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Thursday, August 9, 2018

Tabula Rasa HealthCare price target raised to $76 from $57 at Citi


Citi analyst Stephanie Demko raised her price target for Tabula Rasa HealthCare to $76 saying the company saw continued momentum with a “strong” Q2 beat. The conference call highlighted multiple new initiatives, including expansion into the clinician market and Western Europe, Demko tells investors in a post-earnings research note. She believes Tabula has multiple “shots on goal” to accelerate out-year growth and keeps a Buy rating on the name.

Wright Medical price target raised to $35 from $30 at Cantor Fitzgerald


Cantor Fitzgerald analyst Craig Bijou raised his price target for Wright Medical to $35 saying the company last night posted an “impressive beat and raise” quarter with strength across its portfolio. Wright has strong competitive positions in the faster-growing markets in orthopedics, Bijou tells investors in a post-earnings research note. He reiterates an Overweight rating on the shares.

Acadia guidance creates attractive entry point, says H.C. Wainwright


H.C. Wainwright analyst Andrew Fein believes Acadia Pharmaceuticals’ lowered guidance for 2018 creates an attractive entry point for the shares. The outlook clears the overhang on the company, which should allow for a more “pure” entry point for new investors seeking to capitalize on Acadia’s “depressed share price,” Fein tells investors in a research note. He reiterates a Buy rating on Acadia with a $60 price target.

Acer Therapeutics price target raised to $55 from $50 at H.C. Wainwright


H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Acer Therapeutics to $55 saying the company “substantially extended” its cash runway with last week’s follow-on offering. Its current cash resources should be sufficient to fund operations through 2020, Selvaraju tells investors in a research note. The “added firepower” should permit Acer to “significantly accelerate” clinical development of ACER-001, which in recent months had taken a back seat to Edsivo, the analyst adds. He reiterates a Buy rating on the name.

CVS Health price target raised to $90 from $84 at RBC Capital


RBC Capital analyst George Hill raised his price target on CVS Health (CVS) to $90 and kept his Outperform rating after its Q2 results. The analyst notes that the quarter benefited from expense timing, given that its FY18 outlook has been largely maintained. Hill also maintains his positive outlook on the Aetna (AET) transaction and the impact of regulatory changes on the company.

Wednesday, August 8, 2018

Kyowa Kirin wins second FDA drug OK in 4 months



This is a good year for Kyowa Kirin.
The company touts itself as a Japanese-based drug group with a global focus, and they got a major assist on that score from the FDA on Wednesday with an approval for their cancer drug mogamulizumab. This OK follows close on the heels of another FDA OK for burosumab, a rare disease drug expected to make a significant mark with their partners at Ultragenyx.
Like burosumab, mogamulizumab was dubbed by regulators as a “breakthrough” therapy deserving VIP treatment. To be sold as Poteligeo, the CCR4 drug is designed to treat two rare forms of non-Hodgkin’s lymphoma: mycosis fungoides and Sézary syndrome.
Researchers for Kyowa Kirin came up with a median progression-free survival rate of 7.6 months for the drug, compared to 3.1 months for chemo — that easily qualifies for an accelerated approval at the FDA, which has been speeding the tempo considerably under the urging of Richard Pazdur and now commissioner Scott Gottlieb as well.
A little more than three months ago Kyowa Kirin and Ultagenyx won a green light for burosumab, a drug expected to rise to blockbuster status after being priced at $200,000 for an inherited form of rickets (weakening of the bones in children).
“Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients,” said Pazdur in a statement.

Sarepta all-in on gene therapy pipeline, adds 3 CNS meds in $30M Lacerta deal



Sarepta’s lead gene therapy $SRPT may be on clinical hold, but the brash Duchenne muscular dystrophy company is continuing its deep dive into the field, handing over $30 million in an equity investment in Lacerta in exchange for a group of CNS therapies, including one program focused on Pompe disease.
The biotech reported the deal just after market close on Wednesday, along with a Q2 statement showing growing sales volume for Exondys 51.
In the deal with Lacerta — a spinout from the University of Florida with expertise in AAV vector tech — Sarepta will take over clinical development after the private company has wrapped preclinical work. The pact gives Sarepta 11 gene therapy programs, a big part of the 20 it has hustled into the pipeline.
The clinical hold for Sarepta’s gene therapy for DMD came just days ago, triggered by what the biotech said was a problem on the manufacturing side of things. The hold came shortly after the biotech whipped up some intense enthusiasm for their work based on strong, but very early, responses in the clinic.
Sarepta has been wheeling and dealing its way to an expanded pipeline in the wake of the controversial OK for Exondys 51, a landmark advance only made possible by Janet Woodcock’s insistence that the drug should be OK’d despite the lack of efficacy data. That decision proved unpopular inside the FDA, but wildly successful in the disease community that supported it through approval.