Category: Company Updates

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Madrigal

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)

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Alaunos (TCRT) — Alaunos Therapeutics (TCRT) – Blog Update: Patient #2 on TCR-T Library Therapy Stops Treatment

BIOINVEST BREAKING NEWS – TCRT’s stock is down on heavy volume as a blog post from the husband of treated Patient #2 reported that she has stopped therapy due to a mutation. While social media post are not company press releases, (…more)

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Myovant

Myovant (MYOV) — Myovant Accepts $27 From Sumitovant – Downgrade To Hold

BIOINVEST BREAKING NEWS – Last night, MTSL Recommendation MYOV announced that its board has accepted a $2.9 billion (fully-diluted) takeover offer from Sumitovant Biopharma for $27 per share. While we believed that the original $22.50 offer was way too low, the final price does represent (…more)

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Acadia

Acadia (ACAD) — FDA Advisory Committee Rejects ACAD’s Pimavanserin for Alzheimer’s Disease Psychosis (ADP) 9-3

Acadia (ACAD) – ACAD received bad news when an FDA AdCom voted 9-3 against recommending pimavanserin for Alzheimer’s disease psychosis (ADP). This is disappointing and significantly lowers the probability of the FDA approving pimavanserin for this new indication on the 8/4/22 PDUFA. Read more…

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Esperion Theapeutics

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)

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Myovant

Myovant (MYOV) — FDA Delays MYOV/Pfizer Approval for Endometriosis on Labeling/Post-marketing Requirements

BIOINVEST BREAKING NEWS – FDA Delays MYOV/Pfizer Approval for Endometriosis on Labeling. MYOV and their partner Pfizer announced today a delay on the Supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. In our view, this is clearly a delay and not a rejection. (…more)

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