PTC Therapeutics higher after acquiring Agilis Biotherapeutics

 PTC Therapeutics to acquire Agilis Biotherapeutics

PTC Therapeutics to acquire Agilis Biotherapeutics

PTC Therapeutics (PTCT)  announced that it has entered into an agreement to acquire Agilis Biotherapeutics.

The transaction was approved by the Boards of both companies. The transaction is expected to close in the third quarter of 2018, pending successful fulfillment of all customary closing conditions.

On completion, PTC plans a smooth transition of operations and the integration of Agilis’ talented and dedicated employees to continue the mission of bringing the pipeline of gene therapies for CNS disorders to patients worldwide.

Under the terms of the merger agreement, PTC will pay an upfront consideration of $50M in cash and approximately $150M in PTC common stock, subject to an estimated maximum 9.34M share limit (with any shortfall to be made whole with additional cash consideration). In addition to the upfront payments, potential future consideration includes $60M in development milestones to be paid over the next two years which includes the acceptance of a BLA.

Additionally, the transaction includes up to $535M in success-based milestones in connection with regulatory approvals on the three most advanced programs and receipt of a priority review voucher, as well as tiered commercial milestones of $150M, and 2-6 % of annual net sales for Friedreich ataxia and Angelman syndrome.

PTCT closed at $36.55, it last traded at $39.38.


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The Philly Fed rises to 25.7 in July

The Philly Fed bounce to 25.7

 

The Philly Fed rises to 25.7 in July , Stockwinners
The Philly Fed rises to 25.7 in July , Stockwinners

The Philly Fed bounce to 25.7 from a 19-month low of 19.9 in June and a 1-year high of 34.4 in May was accompanied by an ISM-adjusted Philly Fed rise to 59.7 from 59.4 in June and a 45-year high of 62.5 in May, versus the same 59.7 in April.

The Federal Reserve Bank of Philadelphia reports that regional manufacturing activity continued to expand in July. All the broad indicators remained positive, with the general activity and new orders indexes improving this month. The survey’s price indexes suggest widespread increases for purchased inputs, and more firms reported price increases for their own manufactured goods. Expectations for the next six months continued to moderate but remain positive overall.

Monday’s Empire State headline slipped to 22.6 in July from an 8-month high of 25.0 in June but a lower 20.1 in May, while the ISM-adjusted measure fell more sharply, to 54.6 from a 12-year high of 57.9 in June and 56.9 in May.

The U.S. state of New York has been known by many nicknames, most notably as the Empire State, adopted as late as the 19th century. This nickname has been incorporated into the names of several state buildings and events, and is commonly believed to refer to the state’s wealth and resources.

For later July surveys, analysts expect a Richmond Fed drop to 17.0 from 20.0, a Dallas Fed drop to 30.0 from 36.5, a Chicago PMI decline to 60.0 from 64.1 in June, an ISM drop to 59.0 from 60.2, and an ISM-NMI drop to 58.0 from 59.1

The mix should allow the ISM-adjusted average of the major surveys to slip back to 58 from the 59 cycle-high set in May and June, versus the same 58 readings in six of eight months through April.

Producer sentiment is enjoying a lift from fiscal stimulus, the mining and factory resurgence, and a stronger global economy that has translated to strength in trade in the face of limited capacity constraints and little near-term inflation risk.


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 EU ruling against Google seen as win for Amazon, Apple

EU antitrust ruling against Google seen as win for Amazon, Apple

 

 EU ruling against Google seen as win for Amazon, Apple, Stockwinners
EU ruling against Google seen as win for Amazon, Apple, Stockwinners

The EU has hit Alphabet-owned Google (GOOG; GOOGL) with a record antitrust fine for abusing the dominance of its Android mobile operating system.

Commenting on the decision, Baird analyst Colin Sebastian said he believes it to be a “pro-Amazon” (AMZN) ruling, benefiting the e-commerce giant and potentially Apple (AAPL) as well.

ANTITRUST FINE

The European Commission has fined Google EUR4.34B for breaching EU antitrust rules.

“Since 2011, Google has imposed illegal restrictions on Android device manufacturers and mobile network operators to cement its dominant position in general internet search. Google must now bring the conduct effectively to an end within 90 days or face penalty payments of up to 5% of the average daily worldwide turnover of Alphabet, Google’s parent company,” the Commission stated.

Google CEO Sundar Pichai, in response to the European Commission competition decision, stated that “rapid innovation, wide choice, and falling prices are classic hallmarks of robust competition and Android has enabled all of them.

Today’s decision rejects the business model that supports Android, which has created more choice for everyone, not less. We intend to appeal.”

‘PRO-AMAZON’ RULING:

In a research note to investors, Baird’s Sebastian argued that the European Commission’s ruling against Google is “a bit misguided,” but likely a “relatively minor inconvenience” in the short and medium terms.

Longer-term, the analyst said he sees modest but not unexpected added risk from requirements to support forked versions of Android, and from the direct and/or indirect benefits of this ruling for Apple and Amazon. In practical terms, the EC is saying that Android users need to download the Google apps they want rather than have them pre-installed and implicitly instructs Google to make its apps available on forked-version of Android, even if those apps won’t work as well or as intended on modified operating systems, he contended.

Sebastian believes this ruling should have a limited direct impact on Google since it ostensibly does not force a change to the Google search algorithm and seems relatively straight-forward for Google to comply. However, the bigger issue may be the obvious benefits to Amazon and potentially Apple, he argued.

The analyst pointed out that while Amazon already generates about 50% of commerce and product-related searches, the EC will require Android users to take another step before they can access an alternative product search engine. Additionally, to force Google to support distribution of forked-versions of Android could directly benefit Amazon’s Fire devices, he highlighted.

Nonetheless, the analyst noted that the decision does not change his positive view on Alphabet and reiterated an Outperform rating and $1,300 price target on shares of Google’s parent company.

PRICE ACTION

In morning trading, Class A shares of Alphabet and Amazon are each fractionally lower. Meanwhile, Apple’s stock has dropped almost 1% to $190.12.


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Dropbox drops as Facebook mulls switch to Google

Dropbox drops as Facebook mulls switch to Google for cloud storage

Dropbox drops as Facebook mulls switch to Google, Stockwinners
Dropbox drops as Facebook mulls switch to Google, Stockwinners

Shares of Dropbox (DBX) fell in morning trading following a report that said Facebook (FB) is considering moving its cloud storage away from the file hosting service.

FACEBOOK CONSIDERING SWITCH

Facebook is considering switching to Google (GOOG, GOOGL) for email and productivity applications, The Information reported earlier, citing two people with knowledge of the discussions.

The move would be a setback for Microsoft (MSFT), whose applications Facebook currently uses. Facebook, which has about 27,000 employees, stopped using Google apps inside the company several years ago. Additionally, Facebook is also considering moving its cloud storage to Google from Dropbox, according to The Information.

WHAT’S NOTABLE

Last month, Dropbox announced a new chapter in the evolution of Magic Pocket, its custom-built storage infrastructure, saying it is deploying Shingled Magnetic Recording, or SMR, drive technology to increase overall storage density, reduce the company’s physical data center footprint and provide significant cost savings without sacrificing performance or reliability.

Dropbox said at the time that it expects to have a quarter of its Magic Pocket infrastructure on SMR drive capacity by 2019. In its debut earnings report, Dropbox reported revenue of $316.3M, up 28% from the year-ago period.

PRICE ACTION

Shares of Dropbox are down about 4% to $31.03 in morning trading following the report.


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Arconic higher following report of private equity interest

Arconic higher following report of private equity interest

Arconic higher following report of private equity interest, Stockwinners
Arconic higher following report of private equity interest, Stockwinners

Shares of Arconic (ARNC) are rising following a report that the aluminum producer has received interest from private equity firms including Apollo Global Management (APO).

PE  INTEREST

Arconic has received takeover interest from private-equity firms, including Apollo Global, The Wall Street Journal reported Friday.

A deal for the aerospace parts maker, which currently has a market value of $8.3B, could be worth over $10B, but no buyout agreement is imminent, the report said.

The company, which also holds $6.4B in debt, has a tumultuous recent history, facing an activist investor campaign from Elliott Management after being separated from the aluminum business now known as Alcoa (AA) in 2016.

The campaign led to the resignation of former Arconic Chief Executive Officer Klaus Kleinfeld and an overhaul of the company’s board.

In addition, the company came under scrutiny after investigators discovered its aluminum composite panels contributed to the spread of a fire last year at London’s Grenfell Tower that killed 80 people.

At the time, Arconic said it had no control over how its products were used in the building.

‘PLAUSIBLE LBO CANDIDATE’

Following the WSJ report, Morgan Stanley analyst Rajeev Lalwani said two things stand out to make Arconic a “plausible” leveraged buyout candidate: Its low EV/EBITDA multiple, which creates potentially favorable entry and exit points, and its cash flow profile, which has room for improvement.

The analyst stated that a more lean and efficient approach could support considerably better cash generation.

While the reported private equity interest “adds a level of intrigue,” Lalwani still believes headwinds within it rings and disks business, working capital and CapEx issues and volatility associated with aluminum prices will be the key driver of shares in the near-term.

Given the aforementioned execution concerns, Lalwani kept an Equal Weight rating and $20 price target on Arconic shares.

‘VERY VIABLE LBO CANDIDATE’

Credit Suisse analyst Curt Woodworth said he views Arconic as a “very viable” leveraged buyout candidate given its “highly depressed” multiples, operational and financial mismanagement, and “very strong” positions in automotive and aerospace end markets.

The analyst believes the issues at Firth Rixson are “very fixable” as the company is a new entrant into the disks market and said Arconic could be worth $24-$26 per share in a buyout. Woodworth has an Outperform rating on the shares with a $28 price target.

WHAT’S NOTABLE

On Monday, Arconic announced it had signed a new long-term contract with Boeing (BA) to supply aluminum sheet and plate for all models produced by Boeing Commercial Airplanes.

The multiyear contract, which extends and adds to the companies’ 2014 contract, is the largest to date and captures growth in the build rate increases of the Boeing 737 program.

PRICE ACTION

Arconic rose about 10%, or $1.73, to $19.12 in morning.


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Market higher at midday

Stocks on Wall Street were higher at midday as the S&P 500 rose above 2,800 for the first time since the middle of March.

Stocks on Wall Street were higher at midday as the S&P 500 rose above 2,800, Stockwinners
Stocks on Wall Street were higher at midday as the S&P 500 rose above 2,800, Stockwinners

The Dow has also been strong, though not much of that outperformance is due to JPMorgan (JPM) after the bank and several of its large peers kicked off earnings season with their reports this morning.

ECONOMIC EVENTS:

In the U.S., the June trade price report was mixed, with a weaker than expected 0.4% import price decline and a stronger than expected 0.3% increase in export prices.

The University of Michigan consumer sentiment survey was weaker than expected, falling 1.1 points to a 6-month low of 97.1 in the preliminary print for July. In Asia, China’s exports were strong in June, rising 11.3%, while imports fell a bit short of expectations with an increase of 14.1%.

COMPANY NEWS:

Shares of JPMorgan advanced fractionally after it started off this summer’s earnings season by reporting better than expected earnings for the second quarter. Of note, the bank’s CEO Jamie Dimon said he sees “good global economic growth, particularly in the U.S.”

Meanwhile, Wells Fargo (WFC) slipped 2% after reporting downbeat results for Q2, with the company noting in presentation slides that the third party review of customer accounts is “ongoing.”

Citi (C) shares also fell about 2% after its quarterly report, though the bank’s headline earnings for the quarter beat analysts’ estimates.

In addition, PNC Financial (PNC) reported better than expected results for the quarter and guided for third quarter net interest income to be up low-single digits…

Meanwhile, AT&T (T) was in focus after the U.S. Department of Justice said it plans to appeal the approval of the merger between AT&T and Time Warner. In an interview on CNBC this morning, AT&T CEO Randall Stephenson said that he doesn’t know exactly what the government basis will be for an appeal and that the move by the DOJ “changes nothing”.

Johnson & Johnson (JNJ) dipped about 1% after a Missouri jury awarded $4.69B to 22 women who alleged that use of J&J’s talcum powder products caused their ovarian cancer. The jury award includes $550M in compensatory damages and $4.14B in punitive damages against the company. J&J responded by saying it “intends to pursue all available appellate remedies.”

MAJOR MOVERS:

Among the noteworthy gainers was Biocept (BIOC), which surged 58% after it announced a provider agreement with Alliance Global FZ.

Also higher was Achillion (ACHN), which gained 13% after it said it began dosing in its Phase 1 trial of ACH-5548. Among the notable losers was Gogo (GOGO), which fell 11%, reversing last night’s afterhours gains following the company’s announcement of a strategic review.

Also lower was Ingredion (INGR), which dropped 11% after it announced a $125M cost savings program, provided lower than expected Q2 guidance, and cut its outlook for fiscal 2018.

INDEXES:

Near midday, the Dow was up 93.18, or 0.37%, to 25,018.07, the Nasdaq was up 13.35, or 0.17%, to 7,837.26, and the S&P 500 was up 4.74, or 0.17%, to 2,803.03.


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Zogenix sharply higher on data

Zogenix says primary endpoint achieved in second Phase 3 clinical trial of ZX008

Zogenix sharply higher on data, Stockwinners
Zogenix sharply higher on data, Stockwinners

Zogenix (ZGNX) reported positive top-line results from its second confirmatory Phase 3 study for its investigational drug, ZX008, for the treatment of children and young adults with Dravet syndrome.

Dravet syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures. Previously known as Severe Myoclonic Epilepsy of Infancy (SMEI), it affects one out of 15,700 individuals, 80% of whom have a mutation in their SCN1A gene.

The study results, which are consistent with those reported in Study 1, Zogenix’s first pivotal Phase 3 study, successfully met the primary endpoint and all key secondary endpoints, demonstrating that ZX008, at a dose of 0.5 mg/kg/day, is superior to placebo when added to a stiripentol regimen. Key Findings: Patients taking ZX008 achieved a 54.7% greater reduction in mean monthly convulsive seizures compared to placebo.

The median reduction in monthly convulsive seizure frequency was 62.7% in the ZX008 group compared to 1.2% in placebo patients. ZX008 also demonstrated statistically significant improvement versus placebo in both key secondary measures, including patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval.

ZX008 was generally well-tolerated in this study with the adverse events consistent with those observed in Study 1 and the known safety profile of fenfluramine.

No patient exhibited cardiac valvulopathy or pulmonary hypertension at any time in the study.

Secondary endpoints assessed ZX008 compared to placebo in terms of the proportions of patients who achieved greater than or equal to 50% reductions and greater than or equal to 75% reductions in monthly convulsive seizures, as well as the median of the longest convulsive seizure-free interval.

ZX008 was generally well-tolerated in this study, with the adverse events consistent with those observed in Study 1 and the known safety profile of fenfluramine.

The incidence of treatment emergent adverse events was similar in both the treatment and placebo groups, with 97.7% of patients receiving ZX008 experiencing at least one treatment emergent adverse event compared to 95.5% of patients in the placebo group.

The most common adverse events in the ZX008 group were decreased appetite, diarrhea, pyrexia, fatigue, and nasopharyngitis.

The incidence of serious adverse events was similar in both the treatment and placebo groups, with 14% of patients in the ZX008 group experiencing at least one treatment emergent serious adverse event compared to 15.9% of patients in the placebo group. T

wo patients in the ZX008 group had an adverse event leading to study discontinuation compared to one in the placebo group.

ZGNX closed at $46.30, it last traded at $55.30.


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CA Technologies sold for $18.9 billion

Broadcom to acquire CA Technologies for $44.50 per share in cash

Stockwinners, Winning stock research since 1998
CA Technologies sold for $18.9 billion, Stockwinners

Broadcom (AVGO) and CA Technologies (CA) announced that the companies have entered into a definitive agreement under which Broadcom has agreed to acquire CA to build one of the world’s leading infrastructure technology companies.

Under the terms of the agreement, which has been approved by the boards of directors of both companies, CA’s shareholders will receive $44.50 per share in cash. This represents a premium of approximately 20% to the closing price of CA common stock on July 11, 2018, the last trading day prior to the transaction announcement, and a premium of approximately 23% to CA’s volume-weighted average price for the last 30 trading days.

The all-cash transaction represents an equity value of approximately $18.9B, and an enterprise value of approximately $18.4B.

The transaction is expected to drive Broadcom’s long-term Adjusted EBITDA margins above 55% and be immediately accretive to Broadcom’s non-GAAP EPS.

On a combined basis, Broadcom expects to have last twelve months non-GAAP revenues of approximately $23.9B and last twelve months non-GAAP Adjusted EBITDA of approximately $11.6B.

Broadcom intends to fund the transaction with cash on hand and $18B in new, fully-committed debt financing.

Broadcom expects to maintain an investment grade rating, given its strong cash flow generation and intention to rapidly de-leverage.

The transaction is subject to customary closing conditions, including the approval of CA shareholders and antitrust approvals in the U.S., the EU and Japan.

Careal Property Group AG and affiliates, who collectively own approximately 25% of the outstanding shares of CA common stock, have entered into a voting agreement to vote in favor of the transaction.

The closing of the transaction is expected to occur in the fourth calendar quarter of 2018.


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Pfizer shares lower after talk with President prompts rollback

Pfizer under pressure after talk with President prompts rollback

Pfizer shares lower after talk with President prompts rollback, Stockwinners
Pfizer shares lower after talk with President prompts rollback, Stockwinners

After speaking with President Donald Trump, Pfizer (PFE) stated that it will roll back its July 1 price increases “to give the president an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients.”

Additionally this morning, the company announced that it will reorganize into three units, separating its consumer health-care business, which the drugmaker has been trying to sell since last year, from its groups focused on “innovative” medicines” and “established” medicines.

PRICE ROLLBACK

In a statement provided to CNBC’s Meg Tirrell yesterday, Pfizer said it will roll back its July 1 price increases “to give the president an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients.”

The company released the statement following an “extensive discussion” with President Trump. Pfizer said it will return such prices to their pre-July 1 levels as soon as technically possible, and the prices will remain in effect until the earlier of when the president’s blueprint goes into effect or the end of the year. In addition, the drug giant said that the price declines the company took as of July 1 will remain in effect.

This comes after President Trump called out the company and other drugmakers for raising prices.

In a tweet, Trump previously said Pfizer and peers “should be ashamed that they have raised drug prices for no reason,” accusing the company and industry of “merely taking advantage of the poor and others unable to defend themselves, while at the same time giving bargain basement prices to other countries in Europe and elsewhere.”

BUSINESS REORGANIZATION

This morning, Pfizer also announced it will organize the company into three businesses, namely a science-based Innovative Medicines business that will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer; and a Consumer Healthcare business.

These changes will be effective at the beginning of the company’s 2019 fiscal year, and are not expected to impact current capital allocation priorities or full-year 2018 financial guidance.

READ-THROUGH TO OTHERS IN THE SECTOR

Commenting on the events, Wells Fargo analyst David Maris told investors that drug stocks will not react favorably to this news, given the chilling effect this will likely have on others looking to take price increases.

Nonetheless, the analyst pointed out that the price increases taken in July are only small compared to other increases taken over the past year or several years, so the impact of the rollback to the healthcare system is insignificant in the big picture.

Maris also added that he believes the administration’s and other key legislators’ focus is not only on drug pricing, but on the overall supply chain and delivery system, including drug rebating, co-pay coupons, etc.

WHAT’S NOTABLE

According to Bloomberg, Gilead (GILD), Roche (RHHBY), Novo Nordisk (NVO) and Novartis (NVS) have all sent notices to California health plans rescinding or reducing previously announced price hikes in the wake of a new drug pricing transparency law that was enacted in the state.

The California measure, which is among the most aggressive efforts by states to rein in drug costs, is being challenged in court by the drug industry’s lobbying group, the report noted.

Other large cap pharmaceutical companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), and Sanofi (SNY).

PRICE ACTION

In morning trading, shares of Pfizer have dropped about 0.5% to $37.28.


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21st Century Fox boosts it’s offer for Sky

21st Century Fox boosts offer for Sky to GBP 14 or $32.5B 

21st Century Fox boosts it's offer for Sky , Stockwinners
21st Century Fox boosts it’s offer for Sky , Stockwinners

21st Century Fox (FOXA) and the Independent Committee of Sky PLC (SKYAY) announced that they have reached agreement on an increased recommended pre-conditional cash offer for the fully diluted share capital of Sky which Fox and its affiliates do not already own at a price of GBP 14.00 for each Sky share.

The price of GBP 14.00 per Sky share represents an increase of approximately 12% to the Comcast (CMCSA) offer price of GBP 12.50 per Sky share announced on April 25, Fox says in a statement.

Under the terms of the increased offer, Sky shareholders will be entitled to receive for each Sky share GBP 14.00 in cash.

The increased price includes an amount in lieu of a final dividend in respect of the financial year ended June 30, 2018.

It is intended that the acquisition will be implemented by means of a scheme of arrangement under applicable U.K. law.

The Sky Independent Committee announced that it intends to unanimously recommend that the Sky shareholders unaffiliated with 21st Century Fox vote in favor of the scheme and take no action in relation to the Comcast offer.

Fox currently anticipates that the acquisition will complete in Q3 of 2018.

Fox added that the Sky acquisition is not a condition to completion of the Disney (DIS) transaction.

Completion of the Sky acquisition will not affect the amount or form of consideration that stockholders of 21st Century Fox receive in the Disney deal, it said.

“We strongly believe that a combined 21CF and Sky will be a powerful driver for the continued growth and vibrancy of the UK and broader global creative industries.

The enhanced scale and capabilities of the combination will enrich Sky’s ability to continue on its mission for years to come, especially at a time of dynamic change in our industry.

This transformative transaction will position Sky so that it can continue to compete within an environment that now includes some of the largest companies in the world, but none of whom have demonstrated the same local depth of investment and commitment to the UK and to Europe,” added Fox.


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Bristol-Myers treatment for colorectal cancer approved

Bristol-Myers’ Opdivo approved for MSI-H/dMMR metastatic colorectal cancer

Bristol-Myers treatment for colorectal cancer approved, Stockwinners
Bristol-Myers treatment for colorectal cancer approved, Stockwinners

Bristol-Myers (BMY) announced Opdivo – nivolumab – 3 mg/kg plus low-dose Yervoy – ipilimumab – 1 mg/kg injections for intravenous use received approval from the FDA for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

Approval for this indication has been granted under accelerated approval.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The application was granted Priority Review and Breakthrough Therapy Designation by the FDA.

Among the 82 patients who received prior treatment with a fluoropyrimidine, oxaliplatin and irinotecan, 46% responded to treatment with Opdivo + Yervoy.

The percentage of these patients with a complete response was 3.7%, and the percentage of patients with a partial response was 43%.

Among these 38 responders, the median DOR was not reached; 89% of those patients had responses of six months or longer, and 21% had responses of 12 months or longer.

This trial is ongoing. Among all enrolled patients, 49% responded to treatment with Opdivo + Yervoy; 4.2% experienced a complete response, while 45% experienced a partial response.

Opdivo was discontinued in 13% of patients and delayed in 45% of patients due to an adverse reaction.

Serious adverse reactions occurred in 47% of patients.

The Opdivo + Yervoy combination is also approved in two other tumor types, advanced renal cell carcinoma and unresectable or metastatic melanoma.

Continued approval for these accelerated approval indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.

BMY closed at $56.18.


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Celgene announces positive breast cancer data

Celgene announces IMpassion130 study meets co-primary endpoint of PFS

Celgene announces positive breast cancer data, Stockwinners
Celgene announces positive breast cancer data, Stockwinners

Celgene (CELG) announced that the Phase III IMpassion130 study met its co-primary endpoint of progression-free survival, or PFS.

This is the first phase III study to demonstrate a statistically significant PFS improvement in first-line metastatic or unresectable locally advanced triple negative breast cancer, or TNBC, a type of breast cancer with high unmet need.

Results demonstrated that the investigational combination of Tecentriq plus Abraxane compared to Abraxane monotherapy, as an initial treatment, significantly reduced the risk of disease worsening or death in patients with metastatic or unresectable locally advanced TNBC in the intention-to-treat and PD-L1 positive populations.

Overall survival is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis.

Safety in the Tecentriq plus Abraxane arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.

ABRAXANE is a microtubule inhibitor indicated for the treatment of:

Metastatic breast cancer, after failure of combination chemotherapy
for metastatic disease or relapse within 6 months of adjuvant
chemotherapy. Prior therapy should have included an anthracycline
unless clinically contraindicated.
• Locally advanced or metastatic non-small cell lung cancer (NSCLC),
as first-line treatment in combination with carboplatin, in patients who
are not candidates for curative surgery or radiation therapy.
• Metastatic adenocarcinoma of the pancreas as first-line treatment, in
combination with gemcitabine.

TECENTRIQ is a prescription medicine used to treat:

A type of bladder and urinary tract cancer called urothelial carcinoma.

  • TECENTRIQ may be used when your bladder cancer:
    • has spread or cannot be removed by surgery, and
    • you are not able to take chemotherapy that contains a medicine called cisplatin, or
    • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.

CELG closed at $83.85.


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Spero Therapeutics higher on data

Spero says clinical data demonstrates SPR994 to be well-tolerated 

Spero Therapeutics higher on data, Stockwinners
Spero Therapeutics higher on data, Stockwinners

Spero Therapeutics (SPRO) reported positive results from an interim analysis of its ongoing single ascending dose and multiple ascending dose Phase 1 clinical trial of SPR994, its investigational oral carbapenem product candidate designed for the treatment of Gram-negative infections, in healthy volunteers.

The data demonstrate that SPR994 has a favorable safety, pharmacokinetic and pharmacodynamic profile that supports the advancement of SPR994 to a pivotal Phase 3 clinical trial at a 300 mg dose administered three times per day.

The Phase 1 clinical trial of SPR994 is assessing the safety, tolerability and pharmacokinetics of orally administered SPR994.

Interim Phase 1 results from the SAD portion of the trial demonstrate SPR994 to be well tolerated at doses ranging from 100 mg to 900 mg daily, with linear human pharmacokinetics over the dose range tested.

The data also show that the mean free drug plasma concentrations of tebipenem, the active metabolite of SPR994, remained above the MIC90 for the relevant bacterial pathogens for greater than 50% of an 8-hour dosing interval, consistent with the targeted therapeutic range observed in Spero’s hollow fiber experiments.

The pharmacokinetic profile of SPR994 observed to date in both the SAD and MAD portions of the trial provides evidence supporting SPR994’s administration without regard to meals.

Urine concentration data support the use of SPR994 to treat cUTI, with peak urine concentrations 100-fold higher than maximum concentrations in plasma.

No serious adverse events have been reported in the Phase 1 clinical trial to date.

Oral administration of SPR994 has been well tolerated at all doses tested and results are consistent with available clinical and post-marketing data for Orapenem and other approved IV carbapenem antibiotics.

Orapenem is currently approved in Japan for the treatment of pediatric infections and has the same orally bioavailable active ingredient as SPR994.

To date, the Phase 1 clinical trial has enrolled 115 healthy adult volunteers into 14 SAD cohorts and 1 MAD cohort. The SAD portion of the Phase 1 clinical trial is evaluating formulations of SPR994 at single doses ranging from 100 mg to 900 mg daily.

The MAD portion of the trial is designed to assess the safety, tolerability and pharmacokinetics of SPR994 administered orally to healthy volunteers for 14 days.

The initial MAD cohort received 300 mg of SPR994 administered three times per day and the MAD portion of the trial will continue to dose escalate to determine the maximum tolerated dose.

SPRO closed at $16.89, it last traded at $18.21.


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Biogen sharply higher on data

Eisai and Biogen announce positive results of the final analysis for BAN2401

Biogen sharply higher on data, Stockwinners
Biogen sharply higher on data, Stockwinners

Eisai (ESALY) and Biogen (BIIB) announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease.

The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score and on reduction of amyloid accumulated in the brain as measured using amyloid-PET. Topline results of the final analysis of the study demonstrated a statistically significant slowing of disease progression on the key clinical endpoint after 18 months of treatment in patients receiving the highest treatment dose as compared to placebo.

Results of amyloid PET analyses at 18 months, including reduction in amyloid PET standardized uptake value ratio and amyloid PET image visual read of subjects converting from positive to negative for amyloid in the brain, were also statistically significant at this dose. Dose-dependent changes from baseline were observed across the PET results and the clinical endpoints.

Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as 6 months including at 12 months. BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration.

The most common treatment emergent adverse events were infusion-related reactions and Amyloid Related Imaging Abnormalities. Infusion related reactions were mostly mild to moderate in severity. Incidence of ARIA-E was not more than 10% in any of the treatment arms, and less than 15% in patients with APOE4 at the highest dose per the study protocol safety and reporting procedures.

BIIB closed at $298.81, it last traded at $338. ESALY closed at $71.10.


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Xplore Technologies sold for $90 million

Zebra Technologies to acquire Xplore Technologies for $6.00 per share 

 

Xplore Technologies sold for $90 million, Stockwinners
Xplore Technologies sold for $90 million, Stockwinners

Zebra Technologies (ZBRA) and Xplore Technologies (XPLR) announced that their boards of directors have approved a definitive agreement in which Zebra will acquire all outstanding common stock of Xplore for $6.00 per share in cash.

Under the terms of the agreement, Zebra plans to implement the acquisition via a tender offer. Xplore has established a leading position as an innovative developer of semi-, fully- and ultra-rugged tablets, 2-in-1 laptops, and a range of performance matched accessories.

These products serve existing vertical markets for Zebra such as retail, manufacturing, transportation & logistics and healthcare, and provide an inroad into new markets including oil & gas, utility, government and public safety. Xplore generated revenue of $87M in the 12-month period ended March 31.

Zebra is effecting the acquisition through a public tender offer for 100% of the shares of Xplore.

In connection with the execution of the merger agreement, certain Xplore shareholders have entered into tender support agreements with Zebra pursuant to which they have agreed to tender their shares to Zebra’s offer.

The aggregate consideration of the transaction, including assumed indebtedness, is expected to be less than or equal to $90M.

Zebra expects to fund the transaction with a combination of cash on hand along with fully committed financing available under its credit facility. The transaction is subject to customary closing conditions and is expected to close in Q3.

XPLR closed at $4.12.


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