Category: Company Updates

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Celldex (CLDX) — Barzo 52-Week Data Delivers In A Big Way

BIOINVEST BREAKING NEWS – Celldex (CLDX) — Celldex reported the eagerly-awaited 52-week data for barzolvolimab (c-KIT antibody) in chronic spontaneous urticaria (CSU) as a late-breaker at EADV occurring in Amsterdam. We believe the data is overwhelming positive, continue to paint the best-in-class compound in urticaria and below address reasons for the stock weakness. (…more)

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Viking Therapeutics (VKTX) – VK2735 subQ Moving into Phase III & Oral Phase II by Year End As VK2735 Continues Emergence as Best-in-Class GLP

BIOINVEST BREAKING NEWS – Viking (VKTX) held an excellent Q2:24 call with important positive clinical and regulatory updates for both VK2735 subQ and oral. BUY. (…more)

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Viking Therapeutics (VKTX) – VKTX Down on Positive VK2809 NASH Data

BIOINVEST BREAKING NEWS – Viking Therapeutics (VKTX) – VKTX is trading down after the release of positive 52 week histology data for VK2809 in NASH. In our view, overall investor concerns around timing and likelihood of partnerships for VKTX in the large Obesity and NASH markets are driving the stock down with today’s move a “sell the news” event. (…more)

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Skye (SKYE) — Novo’s Mixed Monlunabant Data Good For SKYE, Despite Selloff

BIOINVEST BREAKING NEWS – Skye (SKYE) This morning Novo Nordisk announced mixed data for their CB1 receptor inverse agonist, monlunabant with solid weight loss but questionable neuropsychiatric side effects. The data showed that after 16 weeks of treatment, patients with a baseline bodyweight of 110.1 kg lost a mean of 7.1 kg after treatment with 10 mg doses of monlunabant. (…more)

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Celldex (CLDX) — The Barzo Phase III Trial To Start Imminently; CindU Data Soon, Too, Then 52-Weeks – BUY

BIOINVEST BREAKING NEWS – Celldex (CLDX) Based upon the timing of the posting of the Phase III CSU trials, we expect Celldex will announce the first patient treated in the study will happen any day. In addition, the Phased II CindU data is also highly likely to be released this month, then the key 52-week Phase II CSU results will also happen sometime this summer/early fall. (…more)

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Precigen

Precigen (PGEN) — PGEN Delivers Excellent PRGN-2012 RRP Data at ASCO (51% CRs)

BIOINVEST BREAKING NEWS – PGEN delivered excellent data for ‘2012 at ASCO yesterday and is now poised to file for FDA approval. The Company reported positive Phase 1/2 pivotal study results for the investigational PRGN-2012 off-the-shelf (OTS) AdenoVerse gene therapy in patients with recurrent respiratory papillomatosis (RRP) in a Late-Breaking oral presentation at ASCO. (…more)

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Celldex (CLDX) – CLDX Reports Strong Phase II CIndU Data for Barzo – BUY

BIOINVEST BREAKING NEWS – Celldex (CLDX) — CLDX released positive topline results from the Company’s 196-patient Phase II clinical trial of barzolvolimab in the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). (…more)

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Vaxart

Vaxart (VXRT) — Vaxart’s Oral Vaccine Platform Validated By $453 Million BARDA Contract For Oral COVID, Phase IIb Will Start This Summer, Data in Q1 2025

Special Update: Vaxart (VXRT) – Right at press time VXRT delivered great news after the close when they announced that it received a project award valued at up to $453 million through the Rapid Response Partnership Vehicle (RRPV). Read more…

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Celldex (CLDX) — FDA Approval Of Xolair For Food Allergies Bodes Well For Barzolvolimab

BIOINVEST BREAKING NEWS – On Friday, the FDA approved Roche/Genentech’s Xolair as the first treatment to help reduce severe allergic reactions brought on by accidental exposure to certain foods. (…more)

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