White House selects vaccine finalists

Novavax sinks after White House omits as COVID vaccine finalist

The New York Times reports that Moderna (MRNA) is among the five finalists selected by the Trump administration as the most likely to produce a vaccine for the coronavirus.

Moderna (MRNA) is one of the finalists

By narrowing the field, the White House is betting it can identify the most promising vaccines at an early stage, speed along the process of determining which will work and ensure that the winner or winners can be quickly manufactured in large quanities, the Times said.

Pfizer is also one of the finalists

The announcement of the decision will be made at the White House in the next few weeks, government officials said.

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AstraZeneca is one of the five companies.

Dr. Anthony S. Fauci, the federal government’s top epidemiologist and director of the National Institute of Allergy and Infectious Diseases, hinted at the coming action on Tuesday when he told a medical seminar that “by the beginning of 2021 we hope to have a couple of hundred million doses.”

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Johnson & Johnson is also a finalist for Covid 19 vaccine

Finalists

A White House announcement is expected in the new few weeks. In addition to Moderna, the winners are AstraZeneca (AZN), Johnson & Johnson (JNJ), Merck (MRK) and Pfizer (PFE), according the Times.

Merck presents results from Phase 3 KEYNOTE-426 study, Stockwinners
Merck is the final company on the list.

B. Riley FBR

B. Riley FBR analyst Mayank Mamtani views the selloff today in shares of Novavax on the New York Times report that the company was not selected as a finalist for the White House’s “Operation Warp Speed” as overdone.

Mamtani reiterates a Buy rating on Novavax. NVAX closed down 11% to $44.25.

Novax did not make the final cut, shares tumble

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Moderna shares jump on Fauci comments, possible COVID-19 vaccine

Moderna rises as Fauci comments on COVID vaccine potential highlighted

Shares of Moderna (MRNA) are trading higher, which is being attributed to comments made earlier this week by Dr. Anthony Fauci, the U.S. National Institute of Allergy and Infectious Diseases Director who has become one of the faces of the Trump administration’s COVID-19 response.

Fauci highlighted Moderna’s COVID-19 vaccine candidate, as well as another one in development at Oxford University, in an interview with National Geographic this week, telling the publication that he believes that the U.S. will have a vaccine ready for general use as soon as January “When we look at the immune response that you can induce with a modest dose – one that’s feasible to be translated into humans – and the amount of time it takes to get to that level of immunity, it is really quite impressive,” Fauci was quoted as saying when discussing both Moderna’s vaccine candidate and the one being developed at Oxford.

Modernal shares are higher on its vaccine potentail

“It is also really easy to scale up with these two, in the sense of making a lot of doses pretty quickly,” he reportedly added.

Dr. Fauci has been government’s leading Covid-19 expert

The interview, published two days ago, may be getting added attention after The Boston Business Journal published a recap with the headline “Fauci singles out Moderna’s coronavirus vaccine as reason for optimism” yesterday afternoon.

Moderna, Inc. (MRNA) is a clinical stage biotechnology company. It develops therapeutics and vaccines based on messenger RNA for the treatment of infectious diseases, immuno-oncology, rare diseases, and cardiovascular diseases.

Covid 19 has killed thousands of people worldwide

As of February 15, 2019 the company had 11 programs in clinical trials and a total of 20 development candidates in six modalities comprising prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, and systemic intracellular therapeutics. Moderna, Inc. also has a collaboration with Lonza Ltd. for the manufacture of mRNA-1273, a COVID-19 vaccine.

MRNA is up 9.5% to $53.50.

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Cash for Cannabis

Members of Congress look for marijuana industry included in virus relief

Members of the U.S. House of Representatives have signed a letter to congressional leaders asking that cannabis businesses be included in future federal relief packages due to COVID-19.

The letter which was sent to House Speaker Nancy Pelosi, a Democrat, and Minority Leader Kevin McCarthy, said in part:

“Thank you for your efforts to address the needs of the American people during the COVID-19 outbreak.

As you draft the next COVID-19 relief bill, we write to ask that you address one of the shortcomings of the CARES Act-the exclusion of state-legal cannabis businesses and their employees.

The COVID-19 crisis response demands the full participation of the American people, businesses, and workforce. However, without relief, a very large population is left without the means to execute the required public health measures and continue to provide financially for their families.

The state-legal cannabis industry is a major contributor to the U.S. economy and workforce, employing over 240,000 workers across 33 states and four territories, and generating $1.9 billion in state and local taxes in 2019.

As states respond to the COVID-19 crisis by shuttering businesses to mitigate the virus’ spread, jurisdictions across the country have recognized cannabis businesses as “essential.”

Essential businesses, in many places, can operate during the pandemic provided they abide by required public health safety measures. Like other businesses with continued operations, cannabis businesses have met the moment by preserving access to treatment for patients with chronic conditions, donating protective clothing, and manufacturing equipment for medical use.

However, unlike other small businesses, cannabis businesses are not eligible for the CARES Act programs.”

Publicly traded companies in the space include Aphria (APHA), Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), India Globalization Capital (IGC), Tilray (TLRY), Trulieve Cannabis (TCNNF) and Zynerba (ZYNE).

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Amarin shares tumble as court voids patent

Amarin ‘strongly disagrees’ with ruling in Vascepa ANDA litigation

Shares of Amarin (AMRN) tumbled in after hours trading after a federal judge ruled patents on its best selling drug, Vascepa was invalid. The company issued the following statement after shares tumbled 65 percent.

Amarin loses patent on its Vascepa, Stockwinners

Vascepa (Icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. It is used along with a proper diet to help lower fats (triglycerides) in the blood. This medication is thought to work by decreasing the amount of triglycerides made by the body.

Amarin Corporation (AMRN) commented on the United States District Court for the District of Nevada’s ruling in favor of the generic companies in the company’s patent litigation against two filers of abbreviated new drug applications, or ANDAs, for Amarin’s VASCEPA capsule franchise.

Vascepa is derived from fish oil, Stockwinners

Based on Amarin’s review of U.S. Food and Drug Administration’s website, an ANDA for VASCEPA has not been approved, which would be required for launch of a generic product in the United States.

The company thus does not believe there is an impending generic launch by the litigants that would compete with VASCEPA at this time.

“Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court’s decision and a preliminary injunction pending appeal to, if an ANDA is approved by FDA, prevent launch of generic versions of VASCEPA in the United States,” said John F. Thero, president and chief executive officer of Amarin.

“At Amarin, we have a strong balance sheet with capacity and flexibility, and we plan to fight to protect our VASCEPA franchise for the benefit of our patients, physicians, the broader healthcare community and our investors.

We believe we are favorably situated to obtain an injunction against generic launch pending appeal, subject to our posting a bond to secure generics’ lost profits in the event that generics prevail on appeal.

UK’s Hikma Pharma. had asked for overturn of the patent

As we work to take all legal actions necessary to defend and protect our intellectual property, we will continue to press forward with our educational and promotional efforts for VASCEPA in treating indicated patients at high risk of cardiovascular events, such as heart attack and stroke. After we determine the outcome of our effort to prevent a generic launch (if an ANDA approval is obtained), we expect to provide an update on how we would adjust certain promotional activities for VASCEPA in the United States.”

Generic drug maker Dr. Reddy’s will be making generic Vascepa

Generic drugmakers Hikma Pharmaceuticals of UK and Dr. Reddy’s Laboratories Limited  (RDY) had asked to overturn the patents so they can begin making generic versions of the medication.

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COVID-19 vaccine is coming

Johnson & Johnson announces lead vaccine candidate for COVID-19

Johnson & Johnson (JNJ) announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020.

JNJ’s Janssen Pharmaceutical promises a Covid-19 Vaccine, Stockwinners

The significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.

Janssen expects a Covid-19 vaccines by 2021, Stockwinners

The company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated time frame in comparison to the typical vaccine development process.

Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1B of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts.

Covid-19 has shut down most of the world, Stockwinners.com

Separately, BARDA and the company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

As part of its commitment, Johnson & Johnson is also expanding the company’s global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries.

The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally.

The company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.

JNJ closed at $123.16, last traded at $128.85.

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SmilesDirect and NBC clash

NBC reports problems with SDC, company claims poor reporting

SmileDirectClub (SDC) promises to fix customers’ smiles for about a third of the cost of traditional braces with at-home teeth straightening, but a number of patients say the aligners instead caused painful problems, NBC News reported yesterday.

SmilesDirect sells braces directly to consumers, Stockwinners

The Better Business Bureau reports more than 1,800 complaints nationwide involving SmileDirectClub, according to the report. Last month, nine members of Congress asked the Food and Drug Administration and the Federal Trade Commission to investigate SmileDirectClub “to ensure that it is not misleading consumers or causing patient harm.”

SmileDirectClub issues the following statement in response to the NBC story on the company.

The company said, in part, “We are disappointed that though we provided NBC with the opportunity to obtain all relevant facts as to the safety and efficacy of teledentistry for the provision of clear aligner therapy, NBC failed to provide its viewers with a balanced and fair news story reflecting those facts.

SDC package, Stockwinners

The piece misrepresents SmileDirectClub and the quality of care provided by the over 250 state-licensed dentists and orthodontists across the country who use our platform to treat their patients. We are surprised by the journalist’s blatant disregard for the facts and failure to include all of the accurate information we provided.

Notably, the almost five-minute report and online story does not include one interview or statement from the more than 750,000 satisfied customers who have used our products to improve their lives, nor does it include a single interview with any of the hundreds of dentists who have publicly supported our technology.

NBC reports a negative story on SDC

In fact, though NBC conducted interviews over the last 30 days with these doctors and customers under the guise of providing a fair and balanced story, their statements were not included or referenced in this story.

NBC airs this report causing SDC shares to tumble, Stockwinners

SmileDirectClub made customers, doctors and team members available for hours of in-person interviews, phone calls and email correspondence. The Company provided a tremendous amount of critical information that would have allowed NBC to report a more accurate and balanced story…There is no investigation into SmileDirectClub by the Federal Drug Administration or the FTC, and SmileDirectClub is in full compliance with FDA regulations, including its 510K manufacturing certification.

The letter referenced from members of Congress to the FDA is based on misinformation originated by dental trade organizations and is nothing more than the latest in a series of anti-competitive publicity tactics designed to attempt to limit our success, which is a direct threat to traditional orthodontia.

Of the nine congressmen who signed this letter, five are dentists, an interest that should be noted by an organization such as NBC Nightly News…Lastly, the California law states that dentists should review the “…patient’s most recent diagnostic digital or conventional radiographs or other equivalent bone imaging suitable for orthodontia.

New radiographs or other equivalent bone imaging shall be ordered if deemed appropriate by the treating dentist.” The doctors who use our platform are required to comply with the laws in every state in which they practice when using our platform, including the laws of the State of California.

While SmileDirectClub disagrees that the legislature should be setting clinical standards, we ensure that our model requires compliance with all laws.”

SDC closed at $15.33, last traded at $14.78.

Note that in recent days, Fidelity and Blackrock took major positions in SmilesDirect.

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Changyou.com sold for $579M

Changyou.com enters into definitive agreement for going private transaction

Changyou.com (CYOU) announced that it has entered into a definitive Agreement and Plan of Merger with Sohu Game, an indirectly wholly-owned subsidiary of Sohu.com (SOHU), and Changyou Merger, a wholly-owned subsidiary of Sohu Game, pursuant to which the company will be acquired by the Sohu Group in an all-cash transaction implying an equity value of the company of approximately $579M.

Changeyou.com sold to Sohu, Stockwinners.com

Pursuant to the terms of the Merger Agreement, at the effective time of the Merger, each Class A ordinary share of the company issued and outstanding immediately prior to the Effective Time, other than the Excluded Shares, will be cancelled and cease to exist, in exchange for the right to receive $5.40 in cash without interest, and each outstanding American depositary share of the company, other than the ADSs representing the Excluded Shares, will be cancelled in exchange for the right to receive $10.80 in cash without interest.

Sohu buys Changeyou.com, Stockwinners

The Merger Consideration represents a premium of 82.4% to the closing price of the company’s ADSs on September 6, 2019, the last trading day prior to the company’s announcement of its receipt of the “going-private” proposal, and a premium of 70.1% to the average closing price of the company’s ADSs during the 30 trading days prior to its receipt of the “going-private” proposal.

The Sohu Group intends to fund the Merger primarily with debt financing.

The Sohu Group has delivered a copy of an executed debt commitment letter to the company pursuant to which Industrial and Commercial Bank of China Limited, Tokyo Branch will provide, subject to the terms and conditions set forth therein, an amount sufficient to fund in full the consummation of Merger and the other transactions related thereto.

The company’s board, acting upon the unanimous recommendation of a committee of independent and disinterested directors established by the board, approved the Merger Agreement and the Merger.

The Special Committee negotiated the terms of the Merger Agreement with the assistance of its financial and legal advisors.

Because the Sohu Group owns over 90% of the voting power represented by all issued and outstanding shares of the company, the Merger will be in the form of a short-form merger of Merger Co. with and into Changyou in accordance with section 233(7) of the Companies Law of the Cayman Islands, with Changyou being the company surviving the Merger.

Shareholder approval of the Merger Agreement and the Merger is not required.

The Merger is currently expected to close in Q2 of 2020. If completed, the Merger will result in the company becoming a privately-owned company wholly owned directly and indirectly by Sohu, its ADSs will no longer be listed on the Nasdaq Global Select Market, and the ADS program will be terminated.

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Hexcel and Woodward merge to form Woodward Hexcel

Hexcel, Woodward announce merger of equals

Woodward (WWD) and Hexcel (HXL) announced a definitive agreement to combine in an all-stock merger of equals “to create a premier integrated systems provider serving the aerospace and industrial sectors,” the companies said.

Woodward and Hexcel agree to merge, Stockwinners

Under the terms of the agreement approved by the Boards of Directors of both companies, Hexcel shareholders will receive a fixed exchange ratio of 0.625 shares of Woodward common stock for each share of Hexcel common stock, and Woodward shareholders will continue to own the same number of shares of common stock in the combined company as they do immediately prior to the closing.

Hexcel and Woodward to merge, Stockwinners

The exchange ratio is consistent with the 30-day average share prices of both companies.

Upon completion of the merger, existing Woodward shareholders will own approximately 55% and existing Hexcel shareholders will own approximately 45% of the combined company on a fully diluted basis.

In connection with the transaction, Woodward is increasing its quarterly cash dividend to 28c a share.

The merger is expected to be tax free for U.S. federal income tax purposes.

The combined company will be named Woodward Hexcel.

For each company’s respective fiscal year 2019 on a pro forma basis, the combined company is expected to generate net revenues of approximately $5.3B and EBITDA of $1.1B, or a 21% EBITDA margin.

The transaction is subject to the approval of the shareholders of both Woodward and Hexcel, as well as other customary closing conditions, including required regulatory approvals.

The parties expect the merger to close in the third calendar quarter of 2020, subject to satisfaction of these conditions.

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Axsome Therapeutics reports positive migraine data

Axsome Therapeutics announces AXS-07 met primary, secondary endpoints

Axsome Therapeutics (AXSM) announced that AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, met the two regulatory co-primary endpoints and significantly improved migraine pain and most bothersome symptoms as compared to placebo in the MOMENTUM Phase 3 trial.

Axsome reports positive migraine data, Stockwinners

AXS-07 also met the key secondary endpoint, demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom from migraine pain.

MOMENTUM was a randomized, double-blind, placebo- and active-controlled trial which enrolled only patients with a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire, or mTOQ-4.

A total of 1,594 patients were randomized in a 2:2:2:1 ratio to AXS-07, rizatriptan, MoSEIC, meloxicam, or placebo, to treat a single migraine attack of moderate or severe intensity.

In addition to a history of inadequate response, enrolled patients exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes including cutaneous allodynia, severe migraine pain intensity, obesity and morning migraine.

The study was conducted pursuant to a FDA special protocol assessment, or SPA.

AXS-07 met the two regulatory co-primary endpoints by demonstrating, with high statistical significance, a greater percentage of patients as compared to placebo achieving pain freedom and absence of most bothersome symptom two hours after dosing.

Superiority of AXS-07 to rizatriptan and MoSEIC meloxicam was established as specified in the SPA, by demonstration of a greater percentage of AXS-07 patients achieving sustained pain freedom from two to 24 hours after dosing, compared to rizatriptan and MoSEIC meloxicam, as well as to placebo.

The positive results on both co-primary endpoints along with the demonstration of component contribution support the filing of an NDA for AXS-07 in the acute treatment of migraine.

AXS-07 provided greater and more sustained migraine pain relief compared to placebo and rizatriptan, which translated to a significant reduction in rescue medication use for AXS-07 compared to placebo and rizatriptan.

The percentage of patients experiencing sustained pain relief from two to 24 hours after dosing was 53.3% for AXS-07, compared to 33.5% for placebo and 43.9% for rizatriptan.

Sustained pain relief from two to 48 hours was also experienced by a statistically significantly greater proportion of AXS-07 patients, compared to placebo and rizatriptan patients.

Rescue medication was used by 23.0% of AXS-07 patients, compared to 43.5% of placebo and 34.7% of rizatriptan patients. AXS-07 provided rapid relief of migraine pain with the percentage of patients achieving pain relief with AXS-07 being numerically greater than with rizatriptan at every time point measured starting at 15 minutes, and statistically significantly greater than with rizatriptan by 60 minutes.

The proportions of patients experiencing pain relief 1.5 hours after dosing were 60.5% for AXS-07 compared to 52.5% for rizatriptan and 48.3% for placebo.

AXS-07 was statistically significantly superior to rizatriptan on several other secondary endpoints including Patient Global Impression of Change and return to normal functioning at 24 hours.

AXS-07 was safe and well tolerated in the trial.

The most commonly reported adverse events with AXS-07 were nausea, dizziness and somnolence, none of which occurred at a rate greater than placebo or greater than 3%.

There was one serious adverse event in the AXS-07 arm which was deemed by the investigator not to be related to study drug.

The MOMENTUM study was conducted pursuant to an SPA with the FDA.

The SPA provides agreement that the overall MOMENTUM trial design and planned analysis adequately address objectives that, if met, will support the regulatory submission for approval of AXS-07 for the indication of acute treatment of migraine in adults with or without aura.

Based on FDA feedback, Axsome believes that MOMENTUM will be the only efficacy trial required to support an NDA filing for AXS-07 for the acute treatment of migraine.

Axsome plans to file the NDA in the second half of 2020. AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC meloxicam and rizatriptan.

AXS-07 is thought to act by inhibiting CGRP release, reversing CGRP-mediated vasodilation, and inhibiting neuro-inflammation, pain signal transmission, and central sensitization.

Axsome’s MoSEIC technology significantly increases the speed of absorption of the meloxicam component after oral administration while maintaining a long plasma half-life.

AXS-07 is covered by 21 issued U.S. and international patents providing protection out to 2036, and Axsome maintains worldwide rights.

Detailed study results, including additional secondary endpoints, will be submitted for presentation at upcoming medical meetings and for publication.

AXS-07 is also being evaluated in the INTERCEPT Phase 3 trial which is a randomized, double-blind, placebo-controlled study evaluating the early treatment of migraine with AXS-07.

In contrast to the ongoing MOMENTUM trial in which patients with a history of inadequate response treated migraine attacks once they have become of moderate or severe intensity, in the INTERCEPT trial, patients are to administer AXS-07 at the earliest sign of migraine pain.

AXSM closed at $101.98.

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BeiGene announces acceptance of supplemental NDA in China for REVLIMID

BeiGene announces acceptance of supplemental NDA in China for REVLIMID for the treatment of lymphoma

BeiGene (BGNE) announced that the China National Medical Products Administration has accepted a supplemental new drug application for #REVLIMID, in combination with rituximab, for the treatment of patients with relapsed or refractory indolent lymphoma.

BeiGene shares have been active lately, Stockwinners

REVLIMID was first approved in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone, in adult patients who have received at least one prior therapy, and the label for the combination was expanded in 2018 to include adult patients with newly-diagnosed multiple myeloma who are not eligible for transplant.

REVLIMID used for the treatment of multiple myeloma, Stockwinners

It is currently marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl, a Bristol-Myers Squibb (BMY) company.

The sNDA is supported by a clinical, non-clinical, and chemistry, manufacturing and control data package, including the results from the pivotal Phase 3 AUGMENT study sponsored and conducted by Bristol-Myers Squibb.

Bristol-Myers treatment for colorectal cancer approved, Stockwinners
Bristol-Myers purchased Celgene and REVLIMID awhile back, Stockwinners

AUGMENT is a randomized, double-blind, multicenter trial in which a total of 358 patients with relapsed or refractory follicular or marginal zone lymphoma were randomized 1:1 to receive REVLIMID and rituximab or rituximab and placebo.

With a median follow-up of 28.3 months, R2 demonstrated clinically meaningful and statistically significant improvement in progression-free survival, evaluated by an independent review committee, relative to the control arm with a 54% reduction in the risk of progression or death.

The median PFS was 39.4 months for the R2 arm and 14.1 months for the control arm with an improvement by more than 2 years. Overall response rate, a secondary endpoint, was 78% in the R2 arm vs. 53% in the control arm, as assessed by the IRC.

Duration of response was significantly improved for R2 vs. control with median DoR of 37 vs. 22 months, respectively.

Bristol Meyers Comments on Celgene purchase, Stockwinners
Bristol Meyers Comments on Celgene purchase, Stockwinners

The most frequent adverse event in the R2 arm was neutropenia, vs. 22% in the control arm.

Additional commonly observed AEs in more than 20% of patients included diarrhea, constipation, cough, and fatigue. Adverse events that were reported at a higher rate in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare.

BMY closed at $63.51. BGNE closed at $173.14.

See our other blogs about BeiGene.

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MorphoSys higher on lymphoma data

MorphoSys says tafasitamab B-MIND study successfully passed futility analysis

MorphoSys (MOR) announced that the ongoing tafasitamab phase 3 B-MIND study has successfully passed the pre-planned, event-driven interim analysis for futility.

MorphoSys higher on lymphoma data, Stockwinners

An independent data monitoring committee reviewed the data and recommended to increase the number of patients from currently 330 to 450.

B-MIND compares the efficacy of the CD19 antibody tafasitamab plus bendamustine with rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma, or r/r DLBCL.

Tafasitamab (MOR208) is a humanized monoclonal antibody , Stockwinners

“Within the interim analysis for futility, data were assessed by the IDMC for the probability of a positive study at primary completion.

The IDMC assessed efficacy data in both the overall patient population as well as in the biomarker-positive subpopulation. The biomarker, described as patients with a low natural killer cell count at baseline, was implemented as a co-primary endpoint in an amendment of B-MIND in the first quarter 2019.

The recommendation to enroll more patients aims to increase statistical power of the study in the biomarker-described patient subpopulation as well as the overall patient population. Data of the analysis were not shared with MorphoSys.

As a continuation of the B-MIND study protocol, enrollment will proceed according to the original inclusion and exclusion criteria to allow for ongoing comparison of the efficacy in the overall and biomarker positive patient population.

Top line results are expected to be available in Q1 2022,” the company stated.

Piper Jaffray Comments

Piper Jaffray analyst Danielle Brill said news that MOR208 successfully passed the B-MIND trial futility analysis is “a positive clearing event for investors” that de-risks the stock, even though enrollment will be expanded from 300 to 450 patients and it is unclear how strong the efficacy signal was in the overall population.

She continues to expect FDA and EMA approval for MOR208 based on L-MIND data by mid-2020 and keeps an Overweight rating on MorphoSys shares.

MOR +$1.98 to $28.09.

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Esperion Therapeutics higher on cholesterol data

Esperion announces JAMA publication of results of Phase 3 study of bempedoic acid

Esperion Therapeutics (ESPR) announce that the results from the 779 patient, 52 week, Phase 3, double-blind, randomized placebo-controlled study of bempedoic acid were published in the Journal of the American Medical Association.

Esperion announces 'positive' top-line results from bempedoic acid study, Stockwinners.com
Esperion announces ‘positive’ results from bempedoic acid study, Stockwinners

Bempedoic acid is being developed as a, convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol added onto maximally tolerated statin therapy.

Bempedoic acid and the bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination tablets’ new drug applications are currently under regulatory review by the U.S. Food and Drug Administration, and the marketing authorisation applications are currently under centralized review by the European Medicines Agency.

Bempedoic acid in action, Stockwinners

Study 2 evaluated the long-term safety, tolerability and efficacy, of bempedoic acid 180 mg versus placebo in 779 patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia inadequately controlled with current lipid-modifying therapies, added-on to maximally tolerated statin therapy, which may mean no statin at all.

The JAMA publication includes results from the primary efficacy endpoint of LDL-C lowering at 12-weeks and key secondary endpoints of safety and tolerability over 52-weeks, including that bempedoic acid: significantly lowered LDL-cholesterol by 17 percent on background maximally tolerated statin therapy at 12 weeks, and the effect was durable through 52-weeks; significantly lowered high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease, by 19 percent, and the effect was durable through 52-weeks; reduced hemoglobin A1c by 0.21% vs. placebo in patients with diabetes at 12 weeks, favorable glycemic control and less worsening of diabetes persisted over the 52-week treatment period.

The study showed overall adverse event rates comparable with placebo at 52 weeks, and the proportion of patients with reported serious adverse events was similar compared with placebo at 52 weeks; and showed adjudicated 3-component major adverse cardiac event rates of 2.7% with BA and 4.7% with placebo.

“The CLEAR Wisdom trial demonstrated that bempedoic acid provided additional LDL-cholesterol lowering in patients on background maximally tolerated statin therapy and had an overall adverse event profile that was comparable to placebo,” said Anne C. Goldberg MD, FACP, FAHA, FNLA, Professor of Medicine, Division of Endocrinology, Metabolism and Lipid Research at Washington University, St. Louis and lead study author.

ESPR +$2.42 to $41.14.

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William Lyon Homes sold for $2.4B

Taylor Morrison to acquire William Lyon Homes for $21.45/share in cash and stock

Taylor Morrison Home (TMHC) and William Lyon Homes (WLH) announced they have entered into a definitive agreement pursuant to which Taylor Morrison will acquire all of the outstanding shares of William Lyon Homes common stock for per share consideration of $2.50 in cash and 0.800 shares of Taylor Morrison common stock, implying a company value for William Lyon Homes of $21.45 per share or $2.4B including assumption of debt.

William Lyon Homes sold for $2.4B in stock, Stockwinners

The transaction consideration mix consists of approximately 90% Taylor Morrison stock and 10% cash.

Based on current trading, Taylor Morrison stockholders will own approximately 77% of the combined company while William Lyon Homes stockholders will own approximately 23%.

The transaction has been unanimously approved by the Boards of Directors of both Taylor Morrison and William Lyon Homes and will be submitted to the stockholders of William Lyon Homes for approval.

Taylor Morrison Home buys William Lyon Homes to expand its footprint, Stockwinners

William Lyon Homes designs, constructs, markets, and sells single-family detached and attached homes in California, Arizona, Nevada, Colorado, Washington, Oregon, and Texas. It sells its homes primarily to entry-level, first-time move-up, and second-time move-up homebuyers. 

Taylor Morrison Home Corporation operates as a public homebuilder in the United States. The company designs, builds, and sells single-family and multi-family attached and detached homes; and develops lifestyle and master-planned communities. It operates under the Taylor Morrison and Darling Homes brand names in Arizona, California, Colorado, Florida, Georgia, Illinois, North Carolina and Texas. 

The issuance of shares of Taylor Morrison common stock in the transaction will also be submitted to the stockholders of Taylor Morrison for approval.

The transaction is expected to close late in the first quarter or early in the second quarter of 2020 and the closing is subject to the satisfaction of customary closing conditions.

William H. Lyon, executive chairman and chairman of the board and holder of approximately 42 percent of the voting power of William Lyon Homes common stock, has agreed to vote all of the shares of William Lyon Homes common stock controlled by him in support of the transaction.

“The strategic combination creates the nation’s fifth largest homebuilder based on the last 12 months of closings, and firmly places Taylor Morrison in a Top 5 position in 16 of the combined 23 markets with an estimated 14,200 closings for the pro forma combined company,” the companies stated.

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Cision sold for $10 per share

Cision to be acquired by Platinum Equity affiliate in deal valued at $2.74B

Cision (CISN) announced that it has entered into a definitive agreement to be acquired by an affiliate of Platinum Equity in an all cash transaction valued at approximately $2.74B.

Cision sold for $2.74B, Stockwinners

Under the terms of the agreement, which has been unanimously approved by the members of Cision Ltd.’s board of directors, an affiliate of Platinum Equity will acquire all of the outstanding ordinary shares of Cision Ltd. for $10.00 per share in cash.

The purchase price represents a 34% premium over Cision Ltd.’s 60-day volume-weighted average price ended on October 21, 2019.

A special meeting of Cision Ltd.’s shareholders will be held as soon as practicable following the filing of a definitive proxy statement with the U.S. Securities and Exchange Commission (“SEC”) and subsequent mailing to its shareholders.

Certain affiliates of GTCR, collectively holding approximately 34% of the outstanding shares of Cision Ltd., have entered into a voting agreement committing them to, among other things, vote in favor of adopting the acquisition agreement.

The proposed transaction is expected to close in the first quarter of 2020 and is subject to approval by Cision Ltd.’s shareholders, along with the satisfaction of customary closing conditions and antitrust regulatory approvals, as necessary.

Cision Ltd. provides public relations (PR) software, media distribution, media intelligence, and related professional services to businesses worldwide. The company enables public relations and communications professionals to manage, execute, and measure their strategic PR and communications programs.

Upon completion of the acquisition, Cision Ltd. will become wholly owned by an affiliate of Platinum Equity.

Cision Ltd. may solicit alternative acquisition proposals from third parties during a “go-shop” period from the date of the agreement until November 12, 2019.

There is no guarantee that this process will result in a superior proposal, and the agreement provides Platinum Equity with a customary right to match a superior proposal and termination fee if a superior proposal is accepted.

Cision Ltd. does not intend to disclose developments with respect to the solicitation process unless and until the company determines such disclosure is appropriate.

“This transaction will provide shareholders with immediate and substantial cash value, while also providing us with a partner that shares in our commitment to customers and employees and can add strategic and operational value,” said Kevin Akeroyd, Cision’s CEO.

“Based on our extensive engagement with Platinum over the past several months, we are confident that Platinum’s support will enable Cision to execute on its strategy and next phase of growth.”

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Watch Shares of Adverum Biotechnologies!

Adverum Biotechnologies reports additional data from Phase 1 trial of ADVM-022

Adverum Biotechnologies (ADVM) announced additional clinical data for the first cohort of patients in the ongoing OPTIC phase 1 clinical trial of ADVM-022, the company’s intravitreal injection gene therapy, in treatment-experienced patients with wet age-related macular degeneration.

Adverum Biotechnologies reports additional data from Phase 1 trial of ADVM-022 in patients with wet age-related macular degeneration, Stockwinners

Adverum also announced enrollment plans for the third and fourth cohorts in the ongoing OPTIC trial.

The third cohort has been initiated and patients will be treated with ADVM-022 at a dose of 2 x 10^11 vg/eye, the same dose used in the second cohort.

Subsequently, patients in the fourth cohort will be treated with ADVM-022 at a dose of 6×10^11 vg/eye, the same dose used in the first cohort.

Since inflammation has generally been mild and responsive to steroid eye drops, patients in the third and fourth cohorts will receive prophylactic steroid eye drops instead of prophylactic oral steroids.

Previously, on September 12, 2019, Adverum presented data from the first cohort in the ongoing OPTIC trial at a pre-specified 24-week time point.

Wet and Dry Macular Degeneration, Stockwinners

The additional data for this cohort includes key outcomes with a median follow-up of 34 weeks.

In treatment-experienced patients previously requiring frequent anti-VEGF injections to maintain vision, the data continue to demonstrate that the single ADVM-022 injection in this cohort was sufficient to maintain vision, with zero rescue injections required for any of the six patients.

Aaron Osborne, MBBS, chief medical officer of Adverum, added, “The clinical profile of ADVM-022 demonstrates this gene therapy’s potential to be a significant advance for patients with wet AMD. It is very encouraging that there continues to be zero rescue injections in this cohort of treatment-experienced patients with more than 6 months follow-up on all patients. We are expanding the development of ADVM-022 and are excited to share that enrollment is now open for the third cohort in OPTIC.

We look forward to being able to deliver this novel intravitreal gene therapy candidate as soon as possible to patients with wet AMD and diabetic retinopathy, our second indication for ADVM-022. We are grateful for all of the investigators, patients, and caregivers who continue to participate in the OPTIC trial.”

Adverum plans to begin dosing patients in the third cohort of the OPTIC trial in the fourth quarter of 2019 and plans to begin enrollment in the fourth cohort in the first quarter of 2020.

Adverum plans to present 52-week data from the first cohort of patients in the OPTIC trial as well as 24-week data from the second cohort of patients in the first half of 2020.

Adverum plans to submit an investigational new drug application for the treatment of ADVM-022 in diabetic retinopathy in the first half of 2020.

Piper Jaffray

Commenting on Adverum Biotechnologies update at AAO, Piper Jaffray analyst Tyler Van Buren notes that zero rescue injections have been required and disease activity by OCT and visual acuity has been maintained with 6 ADVM-022 patients now out to a median of 34 weeks.

Importantly, despite the intense criticism over inflammation and visual acuity fluctuations during the initial data disclosure last month, numerous KOLs at the conference were unconcerned and believe that ADVM-022 looks like a potential treatment option so far, he contends.

Overall, the analyst argues that safety continues to be clean in these initial patients and looks forward to the 52-week update in first half of 2020.

Van Buren reiterates an Overweight rating and $14 price target on the shares as ADVM-022 continues to look like a viable gene therapy candidate for wet AMD, which has $1B-plus potential.

ADVM closed at $5.29.

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