A six-week review by the FDA of Akorn’s (AKRX) Somerset, New Jersey, facility found some of the same data integrity issues that were cited by Fresenius SE (FSNUY) in its cancellation of the $4.3B buyout of the generic drugmaker, Bloomberg reports, citing an unsealed court filing. Delaware Chancery Court JudgeTravis Lasteris scheduled hold a telephonic hearing today on Akorn’s request to provide details on the FDA review before the judge issues a ruling in the case, Bloomberg adds.
Tuesday, September 11, 2018
Insulet price target raised to $130 from $100 at Leerink
Leerink analyst Danielle Antalffy raised her price target for Insulet to $130 from $100 after the company announced that Patrick Sullivan would be stepping down as CEO at the end of this year, passing the baton to current COO Shacey Petrovic on January 1, 2019. The analyst believes this transition indicates that Insulet fundamentals are stronger than ever. In conjunction with the announcement, the company also reiterated full year 2018 sales guidance of $547M-$562M, she adds. Antalffy reiterates an Outperform rating on the shares.
Avid Bioservices price target raised to $11 from $6 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis raised his price target for Avid Bioservices to $11 saying the company’s business development continues to ramp. The analyst reiterates a Buy rating on the shares following the Q1 results.
Exact Sciences price target raised to $85 from $74 at Baird
Baird analyst Catherine Ramsey Schulte raised her price target on Exact Sciences (EXAS) to $85 from $74 citing increased confidence in its partnership with Pfizer (PFE). She sees several different potential outcomes given different assumptions for Pfizer rep productivity and order rate increases. Schulte reiterated her Outperform rating on Exact Sciences shares.
Stryker to acquire Invuity for $190M
Stryker (SYK) announced a definitive agreement to acquire all the issued and outstanding shares of common stock of Invuity (IVTY) for $7.40 per share, or a total equity value of approximately $190M. Invuity specializes in advanced photonics and single-use, lighted instruments that deliver enhanced visualization for a wide variety of clinical applications including orthopaedic and spine surgery, general surgery, and women’s health procedures, and is a recent entrant into the enhanced energy market. Founded in 2004, and headquartered in San Francisco, California, Invuity’s portfolio of products is complementary to the surgical portfolio of Stryker’s instruments business. The boards of directors of both Stryker and Invuity have approved the transaction. The closing of this transaction is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The transaction is expected to close in Q4 and is expected to have an immaterial impact to net earnings in 2018.
Amgen’s AMG420 risk overstated, says Wells Fargo
Wells Fargo analyst Jim Birchenough believes shares of Bluebird Bio (BLUE) have been under pressure on concerns regarding potential competitive risk to BCMA CAR T therapeutic bb2121 from Amgen’s (AMGN) bispecific T cell engager AMG420. The analyst highlights that AMGN420 is a continuous IV infusion and in his opinion not a viable competitor to a single bb2121 cell therapy dose, particularly given long-term durability of response with bb2121. Further, he notes that Amgen’s approved first generation CD19 bispecific engager, BLINCYTO, is dosed as a continuous IV for 4 weeks out of every 6 and achieved only $175M in sales in 2017 following 2015 approval. He does not view this dose schedule for first generation bispecific T cell engagers as commercially viable in a more chronic cancer. Additionally, the analyst points out that Affimed (AFMD) also has a preclinical BCMA engager AFM26, established proof-of-concept data for CD30 bispecific AFM13, and upcoming proof-of-concept data for CD19 bispecific AFM11.
Opko Health comments on continued Nasdaq halt of trading of common stock
Opko Health has had trading in its common stock halted by The Nasdaq Stock Market, and the exchange has advised OPKO that the halt will continue until the company responds to the exchange’s request for information related to the previously reported lawsuit filed by the SEC against a number of individuals and entities, including OPKO and its CEO and Chairman Phillip Frost. As noted previously, the lawsuit does not contain any allegations about OPKO’s financial practices, financial statements or business practices, and OPKO is confident that once a proper investigation is completed and the facts of the case have been fully disclosed, the matter will be resolved favorably for the company. OPKO is working expeditiously to respond to Nasdaq’s request for information, but it cannot currently estimate when trading will resume.
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