Roth Capital biotech analyst to hold an analyst/industry conference call » 13:3706/0206/02/20
Biotech Analyst Rahimi,…
Biotech Analyst Rahimi, along with Dr. Hani Sabbah, Director of Cardiovascular Research at Henry Ford Health, discusses why Cardiolipin holds the key in Cardiomyopathy on an Analyst/Industry conference call to be held on June 12 at 12 pm.
|Over a week ago|
Stealth Biotherapeutics reports Q1 EPS (4c), consensus (9c) » 07:4005/0705/07/20
Stealth is committed to…
Stealth is committed to advancing its ongoing clinical programs in Barth and dry AMD. As previously announced, the company anticipates completing enrollment for its Phase 2b trial in dry AMD by year-end and hopes to see an uptick in enrollment as various regions of the country reopen in the coming weeks. The company is continually monitoring additional risks and potential delays in its clinical study sites and contract research organizations and will provide any further updates as appropriate. Cash and cash equivalents were $31.2M at March 31, compared to $50.8M at December 31, 2019. An additional $20M was received in April, pursuant to a private placement transaction with Morningside Venture Investments.
|Over a month ago|
Stealth Biotherapeutics initiated with a Buy at Roth Capital » 07:4504/1404/14/20
Roth Capital analyst…
Roth Capital analyst Yasmeen Rahimi initiated coverage of Stealth Biotherapeutics with a Buy rating and $9 price target. The analyst says that "strong" 36-week OLE data from TAZPOWER builds the case for elamipretide in Barth syndrome when compared to a natural history control, thus putting a high Probability of Success for Stealth Biotherapeutics to get the go-ahead for NDA filing in Barth in mid-2020.
Stealth Bio reports $20M financing to advance elamipretide development » 09:5804/1304/13/20
Stealth BioTherapeutics announced that it has completed a $20M private placement with Morningside Venture Investments Limited. As part of the financing, Morningside purchased 152,858,460 ordinary shares at a price of $0.13084 per ordinary share. The last reported closing price of the company's American Depositary Shares on Nasdaq was $1.57; each ADS represents 12 ordinary shares. The company expects to use proceeds from this capital raise to advance the company's ongoing development of its lead candidate, elamipretide, its next-generation clinical stage compound, SBT-272, and its pipeline of mitochondrial therapeutics.
Stealth Biotherapeutics price target lowered to $10 from $14 at Nomura Instinet » 06:4804/0304/03/20
Nomura Instinet analyst…
Nomura Instinet analyst Christopher Marai lowered the firm's price target on Stealth Biotherapeutics to $10 from $14 and reiterates a Buy rating on the shares following the company's Q4 results. The analyst cites current estimated approval timelines for the target drop.
Stealth Biotherapeutics price target lowered to $3 from $7 at BMO Capital » 07:4104/0204/02/20
BMO Capital analyst…
BMO Capital analyst Matthew Luchini lowered the firm's price target on Stealth Biotherapeutics to $3 from $7 and keeps a Market Perform rating on the shares. The analyst notes that the company's Phase 2b dry AMD enrollment has been negatively impacted by coronavirus and expected data has been pushed out to the second half of 2021. While he is reducing his expected operating expenses, Luchini also raises his modeled discount rate given that delays and current market conditions will increase Stealth Bio's risk profile as its cash is only expected to last until Q4 of this year.
Stealth Biotherapeutics upgraded to Buy from Neutral at H.C. Wainwright » 07:1704/0204/02/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Yi Chen upgraded Stealth Biotherapeutics to Buy from Neutral with an unchanged price target of $5. The company could have a pre-new drug application meeting with the FDA in mid-2020 and submit the NDA for elamipretide for the treatment of Barth syndrome in the second half of 2020, Chen tells investors in a research note. Further, Stealth shares are currently trading near the company's cash value, adds the analyst.
Stealth Biotherapeutics CEO says 'off to a strong start in 2020' » 07:3204/0104/01/20
"We are off to a…
"We are off to a strong start in 2020, having honed our focus on Barth and our planned expansion into other rare metabolic cardiomyopathies, while continuing to execute on the significant promise of our ophthalmic and other pipeline programs. By decisively reducing expenses in January, our cash and cash equivalents are sufficient through key Barth regulatory interactions in the second half of 2020, bringing us closer to a potential approval with an opportunity for a rare pediatric voucher and expedited regulatory review," said Reenie McCarthy, CEO at Stealth. "We hope to complete enrollment of our Phase 2b study in dry AMD during the second half of this year, keeping us on-track for a second half of 2021 top-line read-out. We are actively planning development initiatives in other rare metabolic cardiomyopathies, on which we hope to engage with the FDA this year. We are also rapidly advancing our pipeline of novel mitochondrial medicines, with SBT-272 being assessed in a Phase 1 clinical trial, preclinical data read-outs expected this year for SBT-272 in amyotrophic lateral sclerosis and multiple system atrophy and SBT-259 in Charcot-Marie-Tooth, and lead optimization underway for our SBT-550 series, targeting the ferroptosis pathway of cell death implicated in neurodegenerative diseases such as Parkinson's."
|Over a quarter ago|
Stealth's RPD designation a 'step in right direction', says Cantor Fitzgerald » 11:4703/0303/03/20
Cantor Fitzgerald analyst…
Cantor Fitzgerald analyst Charles Duncan maintained an Overweight rating and $10 price target on Stealth Biotherapeutics (MITO) following the FDA granting its lead candidate, elami, a Rare Pediatric Disease, or RPD, designation for Barth syndrome. The analyst feels this is a "step in the right direction" prior to the compay's meeting with the FDA in March, and believes it "signals FDA perspective on the patient population and possibly its unmet medical need." Duncan added that he is looking forward to seeing additional data to be presented at upcoming clinical meetings.
Stealth Biotherapeutics jumps after drug granted RPD designation from FDA » 10:1003/0303/03/20
Stealth BioTherapeutics (MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced that the FDA has granted Rare Pediatric Disease, or RPD, designation for elamipretide for the treatment of Barth syndrome, an ultra-rare genetic condition. Under the FDA's RPD designation program, the FDA may grant a priority review voucher to a sponsor who receives approval for a "rare pediatric disease," a serious and life-threatening disease that primarily affects individuals aged from birth to 18 years and fewer than 200,000 people in the United States. "This designation for elamipretide underscores our alignment with the FDA around the significant and urgent unmet medical need for Barth patients," said Reenie McCarthy, CEO of Stealth. "We hope to improve the healthspan of Barth patients, for whom cardiomyopathy, exercise intolerance and debilitating fatigue limit life expectancy and impair quality of life. We are also expanding our development efforts to consider trials in patients suffering from overlapping metabolic cardiomyopathies in diseases such as Duchenne and Becker muscular dystrophies, and Friedreich's ataxia." In morning trading, shares of Stealth Biotherapeutics were higher by 101% to $3.82.