Tag Archives: XERS

Xeris Glucagon Filing Accepted by FDA; June 10, 2019 PDUFA

Xeris Pharmaceuticals announced FDA has accepted the NDA filing for its stable glucagon with a PDUFA date on Monday, June 10, 2019, the Monday of ADA. This confirms FENIX’s previous belief that Xeris’s stable glucagon would have a 10-month review period. Below, FENIX provides thoughts on Xeris’s later-than-anticipated regulatory submission and impending market dynamics in the glucagon rescue market.

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Zealand Initiates Ph3 Dasiglucagon Pediatric Hypoglycemia Study

Zealand announced it has initiated a Ph3 pediatric dasiglucagon hypoglycemia study, which is consistent with timing previously provided by Zealand (September 2018). Recall, Zealand recently released positive topline results for its Ph3 pivotal study in adults. Below, FENIX provides an overview the of pediatric dasiglucagon study as well as thoughts on the pediatric glucagon rescue market.

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Xeris Q2 ’18 10-Q Filing Highlights

Xeris Pharmaceuticals filed its first 10-Q statement since its IPO in June 2018. In the 10-Q, Xeris confirmed filing of its Glucagon Rescue Pen in Q3 ‘18 via the 505(b)(2) pathway. Yesterday, Xeris released its Q2 ’18 earnings but did not have an associated earnings webcast.

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Xeris Glucagon Filed; Q2 ’18 Earnings

Xeris Pharmaceuticals released its Q2 ’18 earnings and disclosed the NDA submission for its Glucagon Rescue Pen. While Xeris did not specify the filing date, it is assumed to have occurred in July or August in accordance with timing from the company’s S-1 document.

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Glucagon: New Xeris Market Survey Detailed in Investor PPT

Today at 4:30pm ET, Xeris has an investor presentation at the Canaccord Genuity investor conference. In advance of today’s presentation, Xeris posted slides late yesterday from a new August 2018 investor presentation in an SEC filing. The slides disclose the results of a 2018 Xeris-sponsored IPSOS market research study that details what the market’s unmet need is for novel glucagon rescue for severe hypoglycemia. Below, FENIX highlights some of the key results from the IPSOS study, including a slide on novel glucagon competitors that may raise worries about intranasal delivery.

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Glucagon: Thoughts on Mylan Generic and Novel Launch Timings

The glucagon market for severe hypoglycemia rescue will be evolving in the near future with the anticipated filings of new ready-to-use products from Lilly and Xeris. However, the upcoming Mylan rescue product announced a few months ago will play a significant role in the rescue market ahead of the novel product launches. Below, FENIX provides a rich analysis on the potential timing of the upcoming glucagon rescue entrants from Lilly and Xeris, including also what Mylan’s product may or may not be.

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Xeris files for $75M IPO

Xeris Pharmaceuticals has filed with the SEC for a $75M IPO under the ticker XERS. Of note, the S1 IPO registration document states FDA filing of G-Pen is anticipated in Q3 ’18, which is later than previously stated by Xeris (late Q2 ’18).

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Xeris completes Ph3 for stable glucagon

Xeris Pharmaceuticals has announced the completion of two Ph3 clinical trials (adults and pediatrics) and one human factors study for its stable glucagon (no reconstitution required). According to the press release, the company anticipates to submit an NDA filing by the end of Q2 ’18.

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