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)
Category: Company Updates
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)
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)
Celldex (CLDX) — Urticaria Competitor Third Harmonic Discontinues Drug – BUY
BIOINVEST BREAKING NEWS – Celldex (CLDX) Urticaria Competitor Third Harmonic Discontinues Drug – BUY – After identifying troublesome liver enzyme elevations in patients in its lead program, newly public Third Harmonic (THRD) announced they are discontinuing development of the compound in urticaria. (…more)
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)
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)
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)
Esperion (ESPR) — ESPR Delivers Positive CLEAR CVOT/Full Data at ACC March
(ESPR) BioInvest News — ESPR has delivered positive top-line data (at least 15% improvement in MACE-4) from their Phase IV Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial. The trial met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg/day NEXLETOL compared to placebo. (More)
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)
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)
Madrigal (MDGL) — MAESTRO-NASH Takes a BOW!
Madrigal (MDGL) — Breaking News: MDGL has pitched a “perfect game” with their pristine MAESTRO-NASH Phase III trial hitting both primary, FDA agreed upon endpoints. The FDA had agreed that even hitting one primary endpoint would lead to approval. (…more)
Esperion (ESPR) — R&D Event Emphasizes Likelihood of CLEAR to Unlock NEXLETOL/NEXLIZET Potential in LDL Space – BUY
(ESPR) BioInvest News — ESPR held an investor R&D event today and did a very solid job of detailing why the upcoming 14,000 patient global cardiovascular outcomes trial (CVOT), CLEAR, is highly likely to deliver a positive result by reducing major adverse cardio events (MACE) by at least 15%. (More)