XLRN News

Acceleron (XLRN) delivered earnings and revenue surprises of -13.10% and -21.02%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?

Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs April 7) * Dr.Reddy's Laboratories Ltd (NYSE: RDY) * Masimo Corporation (NASDAQ: MASI) * Seattle Genetics, Inc. (NASDAQ: SGEN) * Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)Down In The Dumps (Biotech Stocks Hitting 52-week Lows April 7) * Celcuity Inc (NASDAQ: CELC) * Curis, Inc. (NASDAQ: CRIS) * Helius Medical Technologies Inc (NASDAQ: HSDT) * Menlo Therapeutics Inc (NASDAQ: MNLO) * TherapeuticsMD Inc (NASDAQ: TXMD) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)Stocks In Focus COVID-19 Test Sales to Lift GenMark's Q1 Results; Company Raises 2020 Guidance GenMark Diagnostics, Inc (NASDAQ: GNMK) announced preliminary first-quarter results, expecting revenues of about $38.7 million, a 80% year-over-year increase. The company noted that about 80% gross placements included interest in COVID-19 testing SARS-CoV-2 consumable revenues. Analysts, on average, estimate revenues of $24.8 million.The company also raised its full-year revenue guidance from $100-$110 million to $112-$122 million, while the consensus calls for revenues of $108.58 million.The stock climbed 29.56% to $5.83 in after-hours trading.Zomedica Prices Offering of Common Stock, Warrants Zomedica Pharmaceuticals Corp (NYSE: ZOM) said it has priced its previously announced public offering of 33.33 million shares and warrants to purchase up to 1.667 million shares. The company expects gross proceeds of about $4 million from the offering. The offering is expected to close on or about April 9.In after-hours trading, the shares shed 9.95% to 15 cents.Mersana Raises $65M Through At-The-Market Facility Mersana Therapeutics Inc (NASDAQ: MRSN) said it has raised gross proceeds of about $65 million through at-the-market facility with participation based on interest received from Avoro Capital Advisors LLC, Bain Capital Life Sciences, Consonance Capital Investors and David Mott, Mersana's Chairman.The company said it sold about 8.9 million shares at $5.50 per share and 2 million shares at the closing price of $7.74 per share, in each case the market price at the time of sale.Bristol-Myers Squibb Announces Acceptance of U.S. and European Regulatory Submissions for Combo Immunotherapy For Lung Cancer Bristol-Myers Squibb Co (NYSE: BMY) said the U.S. FDA accepted its sBLA for Opdivo-Yervoy combo with a limited course of chemotherapy for the first-line treatment of patients metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. The European Medicines Agency has also validated a type II variation application for the same combo for the same indication, it added.Acceleron's Hypertension Drug Gets Breakthrough Therapy Designation Acceleron Pharma Inc (NASDAQ: XLRN) said the FDA has granted Breakthrough Therapy Designation to sotatercept for the treatment of patients with pulmonary arterial hypertension.FDA Extends Review Period For Roche's Spinal Muscular Atrophy Drug By 3 Months Roche Holdings AG Basel (OTC: RHHBY) said the FDA has extended the PDUFA date for the review of its NDA for risdiplam by three months to Aug. 24 due to a recent submission of additional data made by Roche, including data from the pivotal SUNFISH Part 2 study.Sage Announces Restructuring, Including Workforce Reduction, to Conserve Cash SAGE Therapeutics Inc (NASDAQ: SAGE) announced a restructuring initiative that would help it to advance its corporate strategy and pipeline. The initiative includes elimination of about 53% of its workforce and a reduction in external expenses, which together is expected to result in annualized savings of about $170 million, of which $150 million is related to SG&A expenses.The company said the workforce reduction will primarily affect Zulresso CIV injection commercial operation and related SG&A support functions.Based on the current operating plan and assumptions, Sage expects its cash position to support operations into 2022.The stock added 1.07% to $29.34 in after-hours trading.Idera Announces Private Placement of Up to $20.7M Worth Common Stock and Warrants Idera Pharmaceuticals Inc (NASDAQ: IDRA) announced an funding agreement for privately placing shares of its common stock together with accompanying warrants to purchase additional shares of common stock in two tranches, with the second tranche to be made at the option of the investor.View more earnings on IBBDepending on the extent to which Tranche 2 is closed, and inclusive of proceeds from the exercise of warrants issuable in this private placement, the company said it will receive up to $20.7 million in gross proceeds.The company said it plans to use the proceeds primarily to fund completion of its ongoing ILLUMINATE-301 trial of its lead product tilsotolimod for the treatment of anti-PD-1 refractory metastatic melanoma.The stock surged up 29.03% to $1.60 in after-hours trading.Organovo Terminates Merger With Tarveda Organovo Holdings Inc (NASDAQ: ONVO), a developer of 3-D bioprinted tissues comprising human cells, said it has terminated the merger agreement with Tarveda Therapeutics, which was originally announced Dec. 16. The decision follows Organova's shareholders rejecting the merger at a special meeting of stockholders.The shareholders, meanwhile, approved the proposal to effect a reverse stock split of one share for every 20 to 40 shares of existing common stock.The stock slipped 3.30% to 28 cents in after-hours trading.MediciNova to Initiate Clinical Trial of Investigational Asset MN-166 For COVID-19-induced Respiratory Distress MediciNova, Inc. (NASDAQ: MNOV) said it will initiate a clinical trial of MN-166 for acute respiratory distress syndrome caused by COVID-19."We are very pleased to announce initiation of a clinical trial of MN-166 in ARDS caused by COVID-19. This study also will allow investigators to determine the optimal dose and route of administration in these very critical patients," said Yuichi Iwaki, CEO of MediciNova.Announcements On COVID-Related Impacts Myriad Genetics, Inc. (NASDAQ: MYGN) announced withdrawal of its 2020 financial guidance, citing the impact of the COVID-19 pandemic."....recent social distancing guidelines have had a significant impact on test volume trends in late March and into the fiscal fourth-quarter," said Bryan Riggsbee, interim president and CEO and chief financial officer at Myriad Genetics.Trillium Therapeutics Inc (NASDAQ: TRIL) said it expects a slowdown or potentially a pause in new patient enrolment in its TTI-621 and TTI-622 dose escalation studies. The company, however, said its strong financial position, with about $135 million in cash and investments, will enable it to tide through the crisis and also execute on its key strategic objectives.On The Radar IPO Keros Therapeutics, which develops therapies for hematological and neuromuscular disorders, said it has priced its upsized initial public offering, or IPO, of 6 million at $16 compared to the estimated range of $14-$16. The company's shares will begin trading on the Nasdaq under the ticker symbol KROS.See more from Benzinga * The Daily Biotech Pulse: Sanofi, Regeneron Finalize Praluent Restructuring, Natus Pre-Announces Q1 Shortfall, Alcon To Delay Dividend Initiation * The Week Ahead In Biotech: Spotlight On Q1 Pre-Announcements As COVID-19 Continues To Disrupt Operations * The Daily Biotech Pulse: Fate Therapeutics Inks Cell Therapy Deal With J&J, Zentalis IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Bristol Myers (BMY) and Acceleron received FDA nod for the label expansion of Reblozyl for MDS patients who require RBC transfusions, failing an erythropoiesis stimulating agent.

Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH) (World Health Organization Group 1).

Reblozyl® (luspatercept) Receives Positive CHMP Opinion for the Treatment of Adults with Anemia in Beta Thalassemia and Myelodysplastic Syndromes

Joining me on the call this afternoon are Habib Dable, our Chief Executive Officer; Kevin McLaughlin, our Chief Financial Officer; Dr. Jay Backstrom, our Head of Research & Development; and Sujay Kango, our Chief Commercial Officer. As a reminder, we will be making forward-looking statements regarding our financial outlook.

Acceleron Pharma Inc. (Nasdaq:XLRN) today announced it will host a webcast and conference call on Monday, May 11, 2020 at 5:00 p.m. EDT to discuss its first quarter 2020 operating and financial results.

While stock markets buckle under the pressures of the COVID-19 outbreak, a Lexington biotech developing drugs for blood and musculoskeletal disorders has raised an upsized IPO.

Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that a total of six distinct abstracts on REBLOZYL® (luspatercept-aamt) will be presented at the upcoming 2020 American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program, held May 29-31, and at the 25th Annual European Hematology Association (EHA25) Virtual Congress, held June 11-21.

Acceleron (XLRN) posts a wider-than-expected Q1 loss due to increased operating expenses. The company misses on revenues as well.

It's pretty hard to ignore the impact of Covid-19 on the global and domestic economy. But the shutdown in the U.S. economy, while swift, was also swiftly managed by the administration and Congress, as well as the Federal Reserve. This has helped buoy the markets after a precipitous initial drop. And it has allowed enough time for investors to process everything that has happened and reset their expectations -- looking away from certain risks and into cleaning-supply companies and biotech stocks.Previous to Covid-19, there was the feeling the economy was nearing recession sometime this year. Now we're in one.However, this remains an uneven market. Big stocks like Amazon (NASDAQ:AMZN) and Netflix (NASDAQ:NFLX) are doing even better under these difficult conditions. But other consumer stocks aren't.InvestorPlace - Stock Market News, Stock Advice & Trading TipsThat's why I wanted to talk about an opportunity that doesn't have to do with consumer-driven stocks -- the seven beautiful biotech stocks to buy here. These companies are set up to endure long drug approval processes that happen over good times and bad. * CRISPR Therapeutics (NASDAQ:CRSP) * Acceleron Pharma (NASDAQ:XLRN) * Neurocrine Biosciences (NASDAQ:NBIX) * Galapagos NV (NASDAQ:GLPG) * Incyte Corp (NASDAQ:INCY) * Regeneron Pharmaceuticals (NASDAQ:REGN) * Gilead Sciences (NASDAQ:GILD)They're built to be immune from general market forces, especially the big one these days -- consumer spending -- and to benefit from powerful technology that's popping up in all kinds of industries. Biotech Stocks to Buy: CRISPR Therapeutics (CRSP)Source: Catalin Rusnac/ShutterStock.com CRISPR is a Swiss biotech that is one of the leaders in CRISPR technology. This is a new and fast-growing field. CRISPR (it stands for clustered regularly interspaced short palindromic repeats) is a DNA segment containing short repetitions of base sequences.By using these, scientists are learning to identify where there is a break in the pattern that may signal a disease and then repair (or edit) that sequence. This is a revolutionary concept in treating disease, since it is the first step toward personalized medicine.Currently the research is hoping to build treatments to help battle many different cancers and other diseases. But eventually the technology can be applied to a much broader field of needs.The company is well funded and will continue to make a difference, even sequencing Covid-19.The stock is up 37% in the past year and over 30% in the past month. Acceleron Pharma (XLRN)Source: Pavel Kapysh / Shutterstock.com Acceleron is a biopharmaceutical company that has been around since 2003. Last year was a wild ride for the firm, and the volatility continued into 2020.In September, one of its drugs in trials was rejected by the FDA and the stock tanked. Then, shortly after that, its drug luspatercept, which treats a rare blood disorder, was approved.And then, in late January, data from a Phase 2 trial of another drug it has in the approval process for pulmonary arterial hypertension (PAH), showed significant positive results in treating the disorder. This is the kind of situation that can attract big buying pressure on Wall Street of the kind I want to see in Growth Investor.Needless to say, the stock is now up 134% in the past year, and 38% in the past month.One of its largest shareholders is Bristol Myers Squibb (NYSE:BMY). Acceleron had been doing a lot of work with Celgene when BMY bought Celgene. This is a great partnership to have when looking to market, manufacture and distribute these new drugs. Neurocrine Biosciences (NBIX)Source: Shutterstock Neurocrine Biosciences has been in business for over 25 years and specializes in developing treatments for people suffering with neurological, endocrine and psychological disorders.It currently has treatments for tardive dyskinesia and endometriosis. It has candidates for Parkinson's, uterine fibroids and congenital adrenal hyperplasia. Last year, there was talk that Biogen (NASDAQ:BIIB) may have been looking at NBIX as an acquisition to build on its own work in some of these sectors.It's a solid company that has a good balance of revenue-generating drugs and a solid, focused drug pipeline. Neurocrine has a unique niche and will remain an attractive takeover target for larger pharmaceutical companies and biotechs.The stock is up 17% for the past year, and 20% in the past month. Galapagos NV (GLPG)Source: Jarretera / Shutterstock.com Galapagos is a Belgian company that specializes in small molecule and antibody therapies.It was a solid performer and has been around for over 20 years. But its big break happened last year when Gilead approached the company and offered it a $5 billion partnership deal. This brought the stock to the attention of many U.S. investors who hadn't paid much attention to it.And by December, that partnership paid off. GILD filed with FDA for speedy review of filgotinib, a potential blockbuster drug that GLPG developed and had in Europe in Japan but not the U.S. The U.S. is the market where the money is made, since pricing is far more dynamic than in other countries.The approval came in December. And this could mean big things for both companies. But since then, Covid-19 has taken the spotlight and Gilead's remdesivir has been all the buzz.GLPG stock is up over 80% in the past 12 months, and almost 45% in the past month. Its management has also been wise enough to partner with a genomics company that provides what's sometimes nicknamed "the mother of all technologies" to help discover new treatments and drug combinations. Incyte Corp (INCY)Source: Eyesonmilan / Shutterstock.com Incyte has been around since the early 1990s and is good-sized biopharmaceutical company with a $21 billion market capitalization.Currently it has two drugs in the marketplace, one of those is in the US. Its big drug is Jakafi (ruxolitinib), which treats a rare form of blood cancer and is also approved to manage acute graft-versus-host disease in adults.It also has a drug that it acquired from ARIAD Pharmaceuticals for European distribution. Its Iclusig (ponatinib) is used to treat leukemia, and INCY stock hopes to make the drug available in the U.S. after approval from the FDA.Incyte also has a good number of drugs in the pipeline and has the financial wherewithal to keep moving them forward, even now.The stock is up 36% in the past 12 months, and over 60% in the past month. Regeneron Pharmaceuticals (REGN)Source: madamF / Shutterstock.com Regeneron is one of those biotech stocks that has been a direct Covid-19 beneficiary.It has a number of drugs in the market and around 30 drugs in its pipeline. It has been around since 1988 and has a $62 billion market cap, so this is no one-trick pony rolling the dice on a potential blockbuster. It has built its reputation over time, delivering solid drugs in important sectors.But the added juice at this point is its arthritis drug Kevzara that it co-markets with Sanofi (NASDAQ:SNY). It has been given to patients in China and New York (the co-founder of Regeneron is from Queens) but the testing isn't broad enough to deliver any conclusive information.Obviously, the bet on Kevzara being a treatment is just that, a bet. But it has brought more attention to REGN, which is a quality pharma. And Regeneron also has its eye on the big picture of next-generation technology to supercharge its genomics research at the Regeneron Genetics Center.The stock is up almost 62% in the past year and up 22% in the past month. Gilead Sciences (GILD)Source: Michael Moloney / Shutterstock.com Gilead has been a big name among biotech stocks for a long time. It was a key player in finding a treatment for HIV/AIDS. And was also a pioneer in finding a highly effective once-a-day regimen for hepatitis C.While it still makes a good amount of money from these blockbusters, it hadn't had a big hit in a while and the stock flat-lined as investors wondered if its best days were behind it.But it has made some interesting acquisitions and partnerships in the past couple years, one of those being with Galapagos.And now, remdesivir is in two Phase 3 clinical trials as a treatment for Covid-19. This, along with the promising partnership with GLPG stock that's already delivering results, promises that GILD could beback in the running with two potential blockbusters. Even one would be great news.The stock is on the move, up 30% in the past 12 months, and 13% in the past month. And it is still off its 2015 highs, so there's plenty of headroom if either - or both - these drug live up to their promise.Gilead is one of the "big kahunas" in this space, and now a household name, thanks to the fight against Covid-19. It, too, is partnering with smaller labs to harness the power of the game-changing technology of our time: artificial intelligence (AI). The AI Master KeyIf artificial intelligence sounds futuristic, even far-fetched -- well, keep in mind, you're already using it every day. If you've ever used Alphabet's (NASDAQ:GOOG, NASDAQ:GOOGL) Google Assistant or Apple's (NASDAQ:AAPL) Siri … if you've had Netflix (NASDAQ:NFLX) recommend a movie or Zillow (NASDAQ:Z) recommend a house … even an email spam filter … then you've used artificial intelligence.In this new world of AI everywhere, data becomes a hot commodity.As scientists find even more applications for artificial intelligence -- from hospitals to retail to self-driving cars -- it's incredible to imagine how much data will be involved.To create AI programs in the first place, tech companies must collect vast amounts of data on human decisions. Data is what powers every AI system. As one AI researcher from the University of South Florida puts it, "data is the new oil."To cash in, you'll want the company that makes the "brain" that all AI software needs to function, spot patterns and interpret data.It's known as the "Volta Chip" -- and it's what makes the AI revolution possible.You don't need to be an AI expert to take part. I'll tell you everything you need to know, as well as my buy recommendation, in my special report for Growth Investor, The A.I. Master Key. The stock is still under my buy limit price -- so you'll want to sign up now. That way, you can get in while you can still do so cheaply.Click here for a free briefing on this groundbreaking innovation.Louis Navellier had an unconventional start, as a grad student who accidentally built a market-beating stock system -- with returns rivaling even Warren Buffett. In his latest feat, Louis discovered the "Master Key" to profiting from the biggest tech revolution of this (or any) generation. Louis Navellier may hold some of the aforementioned securities in one or more of his newsletters. More From InvestorPlace * America's 1 Stock Picker Reveals Next 1,000% Winner * 25 Stocks You Should Sell Immediately * 1 Under-the-Radar 5G Stock to Buy Now * The 1 Stock All Retirees Must Own The post 7 Beautiful Biotech Stocks to Buy Here appeared first on InvestorPlace.

Company also exceeds offering target Continue reading...

Q1 2020 Acceleron Pharma Inc Earnings Call

Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that an oral presentation of the PULSAR Phase 2 trial topline results of sotatercept in patients with pulmonary arterial hypertension (PAH) will be presented in a virtual session of the American Thoracic Society (ATS) 2020 Conference on June 24, 2020.

Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that research published in the journal Science Translational Medicine describes how a murine version of the investigational agent sotatercept acts to restore balance in key signaling pathways whose disruption drives the disease pathology of pulmonary arterial hypertension (PAH).

Today we will run through one way of estimating the intrinsic value of Acceleron Pharma Inc. (NASDAQ:XLRN) by...

Q4 2019 Acceleron Pharma Inc Earnings Call

Acceleron Pharma Inc. (Nasdaq:XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today provided a corporate update and reported financial results for the first quarter ended March 31, 2020.

Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).

Acceleron Pharma Inc. (Nasdaq:XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that Jean George is retiring from her position on its Board of Directors.