Seres Therapeutics Inc. (MCRB) 39.16 $MCRB
Seres Therapeutics IPO Highlights Large-Cap Interest in Your Gut
at The Street - Tue Jul 14, 8:17AM CDT
The company is attracting investors looking to get a piece of a company that could be the first to bring a pharmaceutical based on microbiology to market.
KO: 41.19 (-0.19), JNJ: 100.34 (-0.03), PFE: 35.14 (-0.10), DD: 59.28 (-0.29), MCRB: 39.16 (-3.22), GIS: 57.21 (+0.38)
Seres Therapeutics Announces Closing of Initial Public Offering
Business Wire - Wed Jul 01, 3:05PM CDT
Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced the closing of its initial public offering of 8,545,138 shares of its common stock at an initial public offering price of $18.00 per share, which includes the exercise in full by the underwriters of their option to purchase 1,114,583 additional shares of common stock. The shares began trading on the NASDAQ Global Select Market under the ticker symbol "MCRB" on June 26, 2015. All of the shares of common stock in the offering were offered by the company. The net proceeds to Seres Therapeutics from the sale of shares in the offering are estimated to be approximately $139.8 million, after deducting the underwriting discounts and estimated offering expenses.
MCRB: 39.16 (-3.22)
S&P 500 Could Be In Its Most Difficult Period - Cramer's Mad Money (6/30/15)
SA Editor Mohit Manghnani - Seeking Alpha - Wed Jul 01, 6:44AM CDT
Stocks discussed on the in-depth session of Jim Cramer's Mad Money TV Program, Tuesday, June 30. Tuesday was a bad day for Greece, Germany and everyone connected. Cramer said that the Greek default will not mean a Lehman-like situation for Europe,...
FIT: 46.87 (+2.40), TSLA: 266.77 (-15.49), CAG: 44.02 (-0.27), THS: 80.13 (-0.83), PNR: 61.60 (-2.48), KORS: 40.58 (+0.66), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22), TRU: 24.87 (+0.15), ETP: 50.53 (-0.56), WSH: 46.53 (-0.29), MCRN: 20.00 (unch), RCPT: 228.98 (+0.26), AMBA: 118.18 (+0.46), AMZN: 488.00 (-0.10), ALU: 3.59 (+0.03), FCAU: 15.53 (+0.06), ETE: 60.29 (-1.11), ORCL: 39.57 (-0.36), NFLX: 112.51 (+1.96), RDUS: 78.29 (-0.57), ALDR: 48.90 (-0.98), GPP: 15.78 (+0.65), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), TW: 126.93 (-0.95)
IPO Preview: Seres Therapeutics
IPOdesktop - at Seeking Alpha - Wed Jul 01, 6:20AM CDT
Based in Cambridge, MA, Seres Therapeutics (NASDAQ: MCRB ) scheduled a $100 million IPO on Nasdaq with a market capitalization of $582 million at a price range midpoint of $16 for Friday, June 26, 2015. The full IPO calendar is available at ...
MCRB: 39.16 (-3.22)
Jim Cramer's 'Mad Money' Recap: Here Are the Stocks You Could've Picked Off Cheap
at The Street - Tue Jun 30, 6:58PM CDT
A quarter of the market bottomed today, which means stocks in biotech, among other areas, were there for the taking, Cramer says.
FIT: 46.87 (+2.40), TSLA: 266.77 (-15.49), ASPS: 31.24 (-0.30), UNH: 120.86 (-1.79), THS: 80.13 (-0.83), PAH: 24.35 (-0.15), LL: 19.06 (-0.15), PNR: 61.60 (-2.48), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22), TRU: 24.87 (+0.15), WSH: 46.53 (-0.29), MCRN: 20.00 (unch), RCPT: 228.98 (+0.26), REGN: 560.00 (-1.17), HAL: 41.86 (+1.14), CELG: 136.24 (+1.01), NFLX: 112.51 (+1.96), RDUS: 78.29 (-0.57), LEN: 51.99 (+0.24), ALDR: 48.90 (-0.98), GILD: 117.78 (-0.42), GPP: 15.78 (+0.65), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), TW: 126.93 (-0.95)
Five IPOs This Week Have Focus On Health Care Field
at Investor's Business Daily - Mon Jun 29, 4:38PM CDT
Three health care companies are on the list of five IPOs this week that look to raise a combined $767 million. Heading into the July 4 weekend, the five IPOs are down from 13 initial public offerings that priced last week, helping make June one of...
TRU: 24.87 (+0.15), CNXC: 14.98 (-0.32), CNX: 17.55 (+0.89), TDOC: 30.50 (+0.61), CFMS: 21.12 (-0.29), GKOS: 31.98 (+0.97), MCRB: 39.16 (-3.22), NTRA: 20.60 (-0.83)
Seres Therapeutics (MCRB) Stock Declines in Second Day of Trading
at The Street - Mon Jun 29, 3:14PM CDT
Seres Therapeutics (MCRB) shares came back down to earth after spiking more than 65% in its initial day of trading on Friday.
MCRB: 39.16 (-3.22)
Premarket Gainers / Losers as of 9:10 am
Seeking Alpha - at Seeking Alpha - Mon Jun 29, 8:16AM CDT
MBI: 5.80 (+0.03), PBMD: 1.28 (-0.07), SAN: 7.25 (-0.02), VDSI: 26.69 (+0.25), JMEI: 19.42 (+1.00), DB: 33.40 (-0.03), NBG: 0.93 (+0.02), CSIQ: 26.14 (-0.22), MCRB: 39.16 (-3.22), BBVA: 10.21 (+0.02), BLRX: 2.27 (+0.01)
U.S. IPO Weekly Recap: Year's Hottest Deal Pops 186% In Year's Most Active Week With 13 IPOs
Renaissance Capital IPO Research - at Seeking Alpha - Sat Jun 27, 11:49AM CDT
Things just got Seres in the IPO market. Thirteen companies went public this past week , more than any week since October 2014. Seres Therapeutics skyrocketed 186% on its debut - the highest first-day pop since January 2014. The thirteen IPOs...
XTLY: 7.53 (-0.70), TRU: 24.87 (+0.15), CATB: 14.00 (+0.24), GNRT: 14.37 (+0.07), GPP: 15.78 (+0.65), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), YECO: 4.69 (-0.87), MCRN: 20.00 (unch), LNTH: 7.33 (+0.42), BPMX: 2.22 (+0.06), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22)
Seres Therapeutics (MCRB) Stock Spikes in Initial Public Offering
at The Street - Fri Jun 26, 1:20PM CDT
Seres Therapeutics (MCRB) shares are up over 90% in its first day of trading on the Nasdaq.
MCRB: 39.16 (-3.22)
IPO roundup: 5 companies make stock market debut Friday
AP - Fri Jun 26, 12:57PM CDT
NEW YORK (AP) — Five companies made their stock market debut Friday. All the new stocks rose in afternoon trading, but Seres Therapeutics, a biotech company, had the biggest rise. Its shares nearly doubled in its debut.
XTLY: 7.53 (-0.70), GPP: 15.78 (+0.65), GPRE: 25.03 (-0.24), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22)
Seres Therapeutics IPO Soars, Raises $133 Million
at Investor's Business Daily - Fri Jun 26, 12:28PM CDT
Seres Therapeutics (MCRB) turned in the strongest performance of several initial public offerings that began trading Friday. Seres priced at 18, above the high end of its 15 to 17 expected range. Seres stock was up 80%, near 33, in early afternoon...
XTLY: 7.53 (-0.70), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22)
Seres Therapeutics prices upsized IPO; shares begin trading today
Seeking Alpha - at Seeking Alpha - Fri Jun 26, 6:06AM CDT
MCRB: 39.16 (-3.22)
Alarm.com Leads 5 Stocks Launching Trading Friday
at Investor's Business Daily - Thu Jun 25, 7:01PM CDT
Five initial public offerings priced or were set to price late Thursday and begin trading Friday, including the hot cybersecurity company Alarm.com. The debuts come after seven companies launched trading Thursday, including credit rating agency...
XTLY: 7.53 (-0.70), TRU: 24.87 (+0.15), SCTY: 56.20 (+0.43), GPP: 15.78 (+0.65), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), GPRE: 25.03 (-0.24), VSLR: 15.85 (+0.10), MCRB: 39.16 (-3.22), ALRM: 18.00 (-0.78)
Seres Therapeutics, Inc. Announces Pricing of Initial Public Offering
Business Wire - Thu Jun 25, 7:00PM CDT
Seres Therapeutics, Inc. today announced the pricing of its initial public offering of 7,430,555 shares of common stock at a public offering price of $18.00 per share, before underwriting discounts and commissions. All of the common stock is being offered by Seres Therapeutics. In addition, Seres Therapeutics granted the underwriters a 30-day option to purchase up to an additional 1,114,583 shares of common stock from the company at the public offering price. The company's shares are expected to begin trading on The NASDAQ Global Select Market on June 26, 2015 under the ticker symbol "MCRB".
MCRB: 39.16 (-3.22)
Stay Cautious On Seres Therapeutics IPO
Don Dion - at Seeking Alpha - Wed Jun 24, 6:55AM CDT
MCRB: 39.16 (-3.22)
IPO Market Sizzles With 14 Planning To Raise $2.5 Bil
at Investor's Business Daily - Mon Jun 22, 2:16PM CDT
In one of the busiest weeks for IPOs this year, 14 companies are planning to come public and raise about $2.5 billion in proceeds. Initial public offerings in June could hit 34, matching the highest total since 2000, according to Renaissance Capital,...
FIT: 46.87 (+2.40), XTLY: 7.53 (-0.70), GNRT: 14.37 (+0.07), LNTH: 7.33 (+0.42), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22), TRU: 24.87 (+0.15), CNXC: 14.98 (-0.32), RTTR: 3.39 (-0.14), CATB: 14.00 (+0.24), WNFM: (), GKOS: 31.98 (+0.97), GPP: 15.78 (+0.65), FOGO: 19.68 (-0.63), APPF: 14.81 (-2.21), MCRN: 20.00 (unch)
Week Ahead: As Many As 16 IPOs Could Price During The Week Of June 22
Renaissance Capital IPO Research - Seeking Alpha - Mon Jun 22, 10:31AM CDT
16 companies are on the calendar to go public this week and raise $2.5 billion. It should be the year's most active week in the IPO market; the second busiest week saw 10 IPOs in January. Investors have plenty of options this week, so expect IPO...
TRU: 24.87 (+0.15), PIRS: 2.70 (+0.01), CATB: 14.00 (+0.24), WNFM: (), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), LNTH: 7.33 (+0.42), YECO: 4.69 (-0.87), MCRN: 20.00 (unch), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22)
Seres Therapeutics on deck for IPO
Seeking Alpha - at Seeking Alpha - Fri Jun 19, 12:41PM CDT
MCRB: 39.16 (-3.22)
Seres Therapeutics Receives FDA Breakthrough Therapy Designation for Its Lead Product Candidate, SER-109
Business Wire - Fri Jun 12, 6:32AM CDT
Seres Therapeutics, Inc., a leading microbiome therapeutics platform company, today announced that SER-109 (Firmacute Eubacterial Spores, Purified Suspension, Encapsulated), its lead product candidate under investigation for the prevention of recurrent Clostridium difficile infection (CDI) in adults, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA). Breakthrough therapy designation is intended to expedite the development and review of therapeutics for serious or life-threatening conditions where preliminary clinical evidence indicates that the product may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints. This designation allows for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review (if supported by clinical data at the time of submission).
MCRB: 39.16 (-3.22)
Seres Therapeutics IPO Highlights Large-Cap Interest in Your Gut
at The Street - Tue Jul 14, 8:17AM CDT
The company is attracting investors looking to get a piece of a company that could be the first to bring a pharmaceutical based on microbiology to market.
KO: 41.19 (-0.19), JNJ: 100.34 (-0.03), PFE: 35.14 (-0.10), DD: 59.28 (-0.29), MCRB: 39.16 (-3.22), GIS: 57.21 (+0.38)
Seres Therapeutics Announces Closing of Initial Public Offering
Business Wire - Wed Jul 01, 3:05PM CDT
Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced the closing of its initial public offering of 8,545,138 shares of its common stock at an initial public offering price of $18.00 per share, which includes the exercise in full by the underwriters of their option to purchase 1,114,583 additional shares of common stock. The shares began trading on the NASDAQ Global Select Market under the ticker symbol "MCRB" on June 26, 2015. All of the shares of common stock in the offering were offered by the company. The net proceeds to Seres Therapeutics from the sale of shares in the offering are estimated to be approximately $139.8 million, after deducting the underwriting discounts and estimated offering expenses.
MCRB: 39.16 (-3.22)
S&P 500 Could Be In Its Most Difficult Period - Cramer's Mad Money (6/30/15)
SA Editor Mohit Manghnani - Seeking Alpha - Wed Jul 01, 6:44AM CDT
Stocks discussed on the in-depth session of Jim Cramer's Mad Money TV Program, Tuesday, June 30. Tuesday was a bad day for Greece, Germany and everyone connected. Cramer said that the Greek default will not mean a Lehman-like situation for Europe,...
FIT: 46.87 (+2.40), TSLA: 266.77 (-15.49), CAG: 44.02 (-0.27), THS: 80.13 (-0.83), PNR: 61.60 (-2.48), KORS: 40.58 (+0.66), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22), TRU: 24.87 (+0.15), ETP: 50.53 (-0.56), WSH: 46.53 (-0.29), MCRN: 20.00 (unch), RCPT: 228.98 (+0.26), AMBA: 118.18 (+0.46), AMZN: 488.00 (-0.10), ALU: 3.59 (+0.03), FCAU: 15.53 (+0.06), ETE: 60.29 (-1.11), ORCL: 39.57 (-0.36), NFLX: 112.51 (+1.96), RDUS: 78.29 (-0.57), ALDR: 48.90 (-0.98), GPP: 15.78 (+0.65), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), TW: 126.93 (-0.95)
IPO Preview: Seres Therapeutics
IPOdesktop - at Seeking Alpha - Wed Jul 01, 6:20AM CDT
Based in Cambridge, MA, Seres Therapeutics (NASDAQ: MCRB ) scheduled a $100 million IPO on Nasdaq with a market capitalization of $582 million at a price range midpoint of $16 for Friday, June 26, 2015. The full IPO calendar is available at ...
MCRB: 39.16 (-3.22)
Jim Cramer's 'Mad Money' Recap: Here Are the Stocks You Could've Picked Off Cheap
at The Street - Tue Jun 30, 6:58PM CDT
A quarter of the market bottomed today, which means stocks in biotech, among other areas, were there for the taking, Cramer says.
FIT: 46.87 (+2.40), TSLA: 266.77 (-15.49), ASPS: 31.24 (-0.30), UNH: 120.86 (-1.79), THS: 80.13 (-0.83), PAH: 24.35 (-0.15), LL: 19.06 (-0.15), PNR: 61.60 (-2.48), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22), TRU: 24.87 (+0.15), WSH: 46.53 (-0.29), MCRN: 20.00 (unch), RCPT: 228.98 (+0.26), REGN: 560.00 (-1.17), HAL: 41.86 (+1.14), CELG: 136.24 (+1.01), NFLX: 112.51 (+1.96), RDUS: 78.29 (-0.57), LEN: 51.99 (+0.24), ALDR: 48.90 (-0.98), GILD: 117.78 (-0.42), GPP: 15.78 (+0.65), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), TW: 126.93 (-0.95)
Five IPOs This Week Have Focus On Health Care Field
at Investor's Business Daily - Mon Jun 29, 4:38PM CDT
Three health care companies are on the list of five IPOs this week that look to raise a combined $767 million. Heading into the July 4 weekend, the five IPOs are down from 13 initial public offerings that priced last week, helping make June one of...
TRU: 24.87 (+0.15), CNXC: 14.98 (-0.32), CNX: 17.55 (+0.89), TDOC: 30.50 (+0.61), CFMS: 21.12 (-0.29), GKOS: 31.98 (+0.97), MCRB: 39.16 (-3.22), NTRA: 20.60 (-0.83)
Seres Therapeutics (MCRB) Stock Declines in Second Day of Trading
at The Street - Mon Jun 29, 3:14PM CDT
Seres Therapeutics (MCRB) shares came back down to earth after spiking more than 65% in its initial day of trading on Friday.
MCRB: 39.16 (-3.22)
Premarket Gainers / Losers as of 9:10 am
Seeking Alpha - at Seeking Alpha - Mon Jun 29, 8:16AM CDT
MBI: 5.80 (+0.03), PBMD: 1.28 (-0.07), SAN: 7.25 (-0.02), VDSI: 26.69 (+0.25), JMEI: 19.42 (+1.00), DB: 33.40 (-0.03), NBG: 0.93 (+0.02), CSIQ: 26.14 (-0.22), MCRB: 39.16 (-3.22), BBVA: 10.21 (+0.02), BLRX: 2.27 (+0.01)
U.S. IPO Weekly Recap: Year's Hottest Deal Pops 186% In Year's Most Active Week With 13 IPOs
Renaissance Capital IPO Research - at Seeking Alpha - Sat Jun 27, 11:49AM CDT
Things just got Seres in the IPO market. Thirteen companies went public this past week , more than any week since October 2014. Seres Therapeutics skyrocketed 186% on its debut - the highest first-day pop since January 2014. The thirteen IPOs...
XTLY: 7.53 (-0.70), TRU: 24.87 (+0.15), CATB: 14.00 (+0.24), GNRT: 14.37 (+0.07), GPP: 15.78 (+0.65), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), YECO: 4.69 (-0.87), MCRN: 20.00 (unch), LNTH: 7.33 (+0.42), BPMX: 2.22 (+0.06), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22)
Seres Therapeutics (MCRB) Stock Spikes in Initial Public Offering
at The Street - Fri Jun 26, 1:20PM CDT
Seres Therapeutics (MCRB) shares are up over 90% in its first day of trading on the Nasdaq.
MCRB: 39.16 (-3.22)
IPO roundup: 5 companies make stock market debut Friday
AP - Fri Jun 26, 12:57PM CDT
NEW YORK (AP) — Five companies made their stock market debut Friday. All the new stocks rose in afternoon trading, but Seres Therapeutics, a biotech company, had the biggest rise. Its shares nearly doubled in its debut.
XTLY: 7.53 (-0.70), GPP: 15.78 (+0.65), GPRE: 25.03 (-0.24), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22)
Seres Therapeutics IPO Soars, Raises $133 Million
at Investor's Business Daily - Fri Jun 26, 12:28PM CDT
Seres Therapeutics (MCRB) turned in the strongest performance of several initial public offerings that began trading Friday. Seres priced at 18, above the high end of its 15 to 17 expected range. Seres stock was up 80%, near 33, in early afternoon...
XTLY: 7.53 (-0.70), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22)
Seres Therapeutics prices upsized IPO; shares begin trading today
Seeking Alpha - at Seeking Alpha - Fri Jun 26, 6:06AM CDT
MCRB: 39.16 (-3.22)
Alarm.com Leads 5 Stocks Launching Trading Friday
at Investor's Business Daily - Thu Jun 25, 7:01PM CDT
Five initial public offerings priced or were set to price late Thursday and begin trading Friday, including the hot cybersecurity company Alarm.com. The debuts come after seven companies launched trading Thursday, including credit rating agency...
XTLY: 7.53 (-0.70), TRU: 24.87 (+0.15), SCTY: 56.20 (+0.43), GPP: 15.78 (+0.65), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), GPRE: 25.03 (-0.24), VSLR: 15.85 (+0.10), MCRB: 39.16 (-3.22), ALRM: 18.00 (-0.78)
Seres Therapeutics, Inc. Announces Pricing of Initial Public Offering
Business Wire - Thu Jun 25, 7:00PM CDT
Seres Therapeutics, Inc. today announced the pricing of its initial public offering of 7,430,555 shares of common stock at a public offering price of $18.00 per share, before underwriting discounts and commissions. All of the common stock is being offered by Seres Therapeutics. In addition, Seres Therapeutics granted the underwriters a 30-day option to purchase up to an additional 1,114,583 shares of common stock from the company at the public offering price. The company's shares are expected to begin trading on The NASDAQ Global Select Market on June 26, 2015 under the ticker symbol "MCRB".
MCRB: 39.16 (-3.22)
Stay Cautious On Seres Therapeutics IPO
Don Dion - at Seeking Alpha - Wed Jun 24, 6:55AM CDT
MCRB: 39.16 (-3.22)
IPO Market Sizzles With 14 Planning To Raise $2.5 Bil
at Investor's Business Daily - Mon Jun 22, 2:16PM CDT
In one of the busiest weeks for IPOs this year, 14 companies are planning to come public and raise about $2.5 billion in proceeds. Initial public offerings in June could hit 34, matching the highest total since 2000, according to Renaissance Capital,...
FIT: 46.87 (+2.40), XTLY: 7.53 (-0.70), GNRT: 14.37 (+0.07), LNTH: 7.33 (+0.42), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22), TRU: 24.87 (+0.15), CNXC: 14.98 (-0.32), RTTR: 3.39 (-0.14), CATB: 14.00 (+0.24), WNFM: (), GKOS: 31.98 (+0.97), GPP: 15.78 (+0.65), FOGO: 19.68 (-0.63), APPF: 14.81 (-2.21), MCRN: 20.00 (unch)
Week Ahead: As Many As 16 IPOs Could Price During The Week Of June 22
Renaissance Capital IPO Research - Seeking Alpha - Mon Jun 22, 10:31AM CDT
16 companies are on the calendar to go public this week and raise $2.5 billion. It should be the year's most active week in the IPO market; the second busiest week saw 10 IPOs in January. Investors have plenty of options this week, so expect IPO...
TRU: 24.87 (+0.15), PIRS: 2.70 (+0.01), CATB: 14.00 (+0.24), WNFM: (), GKOS: 31.98 (+0.97), APPF: 14.81 (-2.21), LNTH: 7.33 (+0.42), YECO: 4.69 (-0.87), MCRN: 20.00 (unch), ALRM: 18.00 (-0.78), MCRB: 39.16 (-3.22)
Seres Therapeutics on deck for IPO
Seeking Alpha - at Seeking Alpha - Fri Jun 19, 12:41PM CDT
MCRB: 39.16 (-3.22)
Seres Therapeutics Receives FDA Breakthrough Therapy Designation for Its Lead Product Candidate, SER-109
Business Wire - Fri Jun 12, 6:32AM CDT
Seres Therapeutics, Inc., a leading microbiome therapeutics platform company, today announced that SER-109 (Firmacute Eubacterial Spores, Purified Suspension, Encapsulated), its lead product candidate under investigation for the prevention of recurrent Clostridium difficile infection (CDI) in adults, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA). Breakthrough therapy designation is intended to expedite the development and review of therapeutics for serious or life-threatening conditions where preliminary clinical evidence indicates that the product may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints. This designation allows for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review (if supported by clinical data at the time of submission).
MCRB: 39.16 (-3.22)
