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…
Special Update: Vaxart (VXRT) – VXRT has delivered two very good pieces of news – the Company has enrolled its first patient in the COVID vaccine study and also released uniformly positive hamster challenge data. Despite this good fundamental news, the stock has been under pressure from short sellers since then based on an SEC filing of a self offering filed on the same day as the clinical/pre-clinical updates. Read more…
BioInvest News – BMRN/SGMO – Surprise Roctavian CRL – Bad For BioMarin, Good For SGMO – This morning, the FDA issued a surprise Complete Response Letter for BioMarin’s Roctavian, its lead hemophilia A gene therapy program. (…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…
Special Update: Vaxart (VXRT) – Following up on key features and still questions on the exceptional >90% efficacy in the first Phase II/III trial of their mRNA COVID vaccine from Pfizer/BNTX. BUY VXRT here as Rick Bright is back (see below). Read more…
BIOINVEST BREAKING NEWS – In late Breaking News, ALKS announced overwhelming and surprising positive votes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The FDA committees met to discuss ALKS 3831 (olanzapine/samidorphan), a novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with both schizophrenia and with bipolar I disorder.
BioInvest News – BMRN/SGMO – Surprise Roctavian CRL – Bad For BioMarin, Good For SGMO – This morning, the FDA issued a surprise Complete Response Letter for BioMarin’s Roctavian, its lead hemophilia A gene therapy program. (…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)
(ESPR) BioInvest News — Esperion reported financials ($3 million in net sales) after the close yesterday and the stock is under pressure today as the Company continues to struggle with the new drug launch during the COVID-19 crisis.
BIOINVEST BREAKING NEWS – MYOV announced results of an additional secondary endpoint from the Phase III HERO study evaluating relugolix in men with advanced prostate cancer. Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks. (…more)
BIOINVEST NEW RECOMMENDATION – Celldex (CLDX) We are initiating coverage of Celldex Therapeutics (CLDX, $12) with a BUY under $15 and a $30 TARGET PRICE. In our view, CDX-0159, the Company’s anti-C-KIT antibody has blockbuster potential in various mast cell diseases. With a market cap of ~$375 million with ~$200 million in cash, in our view, CLDX is extremely undervalued based on the potential of CDX—0159 alone. (…more)
