Select Medical sees FY19 EPS 97c-$1.13, consensus $1.26

https://thefly.com/landingPageNews.php?id=2844078

Arvinas announces FDA clearance to continue with ARV-110 IND

Arvinas announced that the FDA has cleared the company’s investigational new drug application, or IND, for ARV-110, an oral androgen receptor Protac protein degrader, for the treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC. Arvinas expects to begin enrollment of a Phase 1 clinical trial for ARV-110 in Q1. The Phase 1 study will investigate the safety and tolerability of ARV-110 in patients with mCRPC who have progressed on at least two standard of care treatment regimens and includes exploratory measures of efficacy.
https://thefly.com/landingPageNews.php?id=2844079

AbbVie expects to record Stemcentrx related impairment

In an 8-K filing, AbbVie disclosed that it will record an impairment charge on intangible assets acquired as part of AbbVie’s 2016 acquisition of Stemcentrx, Inc. On December 5, 2018, AbbVie announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating rovalpituzumab tesirine, an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3, as a second-line therapy for advanced small-cell lung cancer. Following this decision, AbbVie began an evaluation of the Stemcentrx-related intangible assets for impairment. The estimated net impact of this impairment and the related adjustment to contingent consideration liabilities is approximately $4B. AbbVie continues to evaluate information with respect to the Stemcentrx-related clinical development programs and will monitor the remaining $1 billion of intangible assets for further impairment.
https://thefly.com/landingPageNews.php?id=2844081

Incyte (INCY) Upgraded by Guggenheim to Buy

Guggenheim upgraded shares of Incyte (NASDAQ:INCY) from a neutral rating to a buy rating in a research note published on Thursday.
https://www.fairfieldcurrent.com/news/2019/01/04/incyte-incy-upgraded-by-guggenheim-to-buy.html

Galapagos, Fibrocor sign partnership in fibrosis

Fibrocor Therapeutics L.P. and Galapagos NV announced a global partnership focused on a novel target for idiopathic pulmonary fibrosis and other indications. Fibrocor specializes in the development of tissue-specific therapeutics to treat the underlying cause of fibrotic diseases of the kidney and other organs. The collaboration announced today concerns a small molecule inhibitor program, currently in the lead optimization stage of development for the treatment of fibrotic diseases of the lung and other organs, the target of which is undisclosed. In exchange for global commercialization rights to Galapagos, Fibrocor will receive an upfront payment, and potentially is eligible for further milestone and royalty payments. Galapagos will be responsible for all further development of the program. “This collaboration validates the fibrosis drug development expertise of Fibrocor,” says Mark A. Steedman, President and CEO of Fibrocor. “I take my hat off to Dr. Richard Gilbert and the scientific team, including Evotec GmbH, our CRO partner, for establishing a compelling data package that ultimately attracted Galapagos, a world-renowned biotech company with a key franchise in fibrosis. We feel this is the beginning of a great relationship and look forward to working with Galapagos to the benefit of fibrosis sufferers everywhere.”
https://thefly.com/landingPageNews.php?id=2844049

Regulus gains after hours on positive preclinical kidney disease data

Nano cap Regulus Therapeutics (NASDAQ:RGLS) is up 8% after hours in response to its announcement of positive results from a new mouse toxicity study of RGLS4326, a candidate for autosomal dominant polycystic kidney disease (ADPKD).

After 13 weeks of dosing, no adverse events or other significant findings were observed across all doses tested. The company plans to restart a Phase 1 trial.

Last summer, it suspended the Phase 1 after seeing “unexpected observations” in the first mouse study that was being conducted in parallel. The company believes the unexpected results were due to technical issues at the contract research organization running the study.

RGLS4326 is a novel oligonucleotide that the company says preferentially targets the kidney by inhibiting an RNA gene called miR-17.

https://seekingalpha.com/news/3420806-regulus-8-percent-hours-positive-preclinical-data-rgls4326

Insmed gains after saying expects drug Arikayce to bring in $9.8 million in Q4

Shares of Insmed Incorporated INSM, +6.76% shot up 18% in after-hours trading Friday after the company announced it expected sales of its antibacterial Arikayce to be $9.8 million for the fourth quarter, with $9.2 million in U.S. sales and $600,000 in sales outside the U.S. The drug is used to treat patients with a lung disease caused by a group of bacteria called Mycobacterium avium complex (MAC) and who do not respond to traditional treatment. Arikayce was granted accelerated approval by the FDA in September. Insmed said more than 500 U.S. patients had started treatment with the drug and approximately 600 physicians had written at least one prescription for the therapy as of Dec. 31
https://www.marketwatch.com/story/shares-of-insmed-shoot-up-18-in-after-hours-after-company-says-it-expects-drug-arikayce-to-bring-in-98-million-in-fourth-quarter-2019-01-04