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)
Special Update: Five Prime (FPRX) – This morning, FPRX announced that it is being bought by Amgen for $38 per share (~80% premium to yesterday’s closing price), representing an equity value of approximately $1.9 billion. 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)
BIOINVEST BREAKING NEWS – This morning NKTR announced that it has signed two deals to advance BEMPEG combos – one with Merck and the other with SFJ. The first is a Phase II/III trial of BEMPEG in combination with Merck’s KEYTRUDA for first-line treatment of patients with metastatic or un-resectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). (…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)
Special Update: Acadia (ACAD) – In another FDA surprise, after the close, the Agency notified ACAD that it has identified deficiencies in the dementia related psychosis (DRP) sNDA for pimavanserin that preclude discussion of labeling and post-marketing requirements. Read more…
Special Update: Five Prime (FPRX) – FPRX announced excellent topline results from the global, randomized, double-blind placebo-controlled Phase II FIGHT trial. Read more…
