AstraZeneca and Merck report prostate cancer data

AstraZeneca, Merck presents results from Phase 3 PROfound trial of LYNPARZA

AstraZeneca (AZN) and Merck (MRK) presented detailed results from the Phase 3 PROfound trial in 387 men with metastatic castration-resistant prostate cancer who have a mutation in their homologous recombination repair genes and whose disease had progressed on prior treatment with new hormonal agent treatments e.g. abiraterone or enzalutamide.

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AstraZeneca and Merck report prostate cancer, Stockwinners

The trial was designed to analyze men with mCRPC harboring HRR-mutated genes in two cohorts: the primary endpoint was in those with mutations in BRCA1/2 or ATM genes and then, if LYNPARZA showed clinical benefit, a formal analysis was performed of the overall trial population of men with HRRm genes.

Merck presents results from Phase 3 KEYNOTE-426 study, Stockwinners
AstraZeneca and Merck report prostate cancer , Stockwinners

Results showed a statistically-significant and clinically-meaningful improvement with LYNPARZA in the primary endpoint of radiographic progression-free survival in BRCA1/2 or ATM-mutated tumors reducing the risk of disease progression or death by a median of 7.4 months versus 3.6 months for those receiving abiraterone or enzalutamide.

LYNPARZA reduced the risk of disease progression or death by 66% for these men. The trial also met the key secondary endpoint of rPFS in the overall HRRm population, where LYNPARZA reduced the risk of disease progression or death by 51% and improved rPFS to a median of 5.8 months vs. 3.5 months for those receiving abiraterone or enzalutamide.

In the key secondary endpoint of time to pain progression, median TTPP was not reached with LYNPARZA and was 9.92 months with abiraterone and enzalutamide in patients with BRCA1/2 or ATM mutations.

Results also showed a trend at this interim analysis time point for improvement in overall survival, another key secondary endpoint. LYNPARZA extended OS to a median of 18.5 months versus 15.1 months for abiraterone or enzalutamide in men with BRCA1/2 or ATM-mutated tumors, of which 81% started on abiraterone or enzalutamide and, following confirmed disease progression, then switched to LYNPARZA.

At this interim analysis, the OS endpoint did not meet statistical significance. In an exploratory analysis, a similar trend in OS was observed at this interim analysis in the HRRm population with a median of 17.5 months for men treated with LYNPARZA vs. 14.3 months for those receiving abiraterone or enzalutamide.

The trial showed a confirmed overall response rate a key secondary endpoint of 33.3% for LYNPARZA vs. 2.3% for abiraterone or enzalutamide in patients with BRCA1/2 or ATM mutations.

In an exploratory analysis of patients in the overall HRRm population, confirmed ORR was 21.7 % for LYNPARZA vs. 4.5% for patients receiving abiraterone or enzalutamide. The safety and tolerability profile of LYNPARZA in the PROfound trial was in line with that observed in prior clinical trials.

The most common adverse events greater than or equal to20% for LYNPARZA compared to abiraterone or enzalutamide were anemia, nausea, fatigue and asthenia, decreased appetite, and diarrhea. Grade 3 or above AEs were anemia, fatigue and asthenia, vomiting, dyspnea, urinary tract infection, nausea, decreased appetite, diarrhea, and back pain. AEs led to discontinuation of treatment in 16% of patients on LYNPARZA vs. 9% on abiraterone and enzalutamide.

AstraZeneca and Merck are also exploring additional trials in prostate cancer, including the ongoing Phase 3 PROpel trial, evaluating LYNPARZA as a first-line therapy in mCRPC for patients with or without HRR mutations, in combination with abiraterone acetate.

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Aptiv, Hyundai Motor to form autonomous driving joint venture

Aptiv, Hyundai Motor to form autonomous driving JV

Aptiv (APTV) and Hyundai Motor Group (HYMTF) announced that they will be forming an autonomous driving joint venture.

This partnership brings together one of the industry’s most innovative vehicle technology providers and one of the world’s largest vehicle manufacturers.

Aptiva scores a victory by forming JV with Hyundai, Stockwinners

The joint venture will advance the design, development and commercialization of SAE Level 4 and 5 autonomous technologies, furthering the partners’ leadership position in the global autonomous driving ecosystem.

The joint venture will begin testing fully driverless systems in 2020 and have a production-ready autonomous driving platform available for robotaxi providers, fleet operators, and automotive manufacturers in 2022.

As part of the agreement, Hyundai Motor Group and Aptiv will each have a 50 percent ownership stake in the joint venture, valued at a total of $4B.

Hyundai forms autonomous driving joint venture, Stockwinners

Aptiv will contribute its autonomous driving technology, intellectual property, and approximately 700 employees focused on the development of scalable autonomous driving solutions.

Hyundai Motor Group affiliates – Hyundai Motor, Kia Motors and Hyundai Mobis – will collectively contribute $1.6B in cash at closing and $0.4B in vehicle engineering services, R&D resources, and access to intellectual property.

The partnership reinforces the companies’ shared vision of making mobility more safe, green, connected, and accessible by advancing the development and commercialization of the highest-performing and safest autonomous vehicles.

Shares of Aptiva are up 1.6% to $88.50.

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Barkerville Gold Mines sold for $256M

Osisko Gold to acquire Barkerville Gold Mines for approximately C$338M

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Osisko Gold Royalties (OR) announced that it has entered into a definitive agreement with Barkerville Gold Mines, pursuant to which Osisko has agreed to acquire all of the issued and outstanding common shares of Barkerville that it does not currently own, by way of a plan of arrangement under the Business Corporations Act.

Concurrent to the Arrangement, Osisko also announces the formation of the North Spirit Discovery Group, the next step in the evolution of Osisko’s accelerator business that Osisko pioneered over the last five years, with the goal of privatizing and surfacing value in resource development projects.

BGM sold to Osisko, Stockwinners.com

Under the terms of the Arrangement, each shareholder of Barkerville will receive 0.0357 of a common share of Osisko for each share of Barkerville held.

The Exchange Ratio implies consideration of C$0.58 per Barkerville share, based on the closing price of Osisko shares on the Toronto Stock Exchange on September 20, representing a 44% premium based on both companies’ trailing 20-day volume weighted average price as at September 20.

The Exchange Ratio implies a total equity value of approximately C$338M on a fully-diluted in the money basis, inclusive of Barkerville shares held by Osisko.

It is anticipated that the Arrangement will be completed in November. Upon completion of the transaction, current Osisko and Barkerville shareholders will hold approximately 91% and 9% of Osisko shares outstanding, respectively.

About the Companies

Barkerville Gold Mines Ltd. is focused on developing its extensive mineral rights package located in the historical Cariboo Mining District of central British Columbia. Barkerville’s Cariboo Gold Project mineral tenures cover 2,039 square kilometres; along a strike length of 67 kilometres which includes several past producing placer and hard rock mines, making it one of the most well-endowed land packages in British Columbia.

Osisko Gold Royalties Ltd is an intermediate precious metal royalty company that holds a North American focused portfolio of over 130 royalties, streams and precious metal offtakes. Osisko’s portfolio is anchored by its 5% NSR royalty on the Canadian Malartic Mine, which is the largest gold mine in Canada.

OR is down $1.18 to $11.07.

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Federal Reserve cuts benchmark interest rate by 25 basis points

Fed Chair Powell says more rate cuts could be needed if economy weakens

The Federal Reserve voted to cut interest rates by a quarter-percentage point for the second time in as many months to cushion the economy against a global slowdown amplified by the U.S.-China trade war. While they left the door open to additional cuts, officials were split over the decision and the outlook for further reductions.

Voting for the today’s 25 basis point cut today were Federal Reserve Chairman Jerome Powell, John Williams, Michelle #Bowman, Lael #Brainard, Richard #Clarida, Charles #Evans, and Randal #Quarles. Voting against the action were James #Bullard, who preferred at the meeting to lower the target range for the federal funds rate to 1.5% to 1.75%, and Esther George and Eric Rosengren, who preferred to maintain the target range at 2% to 2.25%.

FOMC Chair Powell votes for rate cut., Stockwinners

The Federal Reserve said in today’s statement, “Information received since the Federal Open Market Committee met in July indicates that the labor market remains strong and that economic activity has been rising at a moderate rate. Job gains have been solid, on average, in recent months, and the unemployment rate has remained low. Although household spending has been rising at a strong pace, business fixed investment and exports have weakened. On a 12-month basis, overall inflation and inflation for items other than food and energy are running below 2 percent. Market-based measures of inflation compensation remain low; survey-based measures of longer-term inflation expectations are little changed.”

Trade Negotiations

Fed Chair Powell said the Fed has to try to look through near-term volatility due to “complex” trade negotiations to react to the underlying economic situation. Powell said the central bank needs to be careful to not overreact but also to not underreact.

The Fed continues to see a strong labor market and reiterated that economic activity has been rising at a moderate rate. Job gains have been solid, on average, in recent months, and the unemployment rate has remained low.

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There was still a split between solid household spending, but weakening in business fixed investment and exports. Inflation is still running below 2%, while market-based measures of remain low. The Committee continued to appeal to implications of global developments for the economic outlook and low inflation as rationale for the easing.

More from Powell: this is a time of difficult judgments and disparate perspectives. The bulk of the FOMC is taking it meeting-by-meeting. He continues to believe it’s better to be proactive when adjusting policy, and when trouble is seen approaching on the horizon, you should steer away from it if possible. The Fed has repeatedly shifted policy to support the economy, showing the Fed’s willingness to to move based on an evolving risk picture. There’s real uncertainty around the effects of the trade policy. On the funding issues seen this week, Powell said analysts took appropriate actions to address the pressures. If there are additional pressures, analysts have the tools to address the funding pressures and analysts will not hesitate to use them. The Fed will be returning to the question of when to build the balance sheet. The level remains uncertain, however.

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FDA panel approves Aimmune Therapeutics’ peanut allergy treatment

FDA Panel approves peanut allergy treatment, Stockwinners

A Food and Drug Administration panel voted 8-1 in favor of the benefits of Aimmune Therapeutics’ (AIMT) peanut allergy treatment outweigh the risks. The panel also voted 8-1 in favor of the drug’s safety. The body of independent advisers voted 7-2 in favor of effectiveness.

If approved, Palforzia could come with a Risk Evaluation and Mitigation Strategy, or REMS. A REMS includes special steps a physician must take when prescribing a medication to limit serious side effects.

Side effects are key when it comes to Palforzia. In a key study, 11.6% of patients who received the peanut allergy treatment dropped out due to side effects vs. 2.4% of patients who took a placebo. Further, Palforzia patients needed emergency allergy shots more frequently.

Peanut allergy is expected to be a $3.9B market by 2027, Stockwinners

The advisory committee vote is not binding, but is a recommendation to the full FDA.

Peanut allergies are the leading cause of death from food-induced allergic reactions in the United States but a lack of approved preventive treatments has left patients and caregivers desperate for options.

Palforzia, previously known as AR101, is an oral immunotherapy consisting of fixed doses of powdered peanut that is sprinkled over food daily.

While it does not aim to cure peanut allergy, the treatment’s clinical trials have shown that patients consuming small doses of the substance to which they are allergic become desensitized over time, reducing the likelihood or severity of a reaction to it.

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If approved, Palforzia is expected to have a black box warning, the FDA’s harshest, and strict restrictions requiring the therapy to be administered in a certified facility.

Aimmune expects to win approval for use of Palforzia in patients aged 4 to 17 and said it is considering a list price range of between $3,000 and $20,000 a year.

Analyst Comments

Piper Jaffray analyst Christopher Raymond kept an Overweight rating and $60 price target on Aimmune after an FDA’s Allergenic Products Advisory Committee, or APAC, voted in favor of the company’s AR101 peanut allergy drug on both efficacy and safety.

The analyst said, after the vote, he “increasingly likes the chances for Palforzia approval by late January 2020 (if not sooner).” Raymond noted that the stock is likely to open sharply higher on Monday as there is a 30% short interest in Aimmune, and said he is a buyer on the open as he sees “a lot of room to go.”

AIMT last traded at $24.67.

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Assurance IQ sold for $2.35 billion

Prudential acquires Assurance IQ for $2.35B plus additional earnout up to $1.5B

Prudential Financial (PRU) announced that it has signed a definitive agreement to acquire Assurance IQ, “a profitable, fast-growing direct-to-consumer platform that transforms the buying experience for individuals seeking personalized health and financial wellness solutions.”

Prudential Financial (PRU) announced that it has signed a definitive agreement to acquire Assurance IQ, "a profitable, fast-growing direct-to-consumer platform that transforms the buying experience for individuals seeking personalized health and financial wellness solutions."
Prudential pays $2.35 B for Assurance. Stockwinners

Terms of the acquisition include a total upfront consideration of $2.35 billion, plus an additional earnout of up to $1.15 billion in cash and equity, contingent upon Assurance achieving multi-year growth objectives.

Under the terms of the agreement, Assurance will become a wholly owned subsidiary of Prudential under the U.S. Businesses division.

Prudential buys Assurance IQ for $2.5B, Stockwinners

Assurance co-founders Michael Rowell and Michael Paulus will continue to focus on the growth of Assurance.

Rowell will remain CEO of Assurance and report to Andrew Sullivan, who will assume the role of executive vice president and head of U.S. Businesses as of December 1.

Paulus will remain president of Assurance.

The acquisition is expected to be modestly accretive to EPS and ROE starting in 2020.

In addition to enhancing the growth of Prudential’s financial wellness businesses, the acquisition is expected to generate cost savings of $50 million to $100 million, in addition to the $500 million of expected margin expansion by 2022 discussed at Prudential’s June Investor Day.

Prudential plans to use a combination of its current cash, debt financing and equity to fund the acquisition, which is expected to close early in the fourth quarter of 2019. Prudential’s Board of Directors unanimously approved the transaction.

Prudential’s Board of Directors has authorized a $500 million increase to its share repurchase authorization for calendar year 2019.

As a result, the share repurchase authorization for the full year 2019 is $2.5 billion.

As of June 30, Prudential had repurchased $1.0 billion of shares of its common stock under this authorization.

Prudential expects to fully utilize this increased share repurchase authorization by the end of 2019.

PRU +$2.21 to $81.85

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