$MNK FDA grants Synacthen Fast Track status

By |August 25th, 2016|News|

Mallinckrodt (MNK) announced that the FDA has granted its Synacthen (tetracosactide) depot formulation (long acting) a Fast Track status for the treatment of Duchenne muscular dystrophy (DMD). A Phase 1 study is underway.

$NVS late stage study for BAF312 succeeds

By |August 25th, 2016|News|

Novartis (NVS) announced that a Phase 3 study evaluating BAF312 (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS) met its primary endpoint of a reduction in the risk of disability progression versus placebo. Top-line data will be presented on September 17 at the 32nd Congress of the European [...]

$PVCT slumps on pricing of secondary offering

By |August 25th, 2016|News|

Provectus Biopharmaceuticals (PVCT) shares have slumped after the company announced the pricing of its "best efforts" public equity offering. PVCT is offering of 240,000 shares of Series B Convertible Preferred Stock, initially convertible into an aggregate of 24 million shares of common stock, and warrants to purchase up to 24 [...]

$VKTX enters into common stock purchase agreement with Aspire Capital Fund

By |August 25th, 2016|News|

Viking Therapeutics (VKTX) has entered into a common stock purchase agreement with Aspire Capital Fund, LLC under which Aspire will buy up to $12.5 million in stock over the next 30 months at market prices at Viking's discretion. Aspire has made an initial purchase of $500K in shares at $1.50. [...]

$BLRX announces joint venture in China

By |August 25th, 2016|News|

BioLineRx (BLRX) and Chinese venture capital fund I-Bridge Capital have entered into a joint venture in China called iPharma which will develop therapeutic candidates originating primarily from BioLineRx. The products will be aimed at global markets in addition to China. According to the terms of the agreement, ach partner will [...]

$KOOL announces debt conversion

By |August 25th, 2016|News|

Cesca Therapeutics (KOOL) announced that it has converted a $12.5 million senior secured three-year convertible debenture and $8.25 million in interest to 6,102,941 shares of common stock. The action was in accordance with an investment by affiliates of Chinese institutional investor Boyalife Group made in February. Following the conversion, Boyalife [...]

$GALT to terminate development of GR-MD-02

By |August 25th, 2016|News|

Galectin Therapeutics (GALT) shares have fallen sharply after the company announced that it will cease development of NASH candidate GR-MD-02 for the treatment of moderate-to-severe plaque psoriasis after a small open-label Phase 2a study failed to demonstrate at least a 75% improvement in symptoms after 24 weeks of treatment. Results [...]

$MYL reduces EpiPen price after Clinton statement

By |August 25th, 2016|News|

Following Presidential candidate Hillary Clinton's comments on the EpiPen price hike, Mylan (MYL) announced a patient assistance program that reduces out-of-pocket costs as much as 50% off the list price via a savings card that will cover up to $300 of the cost of the EpiPen 2-Pak. In addition, Mylan [...]

$AMGN FDA rejects Parsabiv NDA

By |August 25th, 2016|News|

Amgen (AMGN) announced that it received a Complete Response Letter (CRL) from the FDA related to its New Drug Application (NDA) seeking approval of Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. The company is reviewing the CRL and [...]

Premarket Biotech Digest: New CFO at $ACAD, $INST Reports Positive Results, $NYMX Soars

By |August 25th, 2016|Digest|

[/toggle] ACADIA Pharmaceuticals (ACAD) announced the appointment of Todd Young as EVP, CFO, effective August 22. Young comes to ACAD after spending more than a decade at Baxalta. Baxalta was recently acquired Shire Plc (SHPG). Considering that Young was in a senior finance position at Baxalta when the company [...]

Biotech Trade Alerts Archive -2016-08-24- $ACAD, $INSY, $MNK, $ITEK, $PFE

By |August 25th, 2016|Real Time Trade Alerts|

DRKKD.com Real Time Biotech Trade Alert Service August 24, 2016. Tickers covered: ACAD, INSY, MNK, ITEK, PFE *** L3 or above subscription required to read further... Login or Subscribe/Upgrade here Posted: Wed, 24 Aug 2016 09:56:10 -0400 Ticker: ACAD InPortfolio: Yes ConvictionBuy: Yes Price: 34.70 RiskProfile: Medium InvestmentType: [...]

$ACAD appoints Todd Young as CFO

By |August 24th, 2016|News|

ACADIA Pharmaceuticals (ACAD) announced the appointment of Todd Young as EVP, Chief Financial Officer effective August 22. He joins the firm from Baxalta where he was SVP and Treasurer.

$INSY Phase 3 study of Buprenorphine succeeds

By |August 24th, 2016|News|

Insys Therapeutics (INSY) announced successful results in its Phase 3 study evaluating Buprenorphine Sublingual Spray for the treatment of moderate-to-severe postoperative pain in patients undergoing bunionectomy, a procedure that requires an incision on the top or side of the big toe joint. The primary endpoint was the summed pain intensity [...]

$MNK to sell Nuclear Imaging business to IBA Molecular

By |August 24th, 2016|News|

Mallinckrodt (MNK) has signed a deal to sell its Nuclear Imaging business to IBA Molecular for $690 million. According to the terms of the agreement, IBA Molecular will make an upfront payment of $574 million, contingencies of $77 million and the assumption of $39 million in long-term obligations. The transaction, [...]

$ITEK completes enrollment in late-stage study of lead product candidate

By |August 24th, 2016|News|

Inotek Pharmaceuticals (ITEK) announced that it has completed enrollment in its Phase 3 clinical trial, MATrX-1, evaluating lead product candidate trabodenoson for the treatment of glaucoma. The primary endpoint is the reduction in intraocular pressure (IOP) over three months of treatment versus placebo. Top-line results from the trial are scheduled [...]

$PFE to acquire $AZN’s small-molecule antibiotics operations

By |August 24th, 2016|News|

Pfizer (PFE) has reached an agreement with British drugmaker AstraZeneca (AZN) to buy the latter's small-molecule antibiotics operations in a transaction that could eventually be worth $1.575 billion. The deal will allow AstraZeneca to focus on three main therapy areas and realize value "from the strong portfolio of established and [...]

$CEMP has significant upside

By |August 24th, 2016|News|

Cempra (CEMP) announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia. The review process is now underway. CEMP has already filed an NDA in the U.S., which is currently [...]

$CLVS continues to rally in pre-market trading

By |August 24th, 2016|News|

Clovis Oncology (CLVS) shares surged on Tuesday after the company announced that the FDA has accepted for review its New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged rucaparib for the treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations and [...]

Premarket Biotech Digest: $CLVS Soars, $CEMP Makes Progress With Solithromycin, $MYL Slips

By |August 24th, 2016|Digest|

Clovis Oncology (CLVS) shares surged on Tuesday after the company announced that the FDA has accepted for review its New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged rucaparib for the treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA [...]

Biotech Trade Alerts Archive -2016-08-23- $CEMP, $NWBO, $PRGO, $SPHS, $CVM, $STML, $CYDY, $JNJ, $SVA

By |August 24th, 2016|Real Time Trade Alerts|

DRKKD.com Real Time Biotech Trade Alert Service August 23, 2016. Tickers covered: CEMP, NWBO, PRGO, SPHS, CVM, STML, CYDY, JNJ, SVA *** L3 or above subscription required to read further... Login or Subscribe/Upgrade here Posted: Tue, 23 Aug 2016 11:40:55 -0400 Ticker: CEMP InPortfolio: No ConvictionBuy: No Price: [...]

s2Member®