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Wednesday, January 30, 2019

Morgan Stanley cuts Allergan to Equal Weight on uncertain pipeline, growth

Morgan Stanley analyst David Risinger downgraded Allergan to Equal Weight from Overweight, stating that he lost confidence in its pipeline optionality after management appeared to downplay key first-half catalyst rapastinel for depression on the company’s earnings call. He also lacks conviction in the safety of ubrogepant for migraine since details on liver toxicity have not yet been disclosed, Risinger added. The analyst, who now thinks pipeline and growth uncertainty will continue to constrain the stock’s valuation despite shares being inexpensive, lowered his price target on Allergan shares to $156 from $183.

Biogen price target raised to $341 from $328 at Leerink

Leerink analyst Geoffrey Porges raised his price target for Biogen to $341 from $328 following quarterly results. The analyst reiterates a Market Perform rating on the shares.

TG Therapeutics announces publication of data from triple therapy combo trial

TG Therapeutics announced the publication of results from the multicenter Phase 1 triple combination trial of ublituximab, the company’s anti-CD20 monoclonal antibody, umbralisib, the company’s oral once-daily PI3K delta inhibitor and ibrutinib, the oral Bruton’s tyrosine kinase inhibitor, in The Lancet Haematology. The paper includes safety and efficacy information from patients with relapsed or refractory B-cell malignancies, including 23 patients with chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL, and 23 patients with non-Hodgkin lymphoma, or NHL. Safety data was available from all 46 patients and the triple combination of ublituximab, umbralisib, and ibrutinib was well tolerated with a manageable adverse event profile, and no maximum tolerated dose achieved for the combination. Efficacy data was available from 44 patients and showed the triple combination to be highly active. The overall response rate, or ORR, amongst all evaluable patients was 84%, with 100% of patients with CLL/SLL achieving a response, including 36% achieving a complete response, or CR. Among patients with NHL, 68% achieved a response, including a 71% ORR in follicular lymphoma, a 100% ORR in marginal zone lymphoma and a 100% ORR in mantle cell lymphoma.

Align Technology sales growth should trump earnings reduction, says Barclays

Barclays analyst Steve Valiquette views the key focus of Align Technology’s Q4 report as its 2019 outlook, which he says sees higher operational spending to achieve the same 25% sales growth that is already baked into consensus. Investors historically are more willing to accept annual operational spending volatility in med tech companies, as long as there is visibility that it translates into continued organic revenue hyper-growth, Valiquette tells investors in a post-earnings research note titled “Sales Growth Should Still Trump EPS.” He believes Align fits this criteria, noting the company’s Invisalign franchise is still only 10% penetrated into worldwide orthodontic case starts. As such, the analyst thinks most investors should look past 2019 earnings reduction, “as it makes sense operationally” for Align “to play offense in the ‘clear aligner land grab’ from traditional metal braces.” Valiquette lowered his price target for Align Technology to $260 from $275 and keeps an Overweight rating on the name.

Stemline announces receipt of EMA validation for Elzonris MAA

Stemline announced that the European Medicines Agency, or EMA, has completed its validation of the marketing authorization application, or MAA, for Elzonris. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. Stemline submitted the MAA earlier this month seeking approval of Elzonris for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, or BPDCN. In November 2018, the MAA was granted accelerated assessment. Under European Union legislation, a medicinal product of major public health interest may be reviewed under an accelerated assessment procedure. Accelerated assessment can significantly reduce the timeframe for the EMA Committee for Medicinal Products for Human Use, or CHMP, to review an MAA.

Illumina long-term thesis unchanged despite Q4 negatives, says UBS

UBS analyst Daniel Brennan noted Illumina reported negative NovaSeq data in Q4, but said the long-term thesis remains intact. He said very large markets for Illumina and next-gen sequencing are just opening up, yielding a robust growth opportunity. The company’s demand elasticity remains intact, its financial position remains attractive, and the company remains in a dominant position, according to Brenna. He reiterated his Buy rating and lowered his price target to $350 from $370 on Illumina shares following the company’s quarterly report.

Amgen price target lowered to $192 from $200 at Leerink

Leerink analyst Geoffrey Porges lowered his price target for Amgen to $192 from $200 after reporting Q4 results that beat consensus estimates for revenue and earnings, but with the company’s guidance for revenue to decline by 4%-8% in 2019 and for EPS to be flat to down, despite a mid-single digit share count decline after its large share buyback in 2018. The analyst reiterates a Market Perform rating on the stock.