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

Biopharmaceutical Firm Receives FDA Priority Review and PDUFA Date

Source: Streetwise Reports


October 25, 2017 ( Newswire) Neil Maruoka, an analyst with Canaccord Genuity, provided an update on this biotech's progress through the regulatory approval process for one of its therapeutics.

An Oct. 13 research note indicated the U.S. Food and Drug Administration (FDA) accepted ProMetic Life Sciences Inc.'s (PLI:TSX) biologics license application for Ryplazim (plasminogen) and set a PDUFA date of April 14, 2018.

"We view this to be an important milestone for the company (removing a significant overhang for the stock), as it provides certainty in a process that has been anything but," noted Neil Maruoka, an analyst with Canaccord Genuity. "With an FDA decision date now in hand, we believe that ProMetic now has a clearer pathway to a potential approval of its first major therapeutic."

Maruoka expressed optimism regarding ProMetic's biologic. "We believe the drug could address an unmet clinical need, and we see a strong likelihood that Ryplazim will be approved next year, providing a significant potential catalyst for the stock." In its favor are "strong clinical data, orphan drug status, an accelerated approval pathway and a rare pediatric disease designation."

The FDA also afforded ProMetric "a priority review (and an 'official' six-month review period), and we believe the company is therefore eligible to receive a priority review voucher (PRV) if Ryplazim is approved," Maruoka wrote. "We believe this would be a valuable asset for ProMetic." Such a voucher decreases the review period for a drug to six months from ten. It is "transferable, and PRVs have been sold in the past for over $100M."

In the research report, Maruoka identified cash burn as "the key risk for ProMetic," which he would like to see reduced ahead of the FDA ruling next year.

Along with the anticipated FDA approval of Ryplazim, other short-term catalysts for the company are "more data from PBI-4050" and "the initiation of clinical studies for PBI-4050 in idiopathic pulmonary fibrosis and diabetic kidney disease," the analyst noted.

On ProMetic, Canaccord Genuity has a CA$4.25 per share price target, which, Maruoka explained, "implies a 172% annualized return and continues to support our Buy recommendation." The biotech's stock is currently trading at around CA$1.59 per share.


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 company mentioned in this article is a sponsor of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.

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 one week after the publication of the interview or article. - A Leading Global Investor Website for Biotech Industry Stocks - 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: Newswire

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

Disclaimer/Disclosure: 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: Learn more about publishing your news release on the newswire

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: Global investors must adhere to regulations of each country.

Please read privacy policy: