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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Madrigal

Madrigal (MDGL) & Viking Therapeutics (VKTX) – LLY’s Phase II MASH Data Puts Pressure on MDGL (March 14 PDUFA) & VKTX (Q1 Phase I Oral Data)

BIOINVEST BREAKING NEWS – Viking (VKTX) Viking Therapeutics (VKTX) – LLY’s Phase II MASH Data Puts Pressure on MDGL (March 14 PDUFA) & VKTX (Q1 Phase I Oral Data), Both Still BUYS With Upcoming Catalysts (…more)

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Celldex (CLDX) — Dupixent Receives CRL in CSU – BUY

BIOINVEST BREAKING NEWS – Celldex (CLDX) After the close on Friday, Regeneron and Sanofi announced that the FDA issued a Complete Response Letter (CRL) for Dupixent (“Dupi”) in chronic spontaneous urticaria (CSU). With an expected 2-year delay (or more), this is a major setback for Dupi. And hence, we believe it (…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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Viking Therapeutics (VKTX) – Significantly Undervalued After Roche Pays $2.7 Billion For Competitor

BIOINVEST BREAKING NEWS – Viking (VKTX) Viking Therapeutics (VKTX) – Significantly Undervalued After Roche Pays $2.7 Billion For Competitor, Phase I ‘2735 Oral Proof-of-Concept Data in Q1 2024. (…more)

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Precigen

Precigen (PGEN) — FDA Says PGEN’s 2012 Phase I/II Will Serve as Pivotal, Data in Q224, FDA Also Grants Breakthrough Therapy Designation

BIOINVEST BREAKING NEWS – PGEN received very good FDA news when the agency recently confirmed that the ongoing Phase I/II single arm trial of PRGN-2012 in RRP will serve as the pivotal study to support accelerated approval and no additional randomized, placebo-controlled trial will be required to support submission of a BLA. (…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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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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Celldex (CLDX) — CSU Events Further Solidify Barzo As Best-In-Class – BUY

BIOINVEST BREAKING NEWS – Celldex (CLDX) Underwhelming details of NVS remibrutinib (‘REMI’) Phase III trial in chronic spontaneous urticaria (‘CSU’) were released at a major medical meeting last week. Combining that negative event with two more disappointing regulatory/clinical events – the REGN/SNY’s receipt of a CRL of Dupixent and the failure of AMGN/AZN’s tezepelumab – potential competition for Celldex’s barzolvolimab (‘barzo’) is falling by the wayside. (…more)

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Thorne HealthTech (THRN) — New Recommendation

NEW RECOMMENDATION – We are initiating coverage on Thorne HealthTech (NASDAQ – THRN). For many reasons we believe Thorne is akin to the “Apple” of the nutritional supplement business. (…more)

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