improvement Act of 2018. He sees the removal of current CBD-containing foods, lotions, snacks, oils and other embodiments containing CBD favoring the market adoption of Zynerba’s Zygel. The analyst noted that he has “long expected” the availability of over the counter CBD products during Zygel’s marketing – assuming positive pivotal data in Fragile X patients in the second half of 2019 and approval in the second half of 2020 – but the stance of the agency suggests less availability of CBD-containing products for consumers to choose from. Further, Higgins believes FDA’s publication reflects the agency’s “loss of patience” with these products as the number of and marketing of these products have become “more ubiquitous and aggressive.” Additionally, the analyst thinks the agency may provide and/or reinforce its position against the allowance of marijuana-based products as food or dietary products in its May 31 hearing. He reiterated a Buy rating and $26 price target on Zynerba shares.
OTHERS TO WATCH: Other publicly traded companies in the cannabis space include Aphria (APHA), Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), India Globalization Capital (IGC), MediPharm Labs (MLCPF) and Tilray (TLRY).
Piper says Kura’s potential patient population for tipifarnib keeps growing
After Kura Oncology presented additional data on tipifarnib, a farnesyltransferase inhibitor/HRAS inhibitor that downregulates expression of CXCL12, Piper Jaffray analyst Tyler Van Buren said the number of potential indications for the drug “continues to multiply” as initial clinical data suggest diffuse large B-cell lymphoma and cutaneous T-cell lymphoma patients could benefit from treatment in addition to the already identified cancer indications. The “broad mechanism of tipifarnib is becoming clear” and the potential patient population keeps growing, “well beyond what investors are currently appreciating,” according to Van Buren. He keeps an Overweight rating on Kura shares.
Catalyst Initiates Phase 2b Trial for Treatment of Hemophilia B
Catalyst Biosciences, Inc. (Nasdaq:CBIO), today announced the initiation of enrollment in a Phase 2b study of dalcinonacog alfa (DalcA), a next-generation subcutaneously (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B.
The data from our Phase 1/2 clinical study demonstrated that DalcA is highly efficacious for the treatment of hemophilia B and can achieve Factor IX activity levels well above the 12% expected to prevent spontaneous bleeding, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. We anticipate that this Phase 2b study will further demonstrate DalcAs safety and efficacy as a subcutaneous prophylactic treatment option. Individuals with severe hemophilia B face a lifetime of complicated intravenous treatment regimens. We believe that DalcA may offer a conveniently-dosed subcutaneous prophylactic treatment option that could significantly improve the quality of life for those suffering from severe hemophilia B.
The open-label Phase 2b study will evaluate the ability of DalcA to maintain steady state FIX levels above 12% in individuals with severe hemophilia B. The trial will enroll up to six subjects who will receive a single intravenous dose, followed by daily subcutaneous (SQ) doses of DalcA for 28 days. Pharmacokinetics, pharmacodynamics, safety and tolerability of daily SQ dosing and anti-drug antibody formation will also be monitored. The trial is expected to be completed in the second half of 2019.
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