Category: Company Updates

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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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Sorting Through The Rubble

BIOINVEST SPECIAL UPDATE – Biotechs were under pressure this week as the sudden failure of SVB and drug pricing concerns delivered a double whammy in a continued rising rate environment. In our view, while all biotech stocks are being sold indiscriminately, we believe (…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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Viking (VKTX) — VKTX Delivers Excellent Phase IIb VOYAGER Data in NASH

BIOINVEST BREAKING NEWS – Viking (VKTX) delivered the goods this morning when they announced positive top-line results from its Phase IIb VOYAGER clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). (…more)

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Esperion Theapeutics

Esperion (ESPR) — CLEAR Outcomes Reads Very Positive at ACC & Published in NEJM Editorial – Similar To PCSK9 Outcome Study, Doctors Will Prescribe It & Insurance Will Pay For It – BUY

(ESPR) BioInvest News — The full results from the Cholesterol Lowering via Bempedoic acid (BA), an ACL-Inhibiting Regimen (CLEAR) Outcomes trial – were presented at the American College of Cardiology (ACC) Annual meeting on Saturday by Dr. Steve Nissen (the king of CV drug trials) and simultaneously published in the New England Journal of Medicine. (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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Celldex (CLDX) — Mix-Up At AAD Causes Undue Sell Off; EoE Trial Posted, Begins In May

BIOINVEST BREAKING NEWS – Celldex (CLDX) Celldex shares have been on a downward spiral since the exceptional durability data was presented at the AAAAI meeting in late February; the details are a bit lengthy but we remain steadfast that barzolvolimab (“barzo”) is the best-in-class and exceptionally unique mast cell inhibitor around. (…more)

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