A number of investment brokers have recently updated their price targets on shares of Golden Minerals Company (AUMN). According to the latest broker reports outstanding on Monday 11th of April, 0 analysts have a rating of “strong buy”, 1 analysts “buy”, 0 analysts “neutral”, 0 analysts “sell” and 0 analysts “strong sell”.

Most recent broker ratings

02/29/2016 – Golden Minerals Company had its “buy” rating reiterated by analysts at Rodman & Renshaw. They now have a USD 0.6 price target on the stock.

07/17/2015 – Golden Minerals Company was downgraded to “neutral” by analysts at Roth Capital. They now have a USD 0.4 price target on the stock.

05/13/2015 – Golden Minerals Company was downgraded to “hold” by analysts at Zacks.

08/25/2014 – H.C. Wainwright began new coverage on Golden Minerals Company giving the company a “buy” rating. They now have a USD 1.8 price target on the stock.

The share price of Golden Minerals Company (AUMN) was up +14.77% during the last day of trading, with a day high of 0.55. 494354 shares were traded during the last session.

The stock’s 50 day moving average is 0.47 and its 200 day moving average is 0.30. The stock’s market capitalization is 40.65M. Golden Minerals Company has a 52-week low of 0.13 and a 52-week high of 0.68.

Golden Minerals Company (Golden Minerals) is an exploration stage mining company. The Company owns the Velardena and Chicago precious metals mining operations (the Velardena Operations) in Durango, Mexico; and the El Quevar advanced exploration property in Salta, Argentina. In addition, the Company has a portfolio of precious metals and other mineral exploration properties located in or near metals producing regions of Mexico and Argentina. The Company’s Velardena Operations consist of two underground mines and two processing plants within the Velardena mining district, which is located in the municipality of Cuencame, in the northeast quadrant of the State of Durango, Mexico. The Company’s Zacatecas Mining District is located in the central part of Mexico, in the Faja de Plata mineral belt. The San Diego property, located in Durango, Mexico, lies approximately nine kilometers northeast of the Velardena property.

 

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Broad Street Alerts has not been compensated for this post and we do not hold any positions in any of the securities listed.

PDUFA Date Set for May 1, 2016

SAN DIEGO–(BUSINESS WIRE)–Nov. 2, 2015– ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced that the New Drug Application (NDA) for NUPLAZID^™ (pimavanserin) has been accepted for review by the U.S. Food and Drug Administration (FDA) and the agency has granted it Priority Review. ACADIA is seeking FDA approval of NUPLAZID for the treatment of psychosis associated with Parkinson’s disease. The FDA granted NUPLAZID Breakthrough Therapy designation for this indication in 2014.

The FDA grants Priority Review to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. Priority Review accelerates the review timeline from 10 months to six months from the date of acceptance of filing. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of May 1, 2016.

“The FDA Priority Review designation underscores the potential for NUPLAZID to provide an important treatment to patients with Parkinson’s disease psychosis, a condition for which there is no FDA-approved therapy,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We look forward to working with the FDA during the review.”

NUPLAZID is a new class of non-dopaminergic antipsychotic that acts as an SSIA (selective serotonin inverse agonist), preferentially targeting 5-HT_2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in Parkinson’s disease psychosis.

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions, a diminished quality of life, and significant caregiver burden.

ACADIA’s NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of NUPLAZID for Parkinson’s disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which NUPLAZID showed statistical improvement on all primary and secondary efficacy endpoints with no worsening of motor function. Detailed results of the -020 Study were published in The Lancet.

About NUPLAZID^™ (pimavanserin)

NUPLAZID is ACADIA’s proprietary small molecule that is a selective serotonin inverse agonist preferentially targeting 5-HT_2A receptors that play an important role in psychosis. ACADIA has reported positive Phase III trial results with NUPLAZID. The NDA for NUPLAZID for the treatment of psychosis associated with Parkinson’s disease is currently under Priority Review with the FDA. NUPLAZID is administered orally once-a-day. ACADIA discovered NUPLAZID and holds worldwide rights to this new chemical entity. The trade name NUPLAZID has been provisionally accepted by the FDA. The safety and efficacy of NUPLAZID have not been fully evaluated by any regulatory authority.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has a pipeline of product candidates led by NUPLAZID™ (pimavanserin), for which we have submitted a New Drug Application in Parkinson’s disease psychosis to the FDA and which has the potential to be the first drug approved in the United States for this condition. Pimavanserin is also in Phase II development for Alzheimer’s disease psychosis and has successfully completed a Phase II trial in schizophrenia. ACADIA also has clinical-stage programs for glaucoma and, in collaboration with Allergan, Inc., for chronic pain. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the timing of the potential approval of an NDA for NUPLAZID (pimavanserin); the potential for NUPLAZID to be the first drug approved in the United States for Parkinson’s disease psychosis; the potential benefits to be derived from ACADIA’s product candidates, including NUPLAZID; and the progress, timing and results of ACADIA’s drug discovery and development programs, either alone or with a partner, including the progress and expected timing of clinical trials. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development, approval and commercialization, and in collaborations with others, and the fact that past results of clinical trials and past regulatory decisions may not be indicative of future trial results or regulatory decisions, respectively. For a discussion of these and other factors, please refer to ACADIA’s annual report on Form 10-K for the year ended December 31, 2014 as well as ACADIA’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20151102005516/en/

Source: ACADIA Pharmaceuticals Inc.

Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, 858-558-2871
Director of Investor Relations
or
Media Contact:
Chandler Chicco Agency
David Polk, 310-309-1029 or 805-428-5775

– Builds out infrastructure in advance of April 15, 2016 PDUFA target date –

– EMA accepts Phase 3 trial design –

– Conference call scheduled for 5 p.m. ET today –

NEWTON, Mass., Nov. 12, 2015 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ:CHMA), a late-stage biopharmaceutical company developing Mycapssa™ (octreotide capsules), an investigational oral drug for the maintenance therapy of adult patients with the orphan disease acromegaly, today provided a corporate update and reported financial results for the third quarter ended September 30, 2015.

“Chiasma achieved a series of important milestones in the third quarter that strengthened our foundation for the potential 2016 U.S. launch of Mycapssa™, which, if approved, would be the first oral somatostatin analog available to acromegaly patients,” said Mark Leuchtenberger, Chief Executive Officer of Chiasma. “We began the quarter by completing an upsized initial public offering, which significantly bolstered our balance sheet, and we also continued to build out our infrastructure by making a number of strategic hires in our commercial, medical and development groups.

“We made significant progress with our lead program in both the U.S. and European Union. Our first New Drug Application (NDA) for Mycapssa™ in acromegaly was accepted for filing by the FDA in August, and our Prescription Drug User Fee Act (PDUFA) target date was set for April 15, 2016,” Mr. Leuchtenberger continued. “The European Medicines Agency (EMA) also just recently accepted the protocol for our Phase 3 acromegaly trial of octreotide capsules, which we now expect to initiate by early in the second quarter of 2016. In addition, we have continued to explore additional indications that we might address utilizing Mycapssa™ and our Transient Permeability Enhancer (TPE^®) platform.”

Third Quarter and Recent Highlights:

• Finalized EU Phase 3 trial design: In October, the EMA accepted the design, enrollment criteria and required duration of Chiasma’s Phase 3 trial to evaluate the non-inferiority of oral octreotide to injectable somatostatin analogs. This is an open-label, randomized, active-controlled study that is anticipated to include approximately 150 acromegaly patients in the European Union, the United States and certain other countries.
• Announced FDA acceptance of NDA filing for Mycapssa™: In August 2015, the FDA accepted for filing Chiasma’s NDA for Mycapssa™ for the proposed maintenance therapy of adult patients with acromegaly, an orphan indication. The application is supported by the results from a multicenter Phase 3 study, which evaluated patients for biochemical and symptomatic disease control over a period of up to 13 months during treatment with Mycapssa™.
• Successfully completed initial public offering (IPO): In July 2015, Chiasma completed its IPO of common stock at a price of $16.00 per share. Including the underwriters’ full exercise of their overallotment option, Chiasma issued 7,319,750 shares of its common stock and netted proceeds of approximately $106.5 million.
• Continued to expand and strengthen the leadership team: Chiasma made several key hires during the third quarter as it prepares for the potential commercialization of Mycapssa™. New additions to the team include Anand Varadan as Chief Commercial Officer and William H. Ludlam, M.D., Ph.D., as Vice President of Medical Affairs. Mr. Varadan joined Chiasma from Amgen Inc., where he most recently served as Vice President of Marketing for their U.S. Inflammation and Nephrology Business Unit. Dr. Ludlam came to Chiasma from Novartis Pharmaceuticals Corporation, where he served most recently as Senior Medical Director for U.S. Clinical Development and Medical Affairs, Pituitary Disorders, Rare Diseases Franchise.

Third Quarter 2015 Financial Results:

• R&D Expenses: Research and development expenses were $4.4 million for the quarter ended September 30, 2015, compared to $1.7 million for the same period of 2014. The increase was primarily due to the filing of an NDA for Mycapssa™ in acromegaly in the United States and related activities, expenses associated with the manufacturing process validation, activities related to our planned additional Phase 3 clinical trial for the treatment of acromegaly using Mycapssa™ in Europe and an increase in research and development headcount.
• Marketing, G&A Expenses: Marketing, general and administrative expenses were $4.8 million for the quarter ended September 30, 2015, compared to $13,000 for the same period of 2014. The increase was largely due to the initiation of pre-commercial activities related to Mycapssa™, increased consulting costs, compensation-related expenses associated with the hiring of senior executives and other administrative employees, as well as increased legal fees related to intellectual property protection.
• Net Loss: For the quarter ended September 30, 2015, Chiasma’s net loss attributable to common stockholders was ($9.4) million, or ($0.46) per basic share, compared to net income attributable to common stockholders of $0.6 million, or $12.47 per basic share, for the same period of 2014. The basic share amounts outstanding for the quarter ended September 30, 2015 included the shares of common stock that were issued upon conversion of Chiasma’s redeemable preferred stock in connection with theJuly 2015 IPO; redeemable preferred stock outstanding as of September 30, 2014 was excluded from this calculation in periods before the IPO.
• Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2015 were $162.8 million, compared to $63.3 million as of June 30, 2015. This increase is the result of Chiasma’s successful IPO in July 2015.

2015 Financial Guidance

Chiasma expects its total cash, cash equivalents and marketable securities to be between $145 million and $150 million at December 31, 2015.

Conference Call Reminder

At 5:00 p.m. Eastern Time today, Chiasma’s senior management team will host a conference call to discuss the company’s financial results and other business updates. Investors can access a live and archived webcast of this call via the News & Investors section of the company’s website, www.ChiasmaPharma.com. Individuals may also participate in the live call via telephone by dialing (877) 317-6789 (domestic) or (412) 317-6789 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10075383.

About Acromegaly

Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone (GH), ultimately leading to significant health problems and early death if untreated. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease.

Current treatment options include surgery to remove the pituitary tumor, radiation therapy which destroys any lingering tumor cells and/or medical treatment in cases where these approaches are not possible or fully effective. Today’s medical treatments include dopamine agonists, GH antagonists and injectable somatostatin analogs, the current standard of care. Currently available somatostatin analogs require large needles for injections into the muscle (octreotide) or deep into the tissue underlying the skin (lanreotide).

According to the U.S. National Institutes of Health, acromegaly occurs in approximately 60 people per million in the U.S. In addition, researchers estimate that three to four out of every million people develop acromegaly each year. Because symptoms often develop slowly, diagnosis may be delayed by years or decades, making it difficult to determine the total number of people with the disease.

About Mycapssa™ (octreotide capsules)

Mycapssa™ (octreotide capsules) is an oral drug proposed for the maintenance therapy of adult patients with acromegaly. If approved, octreotide capsules would be the first oral somatostatin analog approved for acromegaly. Chiasma filed a NDA on June 15, 2015 for this product candidate. The FDA has accepted the NDA for filing and the PDUFA date is April 15, 2016. The PDUFA date is the target date for the FDA to complete its review of the NDA. Octreotide capsules have been granted orphan designation in the United States and the European Union for the treatment of acromegaly.

Octreotide capsules are an investigational drug that have not been approved for use in any jurisdiction. The trade name Mycapssa™ has been conditionally accepted by the FDA as the proprietary name for Chiasma’s octreotide capsules product candidate.

About Chiasma

Chiasma is a late-stage biopharmaceutical company focused on improving the lives of patients suffering from orphan diseases by developing and commercializing novel oral forms of therapies that are available today only by injection. The company’s lead product candidate is Mycapssa™ (octreotide capsules), a new investigational drug for the orphan condition acromegaly, developed with Chiasma’s Transient Permeability Enhancer (TPE^®) technology to facilitate gastrointestinal absorption of unmodified drug into the bloodstream safely. Mycapssa™ has not been approved for use in any jurisdiction. Using TPE^® technology, Chiasma is evaluating additional proteins, peptides and small molecule drugs that are currently only available by injection, but could potentially be converted to oral delivery. TPE^® technology is potentially well suited for drugs with chronic indications, where frequent dosing is required and the need for an oral alternative is greatest. Chiasma is a Delaware corporation with a wholly owned Israeli subsidiary.

Additional information can be found at www.ChiasmaPharma.com.

Forward-Looking Statements:

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the safety, efficacy and potential clinical benefits ofMycapssa™, the timing of the FDA’s review of Chiasma’s NDA, the timing of the potential commercial launch ofMycapssa™, the timing of initiation of Chiasma’s second Phase 3 trial to support approval by the EMA and the financial guidance regarding cash, cash equivalents and marketable securities at December 31, 2015. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the regulatory review process generally; the risk that the FDA may not make a decision on Chiasma’s NDA by the PDUFA target date; the risk that the FDAmay determine that that the data included in the NDA are insufficient for approval and that we must conduct additional clinical trials, or nonclinical or other studies before oral octreotide can be approved; the risk that the results of previously conducted studies involving oral octreotide or other product candidates will not be repeated or observed in ongoing or future studies or following commercial launch, if such product candidates are approved; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Chiasma’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk that oral octreotide, if approved, will not be successfully commercialized; the risk of competition from currently approved therapies and from other companies developing products for similar uses; risk associated with Chiasma’s ability to manage operating expenses and/or obtain additional funding to support its business activities; and risks associated with Chiasma’s dependence on third parties, including with respect to the manufacture of commercial supply in anticipation of commercial launch, if oral octreotide is approved. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the final prospectus related to Chiasma’s initial public offering filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as discussions of potential risks, uncertainties and other important factors in Chiasma’s subsequent filings with the Securities and Exchange Commission, including our most recent Quarterly Report on Form 10-Q filed on August 31, 2015. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

Chiasma, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
	Three Months Ended September 30,		Nine Months Ended September 30,
	2015	2014	2015	2014
Revenue from license agreement	$ —	$ 2,604,469	$ —	$ 13,165,795
Operating expenses:
Research and development	4,367,992	1,723,803	10,745,527	4,573,881
Marketing, general and administrative	4,813,658	13,013	10,181,411	1,514,708
Total operating expenses	9,181,650	1,736,816	20,926,938	6,088,589
Income (loss) from operations	(9,181,650)	867,653	(20,926,938)	7,077,206
Other expense (income), net	105,395	(61,933)	303,673	2,701
Income (loss) before provision for income taxes	(9,287,045)	929,586	(21,230,611)	7,074,505
Provision for income taxes	71,540	168,237	145,011	233,339
Net income (loss)	(9,358,585)	761,349	(21,375,622)	6,841,166
Accretion of redeemable convertible preferred stock	(31,226)	(208,741)	(317,801)	(896,559)
Net income (loss) attributable to common stockholders	$ (9,389,811)	$ 552,608	$ (21,693,423)	$ 5,944,607
Net income (loss) per share attributable to common stockholders – basic	$ (0.46)	$ 12.47	$ (3.17)	$ 135.37
Weighted-average common shares outstanding – basic	20,280,385	44,326	6,837,272	43,912
Net income (loss) per share attributable to common stockholders – diluted	$ (0.46)	$ 0.07	$ (3.17)	$ 0.61
Weighted-average common shares outstanding – diluted	20,280,385	11,082,922	6,837,272	11,146,273

Chiasma, Inc.
Condensed Consolidated Balance Sheets Information
(unaudited)
	September 30, 2015	December 31, 2014
Cash and cash equivalents	$ 140,869,221	$ 40,160,435
Marketable securities	21,976,790	—
Prepaid expenses and other current assets	1,400,836	311,299
Property and equipment, net	573,539	615,242
Other assets	404,476	311,730
Total assets	$ 165,224,862	$ 41,398,706
Accounts payable and accrued liabilities	$ 4,531,045	$ 4,318,288
Current maturities of long-term liabilities	1,700,000	—
Long-term liabilities	3,652,211	4,612,450
Total liabilities	9,883,256	8,930,738
Total redeemable convertible preferred stock	—	104,485,972
Total stockholders’ equity (deficit)	155,341,606	(72,018,004)
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)	$ 165,224,862	$ 41,398,706

CONTACT: Media:
         Carolyn Sobczyk
         JPA Health Communications
         (202) 591-4052
         carolyn@jpa.com

         Investors:
         Jason Fredette
         Chiasma, Inc.
         (617) 928-5306
         Jason.Fredette@ChiasmaPharma.com

Chiasma, Inc.

Sarepta Therapeutics Receives Notification of PDUFA Extension for Eteplirsen

PDUFA goal date extended by standard extension period of three months to May 26, 2016 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Feb. 8, 2016– Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for eteplirsen has been extended to May 26, 2016. The rescheduled date for the Peripheral and Central Nervous System Advisory Committee meeting has not yet been determined. The FDA notified Sarepta that its January 8, 2016 submission of 4-year clinical effectiveness data, which included additional six minute walk test (6MWT) and loss of ambulation data compared to a historical control, has been designated as a major amendment to the NDA. TheFDA stated that the PDUFA goal date has been extended by three months to allow for a full review of the submission. As described in the Sarepta Advisory Committee Briefing Document Addendum, the principal basis for establishing the effectiveness of eteplirsen is a comparison of patients in Study 201/202 to a historical control group. “While our primary goal is to bring treatment to patients with Duchenne as quickly as possible, we appreciate the efforts of the FDA to conduct a complete review of all of the data supporting our NDA and we remain committed to working closely with them throughout the remainder of the regulatory process”, said Edward Kaye, Sarepta’s interim chief executive officer and chief medical officer. The FDA has previously granted eteplirsen Priority Review status, which is designated for drugs that provide a treatment where no adequate therapy exists. The FDA also granted Rare Pediatric Disease Designation to eteplirsen, as well Orphan Drug Designation and Fast Track Status. It is estimated that Duchenne muscular dystrophy affects approximately one in every 3,500 – 5,000 boys born worldwide, with 13 percent of people with the disease having mutations addressable by eteplirsen/exon 51 skipping. About Sarepta Therapeutics Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of rare, infectious and other diseases. For more information, please visit us at www.sarepta.com. About Eteplirsen Eteplirsen is designed to address the underlying cause of DMD by restoring the dystrophin messenger RNA (mRNA) reading frame, thus enabling the production of a shorter, functional form of the dystrophin protein. Eteplirsen uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 51 of the dystrophin gene. Approximately 13 percent of the DMD population is amenable to exon 51 skipping. Data from clinical studies of eteplirsen in DMD patients have demonstrated a consistent safety and tolerability profile and have also shown measurable dystrophin protein expression. Promoting the synthesis of a shorter dystrophin protein is intended to slow the decline of ambulation and mobility seen in DMD patients. There currently is no approved treatment in the United States for DMD and eteplirsen has not been approved by the FDA or any regulatory authority for the treatment of DMD. About Duchenne Muscular Dystrophy DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500-5,000 boys worldwide. A devastating and incurable muscle-wasting disease, DMD is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The condition is universally fatal, and death usually occurs before the age of 30. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the rescheduled PDUFA goal date for an FDA decision on our NDA for eteplirsen to allow for a full review by the FDA of the additional 6MWT and loss of ambulation data submitted by the Company on January 8, 2016 in the Sarepta Advisory Committee Briefing Document Amendment which describes the Company’s principal basis for establishing the effectiveness of eteplirsen is a comparison of patients in Study 201/202 to a historical control group; Sarepta’s primary goal of bringing treatment to patients with Duchenne as quickly as possible and its commitment to continue working closely with the FDA throughout the remainder of the regulatory process.; and the potential market size for eteplirsen, Forward-looking statements also include those regarding Sarepta’s future business developments and actions and the timing of the same. These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the FDA may further delay rescheduling or cancel the Advisory Committee meeting or may further delay the PDUFA date for our NDA for eteplirsen; any rescheduled Advisory Committee meeting may not result in decisions or recommendations that result in the approval of eteplirsen by the FDA; the results of our ongoing research and development efforts and clinical trials for eteplirsen and our other product candidates may not be positive or consistent with prior results or demonstrate a safe treatment benefit; there may be delays in Sarepta’s projected regulatory and development timelines relating to additional research, clinical trials and commercialization plans of eteplirsen and the development of Sarepta’s other product candidates for various reasons including possible limitations of Sarepta’s financial and other resources; Sarepta may not be able to successfully complete its planned commercialization of eteplirsen or continue developing its product candidates as planned for a variety of reasons including due to regulatory, court or agency decisions, such as decisions by the USPTO with respect to patents that cover Sarepta’s product candidates, or manufacturing issues; any or all of Sarepta’s product candidates may fail in development or may not receive required regulatory approvals for commercialization; and those risks identified under the heading “Risk Factors” in Sarepta’s 2014 Annual Report on Form 10-K or and most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review. Any of the foregoing risks could materially and adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the Company’s filings with theSEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.   Broad Street Alerts has not been compensated for this post and we do not hold any positions.   Source- Biopharmcatalyst, businesswire http://investorrelations.sarepta.com/phoenix.zhtml?c=64231&p=irol-newsArticle&ID=2136367

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A number of firms have modified their ratings and price targets on shares of Golden Star Resources (NYSE: GSS) recently:

• 4/7/2016 – Golden Star Resources was downgraded by analysts at Zacks Investment Research from a “buy” rating to a “hold” rating. According to Zacks, “GOLDEN STAR RES is an un-hedged gold producer they own the Wassa gold project in Ghana and control a number of gold exploration properties in West Africa. The Company is well funded and has strong, operational focused management experienced in West Africa. The Company has become a producing gold company by consolidating a long-lived production base at Bogoso/Prestea in Ghana. Going forward, the Company will continue to focus on growing its gold business. “
• 4/6/2016 – Golden Star Resources was upgraded by analysts at Zacks Investment Research from a “hold” rating to a “buy” rating. They now have a $0.50 price target on the stock. According to Zacks, “GOLDEN STAR RES is an un-hedged gold producer they own the Wassa gold project in Ghana and control a number of gold exploration properties in West Africa. The Company is well funded and has strong, operational focused management experienced in West Africa. The Company has become a producing gold company by consolidating a long-lived production base at Bogoso/Prestea in Ghana. Going forward, the Company will continue to focus on growing its gold business. “
• 3/29/2016 – Golden Star Resources was downgraded by analysts at Zacks Investment Research from a “buy” rating to a “hold” rating. According to Zacks, “GOLDEN STAR RES is an un-hedged gold producer they own the Wassa gold project in Ghana and control a number of gold exploration properties in West Africa. The Company is well funded and has strong, operational focused management experienced in West Africa. The Company has become a producing gold company by consolidating a long-lived production base at Bogoso/Prestea in Ghana. Going forward, the Company will continue to focus on growing its gold business. “
• 3/28/2016 – Golden Star Resources was upgraded by analysts at Zacks Investment Research from a “hold” rating to a “buy” rating. They now have a $0.50 price target on the stock. According to Zacks, “GOLDEN STAR RES is an un-hedged gold producer they own the Wassa gold project in Ghana and control a number of gold exploration properties in West Africa. The Company is well funded and has strong, operational focused management experienced in West Africa. The Company has become a producing gold company by consolidating a long-lived production base at Bogoso/Prestea in Ghana. Going forward, the Company will continue to focus on growing its gold business. “
• 3/23/2016 – Golden Star Resources was downgraded by analysts at Zacks Investment Research from a “buy” rating to a “hold” rating. According to Zacks, “GOLDEN STAR RES is an un-hedged gold producer they own the Wassa gold project in Ghana and control a number of gold exploration properties in West Africa. The Company is well funded and has strong, operational focused management experienced in West Africa. The Company has become a producing gold company by consolidating a long-lived production base at Bogoso/Prestea in Ghana. Going forward, the Company will continue to focus on growing its gold business. “
• 2/26/2016 – Golden Star Resources had its “sector perform” rating reaffirmed by analysts at National Bank Financial. They now have a $0.50 price target on the stock, up previously from $0.35.

Shares of Golden Star Resources Ltd. (NYSE:GSS) opened at 0.4942 on Monday. The firm has a 50-day moving average price of $0.45 and a 200-day moving average price of $0.27. The firm’s market cap is $128.44 million. Golden Star Resources Ltd. has a 12-month low of $0.14 and a 12-month high of $0.56.

Source: American Banking and Market News

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