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Thursday, January 24, 2019

BioTime initiated with a Buy at Maxim


https://thefly.com/landingPageNews.php?id=2852977

Neurocrine downgraded to Hold from Buy at Needham


Needham analyst Alan Carr downgraded Neurocrine to Hold, saying that the stock looks “fairly valued”. The analyst acknowledges that the launch of Ingrezza in Tardive Dyskinesia has been impressive, but contends that since the management reflected on its likely lack of efficacy in Tourette Syndrome, the program’s long-term success is “already reflected” in the shares.

Varian Medical price target raised to $130 from $115 at RBC Capital


RBC Capital analyst Brandon Henry raised his price target on Varian Medical to $130 after its Q1 results, saying the company’s “gross order outperformance” was geographically broad. The analyst also contends that the company is “benefiting from a strong new product portfolio and what appears to be a continued acceleration in radiation oncology market growth.” Henry keeps his Sector Perform rating on the shares however, noting that the medium term trend in the worldwide radiation oncology market is “difficult to forecast.
https://thefly.com/landingPageNews.php?id=2853057

Proteon Therapeutics announces PATENCY-1 trial results published


Proteon Therapeutics announced the publication in the Journal of Vascular Surgery of results from its Phase 3 PATENCY-1 clinical trial of investigational vonapanitase. Top-line data from PATENCY-1 were publicly announced in December 2016. The study results suggested vonapanitase may improve both fistula use for hemodialysis and secondary patency, which are the co-primary endpoints in Proteon’s ongoing Phase 3 PATENCY-2 clinical trial. The PATENCY-2 clinical trial is fully enrolled and top-line data is expected in March. PATENCY-1 evaluated the safety and efficacy of a single dose of vonapanitase in patients with chronic kidney disease, or CKD, undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. The randomized, double-blind, placebo-controlled clinical trial enrolled 313 treated patients at 31 medical centers in the United States. Patients were followed for up to one year.
https://thefly.com/landingPageNews.php?id=2853061

Bellerophon initiated at Maxim


Bellerophon initiated with a Buy at Maxim. Maxim analyst Caroline Palomeque initiated Bellerophon with a Buy rating and a price target of $3, saying the company’s lead product INOpulse is well positioned in the absence of other “FDA-approved treatment options for pulmonary hypertension associated with Interstitial Lung Disease”. The analyst notes that shares were down significantly in Q3 of 2018 after the company’s phase 3 study in pulmonary arterial hypertension was stopped for futility, but she sees upside from the program’s intact clinical path forward and expectations of more data later this year.
https://thefly.com/landingPageNews.php?id=2853089

Inovio reports second full remission from head & neck cancer after treatment


Inovio (INO) announced that a second patient with HPV-related head and neck cancer treated with INO-3112 in a Phase 1 trial achieved a sustained complete response, full remission, after subsequent treatment with a PD-1 checkpoint inhibitor. This marks the second patient with metastatic cancer observed in full remission after treatment with synthetic DNA vaccine followed by a PD-1 checkpoint inhibitor. Of the four patients who developed progressive disease and were subsequently administered a PD-1 checkpoint inhibitor, two patients rapidly exhibited a complete response. The most recent patient for which data was presented yesterday received pembrolizumab, or Keytruda; while the previously reported complete responder was treated with nivolumab, or Opdivo. The patients moved from metastatic head and neck cancer to no evidence of disease and they remain alive two years after treatment. Keytruda is a registered trademark of Merck (MRK); Opdivo is a registered trademark of Bristol-Myers Squibb (BMY).

Teligent receives FDA approval for Clobetasol Propionate Ointment ANDA


Teligent announced it has received approval of the company’s abbreviated new drug application, or ANDA, from the FDA of Clobetasol Propionate Ointment. This is Teligent’s first approval of 2019, and its thirty-third approval from its internally-developed pipeline of topical generic pharmaceutical medicines.
https://thefly.com/landingPageNews.php?id=2853117