Alnylam Pharmaceuticals pre-announced its unaudited fourth quarter 2018 global net product revenues for ONPATTRO and provided additional updates on the product’s commercial launch. ONPATTRO global net product revenues for the fourth quarter of 2018 were $11M-12M. As of year-end 2018, over 200 patients in the U.S. and EU were receiving commercial ONPATTRO treatment, and approximately 550 total patients worldwide, including patients on commercial drug and patients in clinical studies and in the Company’s global Expanded Access Program, were being treated with patisiran. In the U.S., a total of 250 Start Forms were submitted as of year-end 2018. Of these, approximately 50% were from patients previously treated on the ONPATTRO EAP. The Start Forms came from a diverse range of prescribing physician specialties, including 44% neurologists, 35% cardiologists, and 21% from other specialties. For Start Forms received, 62% of patients were covered by Medicare, 32% were covered by commercial insurers, and 6% were covered by other government insurers. Significant progress has been made with value-based agreements in the U.S. and with market access efforts in the EU. Since launch, Alnylam has completed full VBAs with Harvard Pilgrim Healthcare, Humana, and another top five U.S. payer. Additional VBAs are under negotiation with over 15 other commercial payers with the potential to cover over 90% of commercial lives in the U.S. In addition, the Company today reported that at December 31, 2018, it had cash, cash equivalents and marketable debt securities, and restricted investments, excluding equity securities, of approximately $1.1B. The Company intends to provide 2019 financial guidance on non-GAAP R&D and SG&A expenses and year-end cash balance in connection with its full, audited fourth quarter and year-end 2018 financial results in February 2019.
Monday, January 7, 2019
Immutep enters into clinical trial collaboration agreement with Cytlimic
Immutep Limited announced that it has entered into a clinical trial collaboration agreement, a supply agreement and a service agreement with CYTLIMIC Inc. for its lead product candidate eftilagimod alpha as part of a cancer vaccine. The agreements enable the two parties to collaborate on clinical trials to evaluate efti as part of a therapeutic cancer vaccine containing CYTLIMIC’s innovative cancer peptide vaccine, called CYT001. The trials will be conducted by and are under the control of CYTLIMIC who will fully fund all development costs. Under the collaboration agreement, Immutep will receive an upfront payment of $500,000 and is eligible to receive up to $4.5M in milestone payments upon the achievement of milestones by CYTLIMIC. https://thefly.com/landingPageNews.php?id=2844487
Endologix backs FY19 revenue guidance of at least $140, consensus $140.82M
Endologix reaffirms its previously issued annual guidance and continues to expect 2019 revenue of at least $140 million. The Company anticipates revenue for the first quarter ending March 31, 2019 of approximately $35 million. The Company continues to expect 2019 operating expenses in the range of $130 million to $140 million. The Company’s 2019 financial guidance contemplates the anticipated impact of the voluntary recall of the Nellix System and issuance of its January 4, 2019 field safety notice.
CareDx sees FY18 revenue $76.2M-$76.5M, consensus $74.84M
https://thefly.com/landingPageNews.php?id=284449
Allakos says 92% of patients achieved complete response in Phase 2 trial
Allakos announced top-line results for the Xolair-naive chronic spontaneous urticaria cohort from its Phase 2 study. The study is being conducted at 4 sites in the U.S. and Germany. The principle investigator is Dr. Marcus Maurer, MD, Professor of Dermatology and Allergy at Charite University in Berlin. The Xolair-naive chronic spontaneous urticaria cohort enrolled 13 patients with uncontrolled urticaria despite treatment with H1 antihistamines at doses of up to 4 times the labeled dosage. Antihistamine medication was maintained throughout the screening period and during the study. Baseline symptom scores, as measured by Urticaria Control Test and Urticaria Activity Score were collected over a 4-week screening period. Patients with baseline UCT scores of less than 12, indicative of poorly controlled urticaria, were enrolled in the study and treated with up to 6 doses of AK002 given once monthly. Patients received an initial dose of 0.3 mg/kg at baseline, followed by a dose of 1.0 mg/kg on day 28, and then received monthly doses of either 1.0 or 3.0 mg/kg for a total of 6 doses. The primary efficacy endpoint was change from baseline in UCT assessed at week 22, two weeks after the last dose of AK002.
Diplomat Pharmacy sees FY18 GAAP EPS (8c)-0c, consensus 80c
Lowers FY18 revenue view to $5.5B-$5.6B from $5.5B-$5.7B, consensus $5.56B. 2018 adjusted EBITDA is now expected to be within the range of $167M-$170M, an increase of at least 64% based on the low end of the 2018 range vs. 2017. Prior view was $164M-$170M.
Intersect ENT preliminary FY18 revenue $108.3M-$108.5M; Consensus $107.93M
https://thefly.com/landingPageNews.php?id=2844502
Subscribe to:
Posts (Atom)