Citigroup (NYSE: C) reported its Q1 2026 results before market open. Earnings per share increased compared to a year earlier and exceeded analyst expectations. Revenue also rose year-over-year and...

Albertsons ($ACI) Q4 Earnings Top Estimates; Revenue Falls Short, Guides FY26

Staff Writer - April 14, 2026 8:16 am

Albertsons Companies (NYSE: ACI) reported its fourth-quarter results before market open.The quarter saw adjusted earnings per share of $0.48, surpassing the consensus estimate of $0.43. This figure also marked...

Creative Realities ($CREX) Q4 EPS Misses; Revenue Beats Estimates

NewsDesk - April 14, 2026 8:00 am

Creative Realities (NASDAQ: CREX) reported its fourth-quarter results before market open. The company disclosed a decline in earnings per share compared to a year earlier, missing analyst expectations. Creative...

Earnings Calendar

Date	Time	Symbol	company_name	Period	Metric	Estimate	Surprise	YrAgo	Growth
04/14/2026	BMO	ACI	Albertsons Companies	Q4 2025	EPS	0.43		0.46
04/14/2026	BMO	ACI	Albertsons Companies	Q4 2025	REV	20.48 B	0.00	18.80 B	0.00
04/14/2026	BMO	BLK	BlackRock	Q1 2026	EPS	11.81		11.30
04/14/2026	BMO	BLK	BlackRock	Q1 2026	REV	6.57 B	0.00	5.28 B	0.00
04/14/2026	BMO	BSVN	Bank7	Q1 2026	EPS	1.02		1.08
04/14/2026	BMO	BSVN	Bank7	Q1 2026	REV	23.59 M	0.00	22.59 M	0.00
04/14/2026	BMO	C	Citigroup	Q1 2026	EPS	2.64		1.96
04/14/2026	BMO	C	Citigroup	Q1 2026	REV	23.53 B	0.00	21.60 B	0.00
04/14/2026	BMO	CREX	Creative Realities	Q4 2025	EPS	-0.07		-0.27
04/14/2026	BMO	CREX	Creative Realities	Q4 2025	REV	22.26 M		11.01 M
04/14/2026	BMO	DTST	Data Storage	Q4 2025	EPS	-0.10		0.04
04/14/2026	BMO	DTST	Data Storage	Q4 2025	REV			6.42 M
04/14/2026	BMO	HOVR	New Horizon Aircraft	Q3 2026	EPS	-0.09		-0.17
04/14/2026	BMO	HOVR	New Horizon Aircraft	Q3 2026	REV		0.00		0.00
04/14/2026	BMO	JNJ	Johnson & Johnson	Q1 2026	EPS	2.67		2.77
04/14/2026	BMO	JNJ	Johnson & Johnson	Q1 2026	REV	23.61 B	0.00	21.89 B	0.00

Earnings Calendar

Date	Time	Symbol	company_name	Period	Metric	Estimate	Surprise	YrAgo	Growth
04/14/2026	BMO	ACI	Albertsons Companies	Q4 2025	EPS	0.43		0.46
04/14/2026	BMO	ACI	Albertsons Companies	Q4 2025	REV	20.48 B	0.00	18.80 B	0.00
04/14/2026	BMO	BLK	BlackRock	Q1 2026	EPS	11.81		11.30
04/14/2026	BMO	BLK	BlackRock	Q1 2026	REV	6.57 B	0.00	5.28 B	0.00
04/14/2026	BMO	BSVN	Bank7	Q1 2026	EPS	1.02		1.08
04/14/2026	BMO	BSVN	Bank7	Q1 2026	REV	23.59 M	0.00	22.59 M	0.00
04/14/2026	BMO	C	Citigroup	Q1 2026	EPS	2.64		1.96
04/14/2026	BMO	C	Citigroup	Q1 2026	REV	23.53 B	0.00	21.60 B	0.00
04/14/2026	BMO	CREX	Creative Realities	Q4 2025	EPS	-0.07		-0.27
04/14/2026	BMO	CREX	Creative Realities	Q4 2025	REV	22.26 M		11.01 M
04/14/2026	BMO	DTST	Data Storage	Q4 2025	EPS	-0.10		0.04
04/14/2026	BMO	DTST	Data Storage	Q4 2025	REV			6.42 M
04/14/2026	BMO	HOVR	New Horizon Aircraft	Q3 2026	EPS	-0.09		-0.17
04/14/2026	BMO	HOVR	New Horizon Aircraft	Q3 2026	REV		0.00		0.00
04/14/2026	BMO	JNJ	Johnson & Johnson	Q1 2026	EPS	2.67		2.77
04/14/2026	BMO	JNJ	Johnson & Johnson	Q1 2026	REV	23.61 B	0.00	21.89 B	0.00

Pre Market Insights

What’s happening with Soleno Therapeutics, Inc. ($SLNO) shares surging in early trading?

Catalyst Desk - April 6, 2026 8:40 am

What’s driving Cyclerion Therapeutics, Inc. ($CYCN) shares dropping 19% in early trading?

NewsDesk - April 2, 2026 8:29 am

China Natural Resources, Inc. ($CHNR) shares are climbing ahead of the open

NewsDesk - March 19, 2026 8:58 am

Solo Brands, Inc. ($SBDS) shares are sliding 27 percent before the bell

Catalyst Desk - March 19, 2026 8:55 am

SailPoint, Inc. ($SAIL) shares down 12% pre-market on Fourth Quarter Results

NewsDesk - March 18, 2026 8:18 am

LENSAR, Inc. ($LNSR) shares down 25% in pre-market trading after Termination Of Merger Agreement

NewsDesk - March 17, 2026 8:50 am

Aldeyra Therapeutics, Inc. ($ALDX) shares tumbling 74% in early trading following the Receipt of...

Catalyst Desk - March 17, 2026 8:44 am

Nasus Pharma Ltd. ($NSRX) shares falling 9% in pre-market on Reporting Positive Phase 2...

NewsDesk - March 17, 2026 8:43 am

Pre Market Movers

Top Gainers

Date	Time	Symbol	Company Name	Last Updated	PrevClose	Price	Change	Percent	stockprice52wklow	stockprice52wkhigh	52Wk Range	company_sector	company_industry	dailyvolume	marketcap	Catalyst News
04/14/2026	07:05 PM	SNAL	Snail, Inc. Class A Common Stock	14-Apr 09:20	1.70	0.77	0.39	102.63	0.34	2.15	$0.34 ~ $2.15	Communication Services	Electronic Gaming & Multimedia	816.42	64.23
04/14/2026	07:03 PM	AVNS	Avanos Medical, Inc.	14-Apr 09:19	24.63	24.56	10.03	69.03	9.30	24.70	$9.30 ~ $24.70	Healthcare	Medical Devices	23.40	1.15	This Healthcare Stock Is Rising 69%. It's Getting Bought Out for a Big Premium. Barrons \| 2026-04-14 13:00:00
04/14/2026	06:04 PM	HUBC	HUB Cyber Security Ltd.	14-Apr 09:20	0.12	0.13	0.04	44.44	0.06	66.45	$0.06 ~ $66.45	Technology	Software - Infrastructure	279.65	270.00
04/14/2026	07:05 PM	HOTH	Hoth Therapeutics, Inc.	14-Apr 09:20	0.65	0.72	0.21	41.18	0.49	2.12	$0.49 ~ $2.12	Healthcare	Biotechnology	93.58	8.56
04/14/2026	07:05 PM	SNYR	Synergy CHC Corp.	14-Apr 09:20	0.60	0.80	0.22	37.93	0.55	4.08	$0.55 ~ $4.08	Healthcare	Medical Distribution	46.93	5.35
04/14/2026	07:02 PM	SANA	Sana Biotechnology, Inc.	14-Apr 09:20	3.48	3.98	0.77	23.99	1.53	6.55	$1.53 ~ $6.55	Healthcare	Biotechnology	16.34	928.70
04/14/2026	06:48 PM	GPRO	GoPro, Inc.	14-Apr 09:20	0.88	1.14	0.21	22.58	0.48	3.05	$0.48 ~ $3.05	Technology	Consumer Electronics	39.91	144.19	Why is GoPro stock surging today? Invezz \| 2026-04-14 08:16:46
04/14/2026	07:04 PM	SLNH	Soluna Holdings, Inc.	14-Apr 09:20	1.05	1.14	0.21	22.58	0.42	5.14	$0.42 ~ $5.14	Financial	Capital Markets	13.87	30.50
04/14/2026	07:04 PM	BOLD	Boundless Bio, Inc.	14-Apr 09:19	1.56	1.46	0.26	21.67	0.96	1.78	$0.96 ~ $1.78	Healthcare	Biotechnology	6.01	34.96
04/14/2026	06:55 PM	GIL	Gildan Activewear Inc.	14-Apr 09:19	58.38	70.70	11.69	19.81	40.17	73.70	$40.17 ~ $73.70	Consumer Cyclical	Apparel Manufacturing	405.03	8.93

Top Losers

Date	Time1	Symbol	Company Name	Last Updated	PrevClose	Price	Change	Percent	stockprice52wklow	stockprice52wkhigh	52Wk Range	company_sector	company_industry	dailyvolume	marketcap	Catalyst News
04/14/2026	07:03 PM	CMND	Clearmind Medicine Inc.	14-Apr 09:20	0.91	0.95	-0.48	-33.57	0.60	52.40	$0.60 ~ $52.40	Healthcare	Biotechnology	22.02	120.00
04/14/2026	07:04 PM	CMCT	Creative Media & Community Trust Co	14-Apr 09:20	0.80	0.69	-0.23	-25.00	0.40	144.10	$0.40 ~ $144.10	Real Estate	REIT - Office	5.17	60.00
04/14/2026	03:50 PM	RCT	RedCloud Holdings plc	14-Apr 09:20	0.71	0.82	-0.19	-18.81	0.56	5.36	$0.56 ~ $5.36	Technology	Software - Application	9.58	31.21
04/14/2026	07:05 PM	AIXI	Xiao-I Corporation	14-Apr 09:20	1.08	1.07	-0.23	-17.69	0.08	4.02	$0.08 ~ $4.02	Technology	Software - Application	25.05	11.42
04/14/2026	07:05 PM	SKYQ	Sky Quarry Inc.	14-Apr 09:20	9.20	10.02	-2.02	-16.78	1.66	19.45	$1.66 ~ $19.45	Energy	Oil & Gas Integrated	3.65	25.45	What is Sky Quarry? Little-known energy stock has skyrocketed 266% during the Strait of Hormuz drama Fast Company \| 2026-04-13 14:07:25 Sky Quarry stock skyrockets as US-Iran peace talks fail: is this rally sustainable? Invezz \| 2026-04-13 11:23:21
04/14/2026	04:04 PM	ISPC	iSpecimen Inc.	14-Apr 09:20	0.10	0.10	-0.02	-16.67	0.10	3.18	$0.10 ~ $3.18	Healthcare	Diagnostics & Research	18.80	580.00
04/14/2026	07:03 PM	FDS	FactSet Research Systems Inc.	14-Apr 09:08	223.48	190.26	-36.14	-15.96	185.00	474.79	$185.00 ~ $474.79	Financial	Financial Data & Stock Exchanges	609.67	8.29	The Market Is Too Harsh On FactSet Research Systems Seeking Alpha \| 2026-04-13 17:17:07 Are You Looking for a High-Growth Dividend Stock? Zacks Investment Research \| 2026-04-13 12:46:16 FDS or VRSK: Which Is the Better Value Stock Right Now? Zacks Investment Research \| 2026-04-13 12:40:24
04/14/2026	07:05 PM	CREG	Smart Powerr Corp.	14-Apr 09:20	0.60	0.60	-0.11	-15.49	0.19	14.70	$0.19 ~ $14.70	Utilities	Utilities - Renewable	3.57	13.83
04/14/2026	07:03 PM	GCTK	GlucoTrack, Inc.	14-Apr 09:20	0.73	0.73	-0.13	-15.29	0.62	15.90	$0.62 ~ $15.90	Healthcare	Medical Instruments & Supplies	1.51	420.00
04/14/2026	06:59 PM	CUE	Cue Biopharma, Inc.	14-Apr 09:20	0.44	0.39	-0.07	-15.22	0.17	1.03	$0.17 ~ $1.03	Healthcare	Biotechnology	7.27	34.53

FDA Calendar

Date	Symbol	Company	time	event_type	Drug	Drug Details	Status	Catalyst	target_date_from	target_date_to	Catalyst Summary
09/05/2025	CERO	CERo Therapeutics Holdings	08:00 AM	FDA Decision	CER-1236	For the treatment of Acute Myeloid Leukemia (AML)	Phase 2	Fast Track Designation	09/05/2025	09/05/2025
09/04/2025	AMRX	Amneal Pharmaceuticals	04:01 PM	FDA Decision	Risperdal Consta	An extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial,	Approved	FDA Approval	09/04/2025	09/04/2025
09/04/2025	LLY	Eli Lilly and Company	07:45 AM	FDA Decision	Olomorasib + KEYTRUDA (pembrolizumab)	For the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression = 50%	SUNRAY-01 Phase 3	Breakthrough Therapy designation	09/04/2025	09/04/2025
07/02/2025	TIL	Instil Bio	06:00 AM	FDA Decision	AXN-2510	A PD-L1xVEGF Bispecific Antibody, for the treatment of Relapsed/Refractory Solid Tumors	Phase 1	Investigational New Drug (IND)	11/30/-0001	11/30/-0001	Instil Bio, Inc. (TIL) announced that the U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for AXN-2510. Instil Bio plans to initiate a phase 1 trial of 2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety of 2510 in patients with solid tumors. It also aims to assess the efficacy of the treatment. Additionally, the study will examine the pharmacokinetics and pharmacodynamics of the drug.
07/02/2025	REGN	Regeneron Pharmaceuticals	11:00 AM	FDA Decision	Lynozyfic™ (linvoseltamab-gcpt)	To treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.	Approved	FDA Accelerated Approval	11/30/-0001	11/30/-0001	Regeneron Pharmaceuticals, Inc. (REGN) announced that the U.S. Food and Drug Administration has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. These therapies include a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial.
06/30/2025	TAK	Takeda	08:00 AM	FDA Decision	GAMMAGARD LIQUID ERC [immune globulin infusion (human)]	Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency	Approved	FDA Approval	11/30/-0001	11/30/-0001	Takeda (TAK) announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC immune globulin infusion (human) with less than or equal to 2 µg/mL IgA in a 10% solution. It is the only ready-to-use liquid immunoglobulin therapy with low immunoglobulin A content. The therapy is approved as a replacement treatment for people two years of age and older with primary immunodeficiency.
06/30/2025	UNCY	Unicycive Therapeutics	07:05 AM	FDA Decision	Oxylanthanum Carbonate (OLC)	OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis	New Drug Application (NDA)	Complete Response Letter	11/30/-0001	11/30/-0001	Unicycive Therapeutics, Inc. (UNCY) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Following the NDA submission and routine review, the FDA cited a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) for deficiencies after a cGMP inspection
06/27/2025	SDGR	Schrödinger	08:00 PM	FDA Decision	SGR-1505	For the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.	Phase 1	Fast Track Designation	11/30/-0001	11/30/-0001

Top Gainers

Date	Time	Symbol	Company Name	Last Updated	Close	Price	Change	Percent	Day Range	52Wk Range	dailyvolume	marketcap
04/14/2026	07:05 PM	AGAE	Allied Gaming & Entertainment Inc.	14-Apr 19:05	0.32	0.73	0.41	128.13	$0.28 ~ $0.34	$0.25 ~ $3.79	972.76	12.05
04/14/2026	07:05 PM	RPGL	Republic Power Group Limited Class	14-Apr 19:05	0.53	0.83	0.30	56.60	$0.53 ~ $0.58	$0.40 ~ $103.80	59.45	20.00
04/14/2026	07:05 PM	LIMN	Liminatus Pharma, Inc. Class A Comm	14-Apr 19:05	0.18	0.25	0.07	38.89	$0.18 ~ $0.19	$0.16 ~ $33.66	721.87	4.82
04/14/2026	07:05 PM	NXXT	NextNRG Inc.	14-Apr 19:05	0.42	0.56	0.14	33.33	$0.37 ~ $0.44	$0.32 ~ $3.59	3.63	55.91
04/14/2026	07:05 PM	CIIT	Tianci International, Inc.	14-Apr 19:05	1.38	1.83	0.45	32.61	$1.30 ~ $1.39	$1.26 ~ $21.00	19.99	3.56
04/14/2026	07:05 PM	GBR	New Concept Energy, Inc.	14-Apr 19:05	0.75	0.99	0.24	32.00	$0.72 ~ $0.76	$0.67 ~ $1.78	120.11	3.85
04/14/2026	07:05 PM	MLSS	Milestone Scientific Inc.	14-Apr 19:05	0.29	0.35	0.06	20.69	$0.29 ~ $0.29	$0.22 ~ $1.11	355.69	23.11
04/14/2026	07:05 PM	VSA	VisionSys AI Inc.	14-Apr 19:05	0.60	0.71	0.11	18.33	$0.60 ~ $0.67	$0.48 ~ $212.05	600.15	1.49
04/14/2026	03:57 PM	ILLR	Triller Group Inc.	14-Apr 15:57	0.22	0.26	0.04	18.18	$0.10 ~ $0.22	$0.00 ~ $1.73	355.51	43.40
04/14/2026	07:05 PM	BNBX	BNB Plus Corp.	14-Apr 19:05	0.58	0.68	0.10	17.24	$0.56 ~ $0.69	$0.53 ~ $14.25	2.78	740.00

Top Losers

Date	Time	Symbol	Company Name	Last Updated	Close	Price	Change	Percent	Day Range	52Wk Range	dailyvolume	marketcap	Catalyst News
04/14/2026	07:05 PM	SNAL	Snail, Inc. Class A Common Stock	14-Apr 19:05	1.70	1.05	-0.65	-38.24	$0.75 ~ $2.16	$0.34 ~ $2.15	816.42	64.23
04/14/2026	07:05 PM	ARAI	Arrive AI Inc.	14-Apr 19:05	1.65	1.17	-0.48	-29.09	$0.89 ~ $1.78	$0.51 ~ $40.00	78.22	60.12
04/14/2026	07:05 PM	SURG	SurgePays, Inc.	14-Apr 19:05	0.85	0.62	-0.24	-28.24	$0.73 ~ $0.93	$0.65 ~ $3.47	1.05	16.96	SurgePays, Inc. (SURG) Q4 2025 Earnings Call Transcript Seeking Alpha \| 2026-04-14 18:41:44
04/14/2026	07:05 PM	MIMI	Mint Incorporation Limited	14-Apr 19:05	0.52	0.40	-0.12	-23.08	$0.26 ~ $0.73	$0.25 ~ $13.69	383.42	13.11
04/14/2026	07:04 PM	CTNT	Cheetah Net Supply Chain Service In	14-Apr 19:04	1.68	1.36	-0.32	-19.05	$1.28 ~ $1.69	$1.03 ~ $2.31	1.24	5.48
04/14/2026	07:04 PM	BEAT	HeartBeam, Inc.	14-Apr 19:04	1.20	1.02	-0.18	-15.00	$1.18 ~ $1.26	$0.54 ~ $4.00	488.39	41.33
04/14/2026	04:04 PM	HCHL	Happy City Holdings Limited Class A	14-Apr 16:04	1.62	1.40	-0.22	-13.58	$1.30 ~ $1.85	$0.80 ~ $7.25	92.43	31.10
04/14/2026	05:34 PM	ZSPC	zSpace, Inc.	14-Apr 17:34	0.08	0.08	-0.01	-12.50	$0.07 ~ $0.08	$0.07 ~ $10.35	29.20	1.96
04/14/2026	06:44 PM	BAND	Bandwidth Inc.	14-Apr 18:44	17.95	15.75	-2.20	-12.26	$16.83 ~ $18.13	$11.33 ~ $18.65	305.43	563.40
04/14/2026	06:58 PM	MATH	Metalpha Technology Holding Limited	14-Apr 18:58	1.31	1.16	-0.15	-11.45	$1.14 ~ $1.33	$1.00 ~ $4.17	39.23	56.86

Date	Symbol	Company	time	event_type	Drug	Drug Details	Status	Catalyst	target_date_from	target_date_to	Catalyst Summary
09/05/2025	CERO	CERo Therapeutics Holdings	08:00 AM	FDA Decision	CER-1236	For the treatment of Acute Myeloid Leukemia (AML)	Phase 2	Fast Track Designation	09/05/2025	09/05/2025
09/04/2025	AMRX	Amneal Pharmaceuticals	04:01 PM	FDA Decision	Risperdal Consta	An extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial,	Approved	FDA Approval	09/04/2025	09/04/2025
09/04/2025	LLY	Eli Lilly and Company	07:45 AM	FDA Decision	Olomorasib + KEYTRUDA (pembrolizumab)	For the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression = 50%	SUNRAY-01 Phase 3	Breakthrough Therapy designation	09/04/2025	09/04/2025
07/02/2025	TIL	Instil Bio	06:00 AM	FDA Decision	AXN-2510	A PD-L1xVEGF Bispecific Antibody, for the treatment of Relapsed/Refractory Solid Tumors	Phase 1	Investigational New Drug (IND)	11/30/-0001	11/30/-0001	Instil Bio, Inc. (TIL) announced that the U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for AXN-2510. Instil Bio plans to initiate a phase 1 trial of 2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety of 2510 in patients with solid tumors. It also aims to assess the efficacy of the treatment. Additionally, the study will examine the pharmacokinetics and pharmacodynamics of the drug.
07/02/2025	REGN	Regeneron Pharmaceuticals	11:00 AM	FDA Decision	Lynozyfic™ (linvoseltamab-gcpt)	To treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.	Approved	FDA Accelerated Approval	11/30/-0001	11/30/-0001	Regeneron Pharmaceuticals, Inc. (REGN) announced that the U.S. Food and Drug Administration has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. These therapies include a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial.
06/30/2025	TAK	Takeda	08:00 AM	FDA Decision	GAMMAGARD LIQUID ERC [immune globulin infusion (human)]	Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency	Approved	FDA Approval	11/30/-0001	11/30/-0001	Takeda (TAK) announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC immune globulin infusion (human) with less than or equal to 2 µg/mL IgA in a 10% solution. It is the only ready-to-use liquid immunoglobulin therapy with low immunoglobulin A content. The therapy is approved as a replacement treatment for people two years of age and older with primary immunodeficiency.
06/30/2025	UNCY	Unicycive Therapeutics	07:05 AM	FDA Decision	Oxylanthanum Carbonate (OLC)	OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis	New Drug Application (NDA)	Complete Response Letter	11/30/-0001	11/30/-0001	Unicycive Therapeutics, Inc. (UNCY) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Following the NDA submission and routine review, the FDA cited a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) for deficiencies after a cGMP inspection
06/27/2025	SDGR	Schrödinger	08:00 PM	FDA Decision	SGR-1505	For the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.	Phase 1	Fast Track Designation	11/30/-0001	11/30/-0001