Share on StockTwits
Join our smart investors - Get the best stock directories in  blockchain, cannabis, crypto, AI, IoT, cleantech. Daily podcasts in cannabis and crpto. Just $99  a year

FDA Grants Breakthrough Status to Biopharma's Lead Candidate for Liver Disease

Source: Streetwise Reports

 

February 27, 2018 (Investorideas.com Newswire) The California firm's most advanced asset is advancing through Phase 2b, according to a ROTH Capital Partners report.


In a Feb. 19 research note, analyst Yasmeen Rahimi reported that CymaBay Therapeutics Inc. (CBAY:NASDAQ) is having a strong Q1/19 with respect to continued execution of its clinical programs for its most advanced therapeutic, seladelpar, in nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC).

Most recently, on Jan. 19, CymaBay announced that enrollment finished, ahead of schedule, of 181 NASH patients for its Phase 2b, proof-of-concept study of seladelpar. The primary efficacy outcome will be the change from baseline in liver fat content at 12 weeks, determined by magnetic resonance imaging employing the proton density fat fraction method. These 12-week results are now anticipated in Q2/19, in about mid to late May.

On Jan. 15, the FDA granted breakthrough status to CymaBay's seladelpar for the treatment of PBC. "In regards to PBC specifically, we believe meaningful differentiation for seladelpar will be able to mitigate potential pricing pressures in a market that appears larger than previously thought," Rahimi commented.

Also concerning seladelpar for PBC, the interim Phase 3 NASH data Intercept just released is not expected to negatively impact it, noted Rahimi. In those results, 25 milligrams (25 mg) of obeticholic acid(OCA) showed a one point improvement in fibrosis, alluding to the possibility a 10 mg OCA dose could be included in the label.

Such an FDA-approved expanded label could result in pressure to lower "the PBC pricing for OCA," wrote Rahimi, but likely would not affect the cost of seladelpar for PBC were it approved. This is because seladelpar's other benefits should support a higher cost. Those include no worsening of pruritus at a minimum, no liver impairment, and no worsening of or improvement in fatigue, other quality of life factors and LDL cholesterol.

ROTH has a Buy rating and a $26 per share 12-month price target on CymaBay, whose stock is currently trading at $11.82 per share.

Disclosure:

1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Disclosures from ROTH Capital Partners, CymaBay Therapeutics Inc., Flash Note, February 19, 2019

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of CymaBay Therapeutics, Inc., Intercept Pharmaceuticals, Inc. and Madrigal Pharmaceuticals and as such, buys and sells from customers on a principal basis.

Within the last twelve months, ROTH has received compensation for investment banking services from Madrigal Pharmaceuticals.

Within the last twelve months, ROTH has managed or co-managed a public offering for Madrigal Pharmaceuticals.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.


BiotechIndustryStocks.com - A Leading Global Investor Website for Biotech Industry Stocks

BiotechIndustryStocks.com - investing ideas in biotechnology stocks, medical technology and life sciences

Like Biotech Stocks? View our Biotech Stocks Directory

Get News Alerts on Biotech Stocks


More Info:

Investorideas.com Newswire

This news is published on the Investorideas.com Newswire - a global digital news source for investors and business leaders


Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Contact each company directly regarding content and press release questions. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release on the Investorideas.com newswire https://www.investorideas.com/News-Upload/

Additional info regarding BC Residents and global Investors: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: https://www.bcsc.bc.ca/release.aspx?id=6894. Global investors must adhere to regulations of each country.

Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp


Follow Us on StockTwits