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Week Ahead In Pharmaceuticals

Saturday July 21 st 2018

(RTTNews) – As another week comes to a close, let’s take a look back at some of the stories that made headlines in the pharma space, and look ahead to what’s in store in the coming week.

Tilray Inc. (TLRY) made its debut on the Nasdaq Global Select Market on July 19, becoming the first cannabis company to go public on a U.S. major stock exchange. The shares have gained as much as 87% from the listing price of $17.

Mersana Therapeutics Inc. (MRSN) lost more than 30% of its value this week, following a partial clinical hold on its phase I trial of cancer drug candidate XMT-1522. The partial clinical hold was imposed by the FDA on July 19 after a patient death in the trial.

For Agios Pharmaceuticals Inc. (AGIO), it was a pleasant surprise when the FDA approved Tibsovo (Ivosidenib) for treating relapsed or refractory acute myeloid leukemia patients with an IDH1 mutation on July 20, one month ahead of the agency’s expected decision date.

Now, here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.

1. Lannett Co. (LCI)

The FDA decision on Lannett Co.’s (LCI) Numbrino Cocaine HCl, a proprietary local topical anesthetic with a nasal indication, due July 21, is awaited.

The NDA for Numbrino Cocaine HCl was submitted under 505(b)(2) regulatory pathway, and it is the Company’s first NDA submission to include full clinical trial studies.

The Company believes that Numbrino Cocaine HCl, if approved, may have broad applicability across a number of medical specialties, including Ears, Nose and Throat (ENT), Dermatologists, Obstetrics and Gynecology (OB-GYNs), Ophthalmologists, Emergency-Room (ER) physicians, oral surgeons, Proctologists, Veterinarians, Neurologists, Urologists, pain specialists, Oncologists, Hematologists and Podiatrists.

LCI closed Friday’s trading at $12.35, down 3.52%.

2. GlaxoSmithKline plc (GSK)

An FDA panel is slated to review GlaxoSmithKline’s (GSK) supplemental Biologics License Application seeking approval of Mepolizumab as an add-on to maintenance treatment for patients with eosinophilic chronic obstructive pulmonary disease on July 25, 2018.

Mepolizumab is already approved for use in the U.S., EU, Japan and a number of other countries worldwide under the brand name Nucala as an add-on maintenance treatment for eosinophilic asthma patients.

As recently as December 2017, the FDA expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.

Sales of Nucala were £344 million in 2017 compared to £236 million in 2016.

GSK closed Friday’s trading at $41.87, up 2.90%.

3. Biogen (BIIB)

Biogen is focused on developing innovative therapies for people living with serious neurological and neurodegenerative diseases.

Early this month, the Company announced positive topline results from a phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease.

The final analysis at 18 months of the 856 patient Phase II clinical study in early Alzheimer’s disease demonstrated statistically significant slowing in clinical decline and reduction of amyloid beta accumulated in the brain.

Watch out for…

New analysis from a phase Ib study of Aducanumab, an investigational anti-amyloid beta antibody therapy for mild cognitive impairment (MCI) due to Alzheimer’s disease and mild dementia due to Alzheimer’s disease, dubbed PRIME, are expected to be presented on July 22 at the Alzheimer’s Association International Conference.

Two phase III trials of Aducanumab, dubbed ENGAGE and EMERGE, are underway. The trials are testing the safety and efficacy of Aducanumab in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease.

BIIB closed Friday’s trading at $358.71, up 0.17%.

4. Clearside Biomedical Inc. (CLSD)

Clearside Biomedical Inc. is a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases.

Initial topline results from the Company’s pivotal phase III trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveits, dubbed PEACHTREE, were reported on March 5, 2018, which sent the stock up as much as 69% that day.

According to the trial results reported in March, the trial met the primary endpoint, demonstrating statistically significant improvement in proportion of patients gaining 15 or more letters in visual acuity. All the secondary endpoints were also achieved in the trial.

Watch out for…

Data from the PEACHTREE trial are expected to be presented on Wednesday, July 25 at the 2018 American Society of Retina Specialists Annual Meeting.

CLSD closed Friday’s trading at $10.00, up 0.10%.

5. Indivior PLC (INVVY.OB)

The FDA is due to announce on July 28, 2018 whether it will approve Indivior’s RBP-7000 Risperidone monthly depot for the treatment of schizophrenia.

RBP-7000 is a novel extended-release product using the ATRIGEL delivery system for the subcutaneous administration of Risperidone once every month for the treatment of schizophrenia.

In September 2017, DURECT Corp. (DRRX) assigned certain of its U.S. patent rights on RBP-7000 to Indivior under a patent purchase agreement.

Under the terms of the agreement, Indivior made an upfront non-refundable payment to DURECT of $12.5 million, with the potential for an additional $5 million based upon approval of RBP-7000, as well as quarterly earn-out payments.

INVVY.OB closed Friday’s trading at $22.35, down 1.32%.

6. INSYS Therapeutics Inc. (INSY)

The FDA decision on INSYS Therapeutics’ New Drug Application for a novel formulation of Buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain is expected on July 28, 2018.

On May 22, 2018, an expert panel convened by the FDA had voted not to recommend approval of Buprenorphine.

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

INSY closed Friday’s trading at $7.83, down 5.55%.

7. Theravance Biopharma Inc. (TBPH)

Theravance is a diversified biopharmaceutical company having one approved drug Vibativ, and a couple of drug candidates in clinical testing.

Vibativ is a once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections, and hospital-acquired and ventilator-associated bacterial pneumonia.

Watch out for…

Data from an exploratory phase IIa study of TD-9855 in patients with symptomatic neurogenic orthostatic hypotension (nOH) is expected by the end of this month.

Neurogenic orthostatic hypotension, or NOH for short, results from a deficient release of norepinephrine, the neurotransmitter used by autonomic nerves to send signals to the blood vessels and the heart. NOH is characterized by a chronic and often debilitating drop in blood pressure upon standing, lightheadedness, dizziness, blurred vision and syncope (fainting).

TBPH closed Friday’s trading at $25.90, down 1.48%.

8. Denali Therapeutics Inc. (DNLI)

Denali is a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases.

The Company’s most advanced core programs include LRRK2 inhibitor program to address Parkinson’s disease and RIPK1 inhibitor program to address Alzheimer’s disease and Amyotrophic lateral sclerosis (ALS).

The two most advanced product candidates in the LRRK2 program are DNL201 and DNL151.

DNL201 is currently in a Phase 1 clinical trial in healthy volunteers in the United States, and DNL151 is currently in a Phase 1 clinical trial in healthy volunteers in the Netherlands.

The most advanced product candidate in the RIPK1 inhibitor program is DNL747, which is currently in a Phase 1 clinical trial in healthy volunteers in the Netherlands.

Watch out for…

Top line data from the phase I trial of DNL201 in healthy volunteers, due in the first half of 2018, is awaited.

DNLI closed Friday’s trading at $13.46, down 3.86%.

9. Ra Pharmaceuticals Inc. (RARX)

Ra Pharma is a clinical-stage biopharmaceutical company focused on developing drugs for the treatment of serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system.

The Company’s lead drug candidate is RA101495 that is being developed for convenient self-administered subcutaneous injection for the treatment of paroxysmal nocturnal hemoglobinuria, Myasthenia Gravis, and renal indications such as atypical hemolytic uremic disorder (aHUS) and lupus nephritis.

Watch out for…

Data from a phase 1b clinical trial of RA101495 SC in atypical hemolytic uremic disorder, due mid-2018, is awaited.

RARX closed Friday’s trading at $11.17, up 2.10%.

10. CorMedix Inc. (CRMD)

CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease.

The Company’s lead product candidate is Neutrolin, a non-antibiotic anti-infective developed as a preventative solution to decrease the threat of infection and blood clots (thrombosis), thereby keeping central venous catheters (CVCs) operating safely and efficiently. It is approved as a CE Marked medical device in Europe, but is not approved in the U.S. yet.

Watch out for…

A phase III trial of Neutrolin in hemodialysis patients with central venous catheters, dubbed LOCK-IT-100, is underway. The Company anticipates Data Safety Monitoring Board Review of the LOCK-IT-100 study in July 2018.

CRMD closed Friday’s trading at $0.28, up 3.70%.

11. Bellerophon Therapeutics Inc. (BLPH)

Bellerophon is a late-stage biotherapeutics company.

The Company is developing INOpulse delivery system for the treatment of patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD).

Watch out for…

A phase III INOvation-1 study evaluating INOpulse in patients with pulmonary arterial hypertension is underway. Readout of the interim analysis of this trial due mid-2018 is awaited, with top-line data from the full study anticipated around the end of 2018.

BLPH closed Friday’s trading at $2.62, down 1.87%.

12. Altimmune Inc. (ALT)

Altimmune is a clinical-stage immunotherapeutics company having three clinical product candidates in its pipeline namely, NasoVAX, a phase II seasonal influenza vaccine candidate, HepTcell, a phase I immunotherapeutic candidate for the potential cure of chronic hepatitis B, SPARVAX-L, a phase II Anthrax vaccine, and NasoShield, a next generation Anthrax vaccine, under phase I study.

Watch out for…

Safety and immunogenicity data from phase I study of single dose NasoShield anthrax vaccine are expected in early 3Q, 2018.

ALT closed Friday’s trading at $0.40, up 11.08%.

13. Spring Bank Pharmaceuticals Inc. (SBPH)

Spring Bank Pharma is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers.

The Company’s lead product candidate is Inarigivir, also known as SB 9200, under Phase 2a trial, for the treatment of HBV, dubbed ACHIEVE.

The phase 2a trial has 4 monotherapy dosing regimens of SB 9200 namely, 25mg, 50mg, 100mg and 200mg followed by Viread for the treatment of chronic hepatitis B virus (HBV).

The Company has already reported results from the 24-week trial of both the 25mg and 50mg cohorts of Part A of the ongoing phase II ACHIEVE trial.

Watch out for…

Top-line results from the third monotherapy cohort (100mg) of the ACHIEVE trial due mid-2018, are awaited.

SBPH closed Friday’s trading at $12.56, up 0.96%.

14. Progenics Pharmaceuticals Inc. (PGNX)

On July 30, 2018, Progenics will know whether or not its drug candidate Azedra gets the FDA blessing.

Azedra, a radio-therapeutic, is proposed for the treatment of patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors.

If approved, analysts expect Azedra to rake in peak sales of between $200 million and $300 million.

PGNX closed Friday’s trading at $8.26, down 1.55%.

Food Recall Warning

Product photos are available at https://bit.ly/2LB2gdR 

OTTAWA, July 20, 2018 /CNW/ – MondelÄ“z Canada is recalling Christie brand Ritz Bits Sandwiches (cheese and pizza flavours) from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled products described below.

The following products have been sold nationally.

Recalled products

 

 

What you should do

If you think you became sick from consuming a recalled product, call your doctor.

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.

Background

This recall was triggered by a recall in another country. The Canadian Food Inspection Agency (CFIA) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Illnesses

There have been no reported illnesses associated with the consumption of these products.

More information

 

SOURCE Canadian Food Inspection Agency (CFIA)

TRT Holdings, Inc. Exploring Possible Sale Of Gold’s Gym

DALLAS, July 20, 2018 /PRNewswire/ – TRT Holdings, Inc., the majority shareholder of Gold’s Gym since 2004, says it will put the iconic fitness brand up for sale to focus more on its core business. It has retained Piper Jaffray Co. to conduct a sales process.

“Over the years we have received significant inbound interest from potential owners looking to buy the most iconic brand in fitness,” said TRT Holdings President Blake Rowling. “Given the tremendous growth currently happening in the fitness industry, the stellar leadership team we have in place and the recent excitement surrounding the evolution of the Gold’s Gym brand, that interest has spiked considerably. With TRT Holdings’ increased focus on its Omni Hotels Resorts, we feel that now is the right time to go to market.”

Gold’s Gym CEO Brandon Bean added, “In the last 24 months we’ve rolled out an entirely new Gold’s Gym experience focused on broadening the brand’s appeal, expanding our membership base and getting more people than ever engaged in our unique products and services. The popularity and growth of the Gold’s Gym brand is at an all-time high, and we’re excited to work with a new ownership group to continue this momentum across all our key business units, including our company-owned gyms, domestic and international franchising operations and global licensing program.”

During its partnership with TRT Holdings, Gold’s Gym has grown to 700+ locations across six continents and has differentiated the brand through a series of new fitness offerings, including GOLD’S STUDIO®, the company’s signature boutique-style fitness classes, BOOTCAMP large group training classes and 3D body scanning technology. With a core focus on innovation and expanding the brand’s reach beyond the four walls of the gym, Gold’s Gym also recently launched GOLD’S AMPTM, the first digital personal training and music app from a brick-and-mortar gym.

About TRT Holdings, Inc.
Dallas-based TRT Holdings is a large, diversified private holding company that owns Omni Hotels Resorts and Gold’s Gym, as well as numerous other public and private investments.

About Gold’s Gym
Gold’s Gym has been the world’s trusted fitness authority since 1965. From its beginning as a small gym in Venice, California, Gold’s Gym has grown into a global icon with more than 700 locations serving 3 million people across six continents each day. Featuring personalized transformation plans, state-of-the-art equipment, certified personal trainers, a diverse group exercise program and a supportive, motivating environment, Gold’s Gym delivers the most dynamic fitness experience in the industry. The Gold’s Gym experience recently expanded to include BOOTCAMP group training as well as GOLD’S STUDIO® – which gives members access to boutique-style classes like GOLD’S FIT®, GOLD’S BURNâ„¢ and GOLD’S CYCLEâ„¢, all under the same roof – along with GOLD’S AMPâ„¢, the first digital personal training app from a brick-and-mortar gym. More than a gym, Gold’s Gym combines coaching, community and more than 50 years of fitness expertise to help people around the world achieve their potential through fitness. For more information, visit www.goldsgym.com or follow Gold’s Gym on Facebook, Instagram and Twitter.

MEDIA CONTACT:
Nikki Richardson
nikki@spmcommunications.com
817-329-3257

 

Cision View original content:http://www.prnewswire.com/news-releases/trt-holdings-inc-exploring-possible-sale-of-golds-gym-300684484.html

SOURCE Gold’s Gym

Largo Resources Announces Filing of Final Short Form Prospectus

TORONTO, July 20, 2018 /CNW/ – Largo Resources Ltd. (“Largo” or the “Company“) (TSX: LGO) (OTCQX: LGORF) announces that, further to its earlier press release today, it has obtained a receipt for the filing of its final short form prospectus in connection with the previously announced secondary offering of common shares. A copy of the final short form prospectus and the receipt are available on SEDAR under the Company’s profile at www.sedar.com.

The common shares subject to the offering have not been and will not be registered under the U.S. Securities Act of 1933, as amended, (the “Securities Act”) and may not be offered or sold in the United States absent registration under or an applicable exemption from the registration requirements of the Securities Act. This press release does not constitute an offer to sell or the solicitation of an offer to buy the shares herein described, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About Largo Resources

Largo is a Toronto-based strategic mineral company focused on the production of vanadium flake, high purity vanadium flake and high purity vanadium powder at the Maracás Menchen Mine located in Bahia State, Brazil. The Company’s common shares are principally listed on the Toronto Stock Exchange under the symbol “LGO”. For more information on Largo, please visit our website at www.largoresources.com.

SOURCE Largo Resources Ltd.

Battery Honored With Campaign of the Year: Gold at the Ad Age Small Agency Awards

LOS ANGELES, July 21, 2018 /PRNewswire/ – On Wednesday, July 18, the independent advertising agency Battery took home top honors with Gold for ‘Integrated Campaign of the Year’ for their Netflix is a Joke campaign at the Ad Age Small Agency Awards. The Ad Age Small Agency Awards are the industry’s top honor for independent shops with 150 or fewer employees that demonstrate outsized impact for clients and innovation within their own businesses.

This is the third time that the Ad Age Small Agency Awards has recognized Battery. In 2015, they were honored with Silver for Small Agency of the Year 1-10 employees. Then in 2016, their campaign for Batman Arkham Knight won Silver for “Integrated Campaign of the Year.”

This award comes on the heels of significant momentum for Battery this past year having been recognized as Boutique Agency of the Year by ThinkLA, a top 20 Fastest Growing Private Company by the Los Angeles Business Journal and recently honored by the Cannes Lions International Festival of Creativity, the DAD Association, PromaxGames and The One Show adding to a long list of industry accomplishments for this independent agency founded in 2013.

“It’s absolutely wonderful that Ad Age has this award as independent agencies are becoming more and more important in our turbulent industry landscape. To be honored 3 times by Ad Age in our short 5-year history as an agency is immensely gratifying,” said Anson Sowby, CEO, and co-founder of Battery.

“Humbled and honored by this award. Small is the new big and we couldn’t be happier to be in such great company,” said Philip Khosid, CCO, and co-founder of Battery.

The prestigious award was presented during the Ad Age Small Agency Awards, honoring the best and brightest from the region. Finalists and winners were selected by a high-profile jury, and the full list of Ad Age Small Agency Awards honorees can be viewed online. For more information, visit: http://adage.com/article/agency-news/bssp-named-ad-age-s-small-agency-year/314051.

About Battery

Battery is an independent creative ad agency that makes product advertising as sought after as entertainment. Twice honored as an Ad Age Small Agency of the Year and recognized as a Top 20 Fastest Growing Private Company in LA County in 2016 and 2017. Battery creates global campaigns for such clients as Netflix, AECOM, Activision Blizzard, LEGO and Mike’s Hard Lemonade among others. More information can be found at www.batteryagency.com, or follow them online via Facebook, Twitter, Instagram  YouTube.

About Ad Age Small Agency Awards

Ad Age is a daily must-read for an influential audience of decision-makers and disruptors across the marketing and media landscape. Created in 1930 to cover a burgeoning industry with objectivity, accuracy, and fairness, Ad Age continues to be powered by award-winning journalism. Today, Ad Age is a global media brand focusing on curated creativity, data and analysis, people and culture, and innovation and forecasting.   From vital print editions to must-attend events and innovative platform offerings, its industry-leading offerings include the coveted A-List Creativity Awards, the Ad Age Next Conference, and proprietary data such as the Leading National Advertisers Report from the Ad Age Datacenter.

Cision View original content:http://www.prnewswire.com/news-releases/battery-honored-with-campaign-of-the-year-gold-at-the-ad-age-small-agency-awards-300684443.html

SOURCE Battery