Intercept price target raised to $56 from $51 at Stifel » 12:4908/1008/10/20
Stifel analyst Derek…
Stifel analyst Derek Archila raised the firm's price target on Intercept to $56 from $51 after the company reported Q2 Ocaliva sales that were ahead of consensus forecasts. However, he keeps a Hold rating on the shares as there "remains a big question mark in terms of resolving the complete response letter" the company received in June. While Intercept management said they expect to have an FDA Type A meeting by early Q4, they noted that a single meeting may not be enough to reach alignment with respect to an NDA refiling, Archila tells investors.
Piper Sandler confident in success of Intercept's OCA approval in 2021 » 11:5408/1008/10/20
Piper Sandler analyst…
Piper Sandler analyst Yasmeen Rahimi is confident in the success of Intercept's NDA submission and approval of OCA in 2021, especially with numerous upcoming datasets at the virtual EASL conference that provide more fuel to win the "risk-benefit" argument raised by the FDA. Rahimi, who made no change to the firm's Overweight rating or $82 price target, thinks Intercept is well-funded ahead of addressing the CRL and possible OCA approval for NASH in 2021.
Intercept sees 2020 Ocaliva sales $300M-$320M » 07:0608/1008/10/20
Revenue consensus $288.07M. Sees 220 adjusted operating expenses $460M-$500M.
Intercept no longer expects to launch OCA for NASH in 2020 » 07:0408/1008/10/20
The company said,…
The company said, "On June 29, 2020, we announced that the U.S. Food and Drug Administration had issued a Complete Response Letter egarding our New Drug Application for OCA for the treatment fibrosis due to NASH. As a result, we no longer expect to launch OCA for NASH in 2020."
Intercept reports Q2 EPS ($1.92), consensus ($2.92) » 07:0308/1008/10/20
Reports Q revenue $77.2M,…
Reports Q revenue $77.2M, consensus $72.15M. "Our PBC business achieved its highest quarterly net sales to date in the second quarter," said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. "We plan to continue to invest in our growing PBC business and announced 2020 Ocaliva net sales guidance earlier this morning. We anticipate that our Ocaliva net sales, together with the announced reduction in our 2020 non-GAAP adjusted operating expense guidance, will help to ensure that we are financially well positioned to support the path forward in NASH. In the meantime, we are preparing to meet with the FDA to discuss the basis for resubmission of our NDA seeking accelerated approval of OCA for the treatment of advanced fibrosis due to NASH, and continue to believe that OCA has the potential to become the foundational treatment for these patients. I am encouraged by the outpouring of support we have received from the liver community in recent weeks and we remain committed to our goal of bringing the first therapy to market for patients with this serious condition."
|Over a week ago|
Intercept initiated with an Overweight at Piper Sandler » 16:0507/3007/30/20
Piper Sandler analyst…
Piper Sandler analyst Yasmeen Rahimi initiated coverage of Intercept Pharmaceuticals with an Overweight rating and $82 price target. The analyst has "significant conviction" that Intercept will provide regulators with "compelling" histological and non-invasive datasets that can resolve the FDA's main question over the outcomes benefit-risk ratio for Ocaliva treatment. Further, readout of outcomes benefit for OCA in cirrhotics and label expansion would be a significant value driver in the medium term, says the analyst.
Intercept downgraded to Market Perform from Outperform at JMP Securities » 06:0607/2107/21/20
JMP Securities analyst…
JMP Securities analyst Jonathan Wolleben assumed coverage of Intercept with a Market Perform rating, down from the firm's previous Outperform rating, without a price target. Wolleben says the complete response letter regarding the NDA for obeticholic acid to treat fibrosis due to NASH "caught us by surprise," but notes that the review cycle "already had its twists and turns." Wolleben says the reorganization of the FDA's Office of New Drugs and the COVID-19 pandemic likely didn't make the review process any easier. Given the lack of visibility for OCA in NASH, the analyst is stepping to the sidelines.
|Over a month ago|
Citi upgrades Intercept following pullback ahead of likely NDA refiling » 09:5606/3006/30/20
Citi analyst Joel Beatty…
Citi analyst Joel Beatty upgraded Intercept to Buy from Neutral with a price target of $67, down from $110, as he believes the stock now offers a favorable risk/reward following the pullback in response to the complete response letter issued by the FDA. While he now gives Intercept a 50% probability of approval for obeticholic acid in nonalcoholic steatohepatitis, down from 90% previously, Beatty believes it is likely that the company will be able to refile an NDA in the next several months based on data that already exists and get an advisory committee meeting convened. He also believes there is a strong consensus in the hepatology community that supports approval of OCA for NASH and that an AdCom vote would likely be favorable, Beatty tells investors.
Moderna, PayPal coverage initiations among today's top calls on Wall Street » 09:5506/3006/30/20
MRNA, PYPL, SQ, SPOT, WMG, TME, ICPT, CLX
Check out today's top…
Intercept upgraded to Buy from Neutral at Citi » 09:5006/3006/30/20
Citi analyst Joel Beatty…
Citi analyst Joel Beatty upgraded Intercept to Buy from Neutral.