Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe

TICKERS: IVA

French Biotech Firm Initiates Pivotal Phase 3 Study of Lanifibranor in 900 NASH Patients
Research Report

Share on Stocktwits

Source:

ROTH Capital Partners LLC advised in a research report that Inventiva S.A. has initiated enrollment in its highly anticipated pivotal Phase 3 Study of Lanifibranor in individuals diagnosed with nonalcoholic steatohepatitis. ROTH rates Inventiva a "Buy" with a 12-month price target of €55/share which represents a nearly four-fold increase over the current share price.

In a September 10 research note, Analyst Zegbeh Jallah, Ph.D. of ROTH Capital Partners LLC stated that just a few days ago, clinical stage biotech company Inventiva Pharma (IVA:FR-Paris; IVA:NASDAQ) announced that it had initiated its much-anticipated pivotal Phase 3 study of Lanifibranor (pan-PPAR) in nonalcoholic steatohepatitis (NASH).

The analyst commented that the new Phase 3 NATIVE3 study was supported by the stellar results from the 24-week Phase 2b NATIVE trial of Lanifibranor which met both NASH resolution and fibrosis improvement endpoints and served to greatly differentiate Lanifibranor from other similar drug candidates put forth by competitors. Lanifibranor is believed to offer potential broad benefits in NASH treatment including additional cardiovascular benefits that will be investigated further.

ROTH Capital Partners remains very optimistic and bullish on Inventiva's Lanifibranor program addressing NASH and points out to investors that additional data is expected to come forth in H1/22 from its clinical trials in patients with non-alcoholic fatty liver disease (NAFLD) and Type 2 diabetes (T2DM).

The analyst noted that the Phase 3 NATIVE3 trial evaluating Lanifibranor in NASH has been initiated and that enrollment of the first patients in the study is expected to begin this quarter.

The Phase 3 NATIVE3 is a randomized double-blind study designed to evaluate Lani 800 mg QD and 1200 mg QD versus placebo in F2 (moderate fibrosis) and F3 (advanced fibrosis) patients with NASH. Inventiva plans to enroll 900 participants in Part 1 of the NATIVE3 trial. The company expects "first patient, first visit this quarter and last patient, first visit in H2/22."

The report mentioned that the study has already been signed-off by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The studies primary composite endpoint has been pre-established as "NASH resolution and fibrosis (1-stage) improvement in patients with NASH at 72-weeks."

The analyst remarked that ROTH Capital believes that it expects Inventiva to be able to readily meet both endpoints which would provide a solid path forward for accelerated approval in the U.S. and conditional approval in the EU.

Inventiva is a clinical stage biotech firm that is currently engaged in creating oral small molecule therapies for diseases with unmet medical needs. The company is headquartered in France and is presently focused largely on advancing its primary lead clinical program, Lanifibranor in NASH, along with other medicines in its early-stage pipeline.

Lanifibranor was described in the report as a pan-PPAR agonist that is presently being studied in treatment of NASH patients and in diabetic patients with NAFLD. The firm is also currently conducting clinical programs addressing mucopolysaccharidosis and moderate to severe psoriasis.

ROTH Capital Partners advised that it has a "Buy" rating on Inventiva S.A. with a 12-month price target of €55/share. The firm said the target price was derived by employing discounted cash flow, net present value and sum of the parts valuation metrics to arrive at a value of €48 for Lanifibranor, €2 for Cedirogant, €2 for Odiparcil and €3 for net cash held.

The company's shares trade in France on the Paris Stock Exchange under the symbol "IVA" and last closed for trading at €11.32 on Tuesday, September 14, 2021. The firm's ADR shares also trade in the U.S. on the Nasdaq market under the same ticker symbol.

[NLINSERT]

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his 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: Note. 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) This 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 decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.  

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from ROTH Capital Partners, Inventiva S.A/ADR, Sep. 10, 2021

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 viewsabout 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 Inventiva S.A./ADR and Madrigal Pharmaceuticals and as such, buys and sells from customers on a principal basis.

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. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used
as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors.




Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe