Puma Biotechnology receives FDA Committee Approval for Neratinib

Committee voted 12 – 4 to recommend approval of Neratinib, for the extended adjuvant treatment of HER2-positive early stage breast cancer

The study demonstrated a statistically significant 33% relative reduction of risk of invasive disease recurrence within two years after treatment

pbyi

#Puma Biotechnology $PBYI announced that the U.S. FDA Oncologic Drugs Advisory Committee voted 12 – 4 to recommend approval of PB272, or neratinib, for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable.

The #ODAC vote was based on a review of the clinical development program that included 11 trials in breast cancer and represented approximately 2,000 patient years’ experience. The focus of the meeting was the Phase III ExteNET study, which provided one year of continuous therapy with neratinib after patients completed one year of therapy with a trastuzumab-based regimen.

The study demonstrated a statistically significant 33% relative reduction of risk of invasive disease recurrence within two years after treatment.

ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes appropriate recommendations to the FDA.

Its vote is not binding, but is considered by the FDA in its decision making process. “We appreciate the committee’s comments and the support of the many clinicians, patients and advocates who participated in today’s meeting,” Alan H. Auerbach, CEO and President of Puma Biotechnology, said. “We look forward to further discussion with the FDA.”

The stock was last up over 25.2% to $72.40.

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HIV Vaccine Proves 100% Effective

Overall, 27 of 27 vaccinated participants showed a positive response

The study evaluated a four-dose regimen of PENNVAX-GP DNA

ino#Inovio Pharmaceuticals $INO announced that its #HIV vaccine, #PENNVAX-GP, produced amongst the highest overall levels of immune response rates ever demonstrated in a human study by an HIV vaccine.

The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody immune response as well as a T cell immune response to both potentially prevent and treat HIV.

These preliminary results are from a study supported by the HIV Vaccine Trials Network, or HVTN, and the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, or NIH, in collaboration with Inovio.

The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal, or ID, or intramuscular, or IM, administration in combination with a DNA encoded immune activator, IL-12, or INO-9012.

Overall, 71 of 76 evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens. Similarly, 62 of 66 evaluated participants demonstrated an env specific antibody response. None of the placebo recipients demonstrated either a cellular or an antibody response in the study.

Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 participants demonstrated a cellular response and 27 of 28 demonstrated an HIV env specific antibody response.

Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 demonstrated a cellular response and 19 of 21 demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration.

INO closed at $7.13, last traded at $9.90 in pre-market.

Other shares to watch: $AMGN $BIIB $ABBV $MRK $PFE

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Buy Clovis Ahead of ASCO Meeting

American Society of Oncology Meets June 2-6, 2017 in Chicago

Clovis to Present about its Ovarian Cancer Drug

Clovis to Submit NDA for Ovarian Cancer#Clovis Oncology $CLVS announced that abstracts highlighting progress in the rucaparib clinical development program, its treatment for ovarian cancer, will be presented at the 2017 American Society of Clinical Oncology Annual Meeting taking place June 2 to June 6 in Chicago. #ASCO

Four abstracts highlighting ongoing #rucaparib clinical trials will showcase some of the multiple #cancer types in which the compound is being studied, including germline and somatic BRCA-mutated, relapsed, high-grade ovarian cancer; metastatic castration-resistant prostate cancer associated with homologous recombination deficiency; and HER2 negative metastatic breast cancer.

Rucaparib is Clovis Oncology’s oral, potent, small-molecule inhibitor of #PARP1, #PARP2 and #PARP3.

In December 2016, the #FDA approved rucaparib tablets as monotherapy for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a deleterious BRCA mutation as identified by an FDA-approved companion diagnostic test.

The #ARIEL3 pivotal study of rucaparib is a randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance treatment to platinum-sensitive ovarian cancer patients can extend the period of time for which the disease is controlled after a response to platinum-based chemotherapy.

Top-line results from ARIEL3 are anticipated by the end of June, and the Company plans to provide a more comprehensive presentation of the ARIEL3 results in a scientific session at a medical meeting later this year.

Pending positive data, the Company intends to submit a supplemental New Drug Application for a second line or later maintenance treatment indication within approximately four months of the database lock.

Other stocks to watch in the group: $INCY, $TSRO, $PBYI, $AMGN

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Coherus Biosciences Could Skyrocket

COHERUS BIOSCIENCES LOGOCoherus Biosciences $CHRS could skyrocket in the next few weeks if it receives FDA’s approval, research firms Credit Suisse and Maxim argue.

BACKGROUND: Coherus Biosciences is a developer of #biosimilars — nearly identical copies of original biologic drugs — whose product pipeline includes #CHS-1701, a biosimilar of Amgen’s $AMGN #Neulasta, and CHS-1420, a biosimilar of #AbbVie’s $ABBV #Humira.

The FDA has set an action date of June 9 for its review of CHS-1701, and while CHS-1420 is further out, #Coherus said in its earnings report last week that it expects a May 17 decision in part of its patent battle with AbbVie.

CREDIT SUISSE SAYS COHERUS COULD DOUBLE OR MORE: Last week, Credit Suisse’s Alethia Young highlighted two “major” catalysts for Coherus over the next two months: The possible invalidation of AbbVie’s “135” patent for Humira — which Young calls the “key dosing patent” that would allow Coherus to launch CHS-1420 before 2022 — and the FDA’s decision on CHS-1701. The analyst thinks the “bigger mover” is the 1701 event and she expects “on-time approval” of the product on June 9, though Young cautions that the lack of an Advisory Committee meeting “lowers the visibility” into the agency’s ultimate decision. The analyst reiterates her Outperform rating on the stock and says it could jump 110%-200% or fall 40%-65% as the above mentioned events play out over the next month. Young’s report builds on an April 19 note in which she forecast a 90% chance of CHS-1701 launching in 2018 and a 75% chance of CHS-1420 launching in the U.S. in 2020, adding that Coherus becomes a likely takeover target if those regulatory and patent decisions are settled in its favor.

MAXIM SEES TRANSFORMATIVE DECISIONS: Maxim’s Jason McCarthy argues today that “the best is ahead” as Coherus approaches the inflection points for 1420 and 1701, either of which he says could be “transformative” for the company. The analyst argues that Amgen’s recent lawsuit to protect a Neulasta patent has a low probability of delaying 1701 commercialization, as Coherus doesn’t use the purification process described by that “707” patent. McCarthy also contends that the AbbVie 135 patent fight chances are “in favor of Coherus” due to the latter’s strong focus on intellectual property.

PRICE ACTION: After gaining nearly 11% since its May 8 earnings report, Coherus is down 2% to $21.90 in Monday’s session.

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Puma Biotechnology $PBYI Could Double by the end of May

pbyiAs #PumaBiotechnology $PBYI nears an FDA advisory panel meeting for its breast cancer treatment candidate #neratinib, #Citi argues that a recent hiring push by Puma signals its confidence in securing approval, an event which the research firm says could send shares soaring by 100% or more.

BACKGROUND: The FDA has scheduled a May 24 Advisory Committee meeting for Puma’s neratinib in extended adjuvant treatment of “HER2” early stage breast cancer. In its Q1 earnings report last night, the company confirmed that “we look forward to presenting” at the May 24 meeting. #HER2

CITI SEES POTENTIAL DOUBLE: In a post-earnings research note, Citi’s analyst highlights that Puma accelerated plans for final five-year data from the ” #ExteNET ” neratinib trial to Q2 from the second half, as it will be used during the drug’s May 24 #AdComm. The analyst confirmed with Puma that additional data from the “CONTROL” prophylactic trial will also be presented at the meeting.

Notably, the analyst says he “noticed” that Puma appears to be actively hiring for commercial operations, with the company’s website now showing 18 job listings for roles within outreach, commercial supply chain, market access, reimbursement, and other areas. Though critics may interpret the news as signaling that Puma doesn’t expect to be acquired, the analyst counters that such an argument “doesn’t work too well tactically,” as the stock should gain at least 100% on what he calls an “expected positive” AdComm.

Indeed, the analyst views the hiring push as “obviously reflecting confidence” in approval while both maximizing future sales potential and remaining open to future strategic options, with the analyst reminding investors that Puma CEO Alan Auerbach successfully sold his last company to big pharma.

PRICE ACTION: Shares of Puma Biotechnology are up fractionally to $30.75 in afternoon trading.

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Reverse Stock Splits Destroy Shareholders Value

Reverse-stock-split-thumbnail#NYSE and #Nasdaq are the two major stock exchanges in the U.S.  Both exchanges require stock prices that are traded on their platforms to have a price of one dollar or higher. Stocks that fall below this threshold are delisted. These stocks are then moved to other exchanges such as #OTC or Pink Sheet #PinkSheet which have very low liquidity.

In order to avoid this, companies with sub dollar share prices reverse split their shares. In finance, a reverse stock split or reverse split is a process by which shares of corporate stock are effectively merged to form a smaller number of proportionally more valuable shares. A reverse stock split is also called a stock merger.

If a company has 10 million shares that are trading at $1, it can declare a 1-for-5 reverse stock split. Theoretically, the book value of the company remains the same instead now the company will have 2 million shares that are trading at $5 per share.

Higher share prices however, do not necessarily mean better stock fundamentals. The higher share price, following the split, has now simply masked the company’s declining fundamentals, and market’s view of the company. The higher share price now allows short seller to short the stock although it would be harder to find shares to borrow but this is offset by those investors who give up on the stock and sell at any price.

Below are several examples of such companies:

  • Pain Therapeutics $PTIE engages in developing drugs and focuses its drug development on disorders of the nervous system, such as chronic pain. The company recently declared a 7-for-1 reverse stock split. Shares were trading at 59 cents.

 

  • #NeuroMetrix, Inc. $NURO develops and markets products for the detection, diagnosis, and monitoring of peripheral nerve and spinal cord disorders. The company recently declared an 8-for-1 reverse stock split. Shares were trading at 48 cents.

 

  • Rex Energy $REXX is an independent oil, natural gas liquids and natural gas company operates in the Appalachian Basin. The company recently declared a 10-for-1 reverse stock split. Shares were trading at 42 cents.

 

  • #Rubicon Technology $RBCN is a materials provider focusing in monocrystalline sapphire for applications in optical and industrial systems. Co. designs, assembles and maintains its own proprietary crystal growth furnaces to grow sapphire crystals. The company recently declared a 10-for-1 reverse stock split. Shares were trading at 82 cents.

 

  • The mother of all reverse stock splits award should go to #DryShips $DRYS . DryShips Inc. owns and operates ocean going cargo
    drys
    DryShips stock over the past 12 months

    vessels worldwide. The company has reverse split its shares seven times over the past thirteen months at the expense of its shareholders. The last split was today for 7-for-1, the one before that was in April for 4-for-1. The one prior to that was in February for 8-for-1. This puts the 52-week trading range for this stock at (this is not a typo!) $4.55 to $37,900.80. Shares last traded at $5.35.

 

 

SEC fines Barclays $97M

barclaysThe #SEC announced an enforcement action requiring Barclays Capital to refund advisory fees or mutual fund sales charges to clients who were overcharged.

In a settlement of more than $97M, Barclays agreed to settle three sets of violations that resulted in clients being overbilled by nearly $50M, according to the SEC.

The SEC’s order finds that two Barclays $BCS advisory programs charged fees to more than 2,000 clients for due diligence and monitoring of certain third-party investment managers and investment strategies when in fact these services weren’t being performed as represented.

#Barclays also collected excess mutual fund sales charges or fees from 63 brokerage clients by recommending more expensive share classes when less expensive share classes were available. Another 22,138 accounts paid excess fees to Barclays due to miscalculations and billing errors by the firm.

Without admitting or denying the SEC’s findings, Barclays agreed to create a “Fair Fund” to refund advisory fees to harmed clients.

The Fair Fund will consist of $49.79M in disgorgement plus $13.75M in interest and a $30M penalty. Barclays will directly refund an additional $3.5M to advisory clients who invested in third-party investment managers and investment strategies that underperformed while going unmonitored.

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Changes to S&P Indices

valvoline-hd-logo#S&P Dow Jones Indices will make the following changes to the S&P MidCap 400 and S&P SmallCap 600 indices: #Valvoline $VVV will replace #Noble Corp. $NE in the S&P MidCap 400, and Noble will replace #Celadon Group $CGI in the S&P SmallCap 600 effective prior to the open on Tuesday, May 16.

S&P MidCap 400 constituent #Ashland Global Holdings $ASH is spinning off its remaining stake in Valvoline in a transaction expected to be completed prior to the open on Monday, May 15, pending final conditions. Ashland Global will remain in the S&P MidCap 400 post the spin-off transaction. Noble is ranked at the bottom of the S&P MidCap 400 and is no longer representative of the mid-cap market space. Celadon is ranked near the bottom of the S&P SmallCap 600 and is no longer representative of the small-cap market space.

#MaxLinear $MXL will replace #Exar $EXAR in the S&P SmallCap 600 effective prior to the open on Monday, May 15. MaxLinear is acquiring Exar in a deal expected to be completed on or about that date, pending final conditions.

#Lantheus Holdings $LNTH will replace #Tidewater $TDW in the S&P SmallCap 600 effective prior to the open on Tuesday, May 16. Tidewater is ranked at the bottom of the S&P SmallCap 600 and is no longer representative of the small-cap market space.

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President Comments Move Stocks!

Here is a re-cap of how President Trump’s comments moved stocks last week:

1. STEEL SECTOR: On Thursday, Donald Trump met with several steel company CEOs at the White House to discuss the state of the industry and the administration’s plans to crack down on steel dumping. Following the sit down, he signed a memorandum related to section 232 of the Trade Expansion Act of 1962 and said he has directed the Commerce Department to launch an investigation into whether or not foreign companies, particularly those from China, are dumping steel on the U.S. market. Publicly traded companies in the steel space include Steel Dynamics $STLD , AK Steel $AKS , U.S. Steel $X and Nucor $NUE .TrumpHouseLogo_FINAL-1

2. HOSPITALS: Earlier this week, hospital stocks were under pressure following reports of Health bill progress. CNBC tweeted, “NEW: If health care changes in MacArthur memo are in bill text, they’d get 18-20 new @freedomcaucus votes. Brings total to
25-30, per source.” Publicly traded companies in the space include Community Health $CYH , HCA Holdings $HCA LifePoint $LPNT , Tenet $THC and Universal Health $UHS .

3. TECH COMPANIES: According to a news report by Recode, tech companies such as Amazon $AMZN , Apple $AAPL , Facebook $FB , Google $GOOG; $GOOGL , and Microsoft $MSFT have focused some of their lobbying sums in Washington over the past three months on fighting President Trump, as he looked toward major changes to the U.S. tax code and placed new restriction on foreign immigrants. Both issues are present on many companies’ first quarter lobbying reports, the publication notes.

4. HUMANA: On Friday, Jefferies downgraded Humana $HUM to Hold and lowered his price target on the shares to $221 from $237. The analyst told investors that he views the shares as expensive and pointed out that 2018 premium growth under President Trump is lower than 2017 under Obama. Events that would enhance Medicare Advantage decidedly above Medicaid and Commercial “are not blossoming,” Windley contended.

5. FINANCE-RELATED EXECUTIVE ORDERS: President Trump signed two finance-related executive orders on Friday aimed at unwinding regulations put into place after the financial crisis. The directives target “living wills” that banks must formulate to show how they would be broken up it there is danger of failure. Alongside banking measures, the administration is ordering a review on rules regarding inversions. Publicly traded money center banks include Bank of America $BAC , Citi $C , Goldman Sachs $GS , JPMorgan $JPM , Morgan Stanley $MS , U.S. Bancorp $USB and Wells Fargo $WFC .

6. TAX REFORM: On Thursday, Treasury Secretary Steven Mnuchin said during the International Finance Washington Policy Summit that the Trump administration is close to bringing forward “major tax reform.” The following day, Trump told Associated Press that he will unveil a tax plan next week that includes “massive” tax cut for individuals and businesses.

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$ARWR Arrowhead presents ARC-520, ARC-521 data at International Liver Congress

Stockwinners: stocks to buy, stocks to watch, upgrades, downgrades, earnings, Stocks to Avoid

Arrowhead Pharmaceuticals presented clinical data from a Phase 2 study of ARC-520 and a Phase 1/2 study of ARC-521, the company’s prior generation investigatory medicines that were being studied for the treatment of chronic #hepatitis B virus infection, at The International Liver Congress 2017, the annual meeting of the European Association for the Study of the Liver.

The studies show that RNAi interference as a mechanism can rapidly and significantly reduce HBV viral antigens.

In addition, #RNAi appears to synergize with current standard-of-care nucleotide and nucleoside analogues to rapidly lower serum levels of HBV DNA. Arrowhead is currently developing ARO-HBV, a follow-on product candidate that utilizes the company’s next generation, proprietary subcutaneously administered delivery vehicle, as a potentially curative therapy for patients with chronic hepatitis B infection.

Another stock to watch $ICPT

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AbbVie $ABBV says Study did not meet its end result

AbbVie announced that two Phase 3 studies evaluating #veliparib did not meet their primary endpoints. The studies evaluated veliparib in combination with the chemotherapy regimen carboplatin and paclitaxel in patients with squamous non-small cell lung cancer and triple negative breast cancer.

Full results will be presented at upcoming medical meetings or published in a peer-reviewed journal. “Research shows there is a role for PARP inhibitors in cancers associated with DNA repair deficits, such as those with BRCA mutations.

In these clinical trials, we wanted to explore whether a PA527178_434502233267150_400064991_nRP inhibitor could augment chemotherapy in patients with squamous non-small cell lung cancer and triple negative breast cancer by disrupting the repair of cancer cells,” said Gary Gordon, M.D., Ph.D., vice president, oncology clinical development, AbbVie. “Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients.”

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Pfizer receives grand jury subpoenas from DOJ

Pfizer $PFE confirmed that the company had received grand jury subpoenas from the U.S. Justice Department as part of an antitrust investigation focused onpfizer-logo intravenous saline solution makers, said Reuters.

Note that in a regulatory filing last night, ICU Medical $ICUI disclosed that on April 18, in connection with the Hospira Infusion Systems business that the company acquired in February 2017 from Pfizer.

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ICU Medical received a grand jury subpoena issued by the U.S. District Court for the Eastern District of Pennsylvania, in connection with an investigation by the U.S. Department of Justice, Antitrust Division.

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Earnings Raise Red Flag for Stocks

A review of latest quarterly results from corporate America pointing to a slowing economy. Several key companies have either missed their results or have lowered their forward looking guidance. On April 18, 2017, several major corporations just did that. Much of the today’s market weakness was attributed to the price decline in both Johnson & Johnson (JNJ) and Goldman Sachs images

(GS) following their earnings reports. The weakness in those bluechips caused the Dow Jones Industrial Average (DJIA) to underperform the other major averages and struggle all day. The market action was
an auspicious start to the earnings season, which has been anticipated with great optimism by investors since the November election. Shares of Goldman Sachs fell nearly 5% after reporting downbeat quarterly results, which is exceedingly rare for the investment bank. Commenting on the quarter, Goldman chairman and chief executive officer Lloyd Blankfein called the quarter’s operating environment “mixed,” with client activity “challenged in certain market-making businesses.”jnj

Johnson & Johnson (JNJ) shares dropped 3% after the healthcare giant posted better than expected profits but lower than expected quarterly sales.  Meanwhile, shares of Netflix (NFLX) declined over 2.5% after the company mixed Q1 report and Q2 guidance.

Industrial goods seller, Grainger (GWW) shares dropped to their 52-weeks low after the firm cut its full year Earnings per Shares (EPS) view to $10.0grainger0-$11.30 from $11.30-$12.40. The firm also lowered its  FY17 sales growth view to 1%-4% from 2%-6%. The firm blamed the pricing acceleration and a 1% reduction in sales from foreign exchange as the culprit for the miss.

Among the notable losers on the day was Barracuda (CUDA), which dropped 17% after it reported quarterly results and provided lowered guidance for the first quarter and fiscal 2018. Also lower was Cardinal Health (CAH), which fell 11.5% after announcing that it will acquire a patient product portfolio from Medtronic (MDT) for $6.1B and warning that it now sees its FY18 EPS to be flat to down mid-single digits, citing the impact of generic deflation and other factors.

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