Tuesday, February 5, 2019
Corcept overhang unlikely to lift despite ‘helpful’ response, says B. Riley FBR
B. Riley FBR analyst David Buck reiterates a Neutral rating on shares of Corcept Therapeutics with an $11 price target following another short seller report as well as response from the company. Negative commentary from short-seller reports have raised a number of issues, including off-label promotion, bribing physicians through speaker fees or otherwise to prescribe Korlym, questioning the efficacy of Korlym and using the FDA’s adverse event reporting database to taint the drug as dangerous, and the possible overstatement of sales from the Veteran’s Administration channel, Buck tells investors in an intraday research note. He believes Corcept’s response this morning to the allegations is “helpful,” but he does not expect the overhang to lift immediately from the shares. The stock in midday trading is up 3%, or 32c, to $10.52.
Becton Dickinson price target raised to $274 from $250 at Piper Jaffray
Piper Jaffray analyst William Quirk raised his price target for Becton Dickinson to $274 saying the company reported “solid” fiscal Q1 results, with revenue and earnings ahead of the Street’s expectations. Further, management reaffirmed fiscal 2019 guidance and was upbeat about the product pipeline for the year, Quirk tells investors in a post-earnings research note. The analyst continues to believe Becton is poised to “beat and raise” estimates over the course of 2019. He keeps an Overweight rating on the name.
https://thefly.com/landingPageNews.php?id=2859373
https://thefly.com/landingPageNews.php?id=2859373
What to watch in Eli Lilly earnings report
Eli Lilly (LLY) is scheduled to report the results of its fourth fiscal quarter before the market open on Wednesday, February 6, with a conference call scheduled for 9:00 am EDT. What to watch for: 1. GUIDANCE: Along with its third quarter financial report in late October, the drug giant raised its FY18 EPS view to $5.55-$5.60 from $5.40-$5.50. This past December, the drug company backed its FY18 EPS view and revenue views and gave its perspective on 2019. Lilly said it sees EPS for 2019 to be in the range of $5.90 to $6.00 on a non-GAAP basis. Lilly sees FY19 revenue $25.3B-$25.8B against a consensus of $24.77B, representing mid-single-digit growth driven by volume from newer medicines, including Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant and Lartruvo, as well as the recent launch of Emgality. Having launched ten new medicines over the past five years, the company expects continued pipeline progress in 2019, including U.S. regulatory action for nasal glucagon for hypoglycemia and lasmiditan for acute migraine, as well as new indications for several medicines. The company has revised its 2020 minimum financial expectations and now expects at least 6% compound annual revenue growth from 2015 to 2020 for the full company, and at least 7% compound annual revenue growth for its human pharmaceutical business. 2. GENERIC COMPETITION: Eli Lilly’s second-highest grossing drug in 2017, erectile dysfunction treatment Cialis, is seeing generic competition. This past September Teva’s (TEVA) EVP and Head of Global R&D, Hafrun Fridriksdottir said, “We’re proud to offer an affordable treatment option for the estimated 30M men affected by ED, many of whom will also have symptomatic BPH which is estimated to affect 15M men in the United States.” 3. MIGRAINE PREVENTION DRUG. In late September, Eli Lilly announced that the FDA has approved Emgality for the preventive treatment of migraine in adults. Emgality will be available for pickup at retail pharmacies. Migraine is a disabling, neurologic disease that affects more than 30M American adults. According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the U.S. is estimated to be as high as $56B annually, yet migraine remains under-recognized and under-treated. 4. LOXO ONCOLOGY ACQUISITION: On January 7, Eli Lilly and Loxo Oncology (LOXO) announced a definitive agreement for Lilly to acquire Loxo Oncology for $235 per share in cash, or approximately $8B. Loxo Oncology is a biopharmaceutical company focused on the development and commercialization of highly selective medicines for patients with genomically defined cancers.
Edwards Lifesciences recalls Swan-Ganz Thermodilution Catheter
Edwards Lifesciences is recalling 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured December 26, 2017, to April 19, 2018 due to incorrect assembly and reversal of the catheter tubes, the FDA announced. The recall was initiated December 21, 2018, according to a post to the FDA website that noted “The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.”
Genentech submits sBLA to FDA for Kadcyla
Genentech, a member of the Roche Group, announced completing the submission of a supplemental Biologics License Application, or sBLA, to the FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer, or EBC, with residual disease after neoadjuvant treatment. The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.
https://thefly.com/landingPageNews.php?id=2858815
https://thefly.com/landingPageNews.php?id=2858815
Sanofi says Isatuximab Phase 3 trial meets primary endpoint
Sanofi announced the pivotal Phase 3 trial of isatuximab in patients with relapsed/refractory multiple myeloma met the primary endpoint of prolonging progression free survival in patients treated with isatuximab in combination with pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone alone. Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year. “We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients,” said John Reed, Head of Research and Development at Sanofi. “We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.” Multiple myeloma is the second most common hematologic malignancy[1], with more than 138,0002 new cases worldwide each year. Multiple myeloma remains incurable in the vast majority of patients, resulting in significant disease burden. The randomized, multi-center, open label Phase 3 study, known as ICARIA-MM, enrolled 307 patients with relapsed/refractory multiple myeloma across 96 centers spanning 24 countries. All study participants received two or more prior anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment. The safety profile was evaluated as a secondary endpoint.
https://thefly.com/landingPageNews.php?id=2858817
https://thefly.com/landingPageNews.php?id=2858817
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