Analyst: FDA OK unlikely for Abbott heart device

WASHINGTON -- A medical device industry analyst says Abbott Laboratories is unlikely to win approval anytime soon for its device used to repair heart valve problems, following a tepid endorsement by government experts.

A Food and Drug Administration panel of heart experts voted 5-3 on Wednesday that the benefits of Abbott's MitraClip system outweigh its risks. The panel voted unanimously that the device is safe and 4-5 on the question of whether the device is effective.

The company is developing the MitraClip to repair leaky heart valves.

Wells Fargo analyst Larry Biegelsen said in a note Thursday, "We believe FDA is unlikely to approve the device," until the results of another study are submitted. That study may not be completed until the summer of 2019, according to a government website.

The device is inserted through a catheter placed in the patient's leg. It clips together leaflets of the heart's mitral valve, which is between the left upper and lower chambers, to reduce significant mitral regurgitation. Mitral regurgitation can cause blood to flow backward into the heart's left atrium leading to an irregular heartbeat, heart failure, a stroke or heart attack.

Biegelsen said a delay in approval is unlikely to hurt Abbott's stock, since most Wall Street analysts had low expectations of the product's commercial potential going into the FDA review. Biegelsen holds an "Outperform" rating on the company stock.

Currently mitral regurgitation is treated with blood-thinning drugs for mild regurgitation or surgery for more severe cases. The MitraClip is intended for patients with significant regurgitation who may not be healthy enough to undergo surgery.

Following the meeting Wednesday, Abbott said in a statement, "We are pleased with the outcome of today's panel, and we look forward to continuing discussions with the agency regarding the panel's comments."

Shares of North Chicago, Ill.-based Abbott fell 33 cents to $33.48 in afternoon trading Thursday.

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Threshold Pharma shares rise on analyst upgrade

NEW YORK -- Shares of Threshold Pharmaceuticals Inc. rose Wednesday after a Piper Jaffray analyst upgraded the stock as the company prepares to report more clinical trial data for its experimental cancer drug TH-302.

THE SPARK: Analyst Charles Duncan raised his rating to "Overweight" from "Neutral" and doubled his price target to $10 per share from $5. Threshold is getting ready to report clinical trial data for TH-302 as a treatment for soft tissue sarcoma, but Duncan said investors are overlooking earlier-stage clinical trials of the drug as a treatment for leukemia, multiple myeloma, and gastrointestinal tumors and kidney cancer.

THE BIG PICTURE: TH-302 is designed to become active in parts of the body with abnormally low oxygen levels. Threshold said those conditions exist in many types of solid tumors because of the irregular growth of the blood vessels that feed the tumors. Once the drug becomes active, it stops cancer cells from replicating their DNA and dividing. The company said the drug can also attack oxygenated regions of the tumor.

"We believe that near-term data will enhance conviction on the broad applicability of Threshold's hypoxia-activation platform for targeting a wide range of cancer indications with the potential to substantively add/extend efficacy over standard chemotherapy," said Duncan.

Duncan said he is particularly interested in the possibility that TH-302 could be combined with drugs that block the blood vessel growth in tumors.

The South San Francisco, Calif., company is conducting late-stage trials of TH-302 as a treatment for soft tissue sarcoma and pancreatic cancer and early-stage trials in other cancers. It is developing TH-302 through a partnership with German drugmaker Merck KGaA.

SHARE ACTION: Threshold shares rose 45 cents, or 10 percent, to $4.91 in afternoon trading. The stock has traded between $3.30 and $9.28 in the last year, but has lost about half its value since Sept. 17 when it reported disappointing trial results for TH-302 as a treatment for pancreatic cancer.

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Focus On The Family ‘Analyst’: Gender And Sexuality Are Only Determined By Procreation

Jeff Johnston is Focus on the Family’s resident ex-gay, who regularly promotes harmful ex-gay therapy because he claims conforming to heteronormativity is ideal for society. He applies this to trans people too, rejecting transgender identities as disordered. In a new screed against LGBT equality today, he discounted any understanding of gender whatsoever, claiming the only determining factors in gender are what men and women contribute to human reproduction:

Despite years of brainwashing from academia, radical feminists, the media, and entertainment, most people know that men and women are different, unique and complementary. A society that attempts to erase male and female or to create new categories to stand next to male and female is living in unreality. Which of the supposed “other genders” being created by individuals or groups can reproduce or replicate itself? [...]

As Christians we also reject the reduction of humanity to groups defined by their sexual attractions and behaviors. Male and female are categories of existence – there is the biological reality of being male or female, and we live in the spiritual reality of a masculinity or femininity that reflects God’s image. It is de-humanizing to categorize individuals by the ever-proliferating alphabet of identities based on sexual attractions or behavior or “gender identity” – LGBBTTQQIAAFPPBDSM – however many letters are added. No. We stand with the truth that there are male and female. There is no recently discovered race of “homosexuals” or “gays” or “lesbians.” We don’t define people’s essence, their being, by their sexual appetites or by other desires.

Actually, there is a biological reality of being gay or straight too, and no sexual orientation compromises whether someone is male or female. And gender involves so much more than just whether you contribute sperm or eggs — it is the complex intersection of socially constructed roles, behaviors, expressions, activities, and attributes that might be associated with one’s sex and how they interact with society.

Johnston believes he successfully erased his own sexual identity so now he works to erase others’. His simple-minded view of the world ignores wide swaths of diversity within sex, gender, and sexual orientation to the detriment of all. He may claim that Christians “reject the reduction of humanity,” but his narrow categories for who people can be does just that.

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Stock Chart Gorgeous as Mona Lisa: Top Analyst

The key with this pattern is the neckline -- the line that connects the highs from the two shoulders.

When a stock breaks out above that line, it tells someone like Collins that it's time for a big move higher.

Pfizer's neckline is at $25.80, and it crossed over that level just last week.

But that's not all.

Last week, Pfizer broke out above a key level – a ceiling of resistance at $25.50. If the stock closes above that level again this week, Collins believes the stock could resume its long march higher.

In addition to bullish upside patterns – other patterns suggest downside may be limited.

Collins believes Pfizer has a healthy floor of support at $24.60 and even if that breaks, two more key support levels lie in the $23 range.

What's the bottom line?

"It's rare that you get a safe boring, high-yielding drug stock like Pfizer that also has a really hot chart, at least as interpreted by Tim Collins," said Cramer. "For me, that's still one more reason why Pfizer's a buy buy buy."

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