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Sun, Nov. 8, 5:35 PM
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Mon, Oct. 26, 11:28 AM
- SciVac Therapeutics (OTCQX:SVACF) acquires VBI Vaccines (NASDAQ:VBIV) in an all-stock transaction. Under the terms of the deal, each share of VBIV common stock will be converted into the right to receive 20.808356 shares of SciVac. In aggregate, VBIV shareholders will receive ~541.6M shares of SciVac, representing ~42% of the outstanding shares of the combined company after giving effect to the merger. The new firm will do business as VBI Vaccines.
- OPKO Health (OPK +0.3%) will be the largest shareholder of the combined firm with a ~14% stake.
- SciVac's main product is Sci-B-Vac, a third generation hepatitis B vaccine. VBI is developing prophylactic vaccines against CMV and RSV infection and therapeutic vaccines for brain cancer (glioblastoma) and HCV.
Fri, Oct. 16, 12:32 PM
- Opko Health (OPK +2.5%) initiated with Overweight rating and $14 (47% upside) price target by JP Morgan.
- Jazz Pharmaceuticals (JAZZ +1.7%) initiated with Outperform rating and $200 (44% upside) price target by Northland Capital Markets.
- Mallinckrodt (MNK) initiated with Outperform rating and $92 (37% upside) price target by Northland Capital Markets.
- Shire (SHPG +1.1%) initiated with Outperform rating and $288 (38% upside) price target by Northland Capital Markets.
- Nabriva Therapeutics (NBRV +2.2%) initiated with Outperform rating and $19 (90% upside) price target by Leerink.
- Penumbra (PEN -0.2%) initiated with Buy rating and $48 (20% upside) price target by Canaccord Genuity.
- REGENXBIO (RGNX -3.6%) initiated with Overweight rating and $36 (100% upside) price target by Piper Jaffray.
- Dyax (DYAX -0.9%) upgraded to Outperform from Market Perform by Leerink. Price target raised to $36 (29% upside) from $25.
- Eli Lilly (LLY +1.5%) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $105 (30% upside) from $89.
- Athenahealth (ATHN -4.6%) downgraded to Underperform from Buy by Jefferies. Price target lowered to $105 (22% downside risk) from $125.
- Halyard Health (HYH -1.5%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $27 (6% downside risk) from 38.
Tue, Sep. 15, 11:35 AM
- The FDA approves privately-held Octapharma's NUWIQ, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children with hemophilia A. The approval includes on-demand treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes and perioperative management of bleeding.
- NUWIQ is the first B-domain-deleted recombinant Factor VIII derived from a human cell line, not chemically modified or fused with another protein, for the treatment of hemophilia A, which affects ~16K Americans.
- NUWIQ was cleared in Europe in August 2014.
- Related tickers: (BAX +0.3%)(BXLT -0.5%)(OTCQX:RHHBY +0.6%)(SGMO +2.4%) (OTCPK:CHGCY) (OPK +2.3%)(ALNY)(BIIB +0.5%)(OTCPK:BAYRY +0.4%)
Wed, Sep. 2, 10:33 AM
- The FDA approves Tesaro's (TSRO +4.4%) VARUBI (rolapitant), in combination with other antiemetic agents, for the prevention of delayed nausea and vomiting associated with chemotherapy (CINV) in adult patients. Up to 50% of chemo patients experience delayed CINV (25 - 125 hours after treatment) even when taking a 5-HT3 receptor antagonist (Novartis' Zofran, formerly Glaxo's) and a corticosteroid.
- VARUBI, the company's first approved product, is an antagonist of human substance P/neurokinin 1 (NK-1) receptors with a plasma half-life of ~seven days. Phase 3 results showed a significant reduction in CINV or use of rescue medication when patients were administered a 180 mg dose one - two hours prior to chemo in combination with a 5-HT3 antagonist and dexamethasone.
- Related tickers: (NVS -0.1%)(HRTX +0.2%)(OPK +1%)(INSY +2.7%)(RDHL +1%) (OTC:ESALF) (OTCPK:ESALY) (GALE +0.6%)(GWPH +1.1%)(MRK -0.1%)
Wed, Sep. 2, 9:17 AM
Tue, Aug. 25, 9:19 AM| Tue, Aug. 25, 9:19 AM | 7 Comments
Wed, Aug. 5, 4:02 PM
Thu, Jul. 30, 9:52 AM
- Tesaro (TSRO -3.8%) secures an exclusive license agreement with China-based Jiangsu Hengrui Medicine Co. for the development, registration, manufacture and commercialization of rolapitant in China. Specific financial terms are not disclosed.
- Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist under development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The company's NDA is currently under FDA review with a PDUFA date of September 5.
- CINV-related tickers: (GALE -1.8%)(HRTX -2.2%)(MRK -0.1%)(RDHL -0.1%) (OTC:ESALF) (OTCPK:ESALY) (OPK -1.3%)(INSY -2.3%)(GWPH -2.1%)
Tue, Jul. 28, 1:53 PM
- The FDA accepts for review the New Drug Application (NDA) from OPKO Health (OPK +2.4%) for Rayaldee (calcifediol) for the treatment and prevention of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
- The PDUFA date will be announced when the company receives its 74-Day letter in mid-August.
- There are ~4M Americans with stage 3 or 4 CKD and vitamin D insufficiency.
Fri, Jul. 10, 9:44 AM
- Opko Health (OPK +0.2%) completes enrollment in the pivotal Phase 3 clinical trial assessing its long-acting human growth hormone (hGH-CTP) in growth hormone deficient adults. The treatment period in the randomized, double-blind, placebo-controlled study is 26 weeks followed by a 26-week open-label extension.
- The primary endpoint is the change in trunk fat mass, expressed in kilograms, from baseline to week 26 versus placebo. The projected study completion date is June 2016. If successful, a regulatory submission will follow.
- The value proposition of hGH-CTP is the reduction of injections, from once daily to once weekly.
Thu, Jun. 4, 9:14 AM
Thu, Jun. 4, 8:24 AM
- In a all-stock deal, OPKO Health (NYSE:OPK) acquires Bio-Reference Laboratories (NASDAQ:BRLI) for $52.58 per share or ~$1.47B. BRLI shareholders will receive 2.75 shares of OPK for each BRLI share.
- OPKO intends to leverage BRLI's commercial organization to enhance sales of its diagnostic tests, including 4Kscore, a blood test for prostate cancer.
- OPK is down 7% premarket on increased volume. BRLI is up 43% premarket on robust volume.
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