Category: Company Updates

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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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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) — 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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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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Madrigal

Madrigal (MDGL) — MDGL/VKTX Strong BUYs After Overreaction to Lilly Phase II Data

Madrigal (MDGL) / Viking (VKTX) are both strong BUYS after the overreaction to Lilly’s Phase II, 337 patients, data that showed a 24% weight loss at 48 weeks in the high dose from their new triple drug combo.Madrigal (MDGL) / Viking (VKTX) Strong BUYs After Overreaction to Lilly Phase II Data  (…more)

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