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)
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)
Acadia (ACAD) – Yesterday after the close ACAD announced that it plans to resubmit its supplemental New Drug Application (sNDA) to the FDA for pimavanserin for the treatment of hallucinations and delusions associated with dementia. Read more…
BIOINVEST BREAKING NEWS – Precigen held a virtual R&D presentation yesterday, updating data on five clinical trials from the novel Ultra-CAR-T and AdenoVerse platforms. The company has delivered objective responses in late-stage, refractory cancer patients (AML, ovarian, HPV-positive tumors) utilizing their Ultra-CAR-T system plus which offer the fastest (overnight vs. 4-6 weeks) low-cost CAR-T therapies around. (…more)
Madrigal (MDGL) — MDGL held a two hour conference call after all presentations at EASL to discuss the outstanding resmetirom data presented at yesterday. The Company focused on the 969-patient MAESTRO-NAFLD-1 safety study which showed the compound to have an excellent safety profile along with excellent efficacy. (…more)
Bicycle (BCYC) —We Are Buyers On AACR Weakness. BCYC shares are weak today after presenting updated data on BT8009, a lead BTC clinical compound, at the AACR conference over the weekend. Our investment thesis remains intact. (…more)
(ESPR) BioInvest News — ESPR Raises Cash To Get To CLEAR Outcomes Trial Data in Q12023, Lowering our BUY and our TARGET PRICE. ESPR shares were off 40% after they announced the closing of a $208.8 million of common stock and warrants. (More)
BioInvest News – SGMO’s PhaseI/II Fabry Disease Data Looks Great – In it’s quarterly update, SGMO delivered news across multiple clinical programs today with the stock reacting positively to the excellent Fabry disease data. (…more)
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…
Madrigal (MDGL) — One of the few broadly positive binary events in biotechnology of late, Madrigal’s best-in-class NASH compound is well on its way with de-risked, late-stage clinical results. With this wholly-owned compound heading to blockbuster status, MDGL remains a Top Pick for 2022. (…more)
Alkermes (ALKS) — ALKS was blindsided by JNJ after the close yesterday received notices of partial early termination for two license agreements with Janssen Pharmaceutica N.V., a subsidiary of JNJ. These license agreements are for Alkermes’ nanoparticulate formulation technology, known as NanoCrystal® technology. (…more)
BIOINVEST BREAKING NEWS – Celldex (CLDX) Delivers Outstanding Phase 1b Data, 19 of 20 Urticarial Patients Demonstrate Complete Response After Single Dose of CDX-0159, Raising BUY to 47 (from 30) and TARGET to 70 (from 40), Best in Class and a Pipeline in a Pill? (…more)
