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CELG Makes Blockbuster Purchase, MDXG, NBIX On Watch, Busy Year Ahead For ALNY

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Today's Daily Dose brings you news about Alnylam's upcoming events; Celgene's blockbuster acquisition; Galapagos' osteoarthritis trial data; preliminary Q4 revenue results of Vanda, MiMedx, and Ultragenyx's phase 1/2 study data of DTX301 for the treatment of ornithine transcarbamylase deficiency.

Read on…

Alnylam Pharmaceuticals Inc. (ALNY) has a number of events to watch out for this year.

The Company, which completed submission of its New Drug Application for Patisiran for the treatment of hereditary ATTR (hATTR) amyloidosis to the FDA and EMA last month, expects to gain regulatory approvals in the U.S., and EU in mid- and late 2018, respectively.

Additional data from a phase III clinical trial examining Patisiran in people with hereditary ATTR amyloidosis with polyneuropathy, dubbed APOLLO, are expected to be presented in early, mid-, and late 2018.

The Company is also planning to file for regulatory approval of Patisiran in Japan and other global markets, in mid-2018, and in additional rest-of-world countries in late 2018.

Next in the Company's pipeline is Givosiran, which is in development for the treatment of acute hepatic porphyrias.

The Company expects to present Phase 1/2 open-label extension data of Givosiran in early 2018.

A phase III study of Givosiran, dubbed ENVISION, is underway, and topline interim results from this study are expected in mid-2018. If all goes well as planned, the Company intends to file for accelerated regulatory approval with submission of a New Drug Application in the U.S. in late 2018.

Another drug candidate of importance is ALN-TTRsc02 for the treatment of ATTR amyloidosis. Alnylam plans to initiate a Phase 3 pivotal study program of ALN-TTRsc02 in late 2018.

The other phase III programs worthy of mention are Inclisiran to assess LDL-C lowering and safety in a wide range of patients, and Fitusiran for the treatment of hemophilia and rare bleeding disorders.

Alnylam is collaborating with The Medicines Company (MDCO) for the development of Inclisiran, and with Sanofi (SNY) for the development of Fitusiran.

In related news, Sanofi and Alnylam announced a strategic restructuring of their RNAi therapeutics alliance to streamline and optimize development and commercialization of certain products for the treatment of rare genetic diseases.

Under the restructured alliance, Sanofi obtains global rights for Fitusiran in hemophilia and other rare bleeding disorders, and Alnylam obtains global rights for Patisiran and ALN-TTRsc02.

ALNY closed Friday's trading at $127.73, down 3.21%.

Celgene Corp. (CELG) has agreed to acquire Impact Biomedicines, which is developing treatments for patients with complex cancers, for as much as about $7 billion.

Impact Biomedicines' pipeline is centered on Fedratinib that is being developed initially for the treatment of myelofibrosis (MF) and polycythemia vera (PV). A New Drug Application submission for Fedratinib in myelofibrosis is planned for mid-2018.

Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront, $1.4 billion in regulatory approval milestones, and $4.5 billion in aggregate tiered sales-based milestone payments.

CELG closed Friday's trading at $104.99, down 1.58%.

Exact Sciences Corp. (EXAS) has forecast better-than-expected revenue for the fourth quarter and full year of 2017, thanks to the strengthening demand for its colorectal cancer screening test, Cologuard.

For the fourth quarter of 2017, the Company expects to report revenue between $86.9 million and $87.9 million, well above analysts' consensus estimate of $79.09 million.
The Company had reported revenue of $35.2 million in the fourth quarter of 2016.

For the full-year 2017, the company anticipates reporting revenue between $265.5 million and $266.5 million, while analysts polled by Thomson Reuters expect revenue of $257.58 million. Full-year 2016 revenue was $99.4 million.

The Company completed approximately 176,000 Cologuard tests during the fourth quarter of 2017, and roughly 571,000 tests during the full-year of 2017. This compares favorably with 82,000 Cologuard tests completed in the fourth quarter of 2016, and approximately 244,000 Cologuard tests during the full year of 2016.

We had alerted our premium subscribers to this stock on January 9, 2017 when it was trading around $17.

EXAS closed Friday's trading at $57.53, up 2.48%.

Galapagos NV's (GLPG) phase I study, which evaluated the safety, tolerability, and pharmacokinetics of GLPG1972 in patients aged 50 to 75 years with diagnosis of knee and/or hip osteoarthritis, has yielded positive results.

The study also demonstrated that GLPG1972 reduced the blood level of ARGS neoepitope, an important cartilage breakdown biomarker, by up to more than 50% within two weeks.

The Company, along with its collaboration partner Servier, is expected to start a phase II trial of GLPG1972 in osteoarthritis later this year.

GLPG closed Friday's trading at $98.35, up 1.05%.

Luminex Corp. (LMNX) has forecast better-than-expected revenue for the fourth quarter and full year of 2017.

In the fourth quarter of 2017, revenue is expected to be approximately $78 million, while 5 polled analysts covering Thomson Reuters expect revenue of $76.87 million. In the fourth quarter of 2016, the Company had reported revenue of $72.3 million.

For the full- year ended 2017, revenue is expected to exceed $306 million while consensus estimates of analysts polled by Thomson Reuters, calls for revenue of $305.16 million. The Company had reported revenue of $270.6 million in 2016.

The Company plans to report results for the fourth quarter and full year ended December 31, 2017 on February 12, 2018.

LMNX closed Friday's trading at $20.50, up 1.89%.

MiMedx Group Inc. (MDXG) has reported preliminary record revenue results for the fourth quarter, and full-year 2017, thanks to strong performances by Wound Care, and Surgical, Sports Medicine and Orthopedics segments.

The Company's revenue in the fourth quarter of 2017, is $90.9 million, which has exceeded the $87.95 million consensus forecast of analysts polled by Thomson Reuters.

The full-year 2017 revenue is $324.5 million, which has also beaten the consensus analysts' estimate of $321.54 million.

The Company had recorded revenue of $69.9 million in the fourth quarter of 2016, and revenue of $245.0 million in full year-2016.

The fourth quarter of 2017 marks 28 consecutive quarters of sequential revenue growth and 27 of 28 quarters of meeting or exceeding its revenue guidance, added the Company.

The Company is optimistic that 2018 will be another year of highly predictable quarter over quarter revenue growth, continued strengthening of balance sheet and cash position, and significant gains in profitability.

For the first quarter of 2018, MiMedx expects revenue to be in the range of $90.5 million to $92.0 million, well above analysts' consensus estimate of $87.06 million.

MDXG closed Friday's trading at $13.29, up 1.30%.

Neurocrine Biosciences Inc. (NBIX) expects net product sales of INGREZZA to be approximately $64 million in the fourth quarter of 2017, and total revenue to be about $94 million.

Ingrezza was approved by the FDA for the treatment of tardive dyskinesia last April.

The total revenue includes a $30 million milestone payment received from AbbVie for the FDA's acceptance of the Elagolix endometriosis NDA in the fourth quarter.

For the full year of 2017, preliminary unaudited net product sales of INGREZZA are expected to be approximately $116 million, and total revenue is expected to be about $161 million inclusive of $45 million revenue recognized from collaboration agreements with AbbVie and Mitsubishi Tanabe Pharma Corp.

The Company has a couple of program milestones to watch out for this year, and some of which are:

-- INGREZZA is also being explored in Tourette Syndrome, and phase II trial data in this indication is expected in late 2018.
-- Elagolix for endometriosis is under FDA review, with a decision expected in Q2 2018.
-- Elagolix is also under phase III testing in uterine fibroids, and study results are anticipated this quarter.
-- The Company plans to meet with the FDA this month for determining the NDA path forward for Opicapone for Parkinson's disease.

NBIX closed Friday's trading at $81.73, up 1.81%.

Ultragenyx Pharmaceutical Inc.'s (RARE) interim safety and efficacy data from the first dose cohort of its phase 1/2 study of DTX301 for the treatment of ornithine transcarbamylase (OTC) deficiency looks promising.

According to the Company, patient 1 showed a normalization of ureagenesis that was maintained through 12 weeks, which is viewed to be clinically meaningful and a promising indication of the potential of DTX301.

The data monitoring committee has to review the 12-week safety data for all three patients in the first cohort, after which, the Company expects to be able to move to the higher-dose second cohort.

RARE closed Friday's trading at $50.81, down 0.37%.

Vanda Pharmaceuticals Inc. (VNDA) has announced preliminary unaudited financial results for the fourth quarter and full year 2017, and provided financial guidance for 2018.

For the fourth quarter, the Company expects total net product sales from HETLIOZ and Fanapt to be roughly $44 million. Analysts polled by Thomson Reuters are expecting total sales of $43.32 million for the quarter.

For the full year 2017, Vanda expects total net product sales from HETLIOZ and Fanapt to be about $165 million, while the consensus analysts' estimate calls for total sales of $164.16 million.

Looking ahead to 2018, the Company expects net product sales from both HETLIOZ and Fanapt to be between $180 million and $200 million.

VNDA closed Friday's trading at $15.25, down 1.93%.

by RTT Staff Writer

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