Antares Pharma announced the approval of Xyosted injection by the FDA. Xyosted is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot auto injector. Xyosted has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Monday, October 1, 2018
Oncolytics initiated at Ladenburg
Oncolytics initiated with a Buy at Ladenburg. Ladenburg Thalmann analyst Wangzhi Li started Oncolytics Biotech with a Buy rating and $22 price target. The analyst believes Oncolytics is “significantly under-recognized and undervalued, and presents an attractive investment opportunity.” The company’s lead program Pelareorep is a RNA reovirus oncolytic virus that has been safely dosed in greater than 1,100 patients across a variety of cancers, Li points out.
https://thefly.com/landingPageNews.php?id=2797573
Varian Medical announces first patient treated in India on Halcyon system
Varian announced a 75-year-old male with lung cancer was the first patient in India to be treated on the Halcyon system at Sterling Cancer Hospital in Gujarat. Halcyon simplifies and enhances virtually every aspect of image-guided volumetric intensity-modulated radiotherapy, including improved patient comfort and shortening the time from installation to first-treatment without sacrificing quality. The system is well suited to treat cancer patients, offering advanced treatments for lung, prostate, breast, head & neck, and many other forms of cancer.
https://thefly.com/landingPageNews.php?id=2797657
Aeglea BioTherapeutics gets rare pediatric disease tag on pegzilarginase
Aeglea BioTherapeutics gets rare pediatric disease designation on pegzilarginase Aeglea announced the FDA has granted rare pediatric disease designation to the company’s lead product candidate, pegzilarginase, for the treatment of Arginase 1 Deficiency. This designation by the FDA confirms Aeglea’s eligibility to receive a rare pediatric disease priority review voucher upon approval of a biologics license application for pegzilarginase. Arginase 1 Deficiency is a rare debilitating disease presenting in childhood with persistent hyperargininemia, severe progressive neurological abnormalities and early mortality. https://thefly.com/landingPageNews.php?id=2797675
Sangamo, TxCell announce completion of acquisition of TxCell ordinary shares
Sangamo Therapeutics and TxCell jointly announced the completion by Sangamo of the acquisition of ordinary shares of TxCell, at a price of EURO$2.58 per share in cash, representing approximately 53% of the share capital and voting rights of TxCell, as per the terms of the Share Purchase Agreement entered into on July 20, 2018 and announced previously by TxCell and Sangamo in a joint press release dated July 23, 2018. TxCell will now operate as a subsidiary of Sangamo. Sangamo expects to file on October 2, 2018 a cash simplified tender offer for the purchase of all then outstanding ordinary shares of TxCell, at a price of EURO$2.58 per share. Subject to obtaining at least 95% of the share capital and voting rights of TxCell upon completion of the simplified tender offer, Sangamo will launch a squeeze-out procedure. Following the completion of the squeeze-out procedure, Sangamo will delist TxCell. TxCell’s operations will remain based in Valbonne, France.
https://thefly.com/landingPageNews.php?id=2797685
Akorn hit after Judge rules Fresenius can pull out of takeover
Shares of Akorn (AKRX) are sinking after Delaware Chancery Court Judge Travis Laster ruled that Fresenius (FSNUY) has proper grounds for canceling its $34 per share buyout of the generic drugmaker. The judge, in a 246-page opinion, said that Fresenius “properly exercised its rights” to withdraw from the deal, according to Bloomberg. Before being halted for news, shares of Akorn dropped 47%, or $6.08, to $6.90.
Mallinckrodt Responds to CBS’ 60 Minutes Segment
Mallinckrodt responded to questions received from CBS’ 60 Minutes and provided the following statement:
Mallinckrodt never sold or sent oxycodone or any products to Dr. Schultz, and based on a thorough review of our records, we had no communication with him. As a manufacturer, we do not ship products to independent retail pharmacies, prescribing physicians or end users. We sell only to distributors, and have always complied with our obligation to report suspicious orders from those customers. Mallinckrodt has limited information about shipment of our products between distributors and pharmacies, but with the information available to us, we work closely with law enforcement to combat diversion.
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