Category: Bioscience

Companies to watch in 2016

Some are planning major expansions or restructuring. Some are poised for explosive growth. Others are facing some daunting challenges. But we expect all of them to be making news next year. Here are our picks for companies to watch in 2016 in the Boulder Valley and Northern Colorado.

AEROSPACE

PlanetiQ

Sometime late this year, India will launch two weather satellites developed by Boulder-based startup PlanetiQ, as the result of a 2015 deal with Antrix Corp. Ltd., the commercial arm of the Indian Space Research Organization. Ten more of the satellites are slated for launch for 2017.

PlanetiQ’s 10-kilogram microsatellites will fly the company’s Pyxis-RO sensor that uses radio occultation to measure global temperature, pressure and water vapor in the atmosphere, and electron density in the ionosphere. PlanetiQ plans to sell the data gathered by the satellites to customers in the meteorology, aviation, shipping, defense, intelligence and agriculture industries. PlanetiQ has 12 employees in Boulder and six in Bethesda, Md. In August, when the company announced its move to Boulder, officials said the firm could add one or two dozen employees over the coming months.

Sierra Nevada

Sierra Nevada Corp.’s Space Systems Division in Louisville will be busy this year after landing a piece of $14 billion in NASA contracts to carry supplies and experiments to the International Space Station aboard a versatile, cargo-only version of its Dream Chaser spacecraft, which has folding wings and an added cargo module attached to the back. It had lost out in 2014 on a NASA contract to ferry astronauts to and from the ISS aboard the original, crewed version of Dream Chaser. The division  also has extended deals with international space agencies including the German Aerospace Center to develop Dream Chaser’s crewed and uncrewed capabilities. It also has supplied satellites for ORBCOMM’s global machine-to-machine communications network. Thanks to a $23.2 million incentive package from the state, the Sparks, Nev.-based company is developing an $88 million campus in Colorado Springs to house its new Sierra Completions Division that will create jet interiors and overhaul aircraft.

AGRIBUSINESS

Agrium Inc.

Canada-based Agrium Inc. in 2015 announced two major investments in Northern Colorado that will play out in 2016.

The producer and distributor of crop nutrients, crop-protection products and seeds will add employees in Loveland at one of its subsidiaries, Crop Production Services Inc., and will open an 18,000-square-foot facility in Greeley for researching and testing new fertilizer products.

A company spokesman said Agrium will bring jobs to Loveland, possibly growing to 700 workers from its current headcount of 400 in the Rangeview Office Campus. The additional workers will be housed in a new office building being built by McWhinney Real Estate Services Inc. that Agrium will lease.

The facility in Greeley will employ about a dozen workers, mostly scientists, who will conduct research to develop substances used for pest control or for soil-fertility management, and on how to ramp up the volume of production of ag products it sells primarily in the United States, Canada, South America, Europe and Australia.

Agribotix LLC

Boulder-based Agribotix LLC likely will continue to grow at a rapid clip as it enters agreements with organizations in low-tech cultures to provide them with high-tech data to improve crop yields.

Agribotix, founded in 2013 by Tom McKinnon, designs and manufactures drones that carry a camera and the company’s software system, which collects data to help farmers become more successful. The key selling point is the company’s software that analyzes the data and then provides recommendations on crop management.

It spent much of 2015 securing contracts and entering joint ventures with organizations in Latin America, United Kingdom, East Asia and Australia to provide it services, and it hired Lou Faust to run the company. Faust has more than 30 years of management experience and 10 years on Wall Street as managing director with Salomon Brothers (Citigroup). His expertise is in creating growth strategies, raising capital and leading startups to successful exits.

<b>Natural/Organic: U Baron Group:</b>The company is made up of Izzio’s Artisan Bakery, Etai’s Catering, six Etai’s Bakery Cafes and two full-service restaurants.

Natural/Organic: U Baron Group. The company is made up of Izzio’s Artisan Bakery, Etai’s Catering, six Etai’s Bakery Cafes and two full-service restaurants.
Courtesy U Baron Group

BANKING

Bank of America

Bankers in Boulder and the surrounding area will be waiting to see what impact the second-largest bank in the United States will have on market share when it opens a full-service bank at 1965 28th St. in Boulder later this year.

Announced in 2014, this will be Bank of America’s first full-service bank in Boulder and third in Colorado. It recently opened a full-service bank in Denver and is working on one in Highlands Ranch.

The new bank in Boulder, under construction at the site of a former Wendy’s restaurant, will be approximately 2,850 square feet, with tellers, small-business bankers and mortgage officers and a one-lane, ATM-only drive-through.

Charlotte, N.C.-based Bank of America Corp. is the second-largest bank in the United States with assets of $2.15 trillion and deposits of $1.16 trillion, according to Bankrate.com.

New Resource Bank

San Francisco-based New Resource Bank will open a loan-production office in Boulder, where it wants to provide loans to businesses and nonprofits that benefit the community and preserve the planet. Bill Peterson, executive vice president and chief credit officer, said he believes Boulder fits that niche market.

Colorado Division of Banking documents show that New Resource (OTC Pink: NWBN) has applied to open an office at 1877 Broadway, Suite 100, in the Randolph Center, but Peterson said the bank still is working through internal and regulatory issues and isn’t ready to make a “official announcement.”

The bank makes loans to companies and organizations “that benefit our communities and preserve our planet.” Peterson said the bank works with nonprofits, health and wellness companies, and organizations that work to preserve the environment.

Led by president and chief executive Vincent Siciliano, the bank, as of July, had loans totaling $179.6 million – a 2.8 percent increase compared with the same time in 2014.

BIOSCIENCE

Array Biopharma Inc.

Signs are pointing toward a big 2016 for Boulder-based Array (Nasdaq: ARRY) assuming a trio of Phase 3 trials for the company’s cancer drugs binimetinib and encorafenib can return positive results. Array officials are aiming to submit a New Drug Application to the U.S. Food and Drug Administration for binimetinib in the treatment of NRAS-mutant melanoma in the first half of this year. A regulatory submission for the combination of binimetinib and encorafenib in the treatment of BRAF melanoma also is expected to occur this year.

In December, Array closed a deal with French firm Pierre Fabre to commercialize the two drugs in Europe, Latin America and much of Asia – a pact that gave Array a $30 million payment up front and up to $425 million in milestone payments and royalties.

Clovis Oncology Inc.

Boulder-based Clovis (Nasdaq: CLVS) is likewise pushing toward commercialization this year, albeit amid plenty of turbulence.

The company is aiming to submit a New Drug Application for rucaparib for the treatment of ovarian cancer this year. Clovis also is hoping to receive a decision from the FDA by June on its New Drug Application submitted last summer for rociletinib in the treatment of lung cancer. However, a delay in the rociletinib decision announced in November caused the company’s share price to plunge 70 percent and has spurred lawsuits from shareholders who allege Clovis made false and misleading statements about itself and clinical data regarding one of its cancer drugs.

Heska Corp.

Loveland-based Heska (Nasdaq: HSKA), which sells veterinary diagnostic and specialty products, is coming off of a glowing 2015 that saw the company’s share price more than double.

In November, the company acquired Cuattro Veterinary LLC, giving Heska, which employs about 140 people in Loveland, access to the international market for its blood diagnostic platforms. Profits rose in each of the first three quarters of 2015, including a jump to 20 cents per share in the third quarter of 2015 from 8 cents per share in the same period a year earlier.

Wall Street analysts seem to remain bullish on Heska stock, expecting it to approach $40 per share in the coming year.

ENERGY

Gravity Renewables Inc.

Increased emphasis on renewable-energy projects could send Gravity Renewables Inc. soaring.

The Boulder-based owner and operator of small hydroelectric power plants last year acquired several hydroelectric plants in the Northeast, and signed deals to provide clean hydropower to organizations including St. Lawrence University in Canton, N.Y.; Vassar College in Poughkeepsie, N.Y.; and others.

As of October, Gravity had more than 34 megawatts of hydroelectric projects operating and under development around the country. The company raised $7 million from private backers, according to a February filing with the U.S. Securities and Exchange Commission.

Vestas Wind Systems A/S

The winds of change continue to blow for Vestas Wind Systems A/S, the Danish wind-turbine manufacturer that operates plants in Windsor, Brighton and Pueblo.

Vestas in March announced plans to add 400 production workers to its Windsor facility, including 300 employees and 100 temporary employees. The company followed that up with an August announcement that it would add 350 workers at its Windsor and Brighton plants.

Energy: Vestas In March the company announced plans to add 400 production workers to its Windsor facility, including 300 employees and 100 temporary employees.

Energy: Vestas
In March the company announced plans to add
400 production workers to its Windsor facility, including 300 employees and 100 temporary employees.
Joel Blocker/For BizWest

Fueling the growth have been strong orders from companies such as EDF Renewable Energy, which have prompted the company to add another 100,000 square feet at the Windsor site.

The Broe Group

The first half of 2016 will be telling for a $900 million deal between Encana Corp. and Crestone Peak Resources, a company 95 percent owned by Canada Pension Plan Investment Board and 5 percent by The Broe Group of Denver.

The deal, whereby Encana would sell its Colorado assets to Crestone, originally was expected to close at the end of 2015 but was delayed for up to six months at year-end. Encana’s holdings in the Denver-Julesburg Basin include 51,000 net acres and more than 1,600 wells.

The new venture would operate as a stand-alone business, with Broe assembling a management team for the firm.

<b>Technology: Aleph Objects Inc. </b>The company tripled in revenue in 2015 to $15 million and grew to 100 employees.

Technology: Aleph Objects Inc. The company tripled in revenue in 2015 to $15 million and grew to 100 employees. Courtesy Aleph Objects Inc.

HEALTH CARE

University of Colorado Health

UCHealth was one of the most aggressive health systems in the state in 2015, and that pattern doesn’t look to let up in 2016.

Construction is ongoing at two new UCHealth hospitals in the region: Longs Peak Hospital in Longmont and UCHealth Broomfield Hospital in Broomfield. Those projects followed on the heels of the group’s acquisition of Longmont Clinic at the beginning of 2015.

UCHealth has expanded rapidly since its formation in 2012, through creation of a joint venture4 between Poudre Valley Health System and University of Colorado Hospital. Expansion is under way at Poudre Valley Hospital in Fort Collins, and a new stand-alone emergency room opened in Fort Collins in October.

Boulder Community Health

More expansion is under way for Boulder Community Health, which relocated its major hospital operations to its expanded campus at Foothills Parkway and Arapahoe Avenue in 2014.

Late last year, BCH sold its Broadway campus to the city of Boulder, with additional operations expected to move to the Foothills area over the coming months. BCH plans to build a 75,000-square-foot, three- to four-story building in the Riverbend business park east of the Foothills campus, along with a parking garage.

Boulder Community represents one of the last remaining independent hospitals in the state and has expressed an intent to remain so, even in the face of increasing competition all around it.

NATURAL/ORGANIC

U Baron Group

With the 2012 sale of the Udi’s brand and the gluten-free part of the company to Boulder Brands, the bread makers and business people of the company, newly named U Baron Group, are back to square one: baking handmade breads made with old-world techniques – gluten included.

The unique mission for Izzio’s Artisan Bakery, U Baron’s 25,000-square-foot facility in Louisville named for master baker Maurizio Negrini, is to produce farmer’s market-style bread and sell it nationally, three ways: a bread that’s 90 percent baked and then frozen and finished by grocers and then bagged using Izzio bags, a take-and-bake variety and sliced sandwich bread.

U Baron is a lot bigger than it was when Etai Baron first set up shop in 1994. There is Etai’s Catering, six Etai’s Bakery Cafes and two full-service restaurants. Two additional European-style bread stands are scheduled to open late next summer – in Aurora and Denver.

Meyer’s Natural Foods

Growth in the demand for natural beef products has propelled Loveland-based Meyer Natural Foods to acquire 4.35 acres of vacant land in the Centerra area from University of Colorado Health and begin construction of a 33,000-square-foot corporate headquarters. The buildings will accommodate the company’s growing natural and organic beef business in the United States, as well as its expanding beef export business.

Meyer’s product lines include Laura’s Lean Beef, Dakota Beef and Meyer Natural Angus. Its variety of steak cuts, including filet mignon, ribeye, New York strip and top sirloin, and ground beef are made from cattle raised on a vegetarian diet free of hormones and antibiotics.

OUTDOORS

My Trail Co.

Can Demetri “Coup” Coupounas rebound from the 2015 demise of GoLite, the Boulder-based outdoor retailer he founded with wife Kim? He’ll try by resurrecting the old product line under the new brand My Trail Co. He’s been looking for investors to help the new company sell products online, with an eye on opening its first retail stores along the Front Range this year.

Coupounas said the new model will be to focus on the core products with which the company did well, such as tents, backpacks and rain gear. and eliminate nonessentials such as casual wear.

My Trail’s plan also will be to open stores in the 1,200-square-foot range rather than the 4,000- and 5,000-square-foot stores that ultimately failed under the GoLite flag. Coupounas has so far raised $292,000 through a direct public offering to try to get the new venture off the ground.

Xero Shoes

Feel the World Inc., which does business as Xero Shoes, is hoping to tap into some of the magic that propelled Niwot-based shoemaker Crocs to international fame. Broomfield-based Xero brought in former Crocs chief executive John McCarvel as chairman of the board and lead investor. McCarvel led Crocs’ growth from $645 billion in revenue in 2009 to $1.2 billion in sales in 2013 before retiring in April 2014. With the move, McCarvel reconnected with Xero chief product officer Dennis Driscoll, whom McCarvel originally brought to Colorado as Crocs’ head of global design.

Xero makes a line of minimalist footwear it dubs “lightweight performance recreation sandals.” It moved from Boulder to Broomfield last year as the company experienced rapid growth.

REAL ESTATE

Brinkman Partners

Wrapping up its 10th year in business, Fort Collins-based Brinkman Partners has established itself as a company to watch in the real estate industry as it expands its services and reach in Northern Colorado, the Boulder Valley and metropolitan Denver.

Founded by brothers Paul and Kevin Brinkman, along with others, the company has grown to more than 100 people working to integrate their expertise across a variety of services including commercial brokerage, construction, development, real estate management and capital markets.

Brinkman’s projects run the gamut of office, multifamily, commercial and retail, breweries, health care and tenant finish.

Element Properties

Scott Holton and Chris Jacobs, co-founders of Element Properties, a real estate development company based in Boulder, are incorporating their respect for the environment and the community in their projects, which range from infill and affordable housing to luxury townhomes and mixed-use places.

This coming year, Element will team with Allison Management and the Michaels Organization in a $63 million project, converting 238 apartment units to Boulder’s affordable-housing stock. Element recently added financial partners to its $100 million S’Park mixed-use project in Boulder at the site of the former Sutherland lumber yard.

Last year, Holton and Jacobs sold Element’s property-management division to Heartwood Properties Inc. to focus on development projects. Heartwood Properties Inc., a property-management and brokerage firm, and Heartwood Capital LLC, an affiliate real estate investment firm, share the same address with Element Properties.

TECHNOLOGY

Aleph Objects Inc.

Loveland-based Aleph, founded in 2011, has quickly entrenched itself as a significant player in Northern Colorado’s tech scene.

The company, which manufactures desktop 3-D printers based on open-source hardware specs and software, tripled in revenue in 2015 to $15 million and grew to 100 employees. Company officials say their plan is to keep scaling up, with multiple hardware and software upgrades on tap for this year.

Early this year, the company announced, it will open a fulfillment center in Australia to help grow the company’s international footprint.

Avago Technologies

Fort Collins’ third-largest primary employer is aiming to grow, thanks in large part to an under-construction $57 million expansion of its Harmony Road facility that will add more than 120,000 square feet of space to the 1.2 million-square-foot building.

Avago Technologies (Nasdaq: AVGO), a maker of semiconductors for the cellular and other industries, is co-headquartered in Singapore and San Jose, Calif., but its largest employment presence is in Fort Collins, where it has an estimated 1,300 employees already.

Avago stock has nearly doubled over the past 18 months, fueled in part by the $37 billion acquisition of competitor Broadcom, a deal that is expected to close in February and make Avago a roughly $14 billion-per-year company.

SolidFire Inc.

Hard-charging enterprise storage provider SolidFire figures to keep surging in 2016, although under which flag? California-based NetApp (Nasdaq: NTAP) announced in December plans to acquire Boulder-based SolidFire for $870 million, and it remains to be seen whether SolidFire will maintain its branding or be rolled into the NetApp line.

SolidFire officials have said the plan is still for the company to move into ritzy new downtown Boulder redevelopment PearlWest, where the company leased 62,000 square feet of space last year. But that move now could bring along with it some employees from NetApp, which has an office in east Boulder.

While SolidFire officials, before the acquisition announcement, had said they expected to grow to more than 500 employees in Boulder in coming years, the pace of that growth now depends largely on NetApp’s plans.

Christopher Wood, Dallas Heltzell, Joshua Lindenstein and Doug Storum contributed to this report.

Hach Co., aims to open 86,000-square-foot expansion in 2017

LOVELAND — Officials for Loveland-based Hach Co. on Thursday confirmed reports that the company is moving forward with an 86,000-square-foot expansion project at its existing campus near the Fort Collins-Loveland airport.

The company — which makes instruments, software and reagents used to test water quality for a variety of industries — plans to break ground this spring and open the new research-and-development building in late 2017.

Hach officials did not respond to a request for comment Thursday. But they had previously pegged the cost of the project at $25 million, including $4 million in new equipment.

The new building will add to a Hach campus that already includes more than 200,000 square feet of space spread out among two buildings used for manufacturing, research and development, marketing, technical support, customer service and other business functions. It will house multiple testing and development laboratories, according to a press release.

Hach employs 750 people on its Loveland campus, plus another 50 at a leased space in Fort Collins. In November 2014, the Colorado Economic Development Commission approved the company for $2 million in job-growth incentives if Hach staffed its new facility with at least 204 people. Thursday’s announcement did not specify how many new jobs might be created by the new facility, but noted that the “expansion will offer additional space to support Hach’s near-term and anticipated future growth.”

“Hach has a great history of innovation, and this investment will ensure we continue to develop state of the art new products, attract great talent and maintain our commitment to customers,” Hach president Kevin Klau said in the release.

In addition to the state incentives, the city of Loveland and Larimer County committed $1 million in incentives.

Hach, which moved to Loveland in 1978, was acquired by Danaher Corp., in 1999.

Medical-device maker Nostix acquired by Teleflex

BOULDER — Medical-device developer Nostix LLC in Boulder has been acquired by Teleflex Inc. (NYSE: TFX), based in Wayne. Pa.

Nostix’s small engineering division will remain at its facility at 5545 Central Ave., Suite 170, but its brand will change to Teleflex.

Nostix developed catheter-tip confirmation systems that are used to increase the accuracy of placement of peripherally inserted catheters. They are used as an alternative to X-ray confirmation in adult patients.

Terms of the acquisition were not disclosed. JMP Securities LLC served as financial adviser to Nostix in the transaction.

“Adding the Nostix product line provides our customers with the ability to implement catheter-tip placement solutions that meet their specific therapeutic and budget needs,” said Benson Smith, chairman, president and chief executive of Teleflex, in a prepared statement. “Strategically, the addition of this technology will support Teleflex’s future expansion into tip confirmation for central venous catheters, chronic hemodialysis catheters and ports. We also gain access to an innovative product development pipeline, which includes integrated ultrasound capabilities that will extend our ability to offer differentiated catheter-tip positioning solutions well into the future.”

FDA grants Nivalis orphan-drug designation for cystic fibrosis drug

BOULDER — Nivalis Therapeutics Inc. in Boulder said Friday that it has received orphan-drug designation from the FDA for a drug to treat cystic fibrosis, a genetic condition in which the lungs and digestive system become clogged with thick sticky mucus.

The designation for the drug, called N91115, provides Nivalis with a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees that the FDA uses to fund the new-drug approval process.

“The Orphan Drug Designation represents an important milestone in the development and regulatory strategy for N91115 and underscores the unmet need that remains in treating CF,” said Jon Congleton, president and chief executive officer of Nivalis, in a prepared statement. “We look forward to the continued clinical advancement of this first-in-class CFTR stabilizer, a new approach to modulating the defective CFTR protein.”

The company is seeking Fast Track status for the development of the drug. A Fast Track designation enables more-frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Nivalis (Nasdaq: NVLS) completed an $88.6 million initial public offering in June, and it reported a loss of $6.1 million for its third quarter that ended Sept. 30, its most recent report. Nivalis changed its name from N30 Pharmaceuticals in February 2015.

Colorado offers $11M in incentives to companies eyeing local region

The Colorado Economic Development Commission on Thursday morning approved nearly $11 million in incentives for three companies looking at bringing expansions or new operations to the Boulder Valley and Northern Colorado.

A company nicknamed “Project Transformation” received the largest offer of $8,146,005 to bring 635 jobs to Larimer County. The telecommunications company, according to Office of Economic Development and International Trade officials, already has a presence in Colorado, and is considering locating the new jobs in Arizona and New Mexico in addition to Colorado.

“Project Apothecary” is a life-science company that also has a Colorado presence already. The EDC approved it for $2,385,017 to bring 170 jobs to Weld County, where the company is considering building a new facility. That company is also considering Texas.

Finally, Viega LLC, a manufacturer of plumbing and heating components with its U.S. headquarters in Wichita, Kan., was offered $223,380 by the EDC to bring 20 jobs to a facility it would build in Broomfield. Viega is also considering Georgia and Kansas for the new facility.

CSU’s biopharma center awarded $4.6M contract to create vaccine

FORT COLLINS — Colorado State University has been awarded a 10-month, $4.6 million contract to help develop and manufacture new vaccines to fight encephalitic viruses that cause inflammation of the brain.
The contract, funded by the Department of Defense, is an extension of the successful work already performed on Ebola and Marburg vaccines at CSU’s Biopharmaceutical Manufacturing and Academic Resource Center.

The new funding will be used to develop vaccines for Western, Eastern and Venezuelan equine encephalitis viruses. The mosquito-borne viruses can cause severe long-term disease and possibly death in humans.

The vaccines are intended to protect soldiers from aerosolized exposure to the viruses and could be used for endemic outbreaks.

There are no licensed U.S. Food and Drug Administration-approved human vaccines or therapeutics to protect against or treat such viral infections.

BioMARC is a nonprofit contract manufacturer and a high-containment biopharmaceutical unit launched by CSU in 2006. It has been successfully meeting milestones set last year by the DOD for the Ebola and Marburg vaccines.

BioMARC has approximately 30 full-time employees and about 12 CSU students who will be working at the facility.

Boulder doctor launches startup to help the sleep-deprived

BOULDER — Sleep expert Richard Shane on Tuesday launched Sleep Easily LLC in Boulder, a company that offers a medication-free method to help people overcome sleep difficulties.

Shane, a psychotherapist since 1977 and behavioral sleep specialist for New West Physicians, developed the method to cure his own insomnia. He discovered specific body and breathing sensations that are neurological switches for sleep. He further researched the neurophysiology of sleep and developed his method.

“When someone sleeps poorly, it damages almost every area of their life. Better sleep can help improve health, relationships and productivity,” Shane said. “Sleep Easily’s goal is to help many of the 95 million Americans with insomnia and millions more in Canada.”

Richard Shane

Richard Shane

The Sleep Easily Method uses audio recordings to help trigger sleep using relaxation techniques, said Mary Cochran, the company’s director of marketing.

A Sleepy Easily Method kit, available online for $69 at sleepeasily.com, includes seven recordings in either a male or female voice that are downloadable to a smartphone or MP3 player, a padded pillow speaker, specialized earplug and a 300-page SleepGuide Book.

In an independent study with Sleep Easily used by police, firefighters, commercial airline pilots and the general public, 81.6 percent of participants reported improved sleep, Cochran said. The company is located at 3980 Broadway, Suite 103, in North Boulder. It has four employees.

Clovis Oncology facing class-action lawsuits in wake of stock plunge

BOULDER — Clovis Oncology Inc. (Nasdaq: CLVS) has been named a defendant in at least four class-action lawsuits filed in recent weeks on behalf of shareholders who allege the company and its top executives made false and misleading statements about the company and clinical data regarding one of its cancer drug candidates.

Those statements, the plaintiffs say, led to an inflated share price and, ultimately, the loss of billions of dollars for investors when Boulder-based Clovis’ stock price plunged 70 percent on Nov. 16.

Three such cases were filed in U.S. District Court in Colorado between Nov. 19 and Dec. 14. A fourth was filed Nov. 20 in U.S. District Court in northern California.

Clovis officials declined comment on the pending lawsuits.

Clovis is a clinical-stage pharmaceutical company developing multiple cancer drugs, with plans to commercialize its first, rociletinib, sometime this year in the United States and Europe.

Clovis filed a New Drug Application with the U.S. Food and Drug Administration last summer for approval of rociletinib in treating lung cancer, with a decision expected by March 30 of this year. But on Nov. 16, Clovis disclosed that the FDA had requested more clinical data on rociletinib in part because the number of study patients with unconfirmed responses to rociletinib who had converted to confirmed responses was lower than had been expected. That request was expected to delay the FDA’s decision, and on Dec. 15, Clovis announced that the FDA had extended the goal date by three months to June 28.

Clovis’ share price had risen steadily through 2015 and closed at $99.43 on Friday, Nov. 13. After the early-morning announcement of the FDA request the following Monday, shares closed at $30.24, representing a loss of nearly $2.2 billion in market capitalization. The company’s stock price has languished primarily between $30 and $35 per share since, and was down $1.13 to $29.67 per share in mid-afternoon trading Thursday.

The respective lawsuits were filed in the names of John Moran, Sonny P. Medina, Ralph P. Rocco and Steve Kimbro. They name Clovis CEO Patrick Mahaffy and chief financial officer Erle Mast as defendants, along with the company. The suits aim to represent investors who purchased Clovis stock between Oct. 31, 2013, and Nov. 15, 2015, a period during which they contend that statements made by the company about the progress of rociletinib and the anticipated timeline for commercialization of the drug caused the stock price to rise artificially. The plaintiffs are seeking damages and attorneys’ fees.

The lawsuits contend that Clovis officials knew the data submitted to the FDA on rociletinib was insufficient and could cause a delay in approval before disclosing that information on Nov. 16.

Specifically, the California suit alleges that the company failed to disclose that Clovis’ New Drug Application contained immature data sets based on both unconfirmed and confirmed response rates, and that as the efficacy data matured, the number of patients with unconfirmed responses to the drug who converted to confirmed responses was lower than expected. As a result, the lawsuit alleges that company officials failed to disclose that Clovis’ NDA was likely to be delayed and/or rejected, and that the company was in possession of such data during its third-quarter conference call on Nov. 5 in which company officials discussed Clovis’ financial outlook, including statements implying that commercialization of the drug was imminent.

Clovis, which went public in 2011, was founded in 2009 and has burned through hundreds of millions of dollars in developing drugs. But the company has been eyeing a big year in 2016 for some time, and last summer closed a $298.4 million follow-on stock offering as it prepared for regulatory approvals and commercialization. In addition to rociletinib, the company has been aiming to submit a New Drug Application for rucaparib for the treatment of ovarian cancer sometime this year.

Clovis received a boost in May 2014, when rociletinib was granted Breakthrough Therapy designation by the FDA, a designation intended to help expedite development and review of certain drugs. The company received the same designation for rucaparib early last year.

Array closes deal with French biopharma to advance cancer-fighting drugs

BOULDER — Array BioPharma Inc. on Monday said it has closed its deal with French drugmaker Pierre Fabre to globally develop and commercialize Array’s cancer-fighting drugs, binimetinib and encorafenib.

The deal, announced Nov. 16, cleared its final hurdle when it was approved by the European Commission on Competition, the companies announced Monday.

Boulder-based Array (Nasdaq: ARRY) will receive an upfront payment of $30 million and is entitled to receive up to $425 million if certain development and commercialization milestones are achieved.

Array retains commercialization rights for the two drugs in the United States, Canada, Japan, Korea and Israel. France-based Pierre Fabre will have rights to commercialize both products in all other countries, including Europe, Asia and Latin America.

Binimetinib is intended to treat ovarian and colorectal cancer, and melanoma; encorafenib would treat melanoma.

Array and Pierre Fabre have agreed to split future development costs on a 60/40 basis, with Array paying 60 percent, with initial funding committed for new clinical trials in colorectal cancer and melanoma.

All ongoing binimetinib and encorafenib clinical trials remain substantially funded through completion by Novartis.

Pierre Fabre Oncology is a business unit of the global 10,000-employee Pierre Fabre company. It has more than 1,000 employees, with a strong focus on European markets.

Array BioPharma shares gain 35 percent following Phase 3 trial results

BOULDER — Array BioPharma Inc. shares rocketed up 35 percent in premarket trading Wednesday morning after the company reported promising results for one of its cancer drugs and announced plans for a regulatory submission in the first half of 2016.

In a release, officials for Boulder-based Array (Nasdaq: ARRY) said binimetinib, in a Phase 3 clinical trial looking at its ability to combat NRAS-mutant melanoma, “met its primary endpoint of improving progression-free survival” when compared with chemotherapy. Median PFS in patients receiving binimetinib was 2.8 months versus 1.5 months with chemotherapy.

Binimetinib, the company wrote, “was generally well-tolerated and the adverse events reports were consistent with previous results in NRAS melanoma patients.”

The full results from from the company’s NEMO trial, including progression-free survival, overall survival, objective response rate and other metrics, will be presented in early 2016 at a medical group meeting, the company said.

NRAS melanoma is the fifth most common cancer among men and seventh most common among women in the United States. It occurs in 15 to 20 percent of patients with melanoma and is considered a poor prognostic factor.

The NEMO trial is looking at 402 patients with advanced NRAS-mutant melanoma, with two-thirds of them receiving binimetinib and one-third receiving chemotherapy.

Binimetinib is also in Phase 3 trials looking at its use in treating BRAF-mutant melanoma and low-grade serous ovarian cancer.

“We are excited to announce positive results from the NEMO trial, which suggest binimetinib has the potential to provide an important new treatment option for patients with advanced NRAS melanoma,” Array CEO Ron Squarer said in a prepared statement.

Array officials said they plan to file with the U.S. Food and Drug Administration for approval to market the drug in NRAS melanoma patients in the first half of next year.

The company’s shares went on a tear before markets opened Wednesday, climbing $1.34 to $5.17, up from Tuesday’s close of $3.83. Just days earlier, Array’s share price had hit a 52-week low of $3.72.

Array shares had gained a big boost and were trading above $8 earlier this year when Array acquired worldwide rights to binimetinib and encorafenib from Novartis. But the company’s share price had been slipping steadily ever since. When they hit $3.72 on Friday, it was their lowest point since hitting $2.98 on Oct. 13 of last year.