Treatment


 

On Wednesday, Exelixis (EXEL) announced that it had submitted its supplemental new drug application (sNDA) to the FDA for its advanced kidney cancer treatment. That is because Exelixis drug Cabometyx has already been approved by the FDA for advanced renal cell carcinoma.

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What’s New this Summer? [0.10]

Posted on Aug. 17, 2017, 2:28 p.m. by Stock Gumshoe @ [source]

There’s nothing like a report about a prominent person coming down with a serious illness to prompt the media to zero in on news about potential treatments for that particular condition. Pharmaceutical outfits may not like to cough up the money, but they very much like having an approval date on the calendar, so setting a PDUFA date for a drug is definitely Good News.

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We take a deeper look at Alexion, its new management, and its pipeline below.

Today, we take a deeper look at a mid-cap biotech concern with significant management turnover, a possible new strategic direction and substantial recent insider buying in an exclusive ‘first look’ analysis here on the Insiders Forum.

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Zynerba Midstage Cannabinoid Trial Falls Short [0.01]

Posted on Aug. 14, 2017, 2:10 p.m. by 24/7 Wall St. @ [source]

Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE) saw its shares sink to a 52-week low after the firm announced results from its midstage trial evaluating ZYN002 (cannabidiol [CBD] gel) for the treatment of knee pain due to osteoarthritis.

Excluding Monday’s move, Zynerba has underperformed the broad markets with the stock down 55% year to date.

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We picked Adamas Pharmaceuticals (ADMS) stock in our portfolio last year (see initiation article with full details).

We are reiterating Buy on Adamas stock ahead of PDUFA.

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VivaGel BV already approved for BV treatment in Europe.

This will speed up FDA approval for VivaGel BV for both treatment and prevention of recurrence of BV; global market is ~$1.75 billion.

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Omeros Hoists Sales [0.15]

Posted on Aug. 10, 2017, 4:26 p.m. by Long Investing Ideas from Seeking Alpha @ [source]

Omeros Corporation (OMER) is a $1 billion market cap biopharmaceutical company focused on developing small-molecule and protein therapeutics to treat inflammation, coagulopathies, and central nervous system disorders. By successfully completing the trial (one case study reported here) and filing the sNDA, Omeros expects to undergo label expansion to children (with meaningful clinical need) which would confer an additional six months of marketing exclusivity for OMIDRIA.

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Corbus Pharmaceuticals (CRBP) is a 300 million market cap company focused on developing treatments for rare, life-threatening, chronic inflammatory and fibrotic diseases. Corbus is developing treatments for diseases that are less common (orphan drug status by definition implies less than 200,000 people suffer from the disease) but can be much more severe.

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A company with a trailing P/E ratio of over 30 would most likely be off the cards let alone Celgene (NASDAQ: CELG) with a ratio of 52.

One of Celgene’s key revenue drivers is the continued success in Revlimid, rather alarmingly it contributed to over 62% of the company’s total revenue with global sales hitting $7bn, up 20%.

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Enrollment of PNH patients in ongoing clinical trials for investigational drug, ALXN1210, will ultimately prove to be a strong positive for the company.

While enrollment of patients from the already small Paroxysmal Nocturnal Hemoglobinuria or PNH and Atypical Hemolytic Uremic Syndrome or AHUS patient segments in the ongoing trials evaluating investigational therapy, ALXN1210, in these indications, have reduced the addressable market size for Soliris, it has also brought upon greater awareness about these less known deadly diseases.

Alexion Pharmaceuticals ALXN1210 disease patient PNH Revenue Soliris stock treatment trial

 

Keryx Biopharmaceuticals (KERX) is a $760-million market cap biopharmaceutical company focused on development and commercialization of innovative medicines for people with renal disease. KERX's first approved medicine, AURYXIA (ferric citrate), was approved in 2014 for the treatment of anemia and hyperphosphatemia associated with kidney disease in patients requiring dialysis.

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Of the 30 million people in the United States who consider getting aesthetic treatments like Allergan's Botox, only three million people actually follow through with getting the procedures.

But within that three million, "we see two new groups that are starting to emerge: millennials, which only account for maybe 10, 15 percent of the three million, and males, which also probably account for 10, 15 percent," Saunders told "Mad Money" host Jim Cramer on Monday.

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Recently, Celgene (CELG) and its partner Agios Pharmaceuticals (AGIO) announced that the FDA has approved enasidenib (AG-221) for treating patients with acute myeloid leukemia (AML). I wouldn't say there is a risk right now, but Novartis just recently received approval for its AML drug Rydapt.

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Bioverativ (BIVV) is a recent spin-off from Biogen Idec (BIIB), which focuses on rare blood diseases, primarily hemophilia.

Bioverativ is a global biotechnology company focused on the discovery, research, development and commercialization of therapies for the treatment of hemophilia and other blood disorders.

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Time for value? Given United Therapeutics’ high profitability, we expect that they will get over time a valuation more in line with their peers.

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Spark Therapeutics (ONCE) stock closed higher by 19.72% to $79.72 per share on Wednesday, after the company reported positive phase 1/2 results in patients with Hemophilia A. As Spark Therapeutics continues to make progress for being able to treat diseases with one dose only, it provides a great investment opportunity.

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A blockbuster drug is about to get a chance to have even higher sales. The U.S. Food and Drug Administration (FDA) has expanded its approval of Imbruvica for the treatment of adult patients with chronic graft versus host disease (GVHD) after failure of one or more treatments.

AbbVie chronic GVHD Imbruvica Johnson noted patients quarter sales treatment

 

Shares of Clovis Oncology (CLVS) took a huge hit on Monday falling by more than 13.5%.

Despite shares of Clovis Oncology taking a huge hit on the partnership news, I feel that the stock is a buy.

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Dynavax stock rocketed up more than 70 percent in midday trading Monday after an FDA panel voted in favor of the company's primary drug under development.

The majority of an FDA advisory committee voted "yes" when asked whether data support the safety of Dynavax's Heplisav.

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Trump suggests rougher treatment of suspects [0.08]

Posted on July 29, 2017, 7:12 a.m. by Distressed Volatility @ [source]

President Donald Trump appeared to advocate rougher treatment of people in police custody during a speech in New York. He spoke dismissively of arresting officers who protect suspects' heads while putting them in police cars.

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