Citi analyst Mohit Bansal says that while some might see Sanofi (SNY) giving back all rights back to MyoKardia (MYOK) as a negative, he sees "significant strategic implications in longer term." The move gives MyoKardia more freedom to employ its "Divide and Conquer" precision strategy, Bansal tells investors in a research note titled "Full control makes MYOK an interesting long term play." The analyst also points out that Sanofi's decision was related to wanting U.S. control over Mavacamten, and is not related to the profile of the products. Bansal lowered his price target for MyoKardia to $70 from $90 and keeps a Buy rating on the shares.
https://thefly.com/landingPageNews.php?id=2843005
Thursday, January 3, 2019
Neon Therapeutics expects to fund operating expenses, cap-ex into 2020
Based on its current operating plans, Neon now expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its anticipated operating expenses and capital expenditure requirements into Q2 of 2020. As of September 30, 2018, Neon had $121.7M in cash, cash equivalents and marketable securities.
https://thefly.com/landingPageNews.php?id=2843021
https://thefly.com/landingPageNews.php?id=2843021
Acadia initiated at Deutsche Bank
Acadia initiated with a Hold at Deutsche Bank. Deutsche Bank analyst Pito Chickering started Acadia Healthcare with a Hold rating and $27 price target. The analyst initiated coverage on Healthcare Facilities with a constructive view saying the sector is "relatively defensive" in slowing business cycles and that company cash flows "provide downside protection in volatile markets."
https://thefly.com/landingPageNews.php?id=2843039
https://thefly.com/landingPageNews.php?id=2843039
Deciphera Pharmaceuticals Initiates a Phase 1b/2 Cancer Trial
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced that it has initiated an open-label, multicenter, Phase 1b/2 study of rebastinib, the Company’s investigational small molecule switch control inhibitor of TIE2 kinase, in combination with carboplatin in patients with advanced or metastatic solid tumors.
“We are extremely pleased with the recent progress made on our rebastinib program, including today’s announcement that we have initiated a second Phase 1b/2 clinical study of rebastinib in combination with chemotherapy,” said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. “This second clinical study will evaluate rebastinib in combination with carboplatin, a treatment regimen that, based on preclinical observations, we believe has the potential to be an important new approach to treating patients with advanced solid tumors.”
https://www.businesswire.com/news/home/20190103005177/en/Deciphera-Pharmaceuticals-Initiates-Phase-1b2-Clinical-Trial
Pacira Reports Preliminary 2018 Net EXPAREL® Sales of $331 M
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today reported preliminary unaudited EXPAREL® (bupivacaine liposome injectable suspension) net product sales of $94 million for the fourth quarter of 2018 and $331 million for the full-year, as compared to $79 million and $283 million reported for the fourth quarter and full-year 2017, respectively. The company previously guided to full-year EXPAREL net product sales of $325 to $330 million.
“We are very pleased with our 2018 results, with fourth quarter EXPAREL sales exceeding our expectations and marking the highest quarterly revenues ever reported by Pacira,” said Dave Stack, chairman and chief executive officer of Pacira. “With an expanding number of payers, providers and patients recognizing the value of EXPAREL as a critical component within opioid-sparing pain management strategies, we are entering 2019 with strong momentum. Our robust partnership network also remains a core driver as we continue to focus on maximizing the value of EXPAREL, including its role in transitioning certain inpatient procedures to the ambulatory setting. We are particularly excited by new reimbursement codes, which went into effect on January 1, 2019, that we believe will meaningfully expand patient access through a product-specific C-code for ambulatory surgery centers and a procedure-based D-code for the oral surgery setting.
Looking ahead, we have put in place a number of growth initiatives that include building a pipeline of innovative non-opioid pain management and regenerative health solutions. Our goal is that these, coupled with our unique experience and position in the marketplace as a leader in non-opioid postsurgical pain management, will make a key contribution in confronting the current U.S. pain and opioid crises.”
The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company’s fourth quarter and full-year financial results for 2018. Pacira expects to report its complete financial results for 2018, along with financial guidance for 2019, during the company’s fourth quarter earnings call, which will take place in the first quarter of 2019.
https://globenewswire.com/news-release/2019/01/03/1680035/0/en/Pacira-Reports-Preliminary-2018-Net-EXPAREL-Sales-of-331-Million.html
First Patient Enrolled in Biogen’s Phase 3b MS Study
The first patient has been enrolled in a global Phase 3b study evaluating the efficacy and safety of extended interval dosing (EID; every six weeks) for natalizumab compared to standard interval dosing (SID) in patients with relapsing multiple sclerosis (MS), Biogen Inc. (Nasdaq: BIIB) announced. Currently commercialized under the brand name TYSABRI®, natalizumab 300 mg dosed every four weeks is the only approved dosing regimen.
The new study, NOVA (NCT03689972), is a two-year, prospective, randomized, interventional, controlled, open-label, rater-blinded, international Phase 3b study that will assess the efficacy, safety and tolerability of six-week natalizumab dosing intervals in people with relapsing-remitting MS. Patients who switch to EID after one year of treatment with natalizumab SID will be evaluated in relation to patients receiving continued SID treatment. The study will enroll approximately 480 patients worldwide. The primary endpoint is the number of new or newly enlarging T2 hyperintense lesions at week 48.
“For more than a decade, natalizumab has been considered a highly effective treatment option for patients with relapsing forms of MS,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “The NOVA study may generate valuable data that we hope will answer questions for the scientific community about the efficacy of natalizumab when its dosing schedule is extended to every six weeks, and in conjunction with prior safety analyses, may inform on the drug’s benefit-risk profile.”
NOVA was initiated following analyses that showed that EID was associated with a significant reduction in the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. The pre-specified, retrospective analysis of the U.S. TOUCH (TYSABRI®Outreach: United Commitment to Health) REMS program examined the impact of EID as compared to SID on the risk of PML, and the NOVA study aims to assess the efficacy of EID natalizumab to further evaluate the drug’s benefit-risk profile.
https://globenewswire.com/news-release/2019/01/03/1680036/0/en/First-Patient-Enrolled-in-Biogen-s-Phase-3b-Study-to-Evaluate-Extended-Interval-Dosing-EID-with-Natalizumab-in-Multiple-Sclerosis.html
Ascletis’ IND Filing for Its Third HCV Drug ASC21 Accepted by NMPA
Ascletis Pharma Inc.(1672.HK), a commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and fatty liver diseases, announces today that the investigational new drug application (IND) for its third HCV drug ASC21 was accepted by the National Medical Products Administration (NMPA).
ASC21 is an NS5B nucleotide polymerase inhibitor that has been shown in in vitro studies to have potent, pan-genotypic anti-viral activity and a high genetic barrier to resistance. ASC21, in combination with Ravidasvir, forms a regimen which has the potential to have pan-genotypic activity and to be effective in treating patients with difficult-to-cure genotypes, cirrhosis and HCV/HIV co-infection.
In June 2018, Ganovo®, Ascletis’ first HCV drug got New Drug Application (NDA) approval and launched successfully. On August 1, 2018, Ascletis’ NDA for its second HCV drug Ravidasvir was accepted and designated as priority review in October by NMPA. With three innovative HCV drugs having differentiation in mechanism of actions, Ascletis is committed to treating hepatitis C in greater China with its multiple leading antiviral combinations.
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