GBA Presents: RADIO SAVANT-!

Iveric Bio Announces FDA Has Granted Breakthrough Therapy Designation for Avacincaptad Pegol for Geographic Atrophy


IVERIC bio, Inc. (Nasdaq: ISEE) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for avacincaptad pegol (ACP, also known as Zimura®), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). To date, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation status for this indication, which was granted based on the 12-month pre-specified primary endpoint data in the GATHER1 and GATHER2 pivotal clinical trials.

Breakthrough Therapy designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to show preliminary clinical evidence that the drug may demonstrate substantial improvement in effectiveness or safety over available therapies on a clinically significant endpoint and in general, should show a clear advantage.1

“We believe this Breakthrough designation reflects the fact that both GATHER1 and GATHER2 met their primary endpoint with a safety profile that meets the stringent criteria required,” said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “We are now focused on the execution of our full NDA submission and launch preparation, with the possibility of being first to market. We look forward to working collaboratively with the FDA to expedite the review timeline for avacincaptad pegol and to potentially bringing a new therapy to AMD patients impacted by GA.”
My dumb doc, I told him to buy and hold,
 
I'm locked out everything. If anyone can grab this on Seeking Alpha there's a piece on Goldman's Favorite Growth stocks for any recession or inflation environment<-- one of those.

I saw it to the right when I looked up Harmony Bio.

Would love to know if Harmony is on that list.
Goldman leans to growth picks in either recession scenario
Apr. 03, 2023 5:21 AM ET|SPDR S&P 500 Trust ETF (SPY)|IWV, LVS, AMD, NVDA, OLED, MRVL, TTWO, LLY, MPWR, POWI, SLAB, TER, CSGP, FSLR, CHDN, RGEN, DXCM, VICR, ERII, FTNT, AL, ENPH, NOW, PANW, WDAY, MARA, VEEV, CRWD, PCTY, FIVN, PAYC, QRVO, ABNB, PLTR, ZS, EAF, PLL, LTHM, SWAV, SP500, DT, DDOG, SITM, MP, HRMY, U, CVT, SHLS, DOCN, DOCS, CTKB, DH, AMLX, CRDO...|By: Kim Khan, SA News Editor|7 Comments
d8ffaa9a9e840a505be9166b150fc565023d0b18.webp

Michael M. Santiago
Goldman Sachs is sticking with its S&P 500 (SP500) (NYSEARCA:SPY) target of little change by year end as valuations and earnings face headwinds near term, its equity team said.
"Our Long Duration basket has outperformed the Short Duration basket by 6 pp YTD (2% vs. 8%)," strategist David Kostin wrote in a note. "This has created an asymmetry that supports our recommendation ... to own high-margin growth stocks vs. low-margin growth stocks."
"If the economy avoids recession, real yields are likely to rise and pose a headwind to low-margin growth stocks," Kostin said. "If the economy enters recession investors will likely rotate toward stocks with 'quality' attributes, including high profit margins."
Goldman selected high-margin stocks growth stocks from the Russell 3000 (IWV) excluding Biotech, Financials, Real Estate and Energy with market cap above $1B and revenue of $100M.
The stocks by sector are:
Communications Services
  • Take-Two (TTWO), second twelve months sales growth consensus 25%, net margin consensus 17%
Consumer Discretionary
  • Las Vegas Sands (LVS), 24%, 21%
  • Churchill Downs (CHDN), 15%, 19%
  • Airbnb (ABNB), 15%, 24%
Healthcare
  • Amylyx (AMLX), 64%, 37%
  • Harmony Biosciences (HRMY), 25%, 32%
  • Cytek Biosciences (CTKB), 23%, 15%
  • Definitive Healthcare (DH), 19%, 16%
  • Eli Lilly (LLY), 18%, 30%
  • Shockwave Medical (SWAV), 23%, 21%
  • Veeva Systems (VEEV), 18%, 31%
  • Doximity (DOCS), 20%, 26%
  • Repligen (RGEN), 20%, 21%
  • DexCom (DXCM), 19%, 15%
Industrials
  • GrafTech (EAF), 28%, 19%
  • Vicor (VICR), 21%, 18%
  • Shoals Technologies (SHLS), 40%, 22%
  • Energy Recovery (ERII), 37%, 19%
  • Air Lease (AL), 16%, 23%
  • CoStar Group (CSGP), 17%, 16%
Materials
  • Piedmont Lithium (PLL), 133%, 72%
  • Livent (LTHM), 22%, 37%
  • MP Materials (MP), 44%, 48%
Info Tech
  • Marathon Digital (MARA), 25%, 17%
  • Qorvo (QRVO), 18%, 19%
  • Credo Technology (CRDO), 56%, 18%
  • Unity Software (U), 18%, 16%
  • First Solar (FSLR), 29%, 31%
  • Silicon Labs (SLAB), 17% 16%
  • Five9 (FIVN), 19%, 16%
  • Cvent Holding (CVT), 18%, 19%
  • Teradyne (TER), 20%, 24%
  • DigitalOcean (DOCN), 20%, 28%
  • Palantir (PLTR), 19%, 22%
  • AMD (AMD), 15%, 24%
  • Workday (WDAY), 18%, 20%
  • Marvell (MRVL), 17%, 30%
  • Zscaler (ZS), 27%, 17%
  • Power Integrations (POWI), 19%, 21%
  • Palo Alto Networks (PANW), 20%, 19%
  • Paylocity Holding (PCTY), 20%, 22%
  • Enphase Energy (ENPH), 26%, 19%
  • Datadog (DDOG), 30%, 20%
  • Dynatrace (DT), 20%, 22%
  • CrowdStrike (CRWD), 28%, 19%
  • Fortinet (FTNT), 19%, 21%
  • ServiceNow (NOW), 22%, 22%
  • Paycom Software (PAYC), 21%, 26%
  • SiTime (SITM), 32%, 25%
  • Universal Display (OLED), 19%, 34%
  • Monolithic Power (MPWR), 16%, 34%
  • Nvidia (NVDA), 24%, 31%
Mohamed El-Erian on why the Fed should pause.
 
GBA->INZY
Inozyme Pharma, Inc.
5.63 +0.94 +20%

Vs.

TED->KC
Kingsoft Cloud Holdings Limited
9.23 +1.37 +17%

WHICH ONE WILL HOLD IT'S GAINS?







INZY- $5.85
The company's lead product candidate is INZ-701, a soluble, recombinant, genetically engineered, and fusion protein, which is in Phase 1/2 clinical trials for the treatment of ENPP1 and ABCC6 deficiency, as well as for the treatment of calciphylaxis. It has a license agreement with Yale University for specified therapeutic and prophylactic products.

VS-

KC-$ $9.70
Nice address.
Kingsoft Cloud Holdings Limited
Building E
Xiaomi Sc and Technology Par No. 33 Xierqi Middle Road Haidian District
Beijing 100085
China
 
Goldman leans to growth picks in either recession scenario
Apr. 03, 2023 5:21 AM ET|SPDR S&P 500 Trust ETF (SPY)|IWV, LVS, AMD, NVDA, OLED, MRVL, TTWO, LLY, MPWR, POWI, SLAB, TER, CSGP, FSLR, CHDN, RGEN, DXCM, VICR, ERII, FTNT, AL, ENPH, NOW, PANW, WDAY, MARA, VEEV, CRWD, PCTY, FIVN, PAYC, QRVO, ABNB, PLTR, ZS, EAF, PLL, LTHM, SWAV, SP500, DT, DDOG, SITM, MP, HRMY, U, CVT, SHLS, DOCN, DOCS, CTKB, DH, AMLX, CRDO...|By: Kim Khan, SA News Editor|7 Comments
d8ffaa9a9e840a505be9166b150fc565023d0b18.webp

Michael M. Santiago
Goldman Sachs is sticking with its S&P 500 (SP500) (NYSEARCA:SPY) target of little change by year end as valuations and earnings face headwinds near term, its equity team said.
"Our Long Duration basket has outperformed the Short Duration basket by 6 pp YTD (2% vs. 8%)," strategist David Kostin wrote in a note. "This has created an asymmetry that supports our recommendation ... to own high-margin growth stocks vs. low-margin growth stocks."
"If the economy avoids recession, real yields are likely to rise and pose a headwind to low-margin growth stocks," Kostin said. "If the economy enters recession investors will likely rotate toward stocks with 'quality' attributes, including high profit margins."
Goldman selected high-margin stocks growth stocks from the Russell 3000 (IWV) excluding Biotech, Financials, Real Estate and Energy with market cap above $1B and revenue of $100M.
The stocks by sector are:
Communications Services
  • Take-Two (TTWO), second twelve months sales growth consensus 25%, net margin consensus 17%
Consumer Discretionary
  • Las Vegas Sands (LVS), 24%, 21%
  • Churchill Downs (CHDN), 15%, 19%
  • Airbnb (ABNB), 15%, 24%
Healthcare
  • Amylyx (AMLX), 64%, 37%
  • Harmony Biosciences (HRMY), 25%, 32%
  • Cytek Biosciences (CTKB), 23%, 15%
  • Definitive Healthcare (DH), 19%, 16%
  • Eli Lilly (LLY), 18%, 30%
  • Shockwave Medical (SWAV), 23%, 21%
  • Veeva Systems (VEEV), 18%, 31%
  • Doximity (DOCS), 20%, 26%
  • Repligen (RGEN), 20%, 21%
  • DexCom (DXCM), 19%, 15%
Industrials
  • GrafTech (EAF), 28%, 19%
  • Vicor (VICR), 21%, 18%
  • Shoals Technologies (SHLS), 40%, 22%
  • Energy Recovery (ERII), 37%, 19%
  • Air Lease (AL), 16%, 23%
  • CoStar Group (CSGP), 17%, 16%
Materials
  • Piedmont Lithium (PLL), 133%, 72%
  • Livent (LTHM), 22%, 37%
  • MP Materials (MP), 44%, 48%
Info Tech
  • Marathon Digital (MARA), 25%, 17%
  • Qorvo (QRVO), 18%, 19%
  • Credo Technology (CRDO), 56%, 18%
  • Unity Software (U), 18%, 16%
  • First Solar (FSLR), 29%, 31%
  • Silicon Labs (SLAB), 17% 16%
  • Five9 (FIVN), 19%, 16%
  • Cvent Holding (CVT), 18%, 19%
  • Teradyne (TER), 20%, 24%
  • DigitalOcean (DOCN), 20%, 28%
  • Palantir (PLTR), 19%, 22%
  • AMD (AMD), 15%, 24%
  • Workday (WDAY), 18%, 20%
  • Marvell (MRVL), 17%, 30%
  • Zscaler (ZS), 27%, 17%
  • Power Integrations (POWI), 19%, 21%
  • Palo Alto Networks (PANW), 20%, 19%
  • Paylocity Holding (PCTY), 20%, 22%
  • Enphase Energy (ENPH), 26%, 19%
  • Datadog (DDOG), 30%, 20%
  • Dynatrace (DT), 20%, 22%
  • CrowdStrike (CRWD), 28%, 19%
  • Fortinet (FTNT), 19%, 21%
  • ServiceNow (NOW), 22%, 22%
  • Paycom Software (PAYC), 21%, 26%
  • SiTime (SITM), 32%, 25%
  • Universal Display (OLED), 19%, 34%
  • Monolithic Power (MPWR), 16%, 34%
  • Nvidia (NVDA), 24%, 31%
Mohamed El-Erian on why the Fed should pause.
Incredible how fast the Savant types and finds us great ideas!
 
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