Category: Company Updates

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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)

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Zynerba Pharmaceuticals

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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Nektar

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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Vaxart

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

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)

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Nektar

Nektar (NKTR) — NKTR & BMY Announce Two New Phase III Trials

BIOINVEST BREAKING NEWS – Nektar (NKTR) and partner BMY announced today that the companies have agreed to a new joint development plan to further the advancement of bempegaldesleukin (bempeg/NKTR-214) plus Opdivo (nivolumab) into two new Phase III/registrational trials, bringing the total to five being tested.  In our view, BMS’ renewed (and public) commitment to the bempeg/Opdivo combo has further de-risked the largely out-of-favor NKTR stock. (…more)

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Nektar

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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Sangamo Therapeutics

Sangamo (SGMO) — Data Updates Due For Hem A & Beta – Thal At ASH – BUY

BIOINVEST BREAKING NEWS – Sangamo (SGMO) will have a very busy December, with two clinical data updates coming at the American Society for Hematology (ASH, https://www.hematology.org/Annual-Meeting/). We remain steadfast that SGMO will emerge as the leader in gene therapy for hemophilia A with SB-525. (…more)

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