Monday, January 7, 2019
Apellis initiated at B. Riley FBR
Apellis initiated at B. Riley FBR Apellis resumed with a Buy at B. Riley FBR. B. Riley FBR analyst Polishetty resumed coverage on Apellis with a Buy and $40 price target.
https://thefly.com/landingPageNews.php?id=2844951
Immunomedics initiated at B. Riley FBR
Immunomedics resumed with a Buy at B. Riley FBR. B. Riley FBR analyst Harshita Polishetty resumed coverage on Immunomedics with a Buy and $55 price target.
https://thefly.com/landingPageNews.php?id=2844953
Amgen makes all Repatha device options available in U.S. at 60% reduced price
Amgen announced that all Repatha device options, including the Pre-Filled Syringe and Pushtronex (on-body infusor with prefilled cartridge), are now available at a 60% reduced list price of $5,850 per year. The most commonly used delivery system, the Repatha SureClick autoinjector, was made available at the lower list price of $5,850 on Oct. 24, 2018. The lower priced Repatha options are identical to the Repatha options currently available, but have been introduced to reduce out-of-pocket costs for patients, especially Medicare patients.
https://thefly.com/landingPageNews.php?id=2844971
Novocure reports Q4 revenue $69.6M, consensus $70.47M
Reports Q4 active patients up 30% from last year at 2.4K and prescriptions received up 21% at 1.3K. Novocure plans to discuss these results with investors at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco.
https://thefly.com/landingPageNews.php?id=2844977
Quidel reports preliminary Q4 revenue $132M-$133M, consensus $132.06M
“We had another great quarter, and a remarkable year, a year in which our efforts and excellent performance were driven significantly by the integration of the acquired Triage assets. We unlocked synergies, brought most international businesses within our control, and aggressively paid down debt,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “And we did all that without taking our eye off the ball. Notably, Sofia placements, which for the year were nearly 10,000, were higher than in any prior year since launch by far, further demonstrating the competitiveness and resilience of the Sofia instrument system, as well as the global commercial organization’s proficiency in ‘selling the entire bag’,” added Bryant. These preliminary results are based on management’s initial analysis of operations for the quarter ended December 31, 2018.
https://thefly.com/landingPageNews.php?id=2844987
Arvinas Wins Go-Ahead for PROTAC Therapy
Arvinas Inc (NASDAQ: ARVN) disclosed that it has received authorization to proceed for its IND application for PROTAC therapy to treat patients with metastatic castration-resistant prostate cancer.
The announcement came down Monday that the U.S. Food and Drug Administration(FDA) has cleared the company’s investigational new drug application (IND) for ARV-110, an oral androgen receptor (AR) PROTAC™ protein degrader, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Arvinas expects to begin enrollment of a Phase 1 clinical trial for ARV-110 in the first quarter of this year.
According to CEO John Houston, “This IND clearance is a key step forward for Arvinasand for the field of protein degradation
“Our PROTAC platform has demonstrated exciting promise in preclinical studies and represents an entirely new approach to treating patients with mCRPC and many other diseases. We hope ARV-110 will deliver a much-needed new therapeutic option for patients, and we expect to dose our first patient in the first quarter of 2019.”
ARV-110 was developed using Arvinas’ proprietary technology platform – PROTAC (proteolysis-targeting chimera) protein degraders – that uses small molecules to harness the body’s own natural protein recycling system (the ubiquitin proteasome system) to selectively and efficiently remove disease-causing proteins.
Stemline Applies for Euro Marketing Authorization for ELZONRIS
Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that it has submitted the marketing authorization application (MAA) for ELZONRIS (tagraxofusp) to the European Medicines Agency (EMA). The MAA seeks approval for treating patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the EMA granted the ELZONRIS MAA accelerated assessment.
On December 21, 2018, ELZONRIS was approved by the U.S. Food and Drug Administration (FDA) for the treatment of BPDCN in adult and pediatric patients, two years and older, in both treatment-naïve and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD123-targeted therapy.
“The submission of the ELZONRIS MAA is another major step forward for providing this important targeted treatment to patients, globally,” said Ivan Bergstein, M.D., CEO of Stemline Therapeutics. “We look forward to working closely with the EMA to ensure this treatment is available to patients as quickly as possible. In parallel, our commercial team is continuing its ongoing effort to raise awareness of both CD123 testing and BPDCN worldwide. Potential European approval offers us an opportunity to significantly increase the number of patients who may benefit from ELZONRIS.”
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