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Friday, July 19, 2019

Premarket analyst actions: Blueprint, Millendo, HealthEquity

Blueprint Medicines (NASDAQ:BPMC) initiated with Outperform rating and $120 (22% upside) price target at Baird.
Millendo Therapeutics (NASDAQ:MLND) initiated with Outperform rating and $24 (125% upside) price target at Wedbush.
HealthEquity (NASDAQ:HQY) upgraded to Buy at BofA/Merrill Lynch. Shares up 1% premarket.

Dova launches new indication for Doptelet in U.S.

Dova Pharmaceuticals (NASDAQ:DOVAannounces the commercial availability of DOPTELET (avatrombopag) for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia who have failed to adequately respond to previous therapy.
The FDA approved the expanded use last month.

Amgen, Allergan announce availability of two biosimilars in U.S.

Amgen (NASDAQ:AMGN) and collaboration partner Allergan (NYSE:AGNannounce the commercial availability of MVASI (bevacizumab-awwb), a biosimilar to Roche’s (OTCQX:RHHBY) Avastin, and KANJINTI (trastuzumab-anns), a biosimilar to Herceptin, in the U.S.
The Wholesale Acquisition Cost (WAC) for both will be 15% lower than the reference products. Specifically, MVASI will be priced at $677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial. KANJINTI will be priced at $3,697.26 per 420 mg multi-dose vial.
At launch, MVASI is priced 12% below Avastin’s Average Selling Price (ASP) while KANJINTI is 13% below Herceptin’s ASP.
The WAC does not reflect discounts or rebates.

Thursday, July 18, 2019

Huami set to launch ECG watches outside China


Huami set to launch ECG watches outside China
Huami is to make its new crop of electrocardiogram smartwatches available to international markets, according to a press report.
According to gadgetsandwearables.com most of Amazfit’s smartwatches are currently only available in China.
The move could mean further competition for Apple, Alphabet and Withings, who are already producing watches fitted with electrocardiogram sensors.
The website said that Huami has filed a raft of products with Bluetooth Special Interest Group, arbiter of standards and development of Bluetooth-based technologies.
Huami has already launched several devices in recent months, including the Amazfit Bip Lite, Amazfit Verge Lite, Amazfit Health Watch and the Amazfit Smart Watch 2.
All of these are now certified for launch, including ECG and non-ECG variants of the Amazfit Smartwatch 2.
It’s the Amazfit watch that could be of interest to its rivals – it is designed for health monitoring rather than sport.
In January Alphabet’s life science subsidiary became the latest firm to get an ECG watch approved by the FDA, as different manufacturers attempt to gain market share by boosting the credibility of their products.
Huami’s watches fitted with a heart rate sensor can spot low heart rate, arrhythmia and atrial fibrillation at any time. There is also fall detection thanks to a six-axis accelerometer.
The Amazfit Smart Watch 2 also has health alerts and ECG monitoring capability, and is capable of working independently of a smartphone – although this feature may be reserved for users in China.
Withings is also launching new digital health products as part of a relaunch following its ill-fated merger with Nokia.
The company is describing its BPM Core blood pressure monitor as the “world’s most advanced at-home cardiovascular monitor”.
BPM Core readings can warn users about irregular heart rhythms such as atrial fibrillation and can measure and record stethoscope readings.
The BPM Core is compatible with Apple technology, but Withings has also launched BPM Connect, a blood pressure monitor allowing connectivity without the need for an iPhone nearby.

Denmark’s Genmab raises a bumper $500m-plus in Nasdaq IPO

Genmab has shattered recent records with its Nasdaq listing, raising $506 million to help it advance multiple antibody projects, including in-house candidates.
The company, notable for its collaboration with Johnson & Johnson that yielded blockbuster multiple myeloma therapy Darzalex (daratumumab), is already listed on the Copenhagen stock exchange.
Like other, larger European biotechs it hopes a dual listing will help it to unlock access to US investors, and give it the resources to launch its own products.
Aside from Darzalex, Genmab has also developed Arzerra (ofatumumab) with Novartis for chronic lymphocytic leukaemia, and also has partnerships with Amgen, Bristol-Myers Squibb, ADC Therapeutics, Seattle Genetics and Immatics at various stages of development. It has been working on a follow-up to Darzalex for which J&J recently took up an option.
Around $100 million of the proceeds from the transaction is earmarked to being Seattle Genetics-partnered antibody-drug conjugate (ADC) tisotumab vedotin – currently in mid-stage trials as a treatment for advanced cervical cancer – through late-stage clinical development and to the market, according to the initial public offering (IPO) prospectus.
Tisotumab vedotin targets tissue factor (TF), a protein involved in malignant cell signalling and the growth of blood vessels that feed tumours.
Phase 2 results reported earlier this year showed a 35% response rate as well as a progression-free survival (PFS) of 4.1 months in patients with metastatic or recurrent cervical cancer, results that the investigators said compare favourably to Merck & Co/MSD’s checkpoint inhibitor Keytruda (pembrolizumab) in this population.
Another $275 million will go towards earlier-stage clinical and preclinical programmes, including wholly-owned ADC enapotamab vedotin which it is developing for various solid tumours in early- to mid-stage trials.
Two other in-house oncology drugs are in line for a slice of the new funding – namely an antibody called HexaBody-DR5/DR5 for solid tumours and a bispecific antibody for B-cell malignancies called DuoBody-CD3xCD20 – which are both in phase 1/2 testing.
Some will also go towards an­oth­er bis­pe­cif­ic an­ti­body – Duo­Body-PD-L1x4-1BB – which is being developed alongside BioN­Tech as a cancer immunotherapy and preclinical-stage candidates DuoBody-CD40x4-1BB and DuoHexaBody-CD37.
There have been two other IPOs on the Nasdaq this week as well. Mirum Pharmaceuticals raised $75 million to help fund development of its cholestatic liver disease drugs headed by former Shire drug maralixibat, in a phase 3 trial for progressive familial intrahepatic cholestasis (PFIC).
Meanwhile, Fulcrum Therapeutics raised $72 million for its rare genetic disease candidates, based on a technology that allows genes to be switched on or off. Fulcrum’s lead compound, losmapimod, will shortly start a phase 2b trial in facioscapulohumeral muscular dystrophy (FSHD). It was originally developed by GlaxoSmithKline.

Intuitive Surgical (ISRG) Sees 16%-17% Procedure Growth in 2019

– Bloomberg

Phreesia (PHR) IPO Opens 49% Higher

Today’s IPO for Phreesia, Inc. (NYSE: PHR) opened for trading at $26.75 after pricing its initial public offering