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)
Category: Company Updates
Vaxart (VXRT) — Negating The Egregious NY Times Article
Special Update: Vaxart (VXRT) – Negating The Egregious NY Times Article – While we rarely rebut a short report or bear raid on one of our recommendations, the The NY Times published one of the more egregious “investigative” reports we have ever seen. Read more…
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MTSL Companies Deliver The Goods In Mid-Issue Update
BIOINVEST BREAKING NEWS – In light of the historic, market selloff due to the coronavirus, we thought it was important to update subscribers with a brief summary of the highlights of our recommended stocks during this period of stock corrections unrelated to Company fundamentals. In sum, many of our companies have delivered the positive value creating news that we predicted (…more)
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Myovant (MYOV) — Relugolix Uterine Fibroids Data Highly Competitive
BIOINVEST BREAKING NEWS – A very positive long-term follow-up (88% response rate) from the LIBERTY trial was released yesterday and we believe continues to further solidify relugolix in uterine fibroids (UF). Management will file for an NDA for the use of relugolix+ABT in UF in April (plus a separate filing for the treatment of relugoxi in prostate cancer in Q2:20). For relugolix in endometriosis, we expect MYOV to (…more)
Sangamo (SGMO) — (BMRN/SGMO) Surprise Roctavian CRL – Bad For BioMarin, Good For SGMO
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)
Vaxart (VXRT) — VXRT’s Oral Vaccine for COVID-19 Poised to Enter Human Testing
BIOINVEST BREAKING NEWS – Special Update — NEW RECOMMENDATION: Vaxart (VXRT) – VXRT’s Oral Vaccine for COVID-19 Poised to Enter Human Testing. Read more…
Sangamo (SGMO) — BIIB Steps Up Big With Global Neuro Gene Editing Deal
BIOINVEST BREAKING NEWS – After the close, Sangamo announced a worldwide deal with Biogen for gene regulation therapies in neurology. BIIB is the global leader in developing neuro biologics with the top drugs in multiple sclerosis and an extremely deep Alzheimer’s/ALS R&D pipeline, in our view there is no better partner available than BIIB. (…more)
Nektar (NKTR) — FDA Rejects NKTR’s Oxycodegol 27-0
BIOINVEST BREAKING NEWS – The FDA rejected NKTR’s Oxycodegol (NKTR-181) by a vote of 27-0 at yesterday’s AdCom meeting. As a result of the negative vote the Company will withdraw the NDA for oxycodegol and make no further investment into the program. We listened to the majority of yesterday’s meeting which was mostly (…more)
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Celldex (CLDX) — CDX-0159 – The Mast Cell Warrior (New Recommendation)
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)
Zynerba (ZYNE) — Zygel Topline Results Fall Short of Statistical Significance, 80% of Patients With FMR1 Gene Had Positive Affect
BIOINVEST BREAKING NEWS – Special Update – #ZYNERBA – ZYNE’s stock is down significantly this morning after reporting disappointing top line results from the 14-week pivotal CONNECT-FX (Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X) trial. more…
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Esperion (ESPR) — FDA Approves of NEXLETOL (bempedoic acid)
(ESPR) BioInvest News — FDA approves of NEXLETOL (bempedoic acid)— the first new non-statin once daily LDL-cholesterol lowering medicine in 20 year. With a very seasoned management team that is extremely well-prepared for the imminent launch, on the positive news we reiterate our BUY rating.
Nektar (NKTR) — FDA Panel Will Vote on Oxycodegol (NKTR-181)
BIOINVEST BREAKING NEWS – On January 14-16, there is a Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. After a close review of the FDA briefing documents, the panel will vote on three options for the approval of NKTR-181 on Tuesday (1/14). The choices are for a narrow approval, a broad approval and a recommendation against approval. In our view, the fact that NKTR (…more)
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