Cantor Fitzgerald pharmaceuticals analysts hold analyst/industry conference call » 10:4306/2906/29/20
Pharmaceuticals Analysts, along with Zachary Silbersher, the founding partner of Kroub, Silbersher & Kolmykov (KSK), PLLC, discuss the likelihood that Amarin will win its appeal for Vascepa on an Analyst/Industry conference call to be held on June 29 at 11 am.
Intercept plunges, drags down some NASH peers after CRL from FDA » 07:2606/2906/29/20
ICPT, CBAY, NGM, MDGL, NVO, GNFT, LLY, ALNY
Shares of Intercept…
Shares of Intercept Pharmaceuticals (ICPT) have plunged in early morning trading after the company announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis, or NASH. Based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH, Intercept tells investors. Following the announcement, shares of Intercept are down $25.82, or 33%, to $51.67 in pre-market trading. A number of other companies working on NASH treatments are also moving lower, with CymaBay (CBAY) down about 3% and NGM Biopharmaceuticals (NGM) fractionally lower. Other companies exploring NASH treatments include Madrigal Pharmaceuticals (MDGL), Novo Nordisk (NVO), Genfit (GNFT), Eli Lilly (LLY), and Alnylam Pharmaceuticals (ALNY).
Novo Nordisk reports Rybelsus approved in Japan for treatment of type 2 diabetes » 07:0306/2906/29/20
Novo Nordisk (NVO)…
Novo Nordisk (NVO) announced that the Japanese Ministry of Health, Labour and Welfare has approved Rybelsus, which it calls "the first and only oral glucagon-like peptide-1 receptor agonist in a tablet," for the treatment of adults with type 2 diabetes. Novo Nordisk will now initiate reimbursement negotiations and expects to launch Rybelsus in Japan thereafter. Novo Nordisk and Merck (MRK), known as MSD outside the United States and Canada, will be co-promoting Rybelsus in Japan.
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Healthcare Financial Management Association to hold a virtual conference » 08:5606/2406/24/20
MTBC, NVZMY, NVS, NVAX, MRK, LOGI, REGN, RDY, FREQ, RCKT, TRVI, CSU, NVO
HFMA 2020 Digital Annual…
HFMA 2020 Digital Annual Conference will be held on June 24. Webcast Link
Notable open interest changes for June 23rd » 08:5506/2306/23/20
AAPL, AMRN, BAC, AAL
Monday's total option volume of 25.5 million contracts resulted in net open interest growth of 4.84 million calls and 3.73 million puts. Apple (AAPL), Amarin (AMRN), Bank of America (BAC) and American Airlines (AAL) saw the greatest growth. Top five new positions opened include 51k Ford (F) Aug-20 6 puts, 27k Amarin (AMRN) Sep-20 7 calls, 22k Amarin (AMRN) Sep-20 10 calls, 20k Amarin (AMRN) Sep-20 6 puts and 20k US Steel (X) Aug-20 7 puts.
Unusual call flow in option market yesterday » 07:3506/2306/23/20
Notable call activity was…
Notable call activity was cited Monday in US Steel (X) and Amarin (AMRN).
Double spread collar in Amarin opens bullish position » 12:0006/2206/22/20
Double spread collar in…
Double spread collar in Amarin opens bullish position. Shares little changed this morning near $6.80 with a 4-way spread on the ISE where a customer appears to have sold the Sep 5/6 put spread to buy the Sep 7/10 call spread a total of 20k times, opening on all legs. For the largest tranche of 15k, the net credit on the put spread was 27c and the debit on the call spread 77c, for a net debit of 50c, or about $1M on the package. Net delta on the package is nearly 670k shares, or 9% the average daily turnover in the name. Amarin shares dropped nearly 70% from over $13 to $4 on March 31 related to a court ruling. Today's trade could return a 500% gain to the buyer if shares were to return to double digit territory over the next three months.
Novo Nordisk says Phase 2 AM833 trial reached primary endpoint » 10:3006/1806/18/20
Novo Nordisk announced…
Novo Nordisk announced the headline results from two clinical trials with a novel once-weekly subcutaneous amylin analogue, a Phase 2 monotherapy trial and a Phase 1 combination trial of AM833 and once-weekly subcutaneous semaglutide 2.4 mg. The 26-week blinded Phase 2 monotherapy trial with AM833 investigated safety, tolerability and efficacy for weight management in 706 people with obesity or overweight with at least one weight-related comorbidity. The patients were randomized to treatment with five different weekly doses of AM833, liraglutide 3.0 mg or placebo. Approximately 100 people were included in each treatment arm. The trial reached its primary endpoint by demonstrating a weight loss of 10.8% at week 26 with AM833 at the 4.5 mg dose, compared to a weight loss of 3.0 % with placebo, Novartis said in a statement. The treatment difference was statistically significant and AM833 appeared to have a safe and well-tolerated profile, the company added. The 20-week multiple ascending dose phase 1 trial investigated safety, tolerability, pharmacokinetics and weight loss potential of AM833 administrated in combination with semaglutide 2.4 mg in 80 people with obesity or overweight. After 20 weeks of treatment, participants receiving the highest dose lost an average of 17.1% body weight from a mean baseline body weight of 95.1 kg. The trial investigated the number of treatment-emergent adverse events and AM833 was well-tolerated, with the most common adverse events being gastrointestinal disorders including nausea and vomiting, according to Novartis.
Amarin doubling down on appeal after settlement with Apotex, says SVB Leerink » 09:1206/1706/17/20
SVB Leerink analyst Ami…
SVB Leerink analyst Ami Fadia notes that Amarin (AMRN) has settled Vascepa patent litigation with Apotex. While the analyst doesn't believe the U.S. Vascepa patent litigation settlement with Apotex provides any readthrough on the strength of Amarin's case in the ongoing appeal versus Hikma and Dr. Reddy's (RDY), it consolidates the fate of Apotex with the other generic filers and gives Amarin greater clarity on how generic competition in the U.S. will shape up post the appeals ruling. Fadia thinks the settlement puts more at stake for Amarin, and reflects management doubling down on the strength of its appeal's case, although she doesn't disagree with the decision given the risk/reward on the appeal is heavily skewed to the upside. The analyst continues to assign a 20% Probability of Success that Amarin wins the appeal. Fadia has an Outperform rating on Amarin's shares.
Amarin settlement with Apotex an 'incremental positive,' says Stifel » 08:2806/1706/17/20
AMRN, RDY, TEVA
Stifel analyst Derek…
Stifel analyst Derek Archila reiterates his Hold rating on Amarin (AMRN) shares after the company settled with Apotex regarding its ANDA application for generic Vascepa. Apotex cannot sell a generic version of Vascepa until August 2029, which is the same date as Amarin's settlement with Teva (TEVA), noted Archila. While this settlement with another generic ANDA filer is an "incremental positive," Archila doesn't see this a major stock moving catalyst since Apotex is not a party in the ongoing appeal of the district court's decision invalidating Vascepa's patents, he tells investors. He expects Amarin shares to remain range-bound until closer to the hearing on the Hikma and Dr. Reddy's (RDY) case later this year, added Archila.