Premarket Biotech Digest – $SHPG reports positive results, $TEVA inks an agreement, $NVS files BLA

By |September 12th, 2017|Digest|

CymaBay Therapeutics ($CBAY) announced the grant of Orphan Drug Status to its seladelpar by the European Medicines Agency's Committee for Orphan Medicinal Products. The designation has been granted to seladelpar drug for the treatment of primary biliary cholangitis, a liver disease. The orphan drug [...]

Gilead shows strong prospects in Oncology segment with Kite acquisition $GILD

By |September 7th, 2017|Monthly Investment Ideas|

  Gilead Sciences Inc. ($GILD) recently announced its acquisition of Kite Pharma, giving a major boost to its stock price in the market. The acquisition is important as the merger will allow Gilead to boost its position in oncology segment. It will also fortify the company’s drug pipeline. The company [...]

Premarket Biotech Digest – $INSM reports positive data, $MRK gets EC approval, $LCI receives FDA approval

By |September 5th, 2017|Digest|

Oramed Pharmaceuticals ($ORMP) reported the successful conclusion of its meeting with the FDA with regard to its drug candidate ORMD-0801. The company reported that the FDA gave clear guidance that the regulatory pathway for submission of ORMD-0801 will be a Biologics License Application. This [...]

Premarket Biotech Digest – $IMDZ reports data, $DXTR announced 510(k) clearance, $JNJ terminates collaboration

By |September 1st, 2017|Digest|

Immune Design ($IMDZ) announced interim top line data from a Phase 2 clinical trial assessing the combination of its CMB305 and Roche's TECENTRIQ (atezolizumab) compared to TECENTRIQ alone in 88 soft tissue sarcoma patients. The data showed a treatment effect from CMB305. Data on [...]

Novo Nordisk close to 52 weeks high with new approvals and strong study results $NVO

By |August 31st, 2017|Monthly Investment Ideas|

Novo Nordisk ($NVO) announced a couple of encouraging news as its drug candidates received positive nod from the regulators. The company’s Tresiba, a once a day treatment of adults with diabetes mellitus for improving glycemic control, has been approved by the Canadian regulatory authority. The drug is already approved in [...]

Premarket Biotech Digest – $URGN receives Fast Track Designation, $MDVX receives Australian approval, $AZN inks a new deal

By |August 30th, 2017|Digest|

Tabula Rasa Healthcare ($TRHC) stock perked up as the company announced inking a new deal with CenterLight Healthcare to provide medication risk management services. The company inked the deal through its wholly owned subsidiary CareKinesis. The agreement will be effective from September 1. It [...]

Cara Therapeutics stock to maintain momentum with upcoming catalysts $CARA

By |August 29th, 2017|Monthly Investment Ideas|

Cara Therapeutics Inc. ($CARA) reported its quarterly results. The company announced its net loss for the quarter at $9.3 million, down from a net loss of $13.1 million it had reported for the corresponding quarter of the previous year. On per share basis, the net loss stood at $0.29, down [...]

Premarket Biotech Digest – $NSPR inks new agreement, $AYTU reverse splits stock, $SGMO initiates dosing

By |August 28th, 2017|Digest|

CareDx ($CDNA) stock perked up as the company confirmed Medicare coverage for its AlloSure kidney transplant surveillance test. The coverage will be effective from October 9. The Centers for Medicare and Medicaid Services (CMS) released the final version of the coverage policy issued by [...]

Premarket Biotech Digest – $KMDA receives FDA approval, $LH all clear for acquisition, $KOOL inks new deal

By |August 25th, 2017|Digest|

Kamada Ltd. (NASDAQ:KMDA) stock picked up as the company announced receiving the FDA approval for KEDRAB, its rabies immune globulin. The drug is expected to launched in the US in early 2018. Under the terms of its agreement with Kedrion Biopharma, Kamada holds the [...]

The Medicines Company looks strong ahead of the FDA decisions later this month $MDCO

By |August 24th, 2017|Monthly Investment Ideas|

The Medicines Company ($MDCO) recently reported its second quarter results as the company also provided details about its corporate developments. The Medicines Company’s global net revenue stood at $18.7 million, in comparison to $54.7 million it had reported for the second quarter of the previous year. The company’s net loss [...]

Premarket Biotech Digest – $ACIU announces new discovery, $PMD launches new test, $NSPR receives NYSE notice

By |August 23rd, 2017|Digest|

AC Immune SA ($ACIU) stock perked up as the company announced the discovery of two new antibodies using its proprietary SupraAntigen platform. These antibodies will be used against two targets in the pathogenesis of neurodegenerative diseases. The first is Alpha-synuclein, an established target for [...]

Intersect posts strong Q2 numbers, looks forward to FDA ruling for Sinuvatm ($XENT)

By |August 22nd, 2017|Monthly Investment Ideas|

Intersect ENT Inc. ($XENT) specializes in Ear, Nose and Throat segment where it develops and markets novel drugs devices. It focuses on providing innovating implants for treating various conditions related to ear, nose and throat. The company recently reported its second quarter results where its revenue stood at $24 million, [...]

Premarket Biotech Digest – $WINT announces financial restructuring, $JNJ gets positive court verdict, $BIOC inks new deal

By |August 21st, 2017|Digest|

Ritter Pharmaceuticals ($RTTR) provided details about the Phase 3 program for lactose intolerance (LI) candidate RP-G28. The program incorporates guidance from the FDA during their End-of-Phase 2 meeting. The two studies to be conducted under this phase will both have the change in LI [...]

Premarket Biotech Digest – $GMED receives clearance, $BIOC inks new collaboration, $PFE receives approval

By |August 18th, 2017|Digest|

Opko Health Inc. ($OPK) announced inking a commitment letter with Veterans Accountable Care Group, LLC. The collaboration is related to a Veterans Health Administration (VHA) contract. If the bid turns out to be successful then Opko will acquire a 15% stake in VACO. It [...]

Clovis stock looks promising with strong Rubraca sales numbers $CLVS

By |August 17th, 2017|Monthly Investment Ideas|

Clovis Oncology Inc. ($CLVS) recently announced its second quarter financial results. The company also provided updates about its lead product Rubraca, which was launched in December, 2016. Clovis reported net product revenue for the drug at $14.6 million for the quarter, up from $7 million it had announced for the [...]

Premarket Biotech Digest – $COCP reports data, $SUPN gets favorable ruling, $FOLD receives approval

By |August 16th, 2017|Digest|

VBI Vaccines ($VBIV) announced that the FDA has approved its Investigational New Drug Application (IND) for immunotherapy candidate VBI-1901. The drug candidate is seeking approval as the potential treatment of Glioblastoma Multiforme (GBM), a common and aggressive type of malignant brain tumor. The IND [...]

Verastem stock to retain momentum with strong trial data $VSTM

By |August 15th, 2017|Monthly Investment Ideas|

Verastem Inc. ($VSTM) stock showed impressive performance this year by registering over 177 growth. The company recently reported its second quarter results with its net loss for the period at $13.4 million, up from a net loss of $8.6 million for the corresponding quarter of the previous year. However, the [...]

Premarket Biotech Digest – $SNGX receives funding, $ISRG board approves split, $SHPG receives Canadian approval

By |August 14th, 2017|Digest|

Achieve Life Sciences Inc. (NASDAQ:ACHV) stock perked up as the company announced received the FDA approval for its IND seeking approval to start U.S. clinical trials assessing smoking cessation drug cytosine. The company has already completed two large-scale Phase 3 studies, TASC and CASCAID, [...]

Premarket Biotech Digest – $SGMO announces strong quarterly numbers, $APEN receives FDA alert, $CELG modifies collaboration

By |August 11th, 2017|Digest|

Sangamo Therapeutics ($SGMO) shot up as the company announced better than expected quarterly numbers. For the second quarter ended June 30, 2017, the company reported a consolidated net loss of $12.5 million, or $0.17 per share, compared to a net loss of $26.6 million, [...]

The Medicines Company stock set to benefit from strong quarterly numbers $MDCO

By |August 10th, 2017|Monthly Investment Ideas|

The Medicines Company ($MDCO) stock showed positive reaction to its second quarter earnings announcement. The company reported its global revenue for the quarter at $18.7 million. The revenue figure included $10.7 million as aggregate revenue from Angiomax. Minocin and Orbactive recorded aggregate sales of $8.0 million in the second quarter [...]

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