Category: Company Updates

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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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Celldex (CLDX) — Barzo Follow Up at AAAAI Is Exceptional

BIOINVEST BREAKING NEWS – Celldex (CLDX) The full Phase 1b trial of barzolimab in chronic spontaneous urticaria (CSU) was presented yesterday and continues to support its potential as the best-in-class treatment for urticaria. (…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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Bicycle Therapeutics (BCYC) — BCYC’s BT8009 Delivers Positive Phase I Data at ASCO GI

Bicycle (BCYC) — BCYC announced positive BT8009 Phase I data today in heavily pre-treated cancer patients at ASCO GI. In our view, the strong data point out the potential for BT8009 to become a best in class drug and a significant differentiated treatment option for cancer patients. (…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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Precigen

Precigen (PGEN) — Precigen (PGEN-2012 Shows Strong/Complete Response in 50% of RRP Patients, Raises $75 Million at Large Discount

BIOINVEST BREAKING NEWS – Precigen announced the sale of a wholly-owned non-healthcare subsidiary, Trans Ova Genetics, L.C. (“Trans Ova”) for $170 million. The proceeds will go towards retiring roughly $200 million in convertible debt due in 2023. (…more)

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