Mizuho analyst Irina Koffler lowered her price target for Mallinckrodt to $22 while presenting an initial view of how to value the two separate companies. The analyst reduced estimates for Acthar and took a more “conservative stance” on Amitiza’s long-term outlook. She also penalized the spin company $2 per share for estimated opioid liability. Koffler ascribes $16 per share to the branded business and $6 to the spin company. She reiterates a Neutral rating on Mallinckrodt.
Monday, December 17, 2018
Supernus risk/reward favorable into data release, says Mizuho
Mizuho analyst Irina Koffler sees a favorable risk/reward for Supernus Pharmaceuticals into this month’s adolescent data release after reviewing the SPN-812 pediatric data with a psychiatrist and management. The analyst raised her price target for the shares to $63 from $61 and reiterates a Buy rating on Supernus.
Shire approval another potential headwind for Allergan, says Piper Jaffray
Shire approval another potential headwind for Allergan, says Piper Jaffray. Piper Jaffray analyst David views Shire’s (SHPG) FDA approval Friday for its 5-HT4 receptor agonist Motegrity in chronic idiopathic constipation as another potential headwind for Allergan’s (AGN) Linzess. The headwind is not necessarily in terms of pressure on volumes, but more in terms of the potential for a more challenging payer environment, Amsellem tells investors in a research note. The analyst remains cautious on Allergan given his concerns regarding the trajectory of the commercial portfolio as well as its pipeline. Amsellem reiterates a Neutral rating on the stock with a $164 price target.
Eli Lilly announces Taltz meets primary, secondary endpoints in SPIRIT-H2H study
Eli Lilly announced Taltz met the primary and all major secondary endpoints in the Phase 3b/4 SPIRIT-H2H study, which evaluated the efficacy and safety of Taltz versus Humira in patients with active psoriatic arthritis, or PsA, who are biologic disease-modifying anti-rheumatic drug, or DMARD-naive. The SPIRIT-H2H trial is the first completed large head-to-head, or H2H, superiority study in active PsA. This open-label, randomized, controlled trial is the first and only H2H study that utilizes on-label dosing for both Taltz and Humira and includes concomitant conventional DMARDs. At 24 weeks, patients treated with Taltz met the primary endpoint by demonstrating superiority in improving the signs and symptoms of active PsA compared to Humira as measured by the proportion of patients simultaneously achieving at least a 50% reduction in disease activity, as defined by the American College of Rheumatology, or ACR50, as well as complete skin clearance as measured by the Psoriasis area and severity index. In addition, Taltz met the major secondary endpoints. A total of 566 active PsA patients were enrolled in the study to evaluate the efficacy and safety of Taltz compared to Humira. Patients with active PsA were randomized to receive Taltz at the approved dose, or Humira for a total of 52 weeks, with the primary analysis conducted at 24 weeks. Patients meeting criteria for moderate-to-severe plaque psoriasis received the approved dose of Taltz or Humira.
Nightstar Therapeutics initiated at Barclays
Nightstar Therapeutics initiated with an Overweight at Barclays. Barclays analyst Gena Wang started Nightstar Therapeutics with an Overweight rating and $28 price target. The company’s current enterprise value of $250M does not reflect the potential of its two leading programs in inherited retinal disorders, Wang tells investors in a research note. She estimates total probability-unadjusted peak sales at ~$1B after considering anticipated competition for the two programs. The analyst sees a “reasonable chance” of success for both NSR-REP1 in choroideremia and NSR-RPGR in X-linked retinal pigmentosa. Data readouts in 2019/20 should further characterize the product profiles and generate potential upside, says Wang.
Bristol-Myers announces positive CHMP opinion recommending Sprycel
Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has recommended the expanded approval of Sprycel, in combination with chemotherapy, to include the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. The positive opinion includes the tablet form of Sprycel and the powder for oral suspension formulation, which was first approved by the European Commission in July 2018, making Sprycel the only tyrosine kinase inhibitor with a formulation developed for administration in pediatric patients and patients who cannot swallow tablets. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union.
Pyramid Biosciences announces global license of AstraZeneca TRK program
Pyramid Biosciences announced it has entered into an exclusive, worldwide licensing agreement with AstraZeneca for the development and commercialization rights to a novel Tropomyosin receptor kinase modulator, PBI-100. Pyramid Biosciences seeks to develop the TRK modulator for a range of dermatological and inflammatory diseases, including psoriasis and atopic dermatitis. Under the agreement, Pyramid Biosciences licenses exclusive rights to develop and commercialize the compound globally. Financial terms of the agreement were not disclosed.
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