Sage Therapeutics Trial Fails, Shares Tumble

Sage Therapeutics announces results from Sage-547 trial did not meet endpoint

Sage Therapeutics announces results from Sage-547. See Stockwinners.com for details

Sage Therapeutics (SAGE) reported top-line results from its Phase 3 STATUS Trial of brexanolone, or SAGE-547, in the treatment super-refractory status epilepticus, or SRSE.

The trial was testing Sage’s drug, brexanolone, plus standard of care in patients with super-refractory status epilepticus (SRSE) whose seizures persisted despite earlier treatments, versus a placebo plus standard of care.

The study did not meet the primary endpoint, comparing success in weaning of third-line agents and resolution of potentially life-threatening status epilepticus with brexanolone vs. placebo when added to standard-of-care.

The company is also testing the same drug in post-partum depression, with results of a two late-stage trials in such patients expected before the end of the year. But Tuesday’s failure is raising some doubts about whether that trial will succeed.

There are no treatments for SRSE currently approved by the FDA.

PRICE ACTION:

SAGE closed at $88.52. It last traded at $66.09.


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Short Squeeze in Teva following CEO Announcement

Teva rallies after finding experienced CEO

Teva rallies after finding experienced CEO. See Stockwinners.com for details

Shares of Teva Pharmaceutical (TEVA) surged in morning trading after naming a permanent chief executive officer, ending a months long search for a new chief. The new CEO brings 30 years of global pharmaceutical and healthcare experience.

CEO APPOINTMENT

Teva this morning said that it has named named Kare Schultz to be its new president and CEO. Schultz will relocate to Israel and will be based out of the company’s headquarters in Petach Tikva, the company stated.

He will succeed Yitzhak Peterburg, who has been serving as interim CEO since Erez Vigodman stepped down in February.

Schultz joins Teva from H. Lundbeck (HLUYY), where he has served as president and CEO since 2015. Prior to joining Lundbeck, Schultz worked for nearly three decades at Novo Nordisk (NVO), where he once served as the company’s chief operations officer.

Sol Barer, Teva’s chairman, told the Wall Street Journal that the company searched for months for a CEO to “make sure we got the right person,” adding that “this is a critical time in Teva’s history.”

WHAT’S NOTABLE

In July, rumors had swirled that Teva would name AstraZeneca (AZN) CEO Pascal Soriot as its new CEO.

According to a Calcalist report at the time, Soriot met with Teva’s chairman and search committee and “expressed his agreement” to serve as the next CEO. Soriot later told Bloomberg that he plans on staying at AstraZeneca “for the foreseeable future.”

In addition to Vigodman’s departure in February, Teva CFO Eyal Desheh left the company at the end of June, being replaced on an interim basis by Michael McClellan.

In August, shares of Teva dropped after the company cut its full year outlook and its dividend, citing the impact of increased price erosion in its U.S. Generics business.

DEBT BURDEN

Teva, which is looking to pay down more than $5B of debt this year, is looking for “a series of partners,” a spokeswoman confirmed to Reuters last month, adding that its intent is “not to fund the whole pipeline, just some projects in it. A small part of it.

” The drugmaker is also pursuing the sale of certain non-core assets to extract synergies related to the Actavis Generics transaction, Peterburg has said.

Looking ahead, new CEO Schultz is likely to face pressure from investors to split the company into two businesses.

NEW CEO A “POSITIVE CATALYST”

This morning, BTIG analyst Timothy Chiang upgraded Teva to Buy from Neutral, calling the CEO appointment a “positive catalyst that should help create a floor for the shares and provide a boost to near-term investor sentiment.” #Chiang is upbeat on Teva’s decision to hire “an experienced pharmaceutical executive” as its new chief and is bullish on fremanezumab, Teva’s migraine treatment.

Raymond James analyst Elliot Wilbur said Teva strength today likely reflects the company landing a name brand CEO in Kare Schultz. The analyst said Schultz’s arrival likely marks a short-term bottom in shares, but does not change the need for bold strategic action and heavy investment spend in order to resurrect top line growth in the face of generic headwinds. #Wilbur said financial flexibility remains limited and much remains to be seen in terms of how the company will be reshaped, and doesn’t see favorable risk/reward scenarios even at current depressed levels. Wilbur rates Teva a Market Perform.

SHORT RATIO

The short ratio, short interest ratio (SIR) or float short for a public company is the ratio of tradable shares being shorted to shares in the market, or the float. It is an indirect metric of investor sentiment. When short interest is high, above 40%, it implies company investors hope shares will decline in value.

According to the latest data, 41.9 million shares of TEVA have been shorted as of August 15th. The stock has a 26 million daily average trading volume of 26 million,giving it a short ratio of 1.62.

A short squeeze is a rapid increase in the price of a stock that occurs when there is a lack of supply and an excess of demand for the stock. Short squeezes result when short sellers cover their positions on a stock, resulting in buying volume that drives the stock price up.

PRICE ACTION

Teva is up nearly 16% in Monday’s trading to $17.89. Year-to-date, however, shares are down about 52%.


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Integra LifeSciences Sold for $47M

Natus Medical to acquire Integra LifeSciences for $47M in cash 

Natus Medical to acquire Integra LifeSciences for $47M in cash. See Stockwinners.com for details

Natus Medical (BABY) announced that it has entered into a definitive agreement with Integra LifeSciences (IART) under which Natus will acquire certain neurosurgery business assets from Integra LifeSciences in an all cash transaction for $47.5M.

With current annual revenue of approximately $50M, the acquisition marks Natus’ entry into the $2B global neurosurgery market.

The divestiture by Integra is contingent on the consummation of Integra’s proposed acquisition of Codman Neurosurgery.

As part of the transaction, Natus will acquire the global Camino ICP monitoring product line, including its San Diego manufacturing facility, from Integra.

The sale also includes the U.S. rights relating to Integra’s fixed pressure shunts, as well as U.S. rights to Codman’s DURAFORM dural graft implant, standard EVD catheters and CSF collection systems.

Integra is divesting these assets in connection with the review by the Federal Trade Commission of Integra’s proposed acquisition of Johnson & Johnson’s Codman Neurosurgery assets. Both the divestiture and the pending acquisition of Codman Neurosurgery remain subject to final regulatory approvals and satisfaction of other customary closing conditions.

Both transactions are expected to close in October 2017 after securing regulatory clearance. Natus will use cash on hand and available from its credit facility to fund the acquisition.


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Intra-Cellular Higher on Schizophrenia Data

Intra-Cellular reports positive data for lumateperone in schizophrenia

Intra-Cellular to move forward with lumateperone long-term safety study. See Stockwinners.com Market Radar for details

Intra-Cellular (ITCI) announced “positive” topline data from the first part of an open-label safety switching study in which 302 patients with stable symptoms of schizophrenia were switched from standard-of-care antipsychotic medications to lumateperone with no dose titration of #lumateperone required for a 6-week treatment duration, then switched back to standard-of-care.

In this study, lumateperone was generally well tolerated with a favorable safety profile.

Statistically significant improvements from standard-of-care baseline were observed in body weight, cardiometabolic and endocrine parameters in patients with stable symptoms of schizophrenia when switched to lumateperone and worsened again when switched back to standard-of-care medication.

Additionally, treatment with lumateperone was not associated with the motor or cardiovascular disturbances often associated with other antipsychotic medications. Statistically significant improvement from baseline was observed in the Positive and Negative Syndrome Scale mean total score.

Greater improvements were observed in subgroups of patients with elevated symptomatology such as those with comorbid symptoms of depression and those with prominent negative symptoms.

Related Blogs

You may recall last month ITCI reported positive data and that pushed shares higher. Today’s report should help push shares higher.


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Alnylam Tumbles after Patient Dies

Alnylam suspends dosing in all ongoing fitusiran studies after patient death

ALNY-LOGO

Alnylam Pharmaceuticals (ALNY) announced today an update on the company’s fitusiran and givosiran investigational RNAi therapeutic programs.

With fitusiran, an RNAi therapeutic in development for the treatment of hemophilia A and B with or without inhibitors, Alnylam is reporting a fatal thrombotic event in a patient with hemophilia A without inhibitors in the Phase 2 open-label extension study of fitusiran.

As a result, the company has suspended dosing in all ongoing #fitusiran studies pending further review of the safety event and development of a risk mitigation strategy. “Based on overall consideration of fitusiran’s benefit-risk profile, Alnylam is guiding that it aims to resume dosing as soon as possible upon agreement with global regulatory authorities and with appropriate protocol amendments in place for enhanced patient safety monitoring.”

With givosiran, an RNAi therapeutic in development for the treatment of acute hepatic porphyrias, Alnylam said it has reached alignment with the FDA on a Phase 3 study design which includes an interim analysis based on reduction of a urinary biomarker, aminolevulinic acid, as a surrogate endpoint reasonably likely to predict clinical benefit.

Based on the new givosiran Phase 3 design, the company is now guiding that pending FDA review of the program at the time of interim analysis and assuming positive results, it expects to submit a new drug application at or around year-end 2018.

Based on today’s update, Alnylam will postpone its fitusiran RNAi Roundtable webinar previously scheduled for September 12 until a later date.

“We are deeply saddened to learn of this patient’s death, and we extend our sympathies to his family,” said Akshay Vaishnaw, M.D., Ph.D, Executive Vice President of R&D at Alnylam.

“We believe that fitusiran holds great promise as a potential treatment option for patients with hemophilia, and we remain fully committed to its ongoing development.

Following further investigation of this safety finding, implementation of a risk mitigation strategy, and alignment with global regulatory authorities, we expect to resume fitusiran dosing in our clinical studies as soon as possible, potentially as early as late 2017, with a goal of advancing this innovative investigational medicine to hemophilia patients in need.”

PRICE  ACTION

ALNY has a 52-weeks trading range of $31.38 – $89.45. It closed at $86.02, last traded at $77.00.


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Sarepta Therapeutics Reports Positive DMD Data

Sarepta announces ‘positive’ results in 4053-101 DMD study

 Sarepta announces positive DMD results. See Stockwinners.com for details.

Sarepta Therapeutics (SRPT) announced muscle biopsy results from its 4053-101 study, a Phase 1/2 first-in-human study conducted in Europe to assess the safety, tolerability, pharmacokinetics, and efficacy of golodirsen in 25 boys with confirmed deletions of the DMD gene amenable to skipping exon 53.

Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. It is one of nine types of muscular dystrophy. DMD is caused by an absence of dystrophin, a protein that helps keep muscle cells intact.

The study comprised two parts.

In Part 1, 12 patients were randomized to receive a dose titration of golodirsen or placebo. At the end of Part 1, all 12 patients continued on golodirsen and an additional 13 patients started golodirsen.

In Part 2, all 25 patients were treated for an additional 48 weeks at the time of muscle biopsy.

The analysis included biopsies of the bicep muscle at baseline and on-treatment at the Part 2 Week 48 time point. All 25 participants displayed an increase in skipping exon 53 over baseline levels, representing a 100 percent response rate as measured by RT-PCR and demonstrating proof of mechanism.

Mean dystrophin protein increased to 1.019 percent of normal compared to a mean baseline of 0.095 percent of normal as measured by Western blot, the primary biological endpoint in the study, representing a 10.7 fold increase from baseline.

The study also showed a statistically significant increase in dystrophin immunofluorescence as measured by immunohistochemistry, the secondary biological endpoint in the study, confirming sarcolemma-associated protein expression and distribution.

Francesco Muntoni, principal investigator for this study and Pediatric Neurologist, Great Ormond Street Hospital for Children NHS Foundation Trust and the UCL Great Ormond Street Institute of Child Health, said,

“All treated boys showed the anticipated exon skipping after treatment and this resulted in a mean increase of dystrophin protein, as measured by Western blot, from 0.095 percent at baseline to 1.019 percent of normal after at least one-year of treatment with golodirsen. These data were also supported by the highly statistically significant increase of dystrophin expression at the sarcolemma, as measured by recently developed validated methodology. This is now the second exon-skipping agent to have shown a statistically significant increase in dystrophin production, validating the exon-skipping approach to treating DMD boys with amenable mutations.”

PRICE ACTION

SRPT closed at $41.08. It last traded at $46.50 in pre-market trading.


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Insmed Could be Sold

Insmed seen as potential target after inhaled antibiotic study succeeds

Insmed seen as potential target after inhaled antibiotic study succeeds. See Stockwinners.com Market Radar for details

Insmed (INSM) has announced results from a phase 3 clinical trial, saying its inhaled antibiotic successfully treated patients with a rare lung disease caused by a bacterial infection.

Following the news, Citi analyst Liav #Abraham argued that the positive headline data could increase the likelihood of Insmed being a viable takeover target.

STUDY RESULTS

This morning, Insmed announced top-line data from its Phase 3 CONVERT study, saying it met its primary endpoint of culture conversion by month 6 with statistical and clinical significance.

The study demonstrated that the addition of ALIS to guideline-based therapy eliminated evidence of nontuberculous mycobacterial, or NTM, lung disease caused by MAC in sputum by month 6 in 29% of patients, compared to 9% of patients on GBT alone.

Insmed plans to pursue accelerated approval of ALIS under subpart H based on the data from the CONVERT study, which will be reviewed by the Division of Anti-Infective Products, the company noted.

TAKEOUT TARGET

In a research note this morning, Citi’s Abraham told investors that the positive headline data for Insmed’s ALIS for the treatment of NTM lung disease bode well for the potential approval of the therapy.

The analyst highlighted the clinical meaningfulness of the data, with a 20% difference in culture conversion reported between the active and control arms of the trial.

Additionally, Abraham pointed out that the debate on the stock is likely to shift to the commercial outlook for ALIS, with pricing also being key to the uptake of the drug. The positive headline data “could well increase the likelihood of the company as a viable takeout target,” she argued. Abraham reiterated a Neutral rating on the shares.

ACCELERATED APPROVAL

Also commenting on the announcement, Leerink analyst Joseph Schwartz told investors in a research note of his own that after achieving statistical significance in the primary endpoint for ALIS, Insmed’s management intends on pursuing accelerated approval, in line with the expectations laid out during the company’s recent analyst day.

The higher reported adverse events in the ALIS cohort were expected, and while the secondary endpoint of six-minute walk test did not achieve statistical significance overall, patients who culture converted showed a statistical significant improvement, which was a pre-specified analysis, #Schwartz contended.

The analyst reiterated an Outperform rating on the shares.

Meanwhile, his peer at #Evercore ISI increased his price target for Insmed to $40 from $28 following the clinical data. Analyst Josh #Schimmer noted, however, that the commercial outlook is still not well defined and will likely evolve over time as more is learned about the CONVERT study results, the companion 312 study and the company’s efforts to expand labelled use. Schimmer reiterated an Outperform rating on the shares.

PRICE ACTION

In Tuesday’s trading, shares of Insmed (INSM) are up $14 to $26.


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Otonomy Collapses Following its Drug Failure

Otonomy to immediately suspend all development activities for OTIVIDEX

Otonomy seen rallying up to 95% on positive Meniere's disease data. See Stockwinners.com Market Radar to learn more

Otonomy (OTIC) announced results for its AVERTS-1 Phase 3 clinical trial of OTIVIDEX in patients with Meniere’s disease. The #AVERTS-1 trial was a 16-week, prospective, randomized, double-blind, placebo-controlled trial that enrolled a total of 165 patients with unilateral Meniere’s disease in the United States.

The clinical trial missed its primary endpoint which was the count of definitive vertigo days by Poisson Regression analysis. Patients in both the OTIVIDEX and placebo groups showed similar reductions in the number and severity of vertigo episodes during the three month observation period.

OTIVIDEX patients reported a 58% reduction from baseline in vertigo frequency in Month 3 vs. 55% for placebo patients.

“We are greatly disappointed by these results, and surprised by both the higher placebo response and lower OTIVIDEX improvement than observed in our previous trials.

I would like to thank the many patients and investigators who participated in our Meniere’s clinical program,” said David Weber, Ph.D., president and CEO of Otonomy.

“Based on these results, we are immediately suspending all development activities for OTIVIDEX including the ongoing AVERTS-2 trial.

In addition, the company is undertaking a review of its product pipeline and commercial efforts to identify opportunities to extend its cash runway and build shareholder value.”

As of June 30, 2017, the company held cash, cash equivalents, and short-term investments totaling $150.5M with prior non-GAAP operating expense guidance of $80M-85M for 2017.

The company is withdrawing the spending guidance for the year pending the above-mentioned review.

Note that on August 15th, JPMorgan analyst Anupam Rama gave the drug a 70% chance of approval, and a $28 target price on the stock. OTIC closed at $20.80, last traded at $4.50.


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Medicines Co. Jumps on FDA Approval of Vabomere

The Medicines Co. announces FDA approval of VABOMERE

VABOMERE indicated for the treatment of adult patients with complicated urinary tract infections

Medicines Co. Jumps on FDA Approval of Vabomere. See Stockwinners.com Market Radar

The Medicines Company (MDCO) announced that the U.S. Food and Drug Administration has approved VABOMERE for injection for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Enterobacteriaceae – Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex.

VABOMERE was granted priority review and approval as a Qualified Infectious Disease Product in accordance with the Generating Antibiotics Incentives Now Act, which made VABOMERE eligible for the FDA’s fast-track program, and approval now secures a five-year regulatory extension of exclusivity under the Hatch-Waxman Act, which means that patent coverage and exclusivity in the United States are expected to extend into 2031.

The FDA approval of VABOMERE was supported by TANGO-1, a Phase III, multi-center, randomized, double-blind, double-dummy study to evaluate the efficacy, safety and tolerability of VABOMERE compared to piperacillin-tazobactam in the treatment of cUTI, including acute pyelonephritis, in adults.

[youtube https://www.youtube.com/watch?v=448BfrF69nM?rel=0&controls=0&showinfo=0&w=560&h=315]

The trial enrolled 550 adult patients who were randomized 1:1 to receive VABOMERE as a three-hour IV infusion every eight hours, or piperacillin 4g – tazobactam 500mg as a 30-minute IV infusion every eight hours, each for up to 10 days.

We expect that VABOMERE will be available in Q4.

The FDA approval of VABOMERE triggered a $40M milestone payment obligation to the former securityholders of Rempex Pharmaceuticals, which we acquired in December 2013.


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Kamada Receives FDA Approval for Kedrab

Kamada, Kedrion receive FDA approval for Kedrab for post-exposure prophylaxis

Kamada Receives FDA Approval for Kedrab. See Stockwinners.com Market Radar for details.

Kedrion Biopharma and Kamada (KMDA) announced that KEDRAB has received U.S. FDA approval for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal.

KEDRAB should be administered concurrently with a full course of rabies vaccine.

Rabies is a life-threatening condition that impacts approximately 40,000 people in the U.S. each year, representing an annual market opportunity of $100M-plus.

KEDRAB will launch in the U.S. in early 2018.

Kamada has been selling the HRIG product since 2006 in numerous territories outside of the U.S. under the brand name KamRAB.

Kamada has sold more than 1.4 million vials of KamRAB to date, demonstrating significant clinical experience with the product.

Under the clinical development and marketing agreement between Kedrion Biopharma and Kamada, upon receipt of FDA marketing approval, Kamada holds the license for KEDRAB, and Kedrion Biopharma has exclusive rights to commercialize the product in the U.S. With the approval of KEDRAB, Kedrion Biopharma expands its portfolio of immune globulin products, which includes RhoGAM and GAMMAKED.


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Intra-Cellular Higher on Data

Intra-Cellular says to move forward with lumateperone long-term safety study

 

Intra-Cellular to move forward with lumateperone long-term safety study. See Stockwinners.com Market Radar for details

Intra-Cellular Therapies (ITCI) announced that the U.S. FDA has informed the Company that the FDA (i) has completed its review of the Company’s responses to requests from the FDA for additional information relating to certain findings observed in nonclinical toxicology studies of lumateperone in an animal species and (ii) agrees that the Company has presented adequate data to support its position that the metabolic pathway in the animal species is distinctive from humans, which indicates that the toxicity observed in the animal species is not relevant to humans.

Lumateperone  (developmental code names ITI-007ITI-722) is an investigational atypical antipsychotic which is currently under development by Intra-Cellular Therapies, licensed from Bristol-Myers Squibb (BMY), for the treatment of schizophrenia. It is also being developed by Intra-Cellular Therapies for the treatment of bipolar disorder, depression, and sleep and behavioral disturbance in dementia, autism, and other neuropsychiatric disorders

Accordingly, the Company is moving forward with its long-term safety study of lumateperone and intends to submit a new drug application for the treatment of schizophrenia by mid-2018.

The Company previously announced that the FDA had raised questions relating to certain findings observed in nonclinical toxicology studies of lumateperone in an animal species and requested additional information to confirm that the nonclinical findings are not indicative of a safety risk associated with long term exposure in humans.

The data presented by the Company supports the position that there are significant species differences in the metabolism of lumateperone.

Based on the FDA’s agreement that the Company presented adequate data indicating that the toxicity seen in the animal species is not relevant to humans, the Company is proceeding with its long-term safety study of lumateperone in patients with #schizophrenia.

Further, based on feedback from the FDA, the Company will incorporate additional monitoring in its long-term safety study for metabolites seen in animal species but not seen to date in humans, and also will continue to monitor for toxicities in its nonclinical studies.

With over 1,500 people exposed to date, lumateperone has been well-tolerated with a safety profile similar to placebo.


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Stryker Recalls Oral Care Products

Stryker informs FDA of voluntary product recall involving Oral Care products

Stryker recalls involving Oral Care products. See Stockwinners.com Market Radar

Stryker Corporation (SYK) said that the company has informed the U.S. FDA of a voluntary product recall involving specific lots of Oral Care products sold through the company’s Sage Products business unit.

The recalled products contain Oral Care solutions manufactured for Sage by a third-party supplier and were distributed between July 2015 and August 2017.

The recall is being initiated due to a potential for cross-contamination of Oral Care solutions manufactured by the third party on equipment shared with non-pharmaceutical products, as stated in a Warning Letter from FDA dated July 17, 2017.

To date, Stryker has not been made aware of any serious adverse events associated with the Oral Care products recall.

However, there have been some reports of minor irritation and allergic reaction. Stryker has discontinued business with the third-party supplier and all Oral Care solutions are being manufactured in-house by Sage.

Stryker expects to resume shipping Oral Care products in September and anticipates a return to full supply capacity by year end. Additionally, the FDA Warning Letter sets forth concerns regarding microbiological testing methods used for all products containing solutions sold by Sage.

These include Oral Care solutions in the recalled products and solutions contained in cloth-based products manufactured by Sage.

FDA indicated that products must now be tested using a verified compendial microbiological method, a growth-based method that requires more time to complete than the one previously used at Sage.

Both methods can detect the presence of microorganisms, while the compendial method provides additional information about the type and number of microorganisms. As a result, in August, Stryker placed cloth-based products, which represents approximately 50% of Sage’s revenue, on a temporary ship hold until they are tested using this method.

Stryker anticipates it will resume shipping products manufactured by Sage and tested under the compendial method in September, and anticipates a return to full supply capacity by year end.

SYK closed at $145.51, last traded at $143 in pre-market trading.


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Ironwood Receives FDA Approval of Duzallo

Ironwood receives FDA approval of DUZALLO

Ironwood Receives FDA Approval of Duzallo. See Stockwinners.com Market Radar for more

Ironwood Pharmaceuticals (IRWD) announced DUZALLO was approved by the U.S. Food and Drug Administration as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone.

DUZALLO is not recommended for the treatment of asymptomatic hyperuricemia.

Ironwood expects DUZALLO to be commercially available early in Q4.

DUZALLO is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for this condition, lesinurad.

This fixed-dose combination provides a dual mechanism of action in a single tablet that can address both underlying causes of hyperuricemia – overproduction and underexcretion of serum uric acid.

The FDA approval of DUZALLO was based on the clinical program supporting the ZURAMPIC new drug application and a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination of lesinurad and allopurinol compared to co-administration of separate lesinurad and allopurinol tablets.

The efficacy and safety of lesinurad plus allopurinol were demonstrated in two pivotal Phase III clinical trials, CLEAR 1 and CLEAR 2, which supported the ZURAMPIC NDA. In clinical trials of adult patients with gout who failed to achieve target sUA levels on allopurinol alone, lesinurad in combination with allopurinol nearly doubled the number of patients who achieved sUA target of less than6 mg/dL at month 6, reduced the mean sUA level to less than6 mg/dL by month 1 and maintained that level through month 12.

The most common adverse reactions in clinical trials were headache, influenza, higher levels of blood creatinine, and heartburn. DUZALLO has a boxed warning regarding the risk of acute renal failure.


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Otonomy Could Rise to $28

Otonomy seen rallying up to 95% on positive Meniere’s disease data

Otonomy seen rallying up to 95% on positive Meniere's disease data. See Stockwinners.com Market Radar to learn more

JPMorgan this morning upgraded Otonomy (OTIC) to Overweight from Neutral, saying that the stock could rise up to 95% if the results of an upcoming trial of its #Otividex drug are positive.

Otividex is supposed to treat #Meniere’s disease, which affects the inner ear and causes vertigo and hearing loss.

RISK/REWARD FAVORABLE

There is a 70% chance that the results of the trial will be positive, wrote JPMorgan analyst Anupam Rama in a note to investors. Adjustments the company made ahead of the trial, whose results are due out next month increase the probability that the trial will be successful, according to the analyst. If the results are positive, Otonomy’s stock will jump 65%-95%, while a negative outcome would cause the stock to fall 25%-35%, he predicted.

HIGH UNMET NEED

There are currently no treatments that have been approved specifically for Meniere’s disease, according to Rama. Steroids, which are currently used to treat the condition, produce “variable” outcome that are “not optimal in all cases,” while surgery/ablative treatment is viewed as “a last resort,” he stated. The analyst believes that there is a “high unmet need” for a #Meniere’s disease treatment.

Meniere’s disease is a disorder of the inner ear that causes episodes in which you feel as if you’re spinning (vertigo), and you have fluctuating hearing loss with a progressive, ultimately permanent loss of hearing, ringing in the ear (tinnitus), and sometimes a feeling of fullness or pressure in your ear. In most cases, Meniere’s disease affects only one ear.

TARGET

Rama raised his price target on Otonomy (OTIC) to $28 from $17.

PRICE ACTION

In Tuesday morning trading, Otonomy jumped 8.7% to $18.70.


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