Green Growth Brands CEO Peter Horvath defended the company’s C$2.8B unsolicited takeover bid for Aphria after short-seller Hindenburg Research called the offer “non-credible” and raised questions about the relationship with the two companies, Bloomberg reports, citing Horvath. The CEO said, “We don’t want to put ourselves in a position that jeopardizes our existing business, which has a lot of upside. If there’s anything that would appear inappropriate, we wouldn’t allow this to take place. We’re not into get-rich-quick schemes. We’re looking at real assets, real value, a seasoned management, and a true operating capabilities. At the end of the day, this is going to be up to shareholders to decide. There’s no opportunity to pull a fast one here.
Monday, December 31, 2018
Aclaris market cap should be much greater than $300M: Cantor Fitzgerald
With two commercial drugs, Rhofade and Eskata, and up to six positive data readouts in 2019, Aclaris Therapeutics’ market capitalization should be much greater than $300M, Cantor Fitzgerald analyst Louise Chen tells investors in a research note titled “Don’t Make Me Tell You Until I’m Red In The Face.” The analyst believes Rhofade’s soft re-launch, which started on November 1, is gaining traction and that the drug’s “positive momentum is not getting the attention that it deserves.” Chen previously highlighted Aclaris as one of her top ideas heading into 2019 and she keeps an Overweight rating on the shares with a $50 price targe
FDA requests further stay of Endo’s ongoing litigation
Endo International announced that, due to the ongoing federal government shutdown, the U.S. FDA has requested a further stay of Endo’s ongoing litigation against the FDA for the duration of the shutdown. That litigation challenges the FDA’s authorization of the bulk compounding of drugs, including vasopressin, that have not satisfied the legal requirements under Section 503B of the Drug Quality and Security Act amendments to the Federal Food, Drug, and Cosmetic Act. One of Endo’s subsidiaries, Par Sterile Products, LLC, manufacturers the only vasopressin product currently approved by the FDA, Vasostrict. The suit was most recently stayed until December 31, 2018 and the FDA had committed to use its best efforts to issue a final clinical need determination for vasopressin on or before that date. The FDA has now filed a motion, which Endo did not oppose, seeking a further stay of the suit for the period of time in which the government lacks appropriations. According to the FDA’s motion, absent an appropriation, Department of Justice attorneys and the FDA employees responsible for handling Endo’s litigation and the clinical need determination, respectively, are prohibited from working, even on a voluntary basis, except in very limited circumstances. If the FDA’s motion is granted, the litigation will be stayed for as long as the appropriations lapse continues and Endo is not at this time aware when appropriations may resume.
Doctors impressed by tanezumab data, says Cantor Fitzgerald.
Cantor Fitzgerald analyst Louise Chen says that investors she's spoken with are expecting the data for Pfizer (PFE) and Eli Lilly's (LLY) tanezumab in the first half of 2019 to be similar to or worse than what was seen in the first Phase 3 data set reported on October 23. However, physicians are impressed by the data and do not believe the rapidly progressive osteoarthritis imbalance would impact their desire to prescribe tanezumab if it is approved, Chen tells investors in a research note. The analyst believes the safety for tanezumab will be better than expected and that the drug could replace opioids for the treatment of pain. If that is right, peak sales potential of tanezumab could be billions of dollars, and drive upside to modest expectations for the drug, says the analyst. She keeps an Overweight rating on Pfizer with a $53 price target.
https://thefly.com/landingPageNews.php?id=2842043
https://thefly.com/landingPageNews.php?id=2842043
Merus poised for growth heading into latter half of 2019, says Wedbush
Wedbush analyst David Nierengarten believes Merus (MRUS) has a data-rich 2019 ahead, with key catalysts expected from lead bispecific candidates MCLA-128 in metastatic breast cancer in 2H19, MCLA-117 in r/r AML in 2H19 and MCLA-145 in metastatic colorectal cancer by YE19. The analyst notes that Merus has also resolved the ongoing IP dispute with Regeneron (REGN), which included a cross-license patent agreement and a $15M equity investment by Regeneron in Merus, which valued the 600k share private issuance at $25/share, a 118% premium over the stock’s close December 20. Nierengarten sees the company as poised for growth heading into the latter half of 2019. He reiterates an Outperform rating and $34 price target on Merus shares.
https://thefly.com/landingPageNews.php?id=2842047
Heron Therapeutics: FDA grants Priority Review designation for NDA for HTX-011
Heron Therapeutics announced that the U.S. FDA has accepted the new drug application for Heron’s investigational agent, HTX-011, and has granted it a Priority Review designation. The NDA for HTX-011, which was submitted on October 30, 2018, comprises data from five Phase 2 clinical trials and two Phase 3 clinical trials that included over 1,000 patients undergoing five different surgical procedures. The FDA also indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA set a Prescription Drug User Fee Act goal date of April 30, 2019.
https://thefly.com/landingPageNews.php?id=2842087
Sunday, December 30, 2018
Portola: FDA assigns Dec. 31 PDUFA date to PAS filing for Gen 2 Andexxa process
Portola Pharmaceuticals announced that the U.S. Food and Drug Administration has acknowledged receipt of the company’s Prior Approval Supplement filing for the large-scale Generation 2 manufacturing process for Andexxa. The PAS has been assigned a Prescription Drug User Fee Act date of December 31, 2018. If accepted and approved, the PAS will allow for the broad commercial launch of Andexxa in the United States. Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations, and was approved on May 3, 2018 under the FDA’s Accelerated Approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding
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